Featured

My First Blog Post

What is this blog, who should read it and what will you get?

Be yourself; Everyone else is already taken.

— Oscar Wilde.

This is the first post on my new blog. I’m just getting this new blog going, so stay tuned for more. Subscribe below to get notified when I post new updates.

What is this blog about?

I cover important current national and state-level issues in health care – particularly health care policy and health care law. Because of the nature of the topics I cover, they are at the intersection of health care and politics.

Why is this blog important?

Unfortunately, sources of information about these important issues are often biased, come with a particular political point of view or are written or sponsored by industry interests. Of course, I have biases of my own, but I also have the ability to present an issue objectively and discuss the pros and cons of all sides of the issue so that readers can make an educated opinion on the issue for themselves. I believe that if you give readers balanced and complete information, they will be able to engage in the discussion productively and come to well-informed opinions and solutions.

Of course, there are few issues in health care that I do not have an opinion about, and there are many who, because of my background and experience, want to know how I come out on a particular issue. I will share those opinions with you on the blog, but I will be clear and explicit with you when I am expressing my own view. You can then take it for what its worth.

Who is this blog for?

Really, any one with an interest in topical health care policy and legal issues. However, there are some who may have a particular interest in this blog:

  1. Health care CEOs. Health care leaders are very busy and barraged with information. They simply cannot read everything, and much of what they get is not completely objective. This is a site where CEOs can get up-to-date, important information on topics of importance to health care leaders that they can trust. As a recently retired health system CEO, I know what information CEOs need, and there are few other sources of information written by a CEO for CEOs. This is also a source of information that CEOs can use to provide important updates to their teams and their boards.
  2. Board members of hospitals, health systems, insurance companies and other health care organizations. Health care is complicated. It is particularly challenging for board members who come from other industries to understand the complexities of health care. This blog can serve to keep board members informed about important issues that their companies are likely dealing with, as well as to keep them informed as friends, family, neighbors and colleagues ask them about these topical issues since they are likely aware that they serve on a health care board.
  3. Students and other health care leaders. Students of health care will appreciate how complex issues are presented in an easy to understand blog. Current and future health care leaders need a good source of current information, but also a source that may challenge their thinking or help them think about current health care challenges in a fresh and new way.
  4. Journalists. Health care reporters and journalists can at times be challenged to get the information and background that will really help them understand a complex issue that they must digest in very little time in order to hit deadlines and to ask interviewees the “right” questions. This blog will help them do just that.
  5. Legislators. Legislators have a tough job. They have to make law about complex issues in areas of industry that they may not be expert in. To make matters worse, they are often inundated by parties and lobbyists that are interested in what is best for their business, not necessarily what is best for that state or our country. This is an unbiased source of information to help legislators understand these complex issues and the pros and cons of various positions.

Who am I and why should you trust what I have to write?

I am a physician, board certified in Internal Medicine. I practiced for ten years. I am also a health care attorney. I have taught a course titled Regulation of Health Care Professionals for about 13 years, first at the University of Houston Law Center and most recently at the University of Idaho College of Law. I have also written a text book by the same title.

I was the CEO of a large teaching hospital in the Texas Medical Center for almost four years and most recently, I was the President and CEO of a health system for a little over ten years. That health system was recognized for being a national leader in quality and for its transformation of its business model from fee for service to value (full risk arrangements).

While a health system CEO, I had a blog for about 8 years – Dr. Pate’s Prescription for Change.

How often will I post new information?

I am going to try to write something weekly. I am not going to commit to a specific day. There may be times that I miss a week. There will be others will I will post something more frequently, especially when there is breaking news. So, be sure that you are subscribed to the blog so that you receive notice when I have a new blog post. You can also follow me on twitter. I will tweet my new blog posts. My current twitter handle is @drpatestlukes, but I will be creating a new twitter handle soon given my impending retirement from St. Luke’s Health System. I will let you know as soon as that new twitter account is set up.

Is Getting the COVID Vaccine Taking the Mark of the Beast?

Barbra sent in the following comment to my blog: “I am new to your blog but loved the honesty and caring it portrays. I know this may make you laugh, but I have a sibling who will not get vaccinated. Why?… Because it’s the sign of the beast in the book of Revelations! I mean Holy Cow! I can’t seem to change his mind. Any suggestions?”

I replied to Barbra that I didn’t laugh because this was not the first time people had expressed this concern to me, and those people were very sincere in their concern. I also was told of a woman who came to the hospital severely ill with COVID and subsequently died, but explained prior to her death that she did not take the vaccine because she did not want a chip implanted in her.

As a Christian, I am getting tired of politicians waving their Bibles for photo ops, while not demonstrating the behaviors that the Bible commands of us. Frankly, I wish politicians would spend more time reading their Bibles than waiving them around. So, when people actually want their behaviors to comport with the word of God, I am thrilled and always happy to try to answer their questions. So, I respect that these people expressing their concern about the vaccine are God-fearing and want to do the right thing by God.

With that said, to answer this question, we must turn to the scripture itself. The short answer is that we can conclusively and definitively state that getting the COVID vaccine is not taking the mark of the Beast. What follows is my analysis of scripture that provides us with this answer.

As Barbra points out in her question, the reference to the mark of the Beast occurs in the Book of Revelation. My favorite translation is the New Living Translation, so I will quote scripture from that unless I indicate that I am using a different translation.

The reference to the mark of the Beast occurs in Revelation 13:16-17:

He required everyone – great and small, rich and poor, slave and free – to be given a mark on the right hand or on the forehead. And no one could buy or sell anything without that mark, which was either the name of the beast or the number representing his name.

So, to interpret what is meant by this passage, we must put it in context. Who is he? What is this mark? Why would whoever he is require people to take this mark? Who is the beast?

Revelation is the last book of the New Testament of the Bible. It was written by the apostle John. It is a difficult book for most Christians to understand because it uses apocalyptic language, rich with imagery and symbolism that would have been more familiar to early Church Christians than to us today. While many Christians view Revelation with fear, it is actually a book of hope and great comfort for Christians. Those who should view the book with fear are those who probably won’t read it – those who do not know and have not accepted Christ as their savior.

In fact, God tells us in Revelation 1:3:

God blesses the one who reads this prophecy to the church, and he blesses all who listen to it and obey what it says.

One of the reasons that this prophecy is a blessing is it describes the ultimate triumph of good over evil, God over Satan. We live in a world full of sin. We live in a world where truth has become the enemy and people pervert the word of the Bible and proclaim to be Christians while at the same time expressing hate of others. The good news is that God will only let Satan rule this world for a limited period of time before God and His armies come back, take control of the world, and rule over this world after banishing Satan forever.

So, the majority of the book of Revelation is prophecy (i.e., it provides us divine revelation about future events) and describes what happens in “end times.”

The beginning of the “End Times” is signaled by the rebirth of Israel as a nation, which occurred in 1948. This is the fulfillment of the dry bones prophecy in Ezekiel 37, which is interpreted in Ezekiel 37:21: “I will take the Israelites out of the nations where they have gone. I will gather them from all around and bring them back into their own land.” This sets the stage for the Tribulation period[1]. Thus, we are living in the end times.

It is clear that the rebirth of Israel as a nation is necessary for the fulfilment of future biblical prophecies to be possible. For example, the peace covenant between the antichrist and the leaders of Israel that signals the start of Tribulation would not be possible if there was no nation of Israel.

The Tribulation referred to in the book of Revelation is the Great Tribulation – a seven-year period where the Holy Spirit, the “great restrainer” is removed, allowing Satan to have free reign. It will be a period of false peace, world-wide disasters and tremendous loss of life. In a mockery of the triune God – the Father, the Son and the Holy Spirit, Satan will have his own trinity – Satan (also referred to as the Dragon – a counterfeit God), the Antichrist (also referred to as the Beast – a counterfeit Christ), and the False Prophet (a counterfeit Holy Spirit). Paul warned of a “man of lawlessness” in 2 Thessalonians 2:3,8-9 in a reference to the antichrist. It is John who refers to the antichrist as “the beast” in Revelation 13:1-10.

Now, while God through John does not give us a strict chronology of events and complete clarity as to what all those events are, He does provide some important facts and timelines. As mentioned above, the Bible provides us with an event that signals the beginning of “end times.” Because of that, we know that we are living in those end times. But, the Tribulation comes later (we are in end times, but we have not yet gone through Tribulation) and we know that the antichrist (the beast) is not revealed and does not rise to prominence until the Tribulation period. Thus, no one can be taking the mark of the beast until they are in the Tribulation period and the beast has been revealed. This is how we can be confident that the COVID vaccine does not involve taking the mark of the beast.

Now we can answer the questions about Revelation 13:16-17. Who is “he”? We can tell from the context of the earlier portion of Revelation 13 that the “he” is a reference to the False Prophet. What is the mark? We don’t know. The Bible does not tell us, other than it will be necessary to buy and sell things during this period of the Tribulation. We also know that those who refuse to take the mark will be persecuted by Satan and we know that when God comes back to reclaim His rightful place as King, those who have taken the mark will be punished for taking the mark. We don’t even know whether the mark is something physical – some believe it will be of the nature of a tattoo, others believe it will be a computer chip of some kind – but it may not be a physical mark as it appears to once again be a perversion of the actions of God to preserve His people by Satan to destroy his followers. Revelation 7:3-4:

Wait! Don’t hurt the land or the sea or the trees until we have placed the seal of God on the foreheads of his servants[2]. And I heard how many were marked with the seal of God.

Who is the beast? This is the name John gives to the antichrist.

There are other clues that we are progressing towards the Tribulation period.

The Bible tells us that there will be growing apostasy. Apostasy means a falling away from the truth; willful departure or defection from the faith; or abandonment of the faith.

1 Timothy 4:1-2 King James Version (KJV):

Now the Spirit speaketh expressly, that in the latter times some shall depart from the faith, giving heed to seducing spirits, and doctrines of devils; Speaking lies in hypocrisy; having their conscience seared with a hot iron.

The reference to “latter times” means the “End Times.” We are certainly seeing this prophecy being fulfilled today, and it will greatly increase during the Tribulation. People are promoting lies and conspiracy theories in some cases for power, in others for money, and yet others to curry favor. They are willing to promote lies that will harm others, all the while professing to be Christians. These are the people God refers to in Matthew 7:22-23, where He says that on judgment day, many will call out His name, but He will reply, I never knew you.  Get away from me, you who break God’s laws.

This is why I am very careful about the sources I read, listen to and study. 1 Thessalonians 5:21 tells us that we are to “test everything.” That means that we must constantly evaluate news, doctrine, philosophies, theories and everything else we are told or read against scripture. If it is consistent with scripture, it may or may not be true; but if it is inconsistent with scripture, it is false. We have to be careful about our sources and realize that in the End Times (which we are in now), the Bible teaches us that many, including leaders, will promote false teachings, false religions, false doctrines and the promotion of cults. We see evidence of this every day. We have seen false teachers and many cults since 1948. We see how easily people can be misled, how easily people will adopt beliefs that are verifiably false and how leaders will promote those lies or misinformation in order to further their own goals.

2 Timothy 4:3-4 (NASB):

For the time will come when they will not tolerate sound doctrine; but wanting to have their ears tickled, they will accumulate for themselves teachers in accordance with their own desires, and they will turn their ears away from the truth and will turn aside to myths.

2 Timothy 3:1-8 (NASB):

But realize this, that in the last days difficult times will come. For people will be lovers of self, lovers of money, boastful, arrogant, slanderers, disobedient to parents, ungrateful, unholy, unloving, irreconcilable, malicious gossips, without self-control, brutal, haters of good, treacherous, reckless, conceited, lovers of pleasure rather than lovers of God, holding to a form of godliness although they have denied its power; avoid such people as these. For among them are those who slip into households and captivate weak women weighed down with sins, led on by various impulses, always learning and never able to come to the knowledge of the truth. Just as Jannes and Jambres opposed Moses, so these men also oppose the truth, men of depraved mind, worthless in regard to the faith.

We are warned in 2 Thessalonians 2:3 not to be deceived. Especially dangerous will be those lies that have some element of truth or those promoted by charismatic leaders who promote falsehoods as supposed Christians, but saying other things or demonstrating behaviors that are clearly unbiblical.

When both the creation of the nation state of Israel and the growing apostasy have occurred (and they have), all the pre-conditions for the Tribulation to take place are met. For pre-tribulationists (the view I support), the only remaining event prior to the start of Tribulation is the Rapture.

Rapture

At the time of the rapture, the dead in Christ will be resurrected and those Christians living at the time will be instantly translated into their resurrection bodies and both groups of people will be “caught up” to meet Christ in midair and taken directly to heaven.

John 14:1-3 (NASB):

Do not let your heart be troubled; believe in God, believe also in Me. In My Father’s house are many rooms; if that were not so, I would have told you, because I am going there to prepare a place for you. And if I go and prepare a place for you, I am coming again and will take you to Myself, so that where I am, there you also will be.

1 Corinthians 15:51-54 (NASB):  

Behold, I am telling you a [a]mystery; we will not all sleep, but we will all be changed, 52 in a moment, in the twinkling of an eye, at the last trumpet; for the trumpet will sound, and the dead will be raised imperishable, and we will be changed. 53 For this perishable must put on the imperishable, and this mortal must put on immortality. 54 But when this perishable puts on the imperishable, and this mortal puts on immortality, then will come about the saying that is written: “Death has been swallowed up in victory.

1 Thessalonians 4:13-17 (NASB):

But we do not want you to be uninformed, brothers and sisters, about those who are asleep, so that you will not grieve as indeed the rest of mankind do, who have no hope. 14 For if we believe that Jesus died and rose from the dead, so also God will bring with Him those who have fallen asleep through Jesus. 15 For we say this to you by the word of the Lord, that we who are alive and remain until the coming of the Lord will not precede those who have fallen asleep. 16 For the Lord Himself will descend from heaven with a shout, with the voice of the archangel and with the trumpet of God, and the dead in Christ will rise first. 17 Then we who are alive, who remain, will be caught up together with them in the clouds to meet the Lord in the air, and so we will always be with the Lord.

[There are many views of when the Rapture occurs: pre-tribulationism (which I subscribe to), mid-tribulationism, post-tribulationism, partial rapture, pre-wrath view and others.]

Pre-tribulationism

The Church[3] will not go through the judgments prophesied in Revelation 4-18. Support for this view comes from:

  1. A literal interpretation of the Bible. The Bible is a compilation of many different forms of literature. A literal approach means that when the language is clear and unambiguous, we should accept it literally. On the other hand, we understand that some portions of the Bible are not meant to be read literally, such as parables and apocalyptic literature. This is also true in our everyday life in interpreting what others say. We take others literally, but we know when not to. If I say, it is raining outside, others would be right to conclude that wherever I am located, there is precipitation and rainfall. On the other hand, if I say, it is raining cats and dogs, one would be justified to believe it is raining wherever I am, but one is not intended to believe that cats and dogs are actually falling from the skies.
    1. Revelation 3:10 (NASB): Because you have kept My word of perseverance, I also will keep you from the hour of the testing, that hour which is about to come upon the whole world, to test those who live on the earth. This is a critical promise. God is not promising to spare Christians from all trials in their lives, but rather from “the hour of the testing, that hour which is about to come” or as some other translations state it, “the hour of trial that is coming” – a clear reference to the Great Tribulation.
    1. The Greek word John used is translated “from” carries the meaning of separation, in other words, that believers will be completely separated from these trials/events.
    1. Throughout Tribulation, saints are killed. The word “saint” is not a reference to our colloquial use and meaning of the term, but rather the term for all who are saved in Christ. How can this be if the Rapture occurs before the Tribulation? It is because the Church saints are raptured, but Tribulation saints are not. We currently are living in the Church age, which started at the Pentecost. Church saints are those that were saved prior to the beginning of Tribulation. They will be raptured prior to the start of the Tribulation. There are others who are not saved prior to the Rapture, but become saved during the Tribulation. They are referred to as Tribulation saints and many of them will be martyred during the Tribulation.
    1. There are many references to the Tribulation in the Old Testament and New Testament, yet none of them mention the Church, supporting the notion that the Church is raptured prior to the Tribulation and therefore not present during this 7-year time period.
    1. The great increase in apostasy and the events during the Tribulation occur because of the removal of “the restrainer”- the Holy Spirit. The Holy Spirit indwells in believers, thus, when believers are raptured just prior to the Tribulation, it makes sense that the restrainer is removed allowing Satan and the antichrist to put their plans into effect, though the plans will ultimately fail because God remains all-powerful and in control.

