Does the Updated COVID-19 Booster help Protect against Recent SARS-CoV-2 Variants?

We are currently experiencing what appears to be the second-highest COVID-19 wave of infections since the beginning of the pandemic. Some countries, and now one U.S. state, are reporting more hospitalizations for COVID-19 than at any prior time in the pandemic. It is hard to attribute this to any one particular factor, but likely contributing factors are:

  1. Waning immunity. The evidence is now clear that immunity wanes over months whether generated by infection, immunization or both, however, fortunately, the protection against severe disease, hospitalization and death does appear to last longer.
  2. Low uptake of the updated COVID-19 booster that was released in September 2023. The latest CDC dashboard (as of December 23, 2023) showed that only 18.9% of all adults, shockingly only 11.2% of pregnant women, and only 7.9% of children have received the updated COVID booster.
  3. The near abandonment of mitigation measures allowing for high levels of transmission.
  4. The emergence of variants with enhanced immune escape. RNA viruses such as SARS-CoV-2 are prone to acquire mutations and the likelihood for consequential mutations increases with increasing transmission. It is very likely that some of the major new variants have arisen from chronic infections in immunocompromised persons, however, there is also growing concern for spillback of infections with more diverse mutations from the enormous range of animals that humans have infected with SARS-CoV-2.
  5. Some early reports that show evidence in vitro (in the laboratory) that while the early Omicron variants showed more of a propensity for upper respiratory tract infection, the new globally dominant circulating variant (JN.1) may have developed greater tropism (cells for which the virus has affinity) for the lung. This has created concern (but not proof) that the current circulating variant may have higher likelihood of causing more severe disease. It likely will take a while to determine whether this is the case.

There are many things we can do to protect ourselves from infection, however, immunization has always been foundational to protecting against severe disease if one does become infected. Thus, it is important to examine the effectiveness of the newly updated booster in light of the current variant that has much greater immune escape capabilities than prior variants.

Further, in view of the rapid evolution of variants, it has been concerning to note that even infection has provided protection for a briefer period of time than earlier in the earlier years of the pandemic. For example, an infection with the variant XBB.1.5 which was on a steep rise in the U.S. one year ago, was reported in several studies not to produce the degree of antibody response needed to protect against infections with subsequent variants that developed as off-shoots of this variant. This concern has been heightened in light of recent studies once again confirming that the risks of long-term health consequences (e.g., Long COVID) increase with each infection. That rightly raises the question as to whether the updated booster would then be effective against recent variants.

Investigators just published their findings https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(23)00784-3/fulltext yesterday.

The investigators compared the immune responses to the updated booster in two groups of study participants – one group had no known prior COVID infection and the other group had a confirmed case of COVID with any XBB subvariant prior to receiving the booster. They assessed neutralizing antibody levels prior to vaccination and then 3-4 weeks following the booster dose. Those who had an XBB infection followed by the booster had a statistically significant rise (1.8 – 3.6-fold) in antibody levels against all subvariants tested (XBB.1.5, XBB.1.16, XBB.2.3, EG.5.1, HK.3 and BA.2.86 [this latter one being the immediately preceding and closest related variant to the current JN.1]).

Those boosted who had no known prior COVID-19 also had a statistically significant rise (2.1 – 3.9-fold) in antibody levels against all of the same variants. However, some individuals failed to mount an adequate response following their booster dose.

Of note, when antibody levels were tested on the pre-booster samples for both groups, those with recent XBB infection had 5.7 – 10.4-fold higher neutralizing antibody titers against these recent variants compared to those who had never been infected.

What were some of the limitations of this study?

  1. The study groups were very small. This limits the confidence that these results are generalizable to the entire population.
  2. It is not clear which vaccine brands participants had received, and we cannot be sure that these same results would occur with all three vaccines (Pfizer, Moderna and Novavax). Further, some not previously infected participants had received 5 vaccines prior to the booster, and others 6.
  3. It did appear that there was a bias introduced in that some of the not previously infected participants were much older (one was 81 and one was 89) and we know that people of this age group don’t mount as robust an antibody response to almost anything compared to younger individuals.

What should we take away from this study and other recently published studies.

  1. It does appear increasingly clear that if you have not had a recent infection or the updated booster this Fall, you likely are more susceptible to infection from the newly predominant variant than those who have.
  2. If your last COVID immunization was with the versions of the vaccine prior to the newly updated booster, you likely have much less protection against this new variant than you did against prior variants.
  3. We will listen and watch closely as the FDA’s vaccine advisory group meets this year to consider the next formulation of vaccine booster whether they will recommend a new variant serve as the basis for the next booster and whether they will recommend a second dose of the current booster formulation this spring for those with underlying medical conditions, those who are older, and/or those without prior known infection.

For now, get the newly updated booster if you haven’t done so already. As a side note, and I will write about this in an upcoming blog post, the data just recently published shows that kids have a much better and longer lasting immune response from the COVID vaccines than adults!

Viral Persistence in Kids?

In a blog piece I posted earlier this week, I tried to make the case that the public is being too complacent regarding COVID-19, reinfections and infections in children, especially very young children.

I cited a recent study that reported elevations of a blood test (high sensitivity troponin) in infants hospitalized with COVID-19, especially in those under 3 months of age. The study reported the eventual return to normal levels and the absence of detectable heart problems at 1 year of follow-up, but both the authors of the study and I cautioned that we can’t be sure of the long-term health outcomes for these children. That may have seemed confusing to many readers as to why there would be any concern for these kids’ future health if everything seemed to have resolved.