Second Thessalonians 2:3-7 (NASB): No one is to deceive you in any way! For it will not come unless the apostasy comes first, and the man of lawlessness is revealed, the son of destruction[4], who opposes and exalts himself above every so-called god or object of worship, so that he takes his seat in the temple of God, displaying himself as being God[5]Do you not remember that while I was still with you, I was telling you these things? And you know what restrains him now, so that he will be revealed in his time. For the mystery of lawlessness is already at work; only He who now restrains[6] will do so until He is removed. 

  • The Church is not appointed to wrath. Romans 5:9 (NASB): Much more then, having now been justified by His blood, we shall be saved from the wrath of God through Him. 1 Thessalonians 5:9 (NASB): For God has not destined us for wrath, but for obtaining salvation through our Lord Jesus Christ. Jesus delivers us from the wrath to come.
    • The Rapture is not the Second Coming. Christ does not come to earth in the rapture; he meets us in the air. In the Rapture, Christ comes for His saints. In the Second Coming, Christ comes with His saints.
    • The Rapture occurs in the “twinkling of an eye.” 1 Cor. 15:51-52. In other words, the Rapture occurs suddenly and quickly. The Greek word for “caught up” in 1 Thessalonians 4:13-17 implies a sudden, jerking, violent rendering or taking, much like you might pull a child’s arm who is in the path of a car.
    • References in the Bible to the “blessed hope” refer to the Rapture. Titus 2:13 (NASB): looking for the blessed hope and the appearing of the glory of our great God and Savior, Christ Jesus. The blessing is not only that we will be spared from the Tribulation and its judgments, but that once raptured, we will no longer have to face sickness, sadness, pain or death.

Other views:

Mid-tribulationism

This view holds that the Rapture will occur midway through the 7-year Tribulation, and that the taking up of the two witnesses of Revelation 11 following their resurrection represents the rapture of the Church. Mid-tribulationists believe this to be consistent with the verses that indicate the Church will be delivered from the wrath, and the wrath in Tribulation begins at the midpoint of Tribulation.

Why I do not support this view:

  1. It is not consistent with the literal interpretation of the other scripture I have provided above.
  2. There is no indication in the Bible that the two witnesses represent the Church. It is not entirely clear who the two witnesses are, but there are arguments to be made that they are Moses and Elijah or Enoch and Elijah. But whoever they are, much of Revelation 11 doesn’t make sense unless the witnesses are literally two individuals, not the entire Church.
  3. While the greatest wrath is during the last half of the Tribulation with the most severe judgments, the entire Tribulation period is a “time of trouble” and a period of time characterized by wrath given the acts of ungodly men- growing apostasy and rampant sin with the withdrawal of the restrainer.

Post-tribulationism

This view holds that God will rapture the Church after the Tribulation at the Second Coming. Post-tribulationists argue that Revelation 20:4-6 refers to all believers being resurrected at the end of Tribulation. They also believe that the reference to saints during the Tribulation means the Church has not previously been raptured. Post-tribulationists also believe that Matthew 24:37-40 is describing the Rapture at the Second Coming.

Why I do not support this view:

  1. Rev. 20:4-6 is referring to the resurrection of the Tribulation saints, not the Church saints.
  2. The reference to saints during the Tribulation refers to those persons who were saved after the Rapture, not the Church saints.
  3. Matthew 24:37-40 describes those who are not saved who are taken away to judgment, not raptured to heaven.

So, I hope that this analysis leaves you convinced that the COVID vaccine cannot be the mark of the beast. First, while we are living in end times, the Tribulation has not yet begun. The antichrist is not revealed until the Tribulation period and one cannot take the mark of the beast until one knows how the beast is. Second, as I hope I have made the case, if you are a true Christian who has acknowledged Christ as your savior and repented of your sins, you will not be here for any part of the Tribulation period, so you will not have to make the choice whether to accept the mark of the beast. That will be the choice to be made by those who go through the Tribulation, including those who only come to know and accept Christ after the Rapture and after the Tribulation period is well underway.  

One way that we follow God’s commandments to love others and protect the children is to get vaccinated so that we help bring an end to this pandemic.


[1] There are many references to trials and tribulation throughout the Bible and certainly, we all experience trials and tribulation throughout our lives. However, when I refer to Tribulation in the context of the End Times, I am referring to the “Great Tribulation,” which is a reference to a specific 7-year period of time rather than the general tribulation that we experience throughout our lives.

[2] Those that will be sealed by God are those who come to know Christ and accept Him as savior once the Tribulation begins, after the Rapture has already taken place. God does not need a physical mark to know His children. He knows us by what is in our hearts, our words and our actions that follow.

[3] In the Bible, Church means all those who are saved in Christ during the Church age (which we are living in right now). It has nothing to do with earthly churches. It includes all those, Jews and gentiles, who have been saved through repentance of sin, confession of belief in Christ and asked Jesus into their hearts and lives.

[4] These are references to the antichrist.

[5] This refers to the abomination of desolation.

[6] This refers to the Holy Spirit.

Understanding What is Going on with COVID and a Guide to Making Decisions for Parents, Teachers, and School Board Members

How a viral illness impacts a population will be influenced by the behavior of the virus and the behavior of the people.

Background

What we are seeing today is a consequence of our failure to aggressively decrease the transmission of the virus. The SARS-CoV-2 virus, which causes COVID, is an RNA virus, as opposed to a DNA virus. RNA viruses are well known to mutate frequently.

When the SARS-Co-V-2 virus infects a person, some of the virus will be destroyed by the body’s innate immune system. This is the part of our immune system that can attack invaders without ever having been exposed to the invader before. This is the part of the immune system that gives you a sore or red or swollen arm in the hours and first few days after a vaccination, and may cause some people to have fever, chills, headache and other symptoms that generally resolve after a few days. This is because the innate immune system recognizes the vaccine as something foreign and begins attacking it. That is good, because an activated innate immune system will sound the alarm, so to speak, for antibodies to be produced (this is called humoral immunity) and certain white blood cells (this is called cellular immunity) to be activated (among these are T-cells) that are quite important to both defeating an infection and providing you with the ability to respond quickly if the virus ever tries to infect you in the future.

The virus that escapes the innate immune system then tries to enter cells. There are two ways that the virus can enter cells, but the way most of you have heard is that it binds to the ACE-2 receptor on certain cells (ACE-2 receptors can be found on the cells lining our nasal passages, our lungs, our blood vessels, our heart, our kidneys, our pancreas, our intestines and many other tissues).

The reason that the virus wants to enter cells is that it cannot replicate (i.e., make more viruses) unless it can use the machinery contained within cells to make more virus. There is only one thing, at this point, that can stop whatever virus escapes the innate immune system from entering cells and that is antibodies. The problem is that it takes a week +/- a few days to produce these antibodies if you have never been exposed to this form of the virus before. This is why vaccination is so important, because it allows us to expose our immune system to the protein of the virus that we think is the best target for antibodies. This way, we make very strong antibodies (high levels of so-called “neutralizing antibodies” that are the ones most effective at interfering with the virus’ ability to enter cells) and very targeted antibodies, unlike the immune response which occurs to infection with the SARS-CoV-2 virus in which people generally make lower levels of neutralizing antibodies and more diverse antibodies that are targeted to many other proteins on the virus that do not appear to be very effective at stopping the virus from invading cells. This is why we recommend that all persons who previously had COVID get vaccinated as soon as they recover, in addition to the fact that someone who was previously infected with one form of the virus is likely to be subsequently exposed to more evolved variants in the future, and the lower level of neutralizing antibodies may not be sufficient to overcome the new variant’s ability to evade these antibodies. By being vaccinated, we reduce the time it takes to make antibodies in response to an infection by many days so that these are present to stop the virus that gets past our innate immune system from entering cells. When virus levels are lowered, fewer cells are invaded and less virus can be produced, we get much less ill and we are less likely to be hospitalized, severely ill or even die. That is exactly what we are seeing happening with those who are vaccinated. When they get infected, they are not getting severely ill. Almost everyone with COVID in ICUs, on ventilators and who are dying are those who have not been vaccinated.

Once the virus gets into cells, antibodies can no longer get to the virus and the virus takes over the machinery in cells that allows cells to make proteins. Instead of the normal proteins a cell would make, the virus hijacks the production line and gives instructions for the manufacturing of more SARS-Co-V-2 virus. Those instructions are coded for in the RNA of the virus. Every time a new virus is being produced (and that can be millions of billions of times in a person who is infected), those instructions from the virus’ RNA are having to be copied and sent to the place in the cell where the virus is produced and assembled.

Now, imagine if I gave you a paragraph to copy a million times. What are the chances that you might make a transcribing error? Probably even greater if I told you that you have to write it quickly. These transcribing errors occur in the instructions for production of the virus, as well, and they are referred to as mutations. Most will be of no consequence and don’t change the inherent behavior of the virus. However, some are very significant because they may result in the virus being more contagious, producing more severe illness, and/or evading preexisting immunity to some degree (so-called immune evasion or immune escape). When a mutation occurs that gives the virus an advantage in infecting people, e.g., making the virus more contagious or helping it evade prior immunity, we call that a variant, and if these changes are significant, we call it a variant of concern. When a virus becomes more contagious and/or able to evade prior immunity to some extent, it now may have a “fitness advantage” over other viruses and over prior forms the same virus. The way we see this fitness advantage in real life is by the variant becoming the predominant circulating form of the virus, such as alpha did in March/April and now delta is today.

Last year, many were proposing that we should allow young people to go on with their lives since they were unlikely to die if infected, and this way they could get infected, develop immunity and we would be that much closer to “herd immunity.” I and others argued strongly against this strategy.

The first problem with the argument was the belief by some that achieving herd immunity through natural infection would be a desirable way to bring an end to the pandemic. [While there are disagreements as to whether this was or was not Sweden’s attempted strategy, Sweden’s approach most resembled what a country would do if this was the strategy, and I believe there is general consensus within and outside Sweden that whatever their strategy was, it failed miserably.] Instead, the wide-spread transmission of the virus has merely produced more contagious variants with increasing degrees of immune evasion that are further raising the bar for what it would take to achieve herd immunity, if that is even possible.

There were many problems with this proposed strategy. First, in the modern era of vaccines, I and all those I have asked were unsuccessful in coming up with an example of another viral disease for which herd immunity had been achieved through natural infection. Certainly, neither the U.S. nor the world has ever achieved herd immunity with any other known coronavirus. Second, no one knows the level of population immunity required for herd immunity for this novel virus. Given that the R-naught (R0 or reproduction number) was 2.2 – 2.7 for the original SARS-CoV-2 virus back in December of 2019 (and there are some that believe the true number could be almost double this due to instances of so-called “super spreaders” who end up infecting large numbers of people) at the very beginning of the outbreak, with no one having pre-existing immunity and with no mitigation measures in place, a person infected with SARS-CoV-2 would be expected to infect 2.2 to 2.7 additional people. The mathematical model would then predict that herd immunity would require that roughly 60 percent of the population be immune to safeguard vulnerable individuals within the herd from infection. While these data points were based upon the original SARS-CoV-2 virus circulating at that time, variants have arisen due to the uncontrolled transmission of the virus across the world. Some of these variants have enhanced transmissibility, and because of this biological advantage, have become the dominant forms of the virus in many parts of the world. An increase in contagiousness or transmissibility means that the reproductive number has increased. The so-called delta variant is currently rising in prevalence in the U.S. and is known to be considerably more transmissible with a reproduction number estimated to perhaps be as high as 8. It is now estimated that herd immunity may require up to 85% of the population to be immune, though there is increasing skepticism as to whether herd immunity can ever be achieved with this virus.

Though New York City became an epicenter of COVID activity in March of 2020, with overwhelmed hospitals and health care workers and an excessive mortality rate compared to many other countries, including China, a seroprevalence study conducted in New York City at the end of March 2020 indicated only 22.7 percent of the population had antibodies to the SARS-CoV-2 spike protein.[i] If the mathematical projections were anywhere near correct in the estimation of immunity required in the population for herd immunity, New York City was far from it. Therefore, those who advocated for this strategy risked overwhelming the country’s health care system and causing large numbers of deaths, not to mention the health care costs that would be associated with such resource-intensive hospital care.

These arguments in support of herd immunity, some of which continued to be made in the White House in 2020, became even more outrageous and irresponsible as we entered into clinical trials for vaccines and two mRNA vaccines were shown safe and effective in phase III trials, ultimately receiving emergency use authorizations from the FDA before the end of the 2020.

A third problem with the arguments in favor of achieving herd immunity through natural infection was a huge problem concerning the very foundation for herd immunity – individual immunity. In 2020, we simply did not know whether people who recovered from SARS-CoV-2 infection were immune; whether everyone was immune, including those with asymptomatic or mild infections; and if so, for how long, and whether natural immunity would be protective against variants that would develop over time. We certainly could detect antibodies to the spike protein in most people following infection, but the messaging to the public that the presence of antibodies does not necessarily mean immunity was a challenging one being contrary to commonly held beliefs. Further, with continued high levels of disease transmission around the globe, many new variants of concern have emerged, and no doubt, more will continue to develop, some already demonstrating a degree of immune escape/evasion. Unless immunity to the wild-type virus or prior variants will continue to protect the population from these new variants, any herd immunity developed will be short-lived if new variants spread and have significant and effective immune evasion/escape capabilities.

Early studies showed that while most (but not all) persons mounted an IgG antibody response to infection, few people made high levels of neutralizing antibodies and most people made some, but low levels of neutralizing antibodies. Further, antibody titers tended to decline significantly over two to three months, with some people becoming seronegative. While these data were generally discouraging, we still did not know the indicators of immunity for this disease and therefore, while we suspected that any immunity gained from natural infection might be short-lived (on the order of perhaps 3- 6 months as is typical for other more common coronaviruses), declining levels of IgG antibodies would not necessarily imply a loss of immunity, especially given that we had little data on the cellular immune response to this disease. We would subsequently learn that the protection provided by the mRNA vaccines was far more robust than expected, with adequate protection maintained at one year, and many speculating that protection may last for a number of years, and that in those persons who had COVID and subsequently were vaccinated, there might even be life-time protection.

Though it was difficult to document cases of reinfection because testing was generally by nucleic amplification methods (PCR), which did not preserve a sample of the virus for genetic sequencing, there have been, as of the time of this writing, 169 documented cases with three resulting in death and 82,148 suspected cases of reinfection with 299 resulting in death. Supporting impressions that immunity from the SARS-CoV-2 virus infection may be short-lived, the average time interval between infection and reinfection for the confirmed cases was 115 days.[ii] While with other infections, we often see that a reinfection is milder than the initial infection, that was not true in every case with COVID, including instances where the reinfection was serious enough to require hospitalization and three cases of documented reinfection in which the patient died as a consequence of the reinfection.

The fourth problem was while many of those who advocated for a rush to herd immunity through natural infection considered the U.S. case fatality rate at the time of 1.77% to be low and acceptable, there was generally no consideration or accounting given to the emerging evidence of morbidity associated with COVID. Unfortunately, we are identifying more and more long-term consequences of COVID in those who survive, including those who experience mild disease, that affect their health, cognitive functioning, mental health and well-being.

Delta

So, with this background, what is different about delta and what does this all mean?

As a consequence of uncontrolled transmission, delta has acquired mutations that are serious enough to make it a variant of concern. We have evidence that it is far more contagious and it has acquired some degree of immune evasion, and it may have achieved the trifecta of also creating more severe disease.

Increased transmissibility

Transmissibility reflects how easily a virus spreads within a population. The basic reproduction (R0) and/or the secondary attack rates are often used to make inferences as to transmissibility of a virus. Transmissibility is determined by the infectivity of the virus, the contagiousness of the infected person, the susceptibility of those who are exposed to the person who is infected and environmental factors such as population density or distancing of persons and ventilation in the case of airborne viruses or sanitation practices in the case of food-borne illnesses, as well as the degree of existing immune protection within the population.

The CDC, WHO and a consensus of the world’s public health agencies and experts have concluded that delta is far more contagious and transmissible than the forms of the virus we have previously dealt with in the United States, including the most recently predominant alpha variant.

Public Health England has determined that the delta variant is more transmissible[iii]. A study in England confirmed that there was a significantly higher risk of transmission of COVID due to the delta variant in households than we experienced previously with alpha and prior forms of the virus.[iv] This study found a 64% increase in the odds of household transmission associated with infection with SARS-CoV-2 delta variant compared to alpha. It should be noted that prior to delta, alpha was the most contagious variant in the U.S. It should also be noted that this enhanced household transmission existed despite England having a higher vaccination rate than the U.S. Most cases of infection occurred in unvaccinated persons.

A study here in the U.S. has also confirmed high transmission rates within an indoor athletics facility[v] (in this case a gymnastics facility, but think office or school for other types of facilities) of 20% and a secondary attack rate in households of 53%. A total of 47 persons were infected in this outbreak – 23 gymnasts, 3 staff and 21 household members, although the authors acknowledge that the total number of infections may be underreported. The ages of those infected ranged from 5-years-old to 58-years-old. Two persons required hospitalization, including one who required intensive care. 85 percent of those infected were unvaccinated and six percent had only received the first dose of the two-shot series of vaccine. Only four of the 47 persons infected were fully vaccinated.

Of particular note for schools who in the last school year relied on pods or cohorting to limit outbreaks of infections, this gymnastics facility cohorted gymnasts by gender and skill into 16 groups, each with a different practice schedule, and yet this outbreak extended to ten of the cohorts. The staff indicated that cohorts had limited interaction with each other.

The conclusion of the authors was: “These findings suggest that the B.1.617.2 (delta) variant is highly transmissible in indoor sports settings and within households. Multicomponent prevention strategies (this means vaccination, masks, distancing, enhanced ventilation, etc.) … remain important to reduce the spread of SARS-CoV-2, including among persons participating in indoor sports and their contacts.”

The secondary attack rate of 53% in households (meaning what percent of household members become infected when another member of that household becomes infected) is further evidence of the increased transmissibility of the delta variant, as that attack rate was on the order of 17% with prior forms of the virus[vi]. This is important for school leaders and board members to appreciate, because while it remains true that a relatively low percentage of children become seriously ill or die, unlike last year when children played a limited role in the transmission of COVID, children appear to be far more efficient at transmitting delta. This should be of great concern due to the fact that in Idaho, only 34% of adults ages 25 – 34 are fully vaccinated and only 41% of adults ages 35 – 44 are fully vaccinated, and these would be the expected ages of the parents of school-aged children (household contacts). Thus, if schools do not require multicomponent or multi-layered prevention strategies in schools, we can expect to see much higher infection rates in the students’ households than we saw last year and because 1/2 – 2/3 of their parents remain not fully vaccinated, this poses a huge threat to overwhelm local hospitals[vii]. A discussion of mental health impacts to students will not be complete without the inclusion of the impacts to students who have a parent become seriously ill, or die, due to COVID that may impact the family’s income, whether the child has a surviving parent and if not, who will become the custodian of the child, and in those cases of an older child, the potential knowledge that they may have been the person to infect their parent.

Let’s talk big picture: the delta variant is more transmissible than the coronavirus that caused Middle East Respiratory Syndrome (2012), the coronavirus that caused Severe Adult Respiratory Syndrome (2003), the Ebola virus, the Poliovirus, the seasonal influenza viruses, the 1918 (“Spanish”) influenza virus, and the variola virus that causes Smallpox. You’ll recall from above that the reproduction number (meaning the number of people one person with infection would be expected to infect) for the SARS-CoV-2 virus was 2.2 – 2.7 at the beginning of the pandemic. It now appears that the reproductive number for the delta variant is about 8. That makes the delta variant of SARS-CoV-2 as transmissible as the varicella virus that causes Chickenpox.  Schools have a long history of dealing with childhood illnesses. For school leaders and board members, I am pretty certain that if you knew that there was a child in a class at your school with Chickenpox, you would immediately remove the student from other students and send the child home. My question then is why would you allow students with an equally transmissible virus to remain in your classrooms? Likely, your answer is because we can tell the child has Chickenpox, but we most often will not be able to tell that a child has COVID. True. And, that is why everyone needs to mask. Because with COVID, and especially with delta, children may very well be spreading this highly contagious disease with no one having any idea that the child is infected.

Increased contagiousness

Contagiousness, or the ability to infect someone else, is a factor in determining transmissibility, and in the case of delta, appears to be a significant factor.

There is an important study of an outbreak of COVID caused by the delta variant in which 1 person was responsible for an outbreak involving 167 others[viii]. We gained a lot of understanding because those who were exposed and quarantined were tested by PCR daily. Shockingly, when someone who was exposed first tested positive, they had viral loads 1260 times what we saw with the early forms of the virus. Viral load refers to the amount of virus in a person’s nasal passages. Viral load is important because the higher the load, the more likely someone is to transmit virus to someone else with whom they come into contact and the greater amount of virus the person exposed is likely to receive (the viral dose). There is evidence that the greater the viral dose, the more severe the infection is likely to be.

There are other implications from this study. Prior to delta, the time from exposure to the development of a positive test if the exposed person were to become infected was about 6 days. And, even then, it was not clear that the viral levels were high enough to efficiently transmit. In other words, if we could identify contacts within four or five days and get them to quarantine, we were very likely to prevent the contact who is now infected from infecting anyone else, other than household members. However, the authors of this study found that with delta, the average time from exposure to positive PCR test was 3.7 days, and that by the time they had a positive PCR test, they already had very high levels of virus that would pose a significant threat of transmission. So, our contact tracing efforts that were hugely helpful in containing the spread of infection in schools last year, may be far less effective with delta. Let’s take an example. Sue is an unvaccinated 12-year-old, in sixth grade who plays basketball. Sue is in a classroom with 20 students. She is on a basketball team with 12 students. The school leaders do not require masking or physical distancing, and therefore, there is no consistent physical distancing and the vast majority of students do not wear masks, even though in Idaho only 16 percent of students ages 12 – 15 are fully vaccinated (I only make reference to fully vaccinated rates, because unlike prior forms of the virus where even one dose of vaccine was very protective, one dose provides little protection against delta). On Thursday, Sue begins to feel tired, fatigued and has a stuffy nose. Sue and her parents assume that Sue’s allergies are acting up. But, Sue powers through, especially since she is excited about her sleep-over with six friends on Friday night. On Saturday, Sue tells her parents that she is now getting a headache and feels worse and that this feels different from her allergies. Her parents take her in for a COVID test on Saturday afternoon. The test result comes back positive on Monday. Sue’s parents notify the school on Monday and her sleep-over friends’ parents Monday evening when those parents are home from work. It is at least day 5 for her classmates and basketball teammates and it is day 3 for her sleep-over friends. Let’s just take the 20 classmates. If 16 percent of them are fully vaccinated, that is 3 students who are fully protected. 17 students would be very vulnerable. Let’s take the facility attack rate observed with the gymnastics outbreak mentioned above of 20 percent. That would mean 3 – 4 students would be expected to be infected. However, by the time they realized they were exposed on day 5, they should all have high loads of virus and they will in turn have infected others. And, of course, this doesn’t account for other students infected by Sue through basketball, Sue’s use of the library, Sue passing other students or stopping to talk to them in the halls (reports out of Sydney, Australia suggest that the contact time for exposure may be very brief and that casual contact may be sufficient), and friends from other classes who join her for lunch. This example demonstrates how we may be more likely to experience outbreaks in school this fall with delta.

Increased severity of COVID

It appears that delta is capable of producing more severe disease than prior variants and forms of the SARS-CoV-2 virus did. A study from Canada showed that unvaccinated persons infected with delta had a little over two times the likelihood of hospitalization, almost four times the chance or requiring critical care and a little over two times the risk of dying compared to persons infected with prior variants of the virus[ix]. A study out of Singapore also showed higher odds of requiring oxygen, critical care and dying with COVID caused by delta compared to other variants[x]. And, similarly, a study out of Scotland showed that an unvaccinated person with COVID caused by delta was almost twice as likely to require hospitalization as someone with COVID caused by other variants[xi].

So why do I need to wear a mask if I am vaccinated?

Let’s be clear. The vaccines are extremely effective, but no vaccine is 100% effective and the vaccines were designed to prevent us from becoming severely ill, requiring hospitalization or dying, not to prevent infection even if mild or asymptomatic. If fully vaccinated, you have an 8-fold reduction in the incidence of becoming symptomatically ill with COVID. So, even though we do get a lot of protection from the possibility of becoming ill with COVID if we are fully vaccinated, with 162 million vaccinated Americans, it still means that 34,020 will develop symptomatic COVID per week. On the other hand, the chance of a fully vaccinated person requiring hospitalization or dying from COVID is reduced by a factor of 25 compared to someone who is not vaccinated, which means that we would only expect 162 fully vaccinated Americans to be hospitalized each week and only 6.5 deaths from COVID among the fully vaccinated each week. For comparison, just in Idaho, and currently, our state is not yet being impacted anywhere nearly as bad as many other states, we had 2,259 COVID cases and 14 deaths in the past week. Thus, we would anticipate far fewer cases, hospitalizations and deaths in the entire country among those who are fully vaccinated than the corresponding numbers just in the state of Idaho.

Prior to delta, a study showed that vaccination reduced the viral load in those who became infected by 40 percent and that virus was detectable for a shorter period of time (2.7 days in fully vaccinated persons vs. 8.9 days in others)[xii]. However, with delta, fully vaccinated persons who become infected have viral loads that are comparable to the loads of those who are unvaccinated. So, while the fully vaccinated are highly protected against severe disease, hospitalization and death, we face a dangerous public health situation in which the fully vaccinated may become infected, remain asymptomatic or mildly symptomatic such that they do not realize they are infected, and continue normal interactions because of their vaccination status without wearing a mask based on prior CDC recommendations, while actually playing a significant role in the transmission of the virus. For schools, this means all staff and faculty must wear masks in order to avoid inadvertently creating an outbreak of delta infections among their unvaccinated students.

In addition, the CDC examined 469 cases of COVID occurring in July of this year related to summer events or large gatherings in a town in Massachusetts.[xiii] Sequencing from 133 of those infected confirmed that their COVID was caused by the delta variant. This was of particular interest because Massachusetts reports a 69 percent vaccination rate among eligible residents, much higher than most states in the country. It was also notable because 74 percent of the infections occurred in fully vaccinated persons, and 79 percent of those persons were symptomatic. Four of the five persons hospitalized were fully vaccinated, but none died. Laboratory testing showed that those who were fully vaccinated, yet infected had similar viral loads as those who were unvaccinated and infected. Of note, persons with COVID-19 reported attending densely packed indoor and outdoor events at venues that included bars, restaurants, guest houses, and rental homes.

This town is host to tourists. It is shocking to see how quickly dangerous levels of community spread can occur. On July 3, the MA Department of Public Health had reported a 14-day average COVID-19 incidence of zero cases per 100,000 persons per day in residents of the town in Barnstable County; by July 17, the 14-day average incidence increased to 177 cases per 100,000 persons per day in residents of the town. This is evidence once again, that a 69 percent vaccination rate among those eligible to be vaccinated is not sufficient for “herd immunity,” and that those who are unvaccinated and unmasked present a considerable threat to those who are vaccinated. As long as we have a large number of unvaccinated who are driving transmission and the development of new variants, vaccination by itself is not a sufficient protection from the vaccinated playing an unwilling participant in the transmission chain. Not surprisingly, large gatherings with persons that you do not know without physical distancing remains a high-risk activity for all until we can gain control of the spread of this disease.

With respect to schools, all of the above should certainly be evidence that those staff and teachers who are unvaccinated are at risk for severe COVID Further, vaccinated staff and teachers need to be in an environment where everyone is masked in order to avoid transmitting the virus to friends and family even though they themselves would not be expected to get severe disease.

What is at risk if school boards act recklessly?

First of all, if schools cave to pressure to have all students back for in-person without distancing and without masks, based on all of the above, one would have to imagine there would be a significant chance for a widespread outbreak, which of course would send everyone to remote. Thus, they risk pleasing parents for a short time, but then enraging them when kids now all have to learn at home. And, of course, none of those parents will rush to defend board members or school leaders for doing what the parents wanted. This approach seems short-sighted.

It is still anticipated that all school-aged children will be able to be vaccinated in the first part of 2022. Therefore, a mask requirement would likely not be needed for the entire year, but just until children could reasonably complete the vaccine series. Further, schools benefit financially from children being in person each day. Without a mask requirement, large numbers of children will have to be isolated and others quarantined. Much of this could be avoided with masks and reasonable efforts at distancing. A side benefit is that masking would decrease many other respiratory infections, especially influenza. Again, this would improve attendance and financially benefit the school district. There is no reason that children cannot be in full, in-person attendance, but with appropriate protections.

Further, schools need to help society in decreasing the transmission of this virus. As I mentioned above, the failure to control the transmission of this virus will inevitably result in more variants of concern, perhaps even more contagious, perhaps causing more severe disease and perhaps evading the protections of the vaccine even more significantly. A recent modelling study revealed that “a fast rate of vaccination decreases the probability of emergence of a resistant strain. Counterintuitively, when a relaxation of non-pharmaceutical interventions happened at a time when most individuals of the population have already been vaccinated the probability of emergence of a resistant strain was greatly increased. Consequently, we show that a period of transmission reduction close to the end of the vaccination campaign can substantially reduce the probability of resistant strain establishment. Our results suggest that policymakers and individuals should consider maintaining non-pharmaceutical interventions and transmission-reducing behaviours throughout the entire vaccination period.”[xiv] This actually makes sense because, as a large part of the population becomes immune to one form of the virus, that strain no longer circulates and can open the door to a new form of the virus with immune evasion capabilities, even if that new variant would not have been as fit and would not have been able to compete well with the prior variant. We believe that we saw this play out in South America. As the authors put it: “Our model shows that if at the time a vaccine campaign is close to finishing and nonpharmacological interventions are maintained, then there’s a chance to completely remove the vaccine-resistant mutations from the virus population.”