Part of the reason for the concern is that we simply don’t understand enough about how kids’ immune systems work at this young age against SARS-CoV-2. We know that before age 6 months, a child’s immune system is generally not fully developed. We also know that even in adults with fully developed immune systems, there have been a number of studies suggesting that, at least in those with Long COVID, some have evidence to suggest viral persistence – i.e., the body’s immune system does not completely rid the body of the virus and SARS-CoV-2 may be able to hang out in various parts of the body either dormant (not actively replicating) or still replicating (producing more SARS-CoV-2 viruses). It is logical to at least consider this possibility in children, especially those infants less than 6 months of age. Therefore, I cautioned that we don’t know whether there might be future health consequences for these kids – only time will tell. Afterall, there had been earlier reports of persistence of SARS-CoV-2 in the tonsils and adenoids of children, including children who had mild COVID-19, noted in some children following tonsillectomy and adenoidectomy.

Are there other examples of viruses that persist in our bodies? What are the consequences?

Yes, there are plenty of viruses that can persist in our bodies, some being kept in check by our immune systems, but others causing mischief. For example, both hepatitis B and C viruses can persist and, in fact, are the major causes of chronic liver disease and liver cancer in the world. Because these viruses can ultimately cause cancer, they are referred to as “oncogenic” viruses. There are other oncogenic viruses, such as human papillomavirus, which is almost always the cause of cervical cancer in women.

Another virus that persists in our bodies is the chickenpox virus (varicella-zoster virus). Later in life, when our immune systems weaken with age, and/or when we experience a significant stress or undergo treatment with medications that suppress our immune systems, the virus can escape part of the immune mechanisms that keep it in check causing a painful eruption of a rash along the distribution of one or more of our nerves referred to as shingles.

Measles virus can persist for a period of weeks or months before being cleared in most persons who don’t get vaccinated, but get infected. However, some individuals appear to experience persistence of the virus in their brains that can lead to the dreaded complication of subacute sclerosing panencephalitis (SSPE) years after they seemingly fully recovered from measles, a condition that is almost always lethal.

While there is no evidence to date that SARS-CoV-2 is an oncogenic virus, it is believed that, at least in some cases, the persistence of virus may lead to chronic inflammation that may play a role in Long COVID in adults.

Just a couple of days after writing that note of caution about just assuming that COVID-19 doesn’t cause long-term health consequences in children, I noticed a study published in June of 2023 that I had overlooked – Viral persistence in children infected with SARS-CoV-2: current evidence and future research strategies – The Lancet Microbe. This is a review of the literature looking at tissues of children at autopsy who died from COVID-19, biopsies done on children with MIS-C (multisystem inflammatory syndrome in children) or Long COVID, or examination of tissues removed at surgery from children following COVID-19.

The authors selected 21 papers that examined tissues for the presence of SARS-CoV-2 RNA, proteins or antigens in children below the age of 18 that were obtained at least 24 hours following the diagnosis of COVID-19. This was in order to both assess how widely distributed SARS-CoV-2 would be in children with infection (looking at those specimens obtained shortly following infection) as well as how long after infection evidence of the virus could be identified.

As in adults, evidence of the virus could be detected in the brains of children who died from COVID-19. In children who survived their illness, some had evidence of viral persistence in various locations (including plasma, lymph nodes, tonsils, adenoids, spinal fluid and the intestines) at periods of weeks to months following their infection.

One of the risks of a mother becoming infected while pregnant is stillborn birth or death of the newborn infant. In these cases, the majority of these stillborn infants who had autopsies showed evidence of virus in numerous organs. It appears that the virus’ effects on the placenta and its blood vessels likely contributed to dangerously low oxygen levels to the developing fetus, which may have resulted in the stillbirth. In the autopsy of an infant who died days following birth, evidence of the SARS-CoV-2 virus could be found in organs, including the heart.

There are some indicators that viral persistence may be a cause for MIS-C that generally is not seen until after the child has seemingly recovered from their acute infection.

I don’t know whether any of this will contribute to long term health conditions in some children who have been infected with SARS-CoV-2, especially as infants, but neither does anyone else who is currently giving you the assurance that COVID is mild in children and no cause for concern.

To me, this would be a good reason for schools to invest in improved air handling and air filtration and for hospitals to require masking in nurseries, in neonatal ICUs and in areas of the hospital with sick children. Despite what seems like minor sacrifice to ensure that long-term health of our children and grandchildren, it seems that we are convinced that the children will be just fine without immunizations and with repeated SARS-CoV-2 infections, that there is no need to take any precautions or for anyone to be inconvenienced, and that there is nothing to see here. I pray to God this group think is correct, but as of right now, that conclusion is based on little more than a hope and a prayer rather than on medical and scientific evidence.

What is Dengue Fever?

In my last blog piece, I wrote that we have seen a number of diseases that are not endemic to the U.S. pop up and cause outbreaks. Some of these are infections that we have not previously seen people acquire in the continental U.S., but rather were involving international travelers who acquired the infection elsewhere, then traveled to the U.S., became ill, and were diagnosed with the illness here.

Dengue virus is endemic to over 100 countries in the southern hemisphere, predominantly those in tropical and subtropical regions of the world. While we do occasionally see outbreaks of dengue fever in the U.S. territories of American Samoa, Puerto Rico, and the U.S. Virgin Islands, and the freely associated states, including the Federated States of Micronesia, the Republic of Marshall Islands, and the Republic of Palau, cases in the continental U.S. have historically been in international travelers or travelers from these territories.

In 2020, there was an outbreak of locally-acquired dengue fever in Florida (72 cases), which might be less of a concern if it were not for the pattern of emerging outbreaks of other diseases for which we generally have not seen locally acquired infections in the past, but now have resulted in local outbreaks, especially in Florida – e.g., zika, chikungunya prior to the dengue fever outbreak and most recently malaria (while we have historically had local transmission of malaria, we had eliminated malaria from the U.S. back in 1951). It is interesting to note that the common denominator for these four infections is that they are all transmitted through mosquito bites.

Dengue virus is a flavivirus and flaviviruses cause vector-borne diseases in humans. Vector-borne means that the virus is transmitted to humans through the bite of an insect – typically a mosquito, flea or tick. Dengue virus is transmitted by mosquitoes. Other mosquito-transmitted flaviviruses include the yellow fever virus, Japanese encephalitis virus, the West Nile viruses, and Zika virus.

The mosquitoes that are capable of transmitting dengue virus are of the Aedes species. Modelling studies show that Aedes aegypti and Aedes albopictus mosquitoes could potentially extend their natural habitats in the southern hemisphere up to some areas of the U.S., particularly the southeastern parts of the country.

We may miss cases of dengue fever in the U.S., because in some people (estimated to be about 75% of cases), the illness is mild or even asymptomatic. Those with mild symptoms may attribute them to a cold or the flu, or be seen, but not tested for dengue fever given that this is not something most U.S. doctors have seen before.

Dengue fever can manifest as a severe disease, in fact, it is estimated that 22,000 people die from dengue annually across the globe. Classic dengue fever is characterized by high fever and intense muscle, joint and bone aching, and even muscle spasms, giving rise to its colloquial name, “breakbone fever.”

In classic dengue fever, the first phase of the illness lasts 2 – 7 days. In addition to fever and the muscle, joint and bone pain, some patients will complain of headache, nausea and vomiting and some may experience bruising, bloody nose, or bleeding from their gums. On or about the third day of the illness, most people who are symptomatic with dengue will develop a red rash, that may be smooth, may have tiny bumps, or both. In most cases, the rash does not itch. Some patients will get a rash all over their body, while others will have patchy rashes. When the rash is generalized, it generally begins over the tops of the feet and the back of the hands and then spreads to the arms, legs, abdomen and chest. There is much variation in the possible rashes and in some cases, the particular manifestation of rash tells us what the major underlying pathological process is (e.g., immune reaction versus disruption to the proper functioning of the blood and blood clotting system).

While most people recover within about a week, some people do deteriorate and require hospitalization (about 1 out of every 20 cases). Those at highest risk for severe disease are infants, pregnant moms and those with a reinfection of the virus. They can experience profound fluid losses or maldistribution of these bodily fluids, internal bleeding (sometimes called dengue hemorrhagic fever) and potentially can develop shock (sometimes referred to as dengue shock syndrome).

While many lay people are under the false impression that the initial infection of any illness is the worst, and that subsequent infections will always be milder, this is not always the case, and dengue fever is the classic exception. In the case of dengue reinfections, a phenomenon called antibody-dependent enhancement (ADE) can occur. In essence, what takes place is that the initial infection triggers an immune response. Part of that response is the production of antibodies against the virus. When non-neutralizing antibodies are produced (e.g., antibodies that attach or bind to the virus, but do not interfere with or prevent the virus from entering and infecting cells), there are some cases in which these weak antibodies can actually promote the viral cell entry and infection, often also stimulating an intense inflammatory process, a condition we refer to as ADE.

There is no specific treatment available for treating dengue fever. The efforts to develop a vaccine against this infection has been hampered by the potential for ADE. However, there is a vaccine, though it is not licensed in all countries where dengue virus is endemic.

For now, Americans need not take any specific precautions unless you are planning travel to countries where dengue is endemic. However, we need to be mindful of our own changing and evolving public health situation in the U.S.

With climate change, we may see more and more diseases that are not endemic in the U.S. migrating northward. Further, if we continue to exercise a great deal of complacency against other disease outbreaks in the U.S. such as SARS-CoV-2 and monkeypox, we risk allowing these diseases to become endemic, especially, as we allow new variants to emerge and allow infections to transmit among our wildlife and domesticated animals. We often have an opportunity to eliminate infectious diseases, but that window does not stay open for indefinite periods of time. Further concerning is the fact that after going to the efforts to eliminate a number of vaccine-preventable illnesses in the U.S., we have allowed these diseases to reemerge in outbreaks due to the uncontrolled misinformation, disinformation and anti-vax campaigns that are undermining vaccine confidence in the U.S. and globally.

We are being far too complacent about COVID-19 and potential future pandemics

Part I

I don’t live my life in fear, but I also don’t subscribe to living my life in blissful ignorance and just accept whatever may come my way, or worse, just throwing caution to the wind. My personal approach is to be aware of the risks to the extent possible and reasonable, and then to make decisions as to the degree of mitigation efforts I am willing to undertake to reduce those risks according to how likely I think the risk is and how bad it would be if the risk materialized.

I write about this approach in detail in Chapter 15 of a book that I co-wrote with Dr. Ted Epperly entitled: “Preparing for the Next Global Outbreak: A Guide to Planning from the Schoolhouse to the White House,” released in April of 2023. https://www.press.jhu.edu/books/browse-all?keyword=Pate.