Besides the potential for backfire and the potential that schools contribute to community spread and the development of more problematic variants are the more fundamental questions. Can we expect schools to follow science? Can we expect school leaders and board members to protect students and their families? Can we expect board members to put the welfare of students, their families and our communities ahead of their own self-interests? Do school boards have a responsibility to ensure that they do not inadvertently contribute to community spread of this disease and overwhelming of local hospitals? Ultimately, if there are widespread outbreaks, deaths and long-term health consequences to children and their families, then I suspect we will see taxpayers pay for the potential large liability created by “reckless infliction of harm” on the part of school boards that is excepted from limited liability protection provided by the legislature. I hope it does not come to this. Schools and school leaders should place a high value on science, knowledge and truth. In the end, even if school leaders and school boards fail us, truth will still be truth and this virus will do what it will do. It has already been providing us with the preview of coming attractions.


[i] “Cumulative incidence and diagnosis of SARS-CoV-2 infection in New York.” Rosenberg E S et al. Annals of Epidemiology. 48: 23-29.e4, August 2020. https://doi.org/10.1016/j.annepidem.2020.06.004.

[ii] COVID-19 reinfection tracker. BNO News. Bnonews.com/index.php/2020/08/covid-19-reinfection-tracker/.

[iii] Public Health England. SARS-CoV-2 variants of concern and variants under investigation in England—technical briefing 17. London, United Kingdom: Public Health England; 2021. https://assets.publishing.service. gov.uk/government/uploads/system/uploads/attachment data/ file/997418/Variants_of_Concern_VOC_Technical_Briefing_17.pdf

[iv] https://khub.net/documents/135939561/405676950/Increased+Household+Transmission+of+COVID-19+Cases+-+national+case+study.pdf/7f7764fb-ecb0-da31-77b3-b1a8ef7be9aa.

[v] https://kfor.com/wp-content/uploads/sites/3/2021/07/Click-here-to-read-the-full-report.-1.pdf.

[vi] Madewell ZJ, Yang Y, Longini IM Jr, Halloran ME, Dean NE. Household transmission of SARS-CoV-2: a systematic review and meta-analysis. JAMA Netw Open 2020;3:e2031756. PMID:33315116 https://doi. org/10.1001/jamanetworkopen.2020.31756.

[vii] Idaho’s ICUs are filling up again — this time, patients are in their 30s | Local News | postregister.com

[viii] https://virological.org/t/viral-infection-and-transmission-in-a-large-well-traced-outbreak-caused-by-the-delta-sars-cov-2-variant/724.

[ix] Fisman and Tuite, doi:10.1101/2021.07.05.21260050.

[x] Ong et al. doi:10.2139/ssrn.3861566.

[xi] Sheikh et al. doi:10.1016/S0140- 6736(21)01358-1.

[xii] Thompson et al. doi:10.1056/NEJMoa2107058.

[xiii] Outbreak of SARS-CoV-2 Infections, Including COVID-19 Vaccine Breakthrough Infections, Associated with Large Public Gatherings — Barnstable County, Massachusetts, July 2021 | MMWR (cdc.gov)

[xiv] Rates of SARS-CoV-2 transmission and vaccination impact the fate of vaccine-resistant strains | Scientific Reports (nature.com)

A Note to Those who are Confused, Afraid or just Uncertain about Whether to Get the COVID Vaccine

Thank you for reading this. First of all, I want you to know that I understand your confusion, your fear and your reservations about the vaccines. This is complicated stuff and unfortunately, there are people who are intentionally trying to mislead people and others who are not intending to pass along false information, but doing so because they themselves have been mislead or lied to.

Unfortunately, some have promoted a false narrative for political gain, while having access to testing that the general public does not have, while having access to medical care and medications that many in the general public do not have access to and while getting vaccinated, often before much of the general public had access to vaccines, and then being unwilling to admit that they have been vaccinated or unwilling to answer the question as to whether they have been vaccinated. It was easy for them to promote doing away with public health protections or downplaying the pandemic, when they themselves knew they had far more protection than most of their constituents.

So, let me provide full transparency about me:

  1. I am a life-time Republican. I am a fiscal conservative. When it comes to managing a public health emergency, I do not support Republican or Democratic leaders; I support my country, my state, science, truth and leading by example. If leaders do the same, I will praise them. If leaders don’t, I will criticize them regardless of their party affiliation.
  2. I am retired. I am not financially impacted by whether anyone gets a test or does not, whether they are hospitalized or not, or whether they are vaccinated or not.
  3. I receive no payments from any pharmaceutical company and never have, even while I was in medical practice.
  4. To my knowledge, I do not have any stock in any pharmaceutical companies. The reason I qualify this is that I do have mutual funds that are managed by others. If they do invest in a pharmaceutical company, I am not aware of it and I couldn’t tell you which one.
  5. I currently serve on the Governor’s Coronavirus Work Group, but I receive no compensation for that role.
  6. I have advised the West Ada School District in the past, but despite their offer to compensate me for my time, I declined it.
  7. I have received two doses of the Moderna vaccine. Some of my family members have received Moderna and others have received Pfizer.
  8. I have no intention of running for any elected office. I have had people ask me to serve on the Central District Health Board, school boards and to run for governor. I have declined each.

My motivations for spending so much time in so many different ways to try to help our state through this pandemic and provide people that are interested with good information is (1) I am a Christian and I believe that the Bible teaches us that we should care for one another and put others ahead of ourselves; (2) I am a physician and it pains me to my core to see needless illness, suffering and death; and (3) I am an American and an Idahoan and I want to see our country and state prosper.

Now, I know a lot of people have made their minds up, are not open to discussion and get upset when people discuss vaccination. This article is not intended for that audience. On the other hand, I have spoken with dozens of people who are somewhat skeptical and some that are very skeptical. I have listened to their concerns and answered their questions the best that I could. The vast majority of these folks have followed up with me and indicated that they did go ahead and get vaccinated after our discussions. So, I am going to share some of those questions and my answers below, because it is likely that if they had these questions or concerns, there are others with the same questions or concerns.

  1. Concern: The vaccines are experimental.

Response: The Pfizer, Moderna and J&J vaccines are not experimental. Vaccine opponents have carefully selected words that are calculated to provoke an emotional and negative response from those they hope to influence. Labelling the vaccines “experimental” is intended to scare people. The clinical trials for these vaccines were conducted last year. At that time, they were experimental. These vaccines are no longer considered experimental by physicians, scientists, the FDA and the courts, where plaintiffs unsuccessfully asserted that the vaccines were experimental.

In the United States alone, about 340 million doses of vaccine have been administered. The Pfizer vaccine is being used by 111 countries. The Moderna vaccine is being administered by 61 countries. The J&J vaccine is being administered in 33 countries. If these vaccines were experimental, these would be the largest clinical trials ever conducted, a reason to trust them even more.

So, if you decide not to be vaccinated, at least do not use the false narrative that the U.S. vaccines are “experimental” as your reason.

2. Concern: We don’t have long-term studies on the safety of vaccines.

Response: Minor vaccine reactions (sore arm, redness at the injection site, fever, aches and rashes) generally occur within hours to a few days, but almost always occur within 12 days of vaccination. Serious vaccine reactions usually manifest themselves within hours to days, and almost always within 35 days of the vaccination. Thus, the FDA required a minimum of two months of safety data prior to issuing Emergency Use Authorization for the vaccines.

Because of the size of the trials, the studies were designed to identify adverse effects of the vaccines that occur at the rate of at least 1 in 30,000 or 1 in 40,000 people vaccinated. However, the FDA has continued to monitor the safety of vaccines following the grant of Emergency Use Authorization, such that now we are identifying adverse effects that occur at a rate of 1 in a million or 1 in 10 million vaccinees.

Keep in mind, that we have administered about ten times more COVID vaccines than the number of all other vaccines that we administer in an average year in the U.S. Thus, we don’t need longer term data to identify adverse effects in adults and any adverse effects that we do identify as we have additional time to vaccinate more people will be events that occur at extraordinarily rare levels. Keep in mind, while there have been rare serious adverse events reported with the COVID vaccines, these have largely been events that occur at much higher frequency in those who become ill with COVID.

As we are seeing a surge in new cases across the country due to delta, if you choose not to be vaccinated, at least do not be misled by claims that we need more data or longer-term studies to assess the safety of these vaccines. We have all the data that we need to make a safety assessment of these vaccines, and in every case, the FDA, the CDC, the Advisory Committee on Immunization Practices, and public health and infectious disease experts have concluded that the benefits outweigh the risks.

3. Fear: I don’t want to get the vaccine because I am scared of the side effects.

Response: I can certainly understand this. Most people, like my wife, have very mild side effects. Some, like me, have 1 – 3 days of feeling ill or like they have the flu. Obviously, no one wants to go through these side effects, but again, one should compare the potential side effects to the potential illness with COVID. While many people with COVID have mild symptoms, there are others who experience extreme distress and require hospitalization and some will require a ventilator to breathe for them.

4. Confusion: I am young and healthy, so I don’t need to be worried about getting COVID.

Response: I can certainly understand this sentiment. The fact that you are young and healthy does mean that you are very unlikely to die from COVID. On the other hand, there are many bad things that can happen to you even if you survive. The adverse effects that many fear with the vaccines occur far more often in people who are ill with COVID. With the alpha and now the delta variants, hospitals across the country and world have reported having younger people hospitalized, as well as in the ICU, including young adults in their twenties, thirties and forties. We also see up to a third of young people developing long-COVID following infection, even when that infection was mild. These are often young adults who were active and fit, who are experiencing severe limitations to their activity and exercise tolerance months following the infection.

So, even if you remain unconvinced that the benefits of vaccination outweigh the risks of COVID, please get vaccinated to lessen the possibility that you will infect someone you know and care about who might be at much higher risk for a severe outcome if they get infected.

5. Confusion: I had COVID, so I don’t need the vaccine.

Response: While having COVID does provide some degree of immune protection against re-infection for most, but certainly not all, persons, there is growing evidence that the degree of immune protection is inferior to that provided by vaccines. As we see more and more variants of concern, we have less and less confidence that natural infection will provide people the same degree of immune protection that the vaccine will. Therefore, we recommend that everyone who has previously had COVID get vaccinated once they recover from their illness.

6. Confusion: I can wait and then if I get sick, I can get vaccinated.

Response: This is incorrect. First of all, we do not vaccinate people against COVID who are sick from any infection. Secondly, if you are sick with COVID, it is too late for the vaccine to prevent you from becoming severely ill. The vaccine takes at least a week to produce the kind of immune response that we are looking for. While with previous variants and strains of the virus, even a single dose of vaccine would produce a significant amount of protection, with delta, we are finding that a single dose provides very little protection. Because both doses are required to achieve a robust immune response, we are generally looking at a period of 4 – 6 weeks from the first dose of the series until someone will be maximally protected against the delta variant.

So, if I am persuading you to get vaccinated, please do so ASAP and be sure to go back for your second dose as soon as it is time for it.

If one of the things holding you back from getting vaccinated is the thought that you have time and can get it once you get sick, please know that it is likely it will be too late by then. Please get protected now.

7. Concern: Some are concerned that vaccine “breakthroughs” mean that the vaccines don’t work.

Response: Vaccine breakthroughs are expected. We have known since the clinical trials that the vaccines would not be 100% effective, even though they are not far from it. The key is whether the vaccines can prevent severe illness, hospitalization and death. So, look at the deaths in the US from COVID and May and June. More than 99% of them occurred in the unvaccinated. It you look at the fully vaccinated rate in the U.S. of around 50%, you would expect the deaths to be about 50% in vaccinated persons and 50% in unvaccinated persons if the vaccine was not effective. The fact that deaths from COVID among the vaccinated are less than 1% confirms that these vaccines are highly protective, even if some persons get breakthrough infections.

I hope that if I have addressed your concern, you will get your first dose of vaccine this week. If you still have a concern, an unanswered question or a fear that I have not addressed, write a comment and tell me what that concern or question is and I will do my best to get you an answer.

I care about you. I do not want you to get infected or to inadvertently infect someone else. I want life to get back to normal, but we can’t get there if we allow this virus to continue to spread unabated, continuing to develop new and more threatening variants.

Post-COVID: To Vaccinate or Not to Vaccinate? That is the Question.

With apologies to William Shakespeare for adapting a line from Hamlet to current day questions of great importance, I thought that I would address one of the most common questions I get about COVID. That question comes from those who know or believe that they previously had COVID as to whether they should get vaccinated. My answer is “definitely,” but I seldom have the opportunity to provide a detailed explanation as to why they should get vaccinated. So here goes.

First, a short primer on the immune response to infection with the SARS-CoV-2 virus that causes COVID-19 is in order. [Note: the following is greatly oversimplified, but intended for lay persons so that they can have a basic understanding of the science behind our recommendation that those previously infected with COVID still get vaccinated.]

There are essentially three arms of the immune system – the innate system (I have written previously about this, but for brevity and simplicity, I am not going to discuss this in detail for purposes of this blog post), the humoral system (this is where antibodies come into play) and the cellular system (this includes a range of specialized cells, but for our purposes, we will focus on so-called T-cells).

Various proteins on the surface of a virus can be recognized by the body as being “foreign” and therefore, something to be attacked when the virus enters our body through the nose, throat, lungs, gastrointestinal tract or other sites of entry. By now, most people are aware that for the SARS-CoV-2 virus, the spike protein is one of the most important proteins for the virus’ infectivity, but also for a target by our immune system and vaccines.

When exposed to SARS-CoV-2 and an infection results, our bodies will, in most cases (exceptions include persons who are immunocompromised), produce antibodies that will bind to various sites on the virus in an attempt to mark the virus for attack and destruction and to prevent the virus from being able to invade cells, such as the cells that line our lungs and blood vessels. To enter a cell, the virus needs to attach to a specific receptor on the lining of the cell, much the way that we need a specific key to open a looked door to allow us to enter a room. Not all, in fact, not even most, antibodies are effective in preventing the virus from attaching to the receptor on the cell because they have been developed in response to other proteins on the virus that are not involved in that binding. We have a special name for those antibodies that do bind to the specific site on the virus that then blocks the ability of the virus to attach to the receptor on the cell and gain entry into the cell – they are called neutralizing antibodies.

If you have not previously had COVID and you have not been vaccinated, then once you are exposed and infected by the SARS-CoV-2 virus, your innate immune system will try to hold the virus off for days (as much as 7 – 10) while your body produces antibodies to the virus. This is why vaccinated persons are so much better protected against the virus, because the vaccine causes us to already have these antibodies made and ready or able to produce them much faster than if we have never been vaccinated or exposed to the virus before. Thus, if vaccinated, we have much better chances of preventing these invading virus particles from entering our cells and causing damage, illness and more production of viruses and then more spread throughout our bodies. Most of those who have been previously infected will also have these antibodies ready to go, but I will discuss below why those who have been previously infected will still be better protected by also getting vaccinated.

Unfortunately, once the virus gets inside cells, antibodies no longer work against those virus particles and the virus takes control of the cell’s internal machinery to force it to produce more virus particles. [This is more than you want to know, but one of the reasons that the delta variant seems to be able to evade the immune system to an extent is that when the cell is forced to make more viruses, the viruses are then generally exported out of the cell to then spread to other cells, tissues and organs of the body, but when released outside of the cell, they are now vulnerable to these neutralizing antibodies. However, the delta variant can use another method by which newly produced virus particles spread directly from one cell to another contiguous cell, depriving antibodies of an opportunity to attack the brand-new virus.]