I want to give credit to Steve Skaggs, an executive who I was privileged to work with while I was President and CEO of St. Luke’s Health System. Steve taught me a lot about enterprise risk management, which has greatly informed and evolved my thinking on this subject.

You likely make these same kinds of decisions all the time and don’t realize the connection. Some of you likely just got your spouse or a child an iPhone or iPad or laptop for Christmas. You were faced with a barrage of decisions as to whether you wanted to purchase an extended warranty, a screen protector, a protection plan in the event something happens that is not covered by the warranty or you need a human being to help you with the technology, a protective case for the device, or an insurance plan that will cover loss of the device or damage so severe that the device cannot be repaired. All of these decisions likely caused you to reflect about the person you were getting the gift for; their prior track record of caring for, dropping or losing things; and how long you thought it likely they would use the device until the next must-have model comes out to then weigh against the cost of whatever protection option you were considering.

The thing is that risk mitigation measures involve trade-offs. If I choose not to get the screen protector, then I need to be extra careful not to drop my device because replacing the glass will be more expensive and more of a hassle. I have never lost or needed to repair my iPhone. If I purchase the insurance for my iPhone, I am out the cost if I never need it, but I have the piece of mind that if something does happen to it, I have made a good bargain by having the insurance. Everyone will weigh these factors, but likely give these factors different weight. I am unlikely to lose my iPhone, so it is more of a difficult decision to purchase the insurance; but for certain other members of my extended family, well, let’s just say it is not a difficult decision at all.

So, my general approach to a known risk is to consider how likely the risk is to materialize and how bad it might be if the risk did materialize. Let’s take influenza. I got influenza back when I was a resident physician assigned to work in a busy, county emergency room. I was young, healthy and probably in the best physical condition (other than for sleep deprivation) of my life at that point in time. However, I was miserable for a good 3 – 4 days, and sick enough that I missed about 5 days of work. If I was going to miss 5 days of work, I would have much preferred to have spent those days on a vacation with my wife, rather than at home in bed with fever, terrible body aching and a bad headache risking exposure of my wife and kids. Thus, my future risk calculations as to whether to get a flu shot and have a sore arm for a day or two, but be able to work, versus avoiding the risk of a sore arm every year, but assuming the risk that an average unvaccinated person will get influenza every 4 or so years was a no-brainer. I have received the influenza vaccine every year since then, and to my knowledge, I have not had another case of influenza.

Sometimes making risk mitigation decisions are fairly straightforward. The risk for influenza presents itself every year, generally over the same time period, and is highest among those with exposure to school-aged children. The risk for severe outcomes is highest among those who are over age 65 or under age 5, those who are pregnant, those who have chronic medical conditions (e.g., asthma, diabetes, heart disease). On the other hand, the flu shot is relatively inexpensive or in many cases free of charge, generally easy to get, and side effects mild.

But, sometimes, making risk mitigation decisions are not so straightforward, and we have seen this play-out with the current pandemic. Risk mitigation measures can be far more difficult when a new risk presents itself as the SARS-CoV-2 virus did, and because the risk is new, we actually don’t know how significant the risks are or how likely they are to occur. Unfortunately, we are, in general, very bad at judging these kinds of risks. The first mistake we often make, is we make an assessment of the risk by simply looking around us to see what seems to be happening. We all recall elected officials who were concluding that this couldn’t be a pandemic because people were not “dying in the streets,” perhaps an ignorant or cynical reference to outbreaks of the plague in pre-modern history. Obviously, if that is going to be the standard by which we judge whether to adopt mitigation measures, we are going to under-respond to infectious diseases and experience more illness and death than is necessary, or I would suggest, is prudent.

Looking around us may include more than just looking for dead bodies in the streets. Many will conclude that the risk can’t be that great because I don’t know anyone who is sick or anyone who has died from the disease. However, when a new pandemic is emerging, especially one that has begun overseas, it may take months before you would have people sick in your social circle. SARS-CoV-2 was first recognized to be causing illness in China in December of 2019, but we didn’t recognize the first case in the U.S. until the third week of January in 2020, and we didn’t identify our first case in Idaho until the second week of March. Obviously, the absence of illness affecting members of our family, friends or co-workers did not mean that the threat was not significant, and waiting to prepare and respond until it does will diminish any chance for containment of the spreading disease. As we write in Chapter 1 of our book, by the time the travel ban was implemented in the U.S., a U.S. citizen had already returned from China infected.

Unfortunately, there are many viruses that can cause serious disease and can be circulating around you, but you would not know it based on what I will call anecdotal observations, such as making an assessment solely on whether are any family members, co-workers or friends are sick. That is because, like SARS-CoV-2, oftentimes many of the people a virus infects may have no symptoms (asymptomatic) or may have mild and few, non-specific symptoms (pauci-symptomatic) that does not raise suspicion of the potentially serious virus causing the infection, but rather might be ascribed to having overdone things, being sleep deprived, or perhaps having “allergies.” A notorious example of this is poliovirus. When poliovirus circulates in a population, most parents of children will not know it. Their children may seem fine or may have symptoms that they would ascribe to just having a “stomach flu.” That is because, depending on the strain of poliovirus, only 1 child in 200 or more infected will develop the fully manifest and dreaded poliomyelitis. Going back to our risk framework, one might reasonably assess the risk of contracting poliomyelitis as being low (but increasing given vaccine hesitancy and global travel), but would reasonably have to assess the risk if their child was to get poliomyelitis as quite high since the health outcomes can be quite severe and life-long, including premature death. Then, these risks would be weighed against the cost, hassle and effectiveness of the mitigation measures – a series of 4 shots that every child can receive for free, are widely available in doctor’s offices and public health clinics and are extremely effective providing life-long protection against poliomyelitis.