Once virus has entered cells, we have to rely on a different part of the immune system called the cellular immune system. These are specialized white blood cells. Some of these cells have the ability to identify cells that have been infected and kill the cells, which will stop the cell from producing more virus and often times kill the virus that is inside the cell. These cells are generally called T-cells, and more specifically, cytotoxic T-cells or CD8+ cells.

I think this is enough of a primer for us now to understand the science behind our recommendation that people who have previously had COVID still get vaccinated.

So, let’s look at 3 recent studies. The most recent one is “Antibody response to SARS-CoV-2 infection and BNT162b2 vaccine in Israel,” by Shapira et al posted July 8, 2021 as a preprint article, meaning that this has not yet been peer-reviewed and published in a medical journal. In this study, the authors examined 26,170 blood samples from persons in Israel between November of last year and March of this year. 8,078 of the samples were from persons who had positive tests for COVID, but were asymptomatic before the COVID vaccinations were available. 1,652 of the samples were from people recovering from symptomatic COVID infection. 3,516 samples were taken from people who were vaccinated with the Pfizer mRNA vaccine.

What the authors found was that vaccinated persons had the highest neutralizing antibody levels – nearly three times higher levels than those for persons recovering from COVID. 99.4 percent of the vaccinated individuals had detectable neutralizing antibodies six days or more following the second dose of the Pfizer vaccine, while only 75.7 percent of those recovering from COVID had detectable neutralizing antibody.

The next study is from last month, entitled, “Prior SARS-CoV-2 infection rescues B and T cell responses to variants after first vaccine dose,” by Reynolds, et al, published in the journal Science. This study looked at vaccination (Pfizer) responses to a single dose of the two-dose regimen in health care workers in the UK in those who had not previously been infected and in those who had been infected with the original strain of the SARS-CoV-2 virus. They showed that 96 percent of those health care workers who had been previously infected developed a T-cell response to the spike protein as well as a neutralizing antibody response that was sufficient to provide protection against the alpha and beta variants. Only 70 percent of those health care workers who had not previously been infected developed a T-cell specific response. The T-cell response in those previously infected was 4-fold greater than that of those who had not been previously infected. We refer to the first dose of the mRNA vaccine as the prime and the second dose as the boost. It appears that for those previously infected with COVID, that infection serves as the equivalent of a prime and the first of the two-shot vaccine functions essentially as the boost.

The third study is from March and was also published in Science: “mRNA vaccination boosts cross-variant neutralizing antibodies elicited by SARS-CoV-2 infection,” by Stamatatos et al. The authors in that study found that persons who recovered from COVID had antibodies that routinely could neutralize the original form of the virus. However, the antibodies inconsistently neutralized the beta variant. However, a single dose of mRNA vaccine boosted neutralizing antibody titers against both original strain and the beta variant by up to a 1000-fold.

Therefore, we can conclude that persons who have recovered from COVID certainly do have some degree of immunity, but it is not as robust as the immunity derived from vaccination However, those who have recovered from COVID who then are subsequently vaccinated have even stronger immune responses compared to those who are vaccinated but did not have prior COVID infection.

Those who had COVID last year and are not vaccinated, likely do not have predictable immunity to all of the new variants, especially the delta variant that is now the predominant variant in the US. However, those who had prior COVID and have received the mRNA vaccine should have a high of protection against these variants.

So, if you have had COVID, so long as you have recovered from the initial illness, including those who have PASC (long-COVID), please get vaccinated ASAP if you have not already done so.

The Affordable Care Act Survives Another Challenge in the U.S. Supreme Court

I have previously posted a number of blog pieces on the legal challenges to the Patient Protection and Affordable Care Act (commonly referred to as the Affordable Care Act) since its enactment in March of 2010. To understand the basis for the latest challenge to the constitutionality of the Affordable Care Act (“ACA”), one needs to understand a prior challenge decided by the Supreme Court in 2012.

The Supreme Court was presented with the question as to whether Congress had a Constitutional power that would allow it to pass a law, the ACA, that required people to purchase insurance or pay a penalty. This requirement in the ACA is referred to as the individual mandate, a requirement that notwithstanding certain exceptions, required adult Americans to have qualified health insurance, referred to in the law as “minimum essential coverage,” or pay a penalty each year when they file their taxes.

So, let’s back up a minute. The U.S. Congress may only enact laws for which a power has been granted to it under the U.S. Constitution. One of the broadest powers granted to Congress is under the Commerce Clause of the U.S. Constitution, which allows Congress to regulate interstate commerce. Those challenging the constitutionality of the ACA acknowledged Congress’ power to regulate interstate commerce when people choose to be engaged in the buying and selling of products, but argued to the Court that the Commerce Clause is not so broad as to grant Congress the power to force people into commerce. In other words, if a business sells its products across state lines, Congress certainly has a right to regulate that commerce; however, Congress cannot force persons to buy those products. The U.S. Supreme Court agreed and held that the Commerce Clause of the U.S. Constitution did not grant Congress the power to enact the individual mandate in the ACA and penalize persons for choosing not to purchase insurance. Thus, the U.S. Supreme Court could have struck the ACA down as unconstitutional because Congress’ act exceeded the power granted to it by the Commerce Clause had the Commerce Clause been the only source of authority to Congress in a matter such as this, however, the Court’s majority determined that another power, the Taxing Power, did allow Congress the constitutional power to enact this provision of the ACA.

As broad as the Commerce Clause is, the Taxing and Spending Clause of the U.S. Constitution is even broader. Article I, Section 8 of the Constitution gives Congress the power to “lay and collect taxes, duties, imposts and excises, to pay the debts and provide for the common defense and general welfare of the United States.” Although Congress had referred to a “penalty” for the failure to have qualified health insurance, the Court’s majority interpreted the penalty to be a tax in that it is collected by the IRS, the penalty is based upon income level, the IRS was authorized to deduct the penalty from any tax refund otherwise owed to the taxpayer and the penalty generates revenue for the federal government.

Now, skip forward to 2017. Congress passed an amendment to the ACA that zeroed out the penalty. In other words, while the mandate to have qualified health insurance remained in place, there was no longer a penalty for the failure to maintain such insurance coverage and the IRS changed the form 1040 to no longer require taxpayers to indicate whether they had maintained minimum essential health insurance coverage during that tax year.

This led a group of 18 Republican states led by the state of Texas and two individuals to file suit to again challenge the constitutionality of the ACA. Because there no longer was a penalty and thus no revenue generated by the federal government, plaintiffs argued to the U.S. District Court that the individual mandate could no longer be supported on the basis of the Taxing and Spending Clause (because it could no longer be construed to be a tax if there was no revenue to be generated given that the amount of the penalty was now $0), and therefore was unconstitutional. The District Court agreed.

When a provision of a law is found to be unconstitutional, the court must then decide whether the unconstitutional provision can be severed from the law to allow the remainder of the law to stand. In this case, the District Court judge held that the individual mandate was so critical to the overall functioning of the ACA and such an integral part of the law that the unconstitutional individual mandate could not be severed from the law, and therefore, the entire ACA must be struck down as unconstitutional.

The case went up on appeal to the U.S. Court of Appeals for the Fifth Circuit. That court upheld the lower court’s decision that the individual mandate was now unconstitutional, however, the court determined that the district court judge had not conducted a sufficient legal analysis to determine whether the individual mandate could be severed from the law leaving the remainder of the ACA intact, and therefore, remanded the case back to the district court for this determination.

In a bit of an unusual and certainly surprising move, the U.S. Supreme Court decided to hear this case in this term that began in October of 2020. The reason that is unusual and surprising is that it is generally the practice of the Court to allow cases to fully play out in the lower courts before they hear a case. In other words, what many of us expected was that the district court would decide the issue of severability, that decision would then be appealed to the 5th Circuit by whichever party that did not prevail, the 5th Circuit would then render a decision and then the case would be considered by the U.S. Supreme Court, perhaps in the Court’s term that would begin in October of 2021.

Nevertheless, the Supreme Court heard oral arguments on November 10, 2020 and issued its opinion on June 17, 2021. The case is styled California et al v. Texas et al.

Justice Breyer wrote and delivered the opinion of the majority (7 justices) of the Court.

To understand the Court’s opinion, one must understand what cases are allowed to come before a court. The U.S. Constitution says that federal courts may only decide “cases” and “controversies.” If you are not an attorney, that probably seems like almost anything would qualify, but in fact, there are important limits on the courts. Here are some of the limitations:

  1. Statute of limitations. There are some very important reasons that we place time limits on most things that might otherwise be a cause of action and subject someone to financial liability or could subject someone to arrest for a crime. Examples of those considerations include the availability of records which may no longer be in someone’s possession and witnesses who may no longer be available or remember the event in question. So, as an example of a statute of limitation, if I believed that I was wrongly terminated from my job six years ago, but I didn’t worry about it because I found a new job that I thought was probably better, but then I became disabled and could no longer work and felt that I could really use the money that I might get in a lawsuit against that former employer from six years ago, the laws of most states would bar my lawsuit due to the passage of those intervening six years. Thus, while this may constitute a “controversy,” a federal court would lack the ability to hear the “case” because it would be barred by the applicable statute of limitations.
  2. Another limitation is when a case becomes “moot.” As an example, let’s consider a case in which a homeowner’s association might file suit against a developer who has announced that he will be undertaking a project adjacent to that HOA’s neighborhood that the HOA believes will impair the values of its members’ homes. After the case has been filed, but before the court renders a judgment, the developer announces that his funding has fallen through and he will not be able to undertake the project afterall. The court would then dismiss this case as “moot,” because there no longer is a “controversy.”
  3. There are other limitations that could be considered, but let’s now turn to the limitation that is at question in this case. This is the issue of “standing.” Courts must determine that those who file suit have the standing to do so in order for the court to hear and decide the case. A plaintiff has standing only if he can “allege personal injury fairly traceable to the defendant’s allegedly unlawful con[1]duct and likely to be redressed by the requested relief.”

Let me provide an example to help you understand why standing is so critical to bringing a case. Let’s assume that that someone who is uninsured backs into my mother’s car and causes $500 worth of damage. My mother decides that she doesn’t wish to file a claim with her insurance company because her deductible is $500 and she doesn’t wish to spend the time and go through the trouble to sue the individual who hit her car to recover the $500. However, I feel aggrieved by all of this so I decide to file a lawsuit to recover the $500. The court would likely determine that I do not have standing. It was my mother, not me who suffered the injury (the loss of $500), and absent some other legal right to stand in her shoes (e.g., if my mother was cognitively impaired and I had her power of attorney or if my mother had passed away shortly after the accident and I was named as the executor of her estate) it is my mother, not me who would have standing to file suit. Now, keep in mind, the defendant was wrong in backing into my mother’s car and the defendant did cause damage for which a court could provide a remedy (an award of $500), however, without me having standing, the court will never decide the defendant’s guilt or innocence, nor determine the damages. The case will simply be dismissed for my lack of standing.

So, now let’s see how standing is an issue in the constitutional challenge of the ACA. Recall that the rule of law is that a plaintiff has standing only if he can “allege personal injury fairly traceable to the defendant’s allegedly unlawful con[1]duct and likely to be redressed by the requested relief.” In this case, the Court held that “neither the individual nor the state plaintiffs have shown that the injury they will suffer or have suffered is “fairly traceable” to the “allegedly unlawful conduct” of which they complain.” Let’s examine why.

The individual plaintiffs made their case for standing along the line of this argument. We are law-abiding citizens. We do what the law requires of us, even if there is no penalty for failing to do so. Because the law (the individual mandate) requires us to maintain minimum essential coverage, we do so, but if it were not for the law, we would either not purchase insurance or we would purchase a health plan with far fewer benefits and at a far lower premium that would not meet the minimum essential coverage requirement. Therefore, we are harmed because the minimum essential health plan coverage that we obtain to comply with law is more expensive than the coverage we otherwise would have purchased.

The Court determined that the individual plaintiffs do not have standing because they fail to satisfy the “traceability” requirement of their alleged personal injury. Again, the rule of law is that a plaintiff has standing only if he can “allege personal injury fairly traceable to the defendant’s allegedly unlawful con[1]duct and likely to be redressed by the requested relief.” The Court points out that while the law tells them to maintain qualified insurance coverage, the government has no way to enforce this. With a penalty of $0, there is no ability for the IRS to enforce compliance with the law. The law only provided for the IRS’ ability to enforce payment of the penalty, not the ability to enforce the taxpayer to maintain minimum essential insurance coverage. Thus, the injury that the individual plaintiffs complain of – the cost of maintaining qualifying insurance – cannot be traced to any action on the part of the government. Thus, in order for the individual plaintiffs to have standing, they would have to demonstrate that the injury they complain of (the costs of maintaining the required insurance) can be traced to the government’s actual or threatened enforcement, and they cannot.

The Court then turns to the question of standing for the state plaintiffs. The states alleged that they suffered injury due to the increased administrative burden and costs associated with setting up and running the insurance exchanges, the growth in their Medicaid enrollment and the associated costs to the state as people seek to comply with the law’s requirements for minimum essential coverage and are determined to be eligible for Medicaid, and other acts to comply with the requirements under the ACA. The Court determined that the states had not demonstrated their injury in that they failed to show that in fact the individual mandate without any penalty to individuals did or would cause more people to enroll in state health programs than otherwise would. The Court’s majority again found that like the individual plaintiffs, the states have failed to demonstrate that even if they did incur financial injury that those injuries are due to any actual or threatened action on the part of the federal government or its agencies.

Further, the Court found that many of the administrative burdens and costs the states complained of were not in response to the individual mandate in question, but rather other provisions of the ACA for which the states offered no evidence that the burdens would be relieved if the individual mandate was struck down as unconstitutional and severed from the law. Thus, the states’ injuries are not fairly “traceable” to the section of the law that they assert is unconstitutional and therefore illegal.

Thus, the Court’s majority determined that there was no “case” because none of the plaintiffs had standing to bring the challenge. Thus, the decision of the 5th Circuit was ordered vacated and the case was remanded back to the District Court with instructions for the judge to dismiss the case for lack of standing.

So, the ACA stands as the law of the land. What are the important take-aways from this case?

  1. The first point I would make is that the institution of the Supreme Court has been preserved at a time when we have seen many of our other institutions falter or fail in response to political pressures. Although the Supreme Court is not immune from political processes and influences (justices are appointed through a very political process), it is critical that cases be decided based on the rule of law. The very functioning of our government, our legal system and society is highly dependent upon legal predictability, which requires an adherence to and respect for legal precedents in most cases. The fact that this decision was 7-2 with both Republican and Democrat-appointed justices and conservative and liberal justices in agreement was important to preserving the standing of the Supreme Court (pardon the pun). President Trump was not shy in expressing his disdain for the ACA and pledged that his three Supreme Court justice appointments would help ensure the striking down of the law. Instead, two of the Trump-appointed justices joined with the majority and only one joined the minority in dissent.
  2. The points made in number 1 call into question the very political process that the Senate goes through in regard to confirming judicial appointments to the bench. We will recall Senate Leader McConnell’s intense efforts to stall the confirmation of a justice appointed by a Democratic President in the last year of his term and the threat to do so again, while making a tortured distinction to justify appointing a justice during the last year of a President of the same party. And, then we all witnessed the drama and attempted character assassination of Justice Kavanaugh when he went through Senate confirmation hearings. To what effect? And, this is not a recent phenomenon. There have been many examples of justices being appointed to the bench based upon their expected conservative or liberal leanings who have decided cases in ways that surprised their political supporters. Senate confirmation will remain an important part of the process for judicial appointments, but it is not clear that all the political maneuvering is productive.
  3. The ACA has now withstood three constitutional challenges in the U.S. Supreme Court. It has been the law of the land for 11 years. The ACA is not perfect, but at this point, it seems that the best course is to do the hard work of either trying to improve upon the imperfections in the ACA or to replace it with something better. Further legal challenges are unlikely to be productive.
  4. While many legal experts expected that the challenge would not be successful, it could have been. It was irresponsible of Republicans to bring this case without having a contingency plan in place. It is hard to describe the disruption to the American health care system if all of the provisions of the ACA were suddenly terminated. Among the many disruptions would the end of funding to states for Medicaid expansion, the end of tax credits and subsidies for Americans to purchase health insurance, the end of the health insurance exchanges and their funding, the end of guaranteed issue (the prohibition against insurance companies declining to provide insurance coverage to people based on their past medical history or health risks), the end of community rating (the protection for those at higher risk against being charged significantly higher premiums) and many other provisions that would result in a significant increase in the uninsured and significant increases in bad debt and charity care for health care providers that could result in higher prices at a time when we need to focus our efforts at making health care more affordable.

In future blog posts, I will offer my analysis and recommendations for what we can do to improve the American health care system and reduce health care costs. Until we can address the opportunities to improve health care, I am relieved that the Supreme Court saved us from ourselves.

Can A Hospital Require Its Employees to Be Vaccinated Against COVID?

A number of hospitals and health systems have announced that their employees will be required to be vaccinated against COVID. Among the first to make this requirement was Houston Methodist, a large and well-respected health system in Houston, Texas. A group of employees facing loss of their jobs sued Houston Methodist making a number of claims as to why it was illegal for their employer to require vaccination. That case has now been decided. Before we go through the court’s analysis and decision, let’s frame up some of the issues.

The requirement for vaccinations is not new. Schools have long required certain immunizations for their students. Many readers of my age will remember getting our polio vaccine sugar cubes at school. Hospitals have long required new employees to show evidence of immunity to certain diseases such as hepatitis, measles, rubella and mumps or get vaccinated against these diseases. Most every hospital in the country requires their employees to receive an annual influenza vaccination. Of course, exceptions are made for those with medical contraindications or sincerely-held religious beliefs that would prohibit them from receiving the vaccines.

Conflict arises when an employer has a legitimate interest in desiring to protect its workforce and customers from health risks caused by a contagious disease and when individuals believe that exercise of their personal freedom not to be vaccinated will mean the loss of their employment.

Hospitals face additional pressures to require vaccination than most businesses. First of all, those infected with the contagious disease, in this case COVID, are more likely to seek services from a hospital than many other types of businesses. Whereas with other businesses, someone who is infected with the SARS-CoV-2 virus may be in and out of that business in minutes to hours, those requiring the services of a hospital are often hospitalized for days or weeks posing a more protracted risk to the hospital’s employees. In addition, unlike the services of most businesses, hospital services may require health care workers to be in very close contact with infected patients and cause through the performance of medical procedures a patient to cough or expel more virus than with normal breathing that would occur in most businesses.

Not only do infected persons create a special risk for health care workers, but health care workers can create special risks for certain patients. By the very nature of hospital services, patients often tend to be those that are at highest risk for infection and for worse outcomes from infection. This would include the elderly, those with multiple underlying medical conditions, and patients who are immunocompromised, including patients undergoing chemotherapy, patients preparing for or who have received bone marrow or solid organ transplants and newborns and infants.

In one recent poll, 79 percent of respondents indicated that they want health care workers to be vaccinated to ensure their own safety as potential future patients.

Hospitals obviously have an interest in ensuring that they keep employees safe and maintain sufficient staffing levels to care for patients. Many hospitals also offer their employees and their families self-funded health plan coverage and have an interest in keeping those health care costs down for everyone. It also is unclear at present what liability a hospital may have if a patient were infected by a staff member and suffered harm.

Now, let’s turn to the interest of the plaintiff employees and their claims and examine how the court addressed those claims.

The case was decided by Judge Lynn Hughes in the United States District Court for the Southern District of Texas and the judge entered his decision on June 12, 2021.

The first claim addressed by the court was that the plaintiffs were wrongfully terminated. It is important to note that Texas is an “at-will” employment state. The premise of plaintiffs’ claims regarding wrongful termination was that Houston Methodist was requiring employees to take an experimental vaccine that was dangerous, and because these plaintiffs would not do so, they either had been terminated or were facing termination. The judge concluded that both claims that the vaccine was experimental and that the vaccine is dangerous were false, and that, in any case, whether those claims were true or not, they were legally irrelevant.

The judge points out in his decision that Texas law (even though the case was heard and decided in federal court, the court was required to apply Texas law in deciding the case) only protects employees from being terminated for refusing to commit an act that would potentially impose criminal penalties on the worker. The judge set out the case that plaintiffs would have to prove in order to be protected under a claim of wrongful termination: (1) that plaintiffs wee required to commit an illegal act – one for which they could suffer criminal penalties, (2) plaintiffs refused to commit the illegal acts, (3) plaintiffs were terminated, and (4) that the only reason for termination was their refusal to commit the illegal act.

The judge quickly dismisses this cause of action because receiving a COVID vaccination is neither illegal nor exposes plaintiffs to any criminal penalties.

Next the judge addresses the plaintiffs’ assertions that Houston Methodist’s vaccination requirement violates public policy. The judge points out that Texas law does not recognize an exception to at-will employment for actions inconsistent with public policy, but goes further to state that even if it did, this vaccination requirement would not be contrary to public policy. Judge Hughes references Supreme Court precedent that neither involuntary quarantine for contagious diseases nor state-imposed requirements for mandatory vaccination violate an individual’s due process rights. Further, the Equal Employment Opportunity Commission (EEOC) issued guidance in May that employers can require employees to be vaccinated against COVID-19 subject to reasonable accommodations for employees with disabilities or sincerely-held religious beliefs, and Houston Methodist complied with this guidance.

Plaintiffs also alleged that Houston Methodist’s vaccination requirement violates federal law in that employees cannot be required to take “unapproved” medications, and none of the COVID vaccines have received full approval from the FDA. Judge Hughes pointed to federal law that does allow the Secretary of Health and Human Services to introduce into commerce medical products intended for use during a public health emergency. Further, the court pointed out that the federal law neither expands nor restricts the rights and responsibilities of private employers, in fact, the federal law in question does not apply to private employers. Further still, the federal law does not provide for a private cause of action against either the government or private employers.

Plaintiffs also allege that the vaccine requirement violates federal law that protect human subject in clinical trials. Plaintiffs assert that because the COVID vaccines are not fully approved, their use is experimental and thus, employees cannot be coerced into receiving the vaccines. However, Judge Hughes holds that the vaccines are not experimental, Houston Methodist is not conducting a clinical trial with its employees and therefore, this provision of federal law also does not apply.

Another claim made by plaintiffs was quite shocking. They alleged that Houston Methodist’s vaccination requirement violates the Nuremberg Code analogizing Houston Methodist’s actions to those of forced medical experimentation on Jews during the Holocaust. Judge Hughes rightly chastised plaintiffs for making such a reprehensible analogy and pointed out that private businesses are not subject to the Nuremberg Code.

Here is one of the most important excerpts from Judge Hughes’ opinion:

“Although (plaintiffs’) claims fail as a matter of law, it is also necessary to clarify that (plaintiffs have) not been coerced. (Plaintiffs say that they are) being forced to be injected with a vaccine or be fired. This is not coercion. Methodist is trying to do their business of saving lives without giving them the COVID-19 virus. It is a choice made to keep staff, patients and their families safer. (Plaintiffs) can freely choose to accept or refuse a COVID-19 vaccine; however, if (they refuse, they) will simply need to work somewhere else.”

Where do things go from here? The plaintiffs in this case could file an appeal, but most of the holdings in Judge Hughes’ opinion are well settled law, and it would seem unlikely to me that this decision would be overturned on appeal. I think this case likely settles the matter, at least for workers in Texas.

It is likely that there will be other lawsuits in other states and their states’ laws regarding wrongful termination may differ from Texas’ law to such an extent that would allow plaintiffs to prevail on this claim. However, many of us expect that the FDA may grant full approval to the currently available COVID vaccines in the U.S. over the summer or by early fall. If that happens during the pendency of these lawsuits, it will likely make some of the suits, or at least some of the causes of action, moot in that plaintiffs are likely to make similar arguments to those made in this Texas case that the fact that the vaccines are not fully approved should be a basis to prevent employers from requiring them. The result will be that many of these lawsuits will then be dismissed by the courts.

Thoughts on the New CDC Guidance

One of my Twitter followers asked me for my reaction to the CDC’s welcome, though surprising to many of us, new guidance that fully vaccinated individuals need no longer wear masks in most settings. At the time of the tweet, I was still trying to determine what led the CDC to take this step much sooner than I had anticipated, and my response was not conducive to 140 characters.

Let me first get a few things out of the way. I have tremendous respect and appreciation for the work of the CDC experts and all of their information and guidance during the pandemic. They are under a lot of pressure and the situation is complex and constantly evolving. Oftentimes, there is no “right” answer, but rather the CDC must use their best judgment in coming up with guidance. I have less concern with the guidance itself than with the timing.

Second, I know that everyone is anxious to get back to “normal,” and I know that there is a great deal of frustration with the limitations that we have had to live under during the past 14 months. The genie is out of the bottle and I am not suggesting that the CDC should revoke or revise this guidance or that state and local agencies should not follow the guidance.

The point of this blog piece is two-fold. First, we should always evaluate decisions made so that we learn what worked, what didn’t work or what unintended consequences resulted from the decisions made so that we can employ lessons learned in the future. Second, some people are wrestling with and trying to come to grips with what this means for them. I hope that this additional information will assist people in making individual decisions as to how to deploy this guidance in their own lives.

The timing of this new guidance caught many of us off-guard. The CDC had just issued updated guidance about when people could safely be outdoors without masks. Perhaps the CDC intended to iteratively unveil their guidance, but it seems strange to me that if they were working on guidance that would be much broader and address mask use by vaccinated individuals that they would have issued these two sets of guidance just days apart.

Factors weighing in favor of this guidance:

  1. The CDC is quite right that the vaccines currently authorized in the U.S. are extremely effective, at least against the wild-type virus and B.1.1.7 (the UK variant). At this time, we do not have conclusive data, but it is believed that these vaccines are somewhat less effective at preventing infection by P.1 (Brazil variant) and B.1.351 (South Africa variant), though there is some evidence and it is thought very likely that these vaccines will prevent severe outcomes and death in persons infected with the variants of concern that we have identified.
  • A growing body of evidence suggests that fully vaccinated people are less likely to have asymptomatic infection and potentially are less likely to transmit the infection to others than those who are unvaccinated.
  • Relaxation of the restrictions on fully vaccinated individuals may promote more vaccine hesitant individuals to go ahead and get vaccinated. (There is also a counter-argument below).

Concerns:

  1. Slippery slope and inconsistencies. One of my criticisms of guidance that has been issued or decisions made has been internal inconsistency. Great examples have been some past decisions by school boards (e.g., due to high levels of disease transmission, instruction should move to full remote learning, but all sports could continue in-person) or hospitals (e.g., visitor policies to address the risks of the SARS-CoV-2 virus that allow visitors for transplant patients but not for surgery patients). Although I haven’t heard much yet, I certainly expect the CDC to be challenged as to why they feel that vaccinated individuals may gather without masks and without distancing indoors and outdoors, but they must wear masks while using public transportation and while in facilities included in the exceptions to this new guidance. There may be a good reason, but if it is not apparent, people come to the conclusion that the guidance doesn’t make sense. Every parent knows that when adult decisions are made that appear inconsistent to children, they become confused and don’t have confidence as to how to decide their behavior when the next situation presents itself.

Here is another example of the CDC’s inconsistency. The CDC indicates that vaccinated individuals are very unlikely to become infected and that the vaccines appear to be effective against the variants. But, then why does the U.S. require fully vaccinated international travelers arriving in the U.S. to be tested within 3 days of their flight (or show documentation of recovery from COVID-19 in the past three months) and recommend that these individuals should still be tested 3 – 5 days after their trip? Why is the CDC concerned that those vaccinated individuals may be infected?

  • I have also indicated to some that I wish the CDC had made their guidance a bit more nuanced. I was pleased that they called out the risks for those who are immunocompromised and that they should seek specific guidance from their physicians as following the new CDC guidance may not be safe for them. Many people may not realize that tens of millions of Americans are immunocompromised. Conditions leading to immunocompromise include immunodeficiency disorders, certain malignancies and many people who are undergoing treatment for cancer, many persons who have undergone transplants, persons with HIV infection, and persons taking certain medications to control a number of diseases and conditions. In fact, if your workplace has 100 employees, it is likely that 5 – 10 persons have one of these situations that would classify them as immunocompromised, and of course, more will have a family member at home who would be considered immunocompromised.

But what about other groups of people who are not vaccinated or who are vaccinated, but may not have robust protection from the vaccine (e.g., the frail elderly) who live in the same household with adults who are vaccinated? I would still have concerns about those adults being out in large groups of people without masks in close proximity when the vaccination status of those persons is unknown and then returning home without masks with these vulnerable persons in their households. While the effectiveness of the vaccines against symptomatic infection is quite good (in the 90s), the effectiveness of the vaccines in preventing asymptomatic infection is less (70s and 80s, and we are less certain of these data for many of the variants).

  • As I said, my concern is less about the guidance than the timing. The FDA and CDC has just opened up vaccinations to children age 12 and above. The UK variant (B.1.1.7) is now the most prevalent variant in the U.S. Children play a much greater role in the transmission of this variant than they did in the transmission of the forms of the virus we dealt with for the past year. It seems to me that it would have been advantageous to continue our precautions for another 6 weeks to allow time for more Americans to be vaccinated, including this newly eligible age group. In fact, I think the CDC could have modified their guidance to allow states to implement this new guidance once a target of state residents over the age of 12 (e.g., 70%) were vaccinated to serve as an added inducement for vaccinations of their citizens.
  • Another disconcerting aspect to the timing of this guidance was that the CDC only officially recognized airborne (aerosol) transmission days before this new guidance. Airborne transmission is the reason for greater concern of transmission of the virus indoors as opposed to outdoors. It then is slightly concerning that having just recognized this mode of transmission so recently, the CDC could conclude that vaccinated individuals were safe without masks indoors. They may be, I just wish that they would have explained why they came to that conclusion, if they did. For example, based on the new guidance, teachers could now go mask-less indoors in schools all-day long, surrounded by 30 – 40 students who are unvaccinated. That would not be something I would recommend based on the studies I have seen.
  • I am thrilled that we have such effective vaccines. Preventing people from becoming severely ill or dying is a huge accomplishment, but our long-term success in managing this pandemic is reducing the transmission of the virus so that we avoid the long-term consequences and costs of infection and so that we prevent new variants from arising that might threaten the effectiveness of our vaccines. A central question that I believe that the CDC should have answered for themselves before issuing this guidance was whether this guidance would slow the transmission of the virus. I’m not sure of the answer, but I fear it will not.
  • As I listened to Dr. Walensky, the Director of the CDC, respond to questions about the guidance, it is clear that much of the guidance is provided with the expectation that persons will be honest and exercise concern for others and continue to follow the recommendations for masking and physical distancing if unvaccinated. I will let my readers assess how likely they think that is based upon what we have witnessed in the past year.
  • While the CDC offers the position that this new guidance may be an incentive for unvaccinated Americans to get vaccinated, and I certainly think that is possible, I think it is also possible that it may do the exact opposite. Given that we currently do not have good ways to determine whether persons are vaccinated or unvaccinated in most circumstances, one does have to wonder whether this new guidance has just eliminated a possibly important motivator for those who are hesitant to get vaccinated in that they can just show up to businesses or events unmasked, unvaccinated and without the need for physical distancing. There is a counter-argument to be made that in fact, this has actually provided another motivator for unvaccinated persons to get vaccinated because unvaccinated persons were previously protected by restrictions that required masking, distancing and gathering size limits, but now will be subjected to much greater risk.