The other problem with our risk assessments with new infectious diseases like COVID-19 is a focus on what we doctors would refer to as acute disease outcomes – what happens to the patient during the initial illness – the severity and length of the initial illness, whether the illness is likely to require a trip to the doctor or the emergency room, whether hospitalization is frequently necessary, and whether there is a significant risk of dying from the infection. This is where the media, press and public focused their attention during COVID-19. And, of course, as we saw in this pandemic, there will be those who will actually promote people getting infected as being good for their own health and leading to a state of so-called “herd immunity” (Dr. Epperly and I devote nearly all of chapter 12 of our book to explaining this flawed theory), if they consider the case fatality rate to be acceptably low.

However, as physicians we know (or should know) that there are plenty of viruses that don’t kill their hosts at the time of initial infection, but can cause serious health problems and even death months to years later (e.g., hepatitis C virus, Epstein Barr virus, measles virus, mumps virus, and human papilloma virus just to name a few). That doesn’t mean that all new pandemic viruses will cause long-term health consequences, but when we have high, sustained transmission rates to the extent that the majority of the population is becoming infected, and in many cases reinfected, prudence would call for adopting the “precautionary principle.”

The precautionary principle is often employed when the future risks are unknown, but there is some basis for anticipating that those risks may be significant and potentially serious in the future and the only known way to avoid those potential long term health consequences is to prevent infection until more time can pass to study whether health consequences occur and what they are. In this case, we knew from the original SARS coronavirus outbreak in 2002 – 2003 that even though most common coronaviruses did not cause significant disease burden, this coronavirus caused significant mortality and, in some individuals, long-term health consequences similar to what we began to see with SARS-CoV-2 in late 2020 and early 2021.

In fact, I commonly have heard some commenters recently say that infection is not the same thing as disease. I certainly believed that was likely to be the case in 2020, but I am far less persuaded of our ability to distinguish between the two since 2020, as we have seen increasing evidence of long-term health consequences, even in people who had asymptomatic or pauci-symptomatic infections. Now let me be clear, I am certainly not suggesting that everyone who is infected will develop long-term health consequences. What I am suggesting is that I don’t know who will develop long-term sequelae from infection (let alone multiple reinfections, which as I have pointed out in earlier blog posts do increase the risk of long-term health sequelae), and neither do those who are making that statement. It is not so much that the statement is technically wrong, as it is that I believe that statements like that suggest that we can distinguish at the time of infection those who will develop disease versus those who will not, which clearly is not true and I believe contributes to the public not making accurate risk assessments as they consider what is right for their selves and their families.

I mentioned above two important concepts. First, is that anecdotal observations are inherently biased and prone to misjudging risks. Second, is the precautionary principle when dealing with a novel virus for which there is wide-spread and sustained spread and no long-term follow-up. So, how do we make an accurate assessment of risk? We obtain data and until that point, we exercise the precautionary principle.

Let’s look at just a few examples of data and how they are showing that the conventional wisdom and anecdotal observations during this pandemic were wrong. [Let me just insert here that I have certainly not been right in every instance as I tried to anticipate and predict what would happen with this virus. However, through a combination of the precautionary principle, risk assessment and a healthy dose of good luck, neither my wife nor I, nor another family I regularly advise, have ever (to the best of our knowledge) been infected with SARS-CoV-2 or developed COVID-19. My interest in writing this blog post is not to suggest that I have always been right or that others were wrong. This is not a competition. This is about what can we learn from what we did right and what we did wrong, so hopefully, we can prepare for and manage through the next (and there will be a next) pandemic with better success, less illness and fewer deaths.]

The first example has been the common refrain that COVID just hospitalizes and kills those elderly folks who were going to die anyway. I have been persistent in trying to dissuade people of this notion on the weekly radio show (The Doctors Roundtable segment of Idaho Matters) I appear on (Boise State Public Radio on Wednesdays at 12 noon MT with host Gemma Gaudette). There has been data over the past couple of years that refutes that statement, but let’s look at a recent analysis and study published by the University of Oxford Assessment of COVID-19 as the Underlying Cause of Death Among Children and Young People Aged 0 to 19 Years in the US | Public Health | JAMA Network Open | JAMA Network.

The University’s Department of Computer Science found that during the time period August 1, 2021 through July 31, 2022, COVID-19 was the eighth leading cause of death in children and young people in the U.S. Keep in mind that the prevailing public view and that promoted by a number of physicians who engaged in disinformation campaigns was that children don’t get seriously ill from COVID, COVID is nothing more than a cold in children, and children don’t die from COVID. Further, young, healthy adults at their prime, were also led to believe that COVID, and even repeated COVID infections need not be a concern to them. By the end of this study period, large gatherings had become common-place again, masking seemed to be ever increasingly rare, there was far less interest in testing or receiving antiviral treatment when people became ill, few people were quarantining any longer following exposure to a known case of COVID, and many employers were no longer even requiring infected individuals to isolate. Schools seemed to have little interest in enhancing their air handling and filtration and eventually, to my shock, hospitals began to abandon masking even in cancer treatment areas and in neonatal and pediatric units.