It is for this very reason that we have also just made things riskier for our children under 16 who haven’t yet had an opportunity to get vaccinated and made things much more dangerous for those who are immunocompromised to go to public spaces. We must keep in mind that while children are very unlikely to be hospitalized or die from COVID, we are learning more and more about long-term effects of COVID in people of all ages, including children. I have already heard from some who are immunocompromised who feel that they have just been pushed back into their homes. We should also keep in mind that it is in all of our best interests to prevent immunocompromised individuals from getting infected because it is believed and there is evidence to support that these infected individuals are able to give SARS-CoV-2 essentially a real-life laboratory in which to design new variants that evade whatever limited immune capabilities these individuals have and these new variants can then enter into our general population.

  • Although there is much more that could be discussed, let me end with this. Here is our situation. We do not have enough Americans vaccinated and we are seeing the frequent emergence of new variants ever since last October. While “herd immunity” remains elusive, and likely will for some time, and perhaps we never will achieve herd immunity, we must keep in mind that as new more transmissible variants come on the scene and prevail, the percent of the population necessary to be immune to achieve herd immunity increases, making it even more elusive. Here is the conclusion from a recent preprint modeling study

(https://www.medrxiv.org/content/10.1101/2020.12.23.20248784v1.full.pdf):

“(R)elaxing NPIs (non-pharmaceutical interventions – masking, distancing, gathering size limitations, etc.) before attaining adequate vaccine coverage could result in tremendous loss of potentially averted cases, hospitalizations and mortality. In … (one) … scenario … in which all NPIs are immediately relaxed before the vaccination campaign, the averted infections are nominal. The findings based on this rapid analysis underscore the importance of maintaining NPIs throughout the upcoming SARS-CoV-2 vaccination campaign to maximize the public health benefit.”

In conclusion, let’s celebrate where we are in the U.S. with declining cases, hospitalizations and deaths, the triumphs of medicine and science, and the unprecedented development of highly effective vaccines. But, at the same time, let’s not declare victory yet and realize that as long as the world is not vaccinated and the transmission rates remain high, we remain vulnerable. No question that the new CDC guidance is welcomed by many. But, let us also remember that some among us have reason to now be more fearful.

Call to action:

  1. If you are not yet vaccinated, please do so at the earliest opportunity.
  2. If you choose to remain unvaccinated, please act responsibly to protect others. Frankly, it is also in your best interests to do so. Not only will you be endangered by those who don’t, but if we do experience outbreaks due to those who are unvaccinated taking advantage of this new guidance, that guidance will change, state and local governments may have to act, and frankly, this will provide the fodder for vaccine passports.
  3. Please respect others’ choices to take extra precautions. You likely are not aware of what special circumstances they or their family members may face. The guidance is permission for those who are vaccinated to stop wearing masks under most circumstances, it is not a prohibition against masking and distancing.
  4. I hope that the CDC studies the results from this guidance and if it does create unintended consequences, it needs to learn from this for the future.

It Will Get Worse Before It Gets Better

For the past two months, I have been warning of a likely 4th surge of coronavirus cases in Idaho, likely to occur by late March or sometime in April. I have been pleading with our local school districts not to bring back more students to school than can be successfully distanced given the CDC’s prediction that the UK (B.1.1.7 – Kent) variant would be dominant in the US by the end of March. Obviously, it doesn’t make sense to decrease the precautions you are taking when you will be dealing with a new form of the virus that is 40 – 70 percent more contagious, and reportedly causes more severe disease.

It seems that my warnings have largely been ignored and quite surprisingly, one school district decided that my admonitions were inconvenient, leading the board to determine that they would find another adviser who could be more supportive of their plans to bring back all students without proper distancing.

Even more surprising was the fact that the school board never asked me to explain why I was so concerned, nor the even more obvious question, if they were intent on disregarding my warnings: how can we bring all the students back in the safest possible way given the increased risks? I had offered suggestions last fall as to ways we could safely bring back more students and still maintain six feet of distancing, but no one seemed interested, and now it would be much more difficult. Had we done this planning last summer, we likely could have safely had students for full in-person instruction for most of the school year.

So, I thought that I would take this opportunity to explain to my blog followers why I have been predicting this 4th surge, why I think the evidence has only grown stronger over the past two months to support the likelihood of a 4th surge and also refute some of the reasons given by others as to why they don’t believe such a surge will occur.

  1. Let’s start off with looking at the epi curve for the US (see below).

To understand what I mean by a fourth surge, look at the graph. The first surge began on March 12, 2020. The peak of the first surge came on April 9, 2020 with a 7-day moving average of daily new cases of 9.9 per 100,000 population.

Let’s take a moment to give perspective on what these numbers of new cases mean with respect to the degree of disease transmission. People often ask me when we will achieve herd immunity. I don’t know, other than I know it is not going to be April as a well-known physician author wrote recently (see my prior blog piece for an explanation as to why that is completely unrealistic.) However, I am pretty sure we won’t get there in 2021. While everyone wants to know the percentage of the population that has to have immunity to achieve herd immunity (and no one knows the answer to that), I tell them one way to know when we get there is to look at the 7-day moving average of daily new cases. It should be <1 daily new cases per 100k and remain that low for months. We are nowhere near that.

Community spread is when the level of disease transmission in a community is such that we no longer can identify the source of infection. Early on in the pandemic, there was a period of time that we could identify an exposure from travel or an infected person. When we get to the levels of disease transmission associated with community spread, we no longer can reliably pinpoint sources of infection. Using the metric of the 7-day moving average of daily new cases, community spread is 1 – 9 daily new cases per 100k population. So, you can see that at the peak of the first surge, we were at the highest level of community spread.

When the 7-day moving average of daily new cases per 100,000 is in the range of 10 -24, we refer to that as accelerated community spread and when > 25, we refer to that as the tipping point – generally the point where public health experts would call for serious mitigation measures, e.g., stay-at-home orders, closure of certain businesses, etc.

Now, notice something concerning from the epi curve above. We never came down to that well-controlled level of disease transmission of < 1. The lowest point following the first surge occurred on May 28, 2020 when the 7-day moving average of daily new cases per 100,000 was 6.5 – community spread.

We began the second surge from this elevated level of disease transmission. In other words, we loosened up our restrictions too soon. If you recall, people were celebrating the cases coming down, began getting together in larger groups without masks, believing the worst was over, and surely as we moved into the beginning of summer, the virus would go away, though many of us were warning that there was no evidence that there would be seasonality to this virus, and even if there was, it likely would be back in the fall with a vengeance.

So, the second surge was under way at the end of May/beginning of June and peaked July 22, 2020 at a level of 20.3. Notice that this second surge was higher than the first, and like the first, we again did not come down to levels of disease transmission that were under control before we began the third surge. In fact, the lowest point after the second surge was on September 12, 2020 when the 7-day moving average of daily new cases per 100,000 was 10.3. Note that this low point was higher than the low point following the first surge and represented accelerated community spread.

Having this springboard of accelerated community spread resulted in an even higher third surge that peaked January 8, 2021 with an unbelievably high disease transmission rate reflected by a 7-day moving average of daily new cases of 78.3 per 100,000.

Once again, as happened with each of the two prior surges, cases came down from the peak, and I began hearing the all-to-common refrain by now that things were returning to normal (how soon people forget), but coupled by the even more concerning actions by elected leaders across the country to loosen and often terminate all public health measures in place to contain the spread of the virus.

But, while others saw reason to cheer, I became alarmed in the third week of February when I saw the sharp decline begin to plateau, and like the first two surges, at way too high a level of disease transmission – the lower range of accelerated community spread and the higher end of the range for community spread. I had already seen this movie twice and I knew how it turns out.

  • So, now let’s look at Idaho’s epi curve:

Idaho, too has experienced three surges, but there are a few differences. Our first case was on March 13 and our first surge peaked on April 4, 2020 at 6.5 average daily new cases per 100,000. But by May 13, we were down to average daily new cases of only 1.3, almost at the containment level. The difference from the US disease transmission was, due to the brave actions of our governor, we had a stay-at-home order in place and it worked. Recall that the U.S. was almost 6 times higher than this level of disease transmission. We know that the governor’s actions saved lives.

Our second surge took off in the middle of June and hit a peak on July 19 at a level of daily new cases of 31.9 per 100,000, higher than the U.S. peak for the second surge. Unfortunately, our low point after the second surge was only 13.4 on September 13. This time, without the stay-at-home order and with COVID-fatigue already setting in, like the rest of the country, Idahoans began relaxing their compliance with public health measures too soon.

Our third surge would begin almost immediately and peaked on December 10 with a 7-day moving average of daily new cases of 91.7 per 100,000. Although cases declined significantly after hitting this peak, as they had in every prior surge, again, I became concerned in mid-February when our state cases hit a plateau and remained in the community spread range, even while many were celebrating a return to normal and our elected leaders were saying all kinds of ridiculous things, like this did not even qualify as a pandemic and there was no longer any need to wear masks, physically distance or restrict the size of gatherings. Of course, in an interesting twist of karma, the legislature then found itself with an outbreak of COVID in the Capitol and as a result had to interrupt the session to recess in order to stop the spread of infection among lawmakers and their staff members — a reminder that we can deny COVID, we can spread lies about it, we can create alternative facts, we can find some doctor out there to tell us what we want to hear that has already been debunked by the medical community, and we can embrace conspiracy theories, but that merely plays into the virus’ hands resulting in many needless infections, as science will always prevail in the end.

While the U.S. and Idaho epi curves explain why I was concerned about a possible fourth surge by mid-to-late February, why was I concerned even before then that we would experience a fourth wave?

There have been two times during the pandemic that we could get a preview of coming attractions. The first was at the beginning of the pandemic in January of 2020 when we could look at the outbreak in Wuhan to see what we might eventually be dealing with in the U.S. – cases of pneumonia that seemed to disproportionately land older people in the hospital. The second time has been since December 2020 in Europe, particularly the U.K., as the B.1.1.7 (Kent) variant quickly evolved over the course of just two to three months to become the dominant strain in the U.S. causing an increase in cases in all age groups and a new surge that was far greater than anything the U.K. previously experienced and was really a surge upon a surge. Let’s look at the U.K. epi curve:

The first surge in the UK peaked on April 24, 2020 at a 7-day moving average of daily new cases of 7.1 per 100,000. But, unlike the U.S., the U.K. successfully brought their disease transmission down to below 1 by July 4, 2020 and it remained low for weeks.

By August 6, 2020, cases began to very slowly rise. Then a sharp rise in cases began at the very beginning of October. At the end of October, the U.K. implemented a lockdown, but allowed schools to remain open. Cases peaked on November 16 at a 7-day moving average of daily new cases of 37.3 per 100,000. By December 4, 2020, cases had come down to a low point of 21. Keep in mind, this level is still in the accelerated community spread level of disease transmission.

But something else was happening under the radar. A new variant had emerged in the U.K. just outside of London in the village of Kent in October. This variant came to be known as B.1.1.7. We saw that it only took 2 – 3 months for B.1.1.7 to become the dominant circulating form of the virus in the U.K. While cases were declining from U.K.’s second surge, the proportion of isolates from people infected that were B.1.1.7 were increasing. What happened next? A new, much larger spike in cases began reaching a new peak on January 10, 2021 with a 7-day moving average of daily new cases of 87.9 per 100,000, despite a lockdown in November and a new lockdown in January. The difference? One difference was that the cases in this most recent, higher spike were mostly B.1.1.7. Another difference was that during the November lockdown, schools were kept open.

The U.K. had previously had the same experience with schools that we had in the U.S. Before the variants, we saw few infections in kids and little spread within schools. So, the U.K. locked down essentially everything but schools at the end of October. However, it soon appeared that the transmission characteristics of B.1.1.7 were different than those of the variant we have dealt with around the world for much of the last year. The U.K. started seeing more infections in children and more outbreaks in schools and daycare. And, lest people think that this was something unique to the Brits, we were also beginning to see the same thing happen in Italy, Germany and Denmark where B.1.1.7 was growing in the percentage of isolates causing infection. Then an interesting fact emerged from the data. While B.1.1.7 tended to increase infections in all age groups, the age group with the highest increase in secondary attack rates (i.e., rates of infection of others who are infected) was 30 – 39-year-olds. Why would that be? In the U.K., adults of that age range should mostly be working from home due to the lockdown. My speculation was that this is likely the age of the parents of children in school. In other words, my concern was that they are having in-school transmission among children, many of those infections might have been mild or asymptomatic and not detected, yet the children were going home from school and infecting their parents.

Obviously, at the beginning of February, we still didn’t have all the answers, but this was enough for me to sound the alarm with our local school districts, but one that fell on deaf ears. As one board member told me as I pleaded with the board not to make a decision in February to bring all children back at the end of March when we knew the best physical distancing we could achieve in schools with students in the hybrid model was 4.5 feet and when I assured them that we would know much more about the variants and how vaccinations were going in Idaho by the end of March: “we don’t care about what might happen then, we are just looking at what is happening today.” I was shocked.

Further myopic was the board and administration’s assessment that things would be fine because children seldom get serious illness and by the end of March, teachers would have had an opportunity to be vaccinated. I tried to point out that students and teachers are not the concern based on what we were seeing in Europe. It is the parents in their 30s and 40s who were not expected to be vaccinated in Idaho by the time they were bringing all students back just as the CDC was predicting that B.1.1.7 would be the dominant circulating form of the virus in the U.S. This didn’t seem to influence them in the least, I presume because they assume that 30- and 40-year-olds don’t get seriously ill. Again, I tried to explain that studies were coming back suggesting that B.1.1.7 was 40 – 70 percent more transmissible and early reports out of the U.K. were that this variant caused more severe illness. I also tried to point out that there are many parents in this age range who have serious underlying health conditions that place them at increased risk, and there are many who are taking chemotherapy for cancer, have immune deficiencies or are taking immunosuppressive medications and may not do well if they become infected with a more transmissible and virulent form of virus. I also tried to point out that some students, especially those in socioeconomically disadvantaged situations may be living in multi-generational households with older family members who may not be vaccinated, and will be at very high risk due to age and potentially underlying medical conditions. It was if I was talking to myself.

By this time, it was not only the UK, but Italy, Germany, and Denmark that would give the world warnings that B.1.1.7 transmission characteristics were different. While children did not seem to get sick as often as adults and did not seem to spread infection within schools or contribute to community spread prior to the rise in B.1.1.7, the countries and others were now indicating that there seemed to be significant spread in schools that was contributing to community spread and these countries were now closing schools. They warned the world that B.1.1.7 is more transmissible, causes more severe disease and that it is much more difficult to contain its spread. The U.K. warned that maintaining physical distance was the only hope to controlling the spread of this variant.

So, for all these reasons, I was very concerned that this was exactly what would happen in the U.S. Why would we be different? Some dismissed my concerns believing that what happens in Europe has no bearing on what will happen in the U.S., let along Idaho. Then it started happening in Canada. That still did not persuade people. But, recently, it started happening in the U.S. While I had hoped that I was wrong and overreacting, all the evidence kept affirming my fears. So, let’s look at a few examples of this additional evidence.

  1. Outbreak of B.1.1.7 infections in Minnesota in late January into February 2021. From the Minnesota Department of Health – Since late January, at least 84 cases of COVID-19 have been linked to participants in both school-sponsored and club sports activities, including hockey, wrestling, basketball, alpine skiing, and other sports. In addition, health officials have seen increases in cases in Carver County gyms and fitness centers, with many of the cases linked to the sports-related cases. The Minnesota Department of Health (MDH) has observed a concerning increase in the rate of growth of cases in Carver County over the past month (a 62% increase between the week beginning Jan. 27 to the week beginning Feb. 24). Case rates in Carver County are now approaching rates seen in October 2020, and a high proportion (35%) are under age 20.

“We are increasingly concerned about dramatic increases in cases, particularly in Carver County where the B117 variant has been confirmed.”

Through recently completed whole genome sequencing of a portion of the sample specimens from the outbreak cases, health officials confirmed 27 cases of the B117 variant, a highly contagious and potentially more virulent variant first identified in the United Kingdom. Cases have occurred in athletes, coaches, students, and household contacts. Multiple schools, both public and private, have confirmed cases tied to the variant strain cases. Many of the people with B117 variant COVID-19 attended school or sports activities while infectious. The concern is this highly contagious variant has the potential to spread exponentially and quickly across youth who are largely unprotected by vaccines.

  • In one week in early March, Duke University had an outbreak of COVID cases among students. The number of new cases in that one week exceeded the total number of cases that occurred during the entire Fall semester.
  • We have seen a large outbreak of new COVID cases in Eastern Idaho. Looking at just one of the involved counties, Bonneville, the peak occurred on March 14 and reached a 7-day rolling average of daily new cases of 72.8 per 100,000.
  • Although we do not do enough sequencing in the United States or in Idaho to know what percent of cases are currently caused by B.1.1.7, we do know that B.1.1.7 is significantly increasing and has become the most frequently identified variant of concern in samples that are sequenced. European countries have warned that once B.1.1.7 surpasses accounting for half of the circulating virus, we can expect a soon upcoming surge.
  • The testing positivity rate in Idaho had fallen to 4.5% by the third week of February, but has increased to 5.5% by mid-March.
  • What is happening now?
  1. New cases in the U.S. are up 20% from the prior two weeks.
    1. Cases are in the accelerated community spread category, increasing and staying high in 28 states plus the Virgin Islands and Washington D.C.
    1. Deaths are increasing in 8 states plus Washington D.C.

I could keep on going with examples, but let’s look at one more local indicator that I find fascinating.

This is the wastewater testing for SARS-CoV-2 virus done by the City of Boise. It shows that we got to a low on February 14 of about 33,000 virus copies per liter, but it has been increasing since then, signifying more virus (i.e., more infections). By March 17 it had peaked at about 293,000 virus copies per liter. As of the last date of data available (March 25) the count was about 160,500, i.e., almost a 5-fold increase in viral levels from the low just the month before.

So, I will stop here and address some of the counter-arguments. But, hopefully you can get a sense of why I have been predicting this upcoming 4th surge.

Arguments:

  1. The vaccine roll-out will stem this surge. My response – I hope so, but don’t think so. We simply do not have enough people vaccinated to get us anywhere near herd immunity. For more on this, see my prior blog piece.
  2. We don’t have to worry about Boise or West Ada schools because the CDC said we can operate schools safely with only 3 feet of distancing. Response – Wrong. The CDC has indicated that 3 feet of distancing is not recommended for schools in communities with the highest levels of disease transmission (which is what the CDC considers Ada County to be in) and the CDC indicated that in all cases there should always be at least 6 feet of distancing when students have masks off (for example, the cafeteria), but in all the schools I inspected, I never found a school that could get more than 4.5 feet of distancing in the cafeteria with only half the students in attendance.
  3. We have been able to prevent transmission among health care workers in hospitals where they often work less than 3 feet apart. Response – Two big differences. First, the majority of health care workers have been vaccinated. Almost no children have been vaccinated. Second, this was the experience with the wild-type virus, not B.1.1.7. In fact, one of the Duke hospitals just reported an outbreak of COVID cases on a cancer unit involving 20 staff and patients.
  4. We don’t have to be concerned because it has warmed up and everyone will be outside and so we won’t have much spread of the virus. Response – (1) There is absolutely no evidence of seasonality of this virus. (2) Why do you think that will be the case this year when it wasn’t last year? Note from the epi curves for the US and Idaho above that the surges in the summer were far greater than the first surges in March/April of last year. People don’t spend all day, every day during the warmer months outside. In fact, in many places in the country, the heat and humidity cause people to move indoors during the middle of the day for air conditioning.

Well, we will know soon enough who is correct. I pray that I am wrong, but as I review the activity around the world and in the U.S. and even here in Idaho, I only become more and more convinced that I am right. We will know soon enough.

No, We will not have Herd Immunity by April

Dr. Marty Makary is a brilliant physician and communicator. I am a fan. However, he just wrote an Opinion piece for the Wall Street Journal entitled, “We’ll Have Herd Immunity by April.” He could not be more mistaken.

He points to the significant decline in cases, his projection that 55 percent of Americans have natural immunity from past infection and an assertion that 15 percent of Americans have been vaccinated.

So, let’s understand why we are nowhere near herd immunity:

  1. Yes, cases are down. They are down following an all-time high surge that just two months ago was threatening to overwhelm our health care system. Cases always come down after a surge, and holidays are notorious for creating surges in cases due to travel and extended families and friends getting together.

So, are the cases down at a level that would suggest the pandemic is coming under control? No. Our current 7-day moving average of daily new cases per 100,000 in the U.S. is at 23.9. We have had 3 spikes or waves in the U.S. of cases. Our first was in March of 2020 at the onset of the pandemic. You might recall that cases were so alarming back then that many states implemented stay-at-home orders or lockdowns. So, what was the 7-day moving average of daily new cases per 100,000 in the U.S. at the peak of that first spike or wave? 9.8.

Our second spike or wave of cases was far greater and occurred during the summer. Well, what about the second spike or wave? What was the 7-day moving average of daily new cases per 100,000 in the U.S. at the peak of that wave? 20.4.

As you can see, cases have not even come down to the highest point they previously were with our first two waves. So, it seems premature to be declaring victory. We have all become a bit numbed to the numbers. We are currently at levels of disease transmission that last year would have been quite alarming. But, with each higher wave of cases, hospitalizations and deaths, we have become so conditioned to the large numbers that we think when cases are coming down from an all-time high that we must be on the home stretch.

So, how do we put these numbers in perspective? The Harvard Global Initiative sets 25 daily new cases per 100,000 as the level at which lockdowns, stay-at-home orders, etc. are indicated. Remember the White House Coronavirus Task Force chaired by Vice President Pence? The number they used for when transmission was out of control and required significant restrictions – 14. So, I think Dr. Makary is painting a far rosier picture of where we are than what the data shows.

Here’s additional perspective. Remember back at the beginning of the pandemic when our objective was to avoid community spread? Community spread was when there was so much spread within a community that we could no longer identify the source of infection for people who tested positive for COVID. Translated into daily new cases per 100,000, community spread is 1 – 9. Over 9 is accelerated community spread. That is where the U.S. is now.

So, if we were to get to herd immunity, what level of daily new cases per 100,000 would that be? Answer – less than 1. As you can see, we are nowhere close to this.

  • Dr. Makary projects that 55 percent of the American population has been infected. The problem is there is no way to prove or disprove that assertion. No serologic survey in the U.S. would lead us to that conclusion. Dr. Makary rightly points out that people may have immunity even without measurable antibodies due to T-cell mediated immunity. This is true, but again, doesn’t help us get to the number of people who have immunity, because we cannot routinely test for T-cell mediated immunity.

The CDC has made its own projections about how many Americans have been infected (and then presumably are immune, however, we are not inclined to believe that everyone who has been infected does have persistent immunity). Their projection is 83,111,629. Using the most recent U.S. population number, that would mean 25 percent of Americans have been previously infected and might still be immune – less than half of what Dr. Makary projects. We can’t know who is right.

But Dr. Makary goes on to make a statement that we know is incorrect. He states, “Herd immunity has been well-demonstrated in the Brazilian city of Manaus, where researchers … reported the prevalence of prior COVID-19 infections to be 76%, resulting in a significant slowing of the infection.” You may recall that Brazil did have a massive explosion of COVID cases at the beginning of the pandemic in the spring of 2020. Manaus was hit particularly hard. In less than 10 days, the health care system in Manaus was overwhelmed. Patients were turned away from hospitals bursting at the seams with COVID patients. Many who died of COVID were placed in mass graves.

Mathematical projections of the numbers of people who would have to be immune in a population (a herd) to make it difficult for the virus to circulate in the herd and infect those few who are vulnerable was 60 percent and virologists and our own public health experts anticipated that the actual threshold for herd immunity might be 60 – 70 percent. When scientists determined that 76% of the population of Manaus had been infected, the highest prevalence of any place in the world that I am aware of, it is true that we certainly presumed that Manaus likely had achieved the level of infection necessary to achieve herd immunity. But, where Dr. Makary is mistaken is his assertion that herd immunity was “well-documented in the Brazilian city of Manaus.” In fact, subsequent events disproved herd immunity in Manaus.

Recently, Manaus went through a new surge in COVID cases overwhelming their hospitals, not in 10 days as previously, but now in 24 hours. This is a strong argument against herd immunity. Hospitals quickly ran out of oxygen. Some hospitalized patients died because there was no supplemental oxygen to administer. Many more people died at home due to the lack of hospital capacity. This second wave was greater than the first. This is not consistent with herd immunity.

Now, one could argue that perhaps Manaus had reached herd immunity, but people’s immunity from previous infection with prior variants had waned, and they no longer maintained herd immunity. True, that may be the case. However, if true, that should also cause us concern in the U.S. that not all the people Dr. Makary believes have previously been infected remain immune. One could also argue, well the people of Manaus probably developed herd immunity to the D614 or D614G variants that were common at the time, but they just were not immune to the new variant, P.1. Also, very possibly true. But, in either case, what good is herd immunity, then? In the U.S., we have at least four new variants of concern (more variants than that, but I am just referring to the variants that have us worried). And, in either case, then why should Dr. Makary convince us that the U.S. will achieve herd immunity by April and all will be fine?

  • Dr. Makary asserts that 15% of Americans have been vaccinated. However, based on the latest numbers reported by the CDC, only 5% of the American population has been fully vaccinated, and with the most generous interpretation of the percentage of Americans “vaccinated” to include those who have only received their first dose, it would be 12.7%.

I am sorry to tell you that I don’t perceive any situation by which the United States achieves herd immunity by April of this year. The previous mathematical projection of 60 – 70% of people needing to be immune in order to achieve herd immunity has been revised upwards to perhaps 85% because models predict that a far more contagious variant will become dominant in the United States in March. In calculating the percentage of population necessary to achieve herd immunity, everyone who can be infected and transmit the disease must be included in the denominator. It is estimated that 24% of the American population is under the age of 18. There currently is no approved vaccine for children under the age of 16 and it is unlikely there will be until at least summer. If the percent of the population under 16 is 20%, then already, if everyone else in the country over the age of 16 has been infected and/or received a COVID vaccination, we would only get to 80% immunity. But, then again, we know that surveys tell us something on the order of 30% of Americans are either vaccine-hesitant – they want to wait 6-12 months before they get vaccinated or they are telling us that they will not get vaccinated.

Let’s march on. We will get there; we just won’t get there by April. Please don’t let your guard down. Stay home if you are sick. Get vaccinated if and when you can. Avoid gatherings of people other than those you live with, particularly indoors. Wear a mask when you are around people you do not live with. Wash or sanitize your hands often and every time after touching surfaces that are in public spaces. Keep a physical distance from others of at least 6 feet.

I haven’t posted many blog pieces lately, and that is because I am writing a book. But, I worry that you are hearing and reading a lot of false or misleading information right now, so I am going to try to write more often. As the co-author of the book we are working on often says, “Stay positive and test negative!”

Commonly Asked Questions about the New (Pfizer) COVID Vaccine

Should I get the vaccine?

For most people, the answer is yes. For this first vaccine, you will have to be at least 16 years of age. Those who have had severe allergic reactions (e.g., anaphylaxis) to any components of this vaccine in the past will not be eligible to receive the vaccine. We don’t yet have enough data to know whether the vaccine is safe for pregnant or lactating mothers.

When will we be able to vaccinate young children?

We don’t know yet, though I would anticipate that we may be able to do so sometime between the end of this school year and before the start of the next.

How many shots do I have to get?

Two shots separated 21 days apart.

How long until I have to get the next set of shots?

We don’t know yet, but we are anticipating that it may be as soon as a year or as long as three years. We will know better before you will be due for next year’s shots if it is a year.

Is the vaccine safe?

Yes, no serious safety concerns have been identified in the clinical trials thus far. With that said, side effects with vaccines are common, and often are evidence of the body mounting the desired strong immune response we are seeking. The most commonly reported side effects were pain at the injection site, fatigue, headache, muscle aches, chills, joint pain and fever.  These side effects are generally short-lived and typically resolve within several days of receiving the vaccine. These side effects tend to be very mild with the first shot and more severe with the second. Interestingly, older recipients of the vaccine tended to have milder symptoms with both shots.

How effective is the vaccine?

The vaccine is highly effective appearing to prevent COVID in 95 percent of those vaccinated, and in those few who still got infected despite getting the vaccine, they appeared to have significant protection against getting severe disease that would result in hospitalization or death.

When can I get the vaccine?

Because of demand and the fact that the vaccine is being manufactured and distributed, each state will get their vaccine in allotments every month, with the first shipments being received in mid-December. People will be divided up into priority groups that will determine when you will be eligible for vaccination. The first priority group is health care workers and residents of long-term care facilities. They will be able to be vaccinated starting this month. We don’t know the schedule for when additional groups will be eligible to receive the vaccine, but we would expect that high risk individuals may be able to be vaccinated as soon as February and the general population perhaps as early as April. However, watch your local news for public service announcements as to when it is time for you to be vaccinated.

Where will I go to get vaccinated?

Your primary care provider, local hospital and local pharmacy may be offering the vaccine. Information as to vaccination sites will be made available before the time you become eligible.

Is there a cost for the vaccine?

The vaccine is free, though there may be an administration fee charged by the provider. Be sure to check ahead of your appointment for vaccination whether you will need to pay anything at your visit or whether they will bill your insurance.

Once I get the vaccine, do I still have to wear a mask? Yes, we will all have to continue following all of the public health advice about staying home when we are sick, washing or sanitizing our hands frequently, covering our coughs and sneezes, keeping a distance of at least six feet from others with whom we do not live, and wearing masks anytime we are outdoors and cannot maintain the six feet of separation from others or indoors anytime we are with individuals who are not part of our household regardless of distance until a sufficient number of Idahoans and Americans have been vaccinated for us to achieve herd immunity (likely next fall). It is not yet known whether people who are vaccinated and are exposed to the SARS-CoV-2 virus might be able to transmit that virus to others even though they themselves are protected from infection so these infection control measures remain important for now.