What specifically did this analysis find:

  • Among children and young people aged 0 – 19 years in the U.S., COVID-19 ranked eighth among all causes of death; fifth among all disease-related causes of death (i.e., excluding things like accidents); and first in deaths caused by infectious or respiratory diseases.
  • By age group, COVID-19 ranked seventh (infants), seventh (1–4-year-olds), sixth (5–9-year-olds), sixth (10–14-year-olds), and fifth (15–19-year-olds).
  • COVID-19 was the underlying cause for 2% of deaths in children and young people (800 out of 43,000), with an overall death rate of 1.0 per 100,000 of the population aged 0–19. The leading cause of death (perinatal conditions) had an overall death rate of 12.7 per 100,000; COVID-19 ranked ahead of influenza and pneumonia, which together had a death rate of 0.6 per 100,000.
  • Like many diseases, COVID-19 death rates followed a U-shaped pattern across this age-range. COVID-19 death rates were highest in infants aged less than one year (4.3 per 100,000), second highest in those aged 15–19 years (1.8 per 100,000), and lowest in children aged 5 –9 years (0.4 per 100,000).
  • Overall, deaths in children and young people were higher during the Delta and Omicron waves compared to previous waves (pre-July 2021), likely reflecting the higher numbers infected during these periods. Nevertheless, in the pre-Delta period of the pandemic, COVID-19 still ranked as the ninth leading cause of death overall.
  • The month with the highest number of COVID-19 related deaths in 0 – 19-year-olds was January 2022 at 160.

Keep in mind that these statistics are only for those deaths that were reported as having been caused directly by COVID-19. Deaths where COVID-19 might have been a contributing cause to the death, but not the primary cause, were not included. Had the researchers included this group, the numbers would have been considerably higher.

Some have argued once confronted with data like this that the children who were hospitalized and died were those with serious underlying health conditions. However, another study showed that more than half of the children who developed severe disease were otherwise healthy and could not have been predicted to have developed severe disease.

Despite this data, the general public still is under the belief that COVID in children is no worse than a cold, and this, together with the vaccine hesitancy resulting from wide-spread, coordinated anti-vax and vaccine disinformation campaigns, likely accounts for the very low percentage of children, especially the youngest children being vaccinated with the COVID-19 vaccines.

Obviously, the absolute numbers of deaths in children from COVID-19 are low in comparison to older adults, but relative to other things that kill children, COVID-19 was significant.

The low absolute numbers caused some physicians to argue against COVID-19 boosters for children. Of course, some of these physicians were the same ones who spread vaccine disinformation and argued against anyone getting the COVID vaccines. Nevertheless, I was appalled to hear even a few reputable doctors argued against the COVID-19 boosters for children due to the low risk of serious illness or death. That has never been the sole or even major criteria for developing and administering children’s vaccines. It was yet another message to the public that we need not be concerned about long-term health impacts to children from repeated SARS-CoV-2 infections. Frankly, the truth is that we are only now beginning to comprehend the long-term health consequences of the initial infection, let alone from repeated infection, and none of these physicians can guarantee that children will not suffer long-term consequences. If the vaccine was not proven safe and effective in the general pediatric population, then withholding boosters might be a valid consideration. But, if some arbitrary hospitalization or mortality rate threshold is now going to be the criteria for childhood vaccines, there are going to be a lot of vaccines falling off the recommended childhood vaccination list. That would be a tragic mistake.

Why would I even think that long-term health consequences could be possible in children? Well, first of all, we see many signals for long-term health consequences in adults, and I have previously written a number of blog posts on that subject.

Nevertheless, I learned in medical school that children are not little adults. That means that we cannot necessarily assume that children will be affected by infection in the same manner as adults. Further, even disease in very young children can be different than in older children.

Because of the widespread misinformation that COVID-19 was not dangerous for kids and for young adults, we saw that pregnant women were often not aware of the increased risk to their unborn children from COVID-19, sometimes with disasterous outcomes. I also was appalled that some hospitals were not requiring masking in their pediatric and neonatal intensive care units. In addition, I worried for the young infants that I saw parents carrying into large gatherings, stores and restaurants.

Here are two recent studies that should cause all of us pause:

First is a prospective, multicenter trial that was conducted during the first two years of the pandemic. It was published in The Journal of Pediatrics on December 20, 2023. https://doi.org/10.1016/j.jpeds.2023.113876.  Three groups were compared: (1) 152 infants hospitalized for treatment of COVID-19; (2) 79 infants who were hospitalized for acute infections other than COVID-19; and 71 healthy controls who were not hospitalized or ill.

The study was designed to merely measure the levels of high sensitivity troponin, a blood marker for heart cell (myocyte) injury. If you have presented to the emergency room with chest pain, there is a good chance that you had a blood test for this marker, which in adults we use as one of the potential indicators of heart attack. High sensitivity troponin can be elevated with any cause of myocardial (heart muscle) injury, including myocarditis.

Those children hospitalized with COVID-19 were significantly more likely to have elevated high sensitivity troponin levels than either the healthy infants or the infants with other non-COVID infections, and those infants less than 3 months of age were especially more likely to have an elevation of troponin levels with infection.

The good news is that the troponin levels gradually returned to normal and the children showed no clinical evidence of heart disease at one year of follow-up. On the other hand, it remains unclear whether there are any long-term consequences until these children can be followed further out. [You might be asking yourself why the need to follow these children out further if everything looked okay 1 year later. That is because the immune systems of infants less than 6 months of age is immature and not fully developed. We are still learning about the immune response in adults to SARS-CoV-2 and we know almost nothing about the immune response in infants this young. We do see evidence of viral persistence in some adults and so a reasonable question would be whether these children clear the virus from their system.]

The other study was published in March of 2023. https://jamanetwork.com/journals/jamanetworkopen/ fullarticle/2802745. The researchers looked at the neurodevelopmental outcomes of infants born to mothers who had COVID-19 during their pregnancy compared to infants born to mothers with no known COVID-19 during their pregnancies. This was a cohort study of 18,355 infants delivered after February of 2020. After controlling for other risk factors such as premature delivery, the researchers found that male, but not female, infants born to mothers who had COVID-19 during their pregnancy were more likely to receive a neurodevelopmental diagnosis in the first year of life.

I have not provided an exhaustive review of studies looking at outcomes of infection in infants, but rather, I am just trying to make a point. I don’t know whether any of the infants with elevated troponin levels or any of the infants with neurodevelopmental delays will have long-term consequences from their exposure to the SARS-CoV-2 virus, but, neither does anyone else. I think if you asked any pediatrician, would you want your child or grandchild to be born with elevated troponin levels or to be diagnosed with a neurodevelopmental delay, they would respond that they would prefer they not be. The problem is that we won’t know whether there are long-term health consequences for years. I pray that there will not be. To me, it just seems prudent to exercise the precautionary principle until we know.

I have used infants as an example to make a point. We know the least about them, and they have no way to protect themselves. However, there are far more studies and reason for concern about the long-term health consequences in adults. I am surprised that employers are not exploring options to help protect their employees because if I am correct, even if they were to only act in their self-interests, not protecting their employees will impact their health plan costs, disability insurance costs, employee productivity, profitability, and recruitment costs.

In part 2 of this blog series, I will explain how we are being too complacent in our planning (or lack thereof) for the next pandemic.

What if you think you are protected from moderate or severe COVID-19, but aren’t?

It is estimated that 18.2% of adults over the age of 18 have had the updated COVID-19 vaccine booster as of the first week of this month. That same percentage for children ages 6 months – 17 years is only 7.8%. No doubt there is greater vaccine hesitancy due to rampant vaccine disinformation and anti-vax campaigns. The intended audience for this blog post is not this group, but rather those who have not received the updated booster because they were not aware one was available or because they did not believe it was needed due to prior vaccination or infection.

A recent study (BNT162b2 XBB1.5-adapted Vaccine and COVID-19 Hospital Admissions and Ambulatory Visits in US Adults | medRxiv) looked at the efficacy of the updated XBB.1.5 Pfizer-BioNTech COVID-19 vaccine booster (2023-2024 formulation) in preventing the need for medically-attended care (office visit, urgent care visit, emergency room visit or hospitalization) for COVID-19 among adults a median of 30 days post-booster compared to a group that did not receive any updated booster regardless of prior infection or vaccination history. The median age of the study participants was 54 years. The study was conducted on patients cared for by a health system in California (Kaiser Permanente Southern California) between October 11 and December 10 of this year.

The adjusted odds ratios for the reduction in need for medically-attended care in the updated booster group were 0.37 for hospitalization and 0.42 for all other sites of care.

The most shocking finding was reported by the authors of this study in this statement: “Compared to the unvaccinated, those who had received only older versions of COVID-19 vaccines did not show significantly reduced risk of COVID-19 outcomes, including hospital admission.”

What does all this mean in plain English (at least as plain as I can make it)?

  • Prior vaccination and/or infection does provide some degree of immunity for a period of time, but that protection wanes over time and is not durable (in other words, does not last for years). Thus, until new vaccines are available (there are some very promising ones undergoing clinical trials now), maintaining immune protection from moderate to severe disease will require updated boosters or alternatively repeated reinfections (however, my last blog piece and other prior ones have indicated why this is a foolish and dangerous approach).
  • Because of rampant transmission among large populations of people across the world, including immunocompromised individuals, the SARS-CoV-2 virus is evolving through recombination (the swapping of genetic material between two or more SARS-CoV-2 viruses with different sequences in the same person) and mutations (changes that add to or subtract from the genetic sequence of the virus during the process of copying the genetic code in making new viruses in infected cells). Some of these genetic changes have resulted in newer forms of the SARS-CoV-2 virus being more immune evasive (i.e., being able to get around some of the body’s immune defenses, including antibodies). [I should note that SARS-CoV-2 is behaving in a way that is unprecedented. We have never had a virus be able to circulate in the general population infecting persons of all ages throughout the year for this many years, causing so many reinfections through immune evasion and evolve to the point that recombinant viruses have now been driving the pandemic for two years now. In view of this and other aspects of this virus that I have written about throughout the pandemic, I believe that the public’s confidence that repeated infections are of no significant concern to long-term health could very well end up being unjustified.]
  • Because a higher proportion of the population received earlier vaccination, it would seem that some of the fall-off in booster uptake is not vaccine hesitancy, but rather a mistaken notion that boosters are not needed because of their prior vaccination and possibly because of the commonly- held notion that so-called “hybrid immunity” (the immunity resulting from a combination of prior vaccination and infection) is the ultimate immunity against reinfection.
  • There is also a commonly-held belief that reinfections are always milder and/or the virus is evolving to become milder thus contributing to a sense of complacency about the need for subsequent boosters.
  • While no doubt, there has been some degree of population immunity that has heretofore protected us from the high levels of deaths and hospitalizations that we previously saw in the Delta (fall 2021) and early Omicron (winter 2022) waves, this study is a warning, as well as what we are currently seeing in a number of countries recently with significant rises in hospitalizations and deaths, that the virus is evolving enough and our prior immunity is waning enough that relying on prior vaccinations and remote infections may no longer be sufficient protection against moderate and severe disease, and we could potentially see higher rates of disease and severe illness in the near future.
  • The good news is that the newly updated booster is effective in significantly reducing the risk for moderate and severe COVID-19. The bad news is that a very small percentage of the population has received the new booster.
  • My fear is that a lot of people travelled and gathered with others for the holidays believing that they had a lot more immune protection from moderate and severe disease than they really did. If so, we could see a significant rise in urgent care visits, emergency room visits, hospitalizations, and God-forbid, deaths over the next two to three weeks.
  • If you have not received the newly updated COVID-19 booster and have not had COVID-19 in the past couple of months, it is not too late to get boosted. I would get it tomorrow, if I were you. And, the good news is that if you have concerns about the mRNA vaccines, you can get the Novavax booster, which is a rather “old-fashioned” type of vaccine that we have used for many years prior to this pandemic.

The Risk for Long COVID increases with each Infection

A growing body of research is all coming to the same conclusion: SARS-CoV-2 reinfections are cumulatively increasing the risks for long-term health consequences. A recently published study from Canada (Experiences of Canadians with long-term symptoms following COVID-19 (statcan.gc.ca) is one of the more recent studies on this subject.

In a survey of Canadians, as of June of this year, approximately 2/3 of those surveyed reported a confirmed or suspected case of COVID-19 since the beginning of the pandemic, and many of this group reported reinfections, as well.

Approximately 3.5 million Canadian adults reported Long COVID symptoms at any point of the pandemic (occurring in about 16% of all adults previously infected), and as of June, 2.1 million were reporting persistence of their symptoms. Roughly half reported no improvement in their symptoms since their onset. [Note: I have discussed what Long COVID is, the nature of the symptoms, the suspected pathophysiology of the disease, and other long-term health consequences of COVID-19 extensively in prior blog posts if you need a refresher.]

Of note, while most countries use one- or two-month’s duration of symptoms in their case definition of Long COVID [The World Health Organization uses two months in its case definition]; Canada has a more restrictive case definition requiring at least 3 months for the duration of symptoms before calling it Long COVID.

People of the world are at risk for reinfections due to:

  1. The waning of both vaccine-induced and infection-induced immunity;
  2. The low percentage of children that have been vaccinated;
  3. The low uptake of annual COVID-19 boosters;
  4. The low rate of antiviral treatment of early COVID-19 to minimize the chances for serious illness and Long COVID.
  5. The high percentage of persons who are asymptomatic or pauci-symptomatic (few symptoms often mistaken for allergies or a “cold”) but nevertheless capable of transmitting the virus to others.
  6. Lack of media attention and/or misunderstanding of what the end of a public health emergency means and what it doesn’t mean;
  7. The significant transmission levels of SARS-CoV-2 across the world and the infection of immunocompromised persons, both of which are driving the evolution of increasingly immune evasive variants;
  8. The abandonment of most non-pharmaceutical measures to reduce infections in communities;
  9. The resistance to adopting enhanced ventilation and air filtration in schools and other public buildings;
  10. The significant transmission of infection in health care facilities;
  11. The general public’s lack of understanding of the long-term health risks from COVID-19;
  12. Disinformation campaigns that promote infection as a way to boost immunity or to achieve herd immunity (both of these assertions have been disproven);
  13. The misinformation campaign of “vax and relax”;
  14. The lack of reporting of cases and community transmission levels;
  15. The marked reduction in testing;
  16. Confusing guidance on isolation and quarantine that was also often not evidence-based; and
  17. The well-documented fact that many employees are not staying home when ill, sometimes due to the lack of sick-time or paid time off.

The surveys revealed that the risk for long-term symptoms increased with each infection:

14.6% of those surveyed reported long-term symptoms following their first infection. That percentage increased to 25.4% with two infections and to 37.9% with 3 or more infections. In other words, this study (and others) suggests that the risk for long-term symptoms and Long COVID is cumulative.

I should also point out that there may be other long-term health consequences from COVID-19 that do not cause symptoms and there are other conditions, as have occurred following some other viral infections, that may not become manifest for years or decades.

There has also been little public discussion as to the economic implications of Long COVID – worker productivity, increases to employer health plan costs, rising insurance premiums, loss of employment, disability rates, and increases in life insurance pay-outs, among others.

In this study, of those that developed Long COVID, 22.3% were impacted to the extent that they missed time from school or work – on average 24 days. Given the large numbers of Canadians afflicted, the researchers estimated a total loss of about 14.5 million days of work and school among all Canadian adults. [Note that the population of the US is roughly 10 times that of Canada.] Approximately 5.3% of Canadian workers sought disability or worker’s compensation for Long COVID, and 93.8% of these applicants were approved. Of note, some of the most common occupations involved those with serious shortages in the U.S., e.g., healthcare, social services and education.

I fear that the majority of the population in the U.S. have become far too misinformed and complacent about COVID-19 and the risks for long-term health consequences. Unfortunately, I also fear that we will only come to appreciate these years from now, with profound regret, as we see the true impact of this disease and multiple reinfections, and God-forbid, not only in adults, but sadly our children.

Medical Considerations for Domestic and International Travel During the Holidays

Many Americans will travel either domestically or internationally during the upcoming holiday season, either for business, vacation or to visit family and friends.  Unfortunately, in my experience, most people do not consider the potential for getting ill while away from home, where they would go for health care if they became ill especially on a holiday, how they would communicate their health history and medications to health care providers who may not speak English if travelling abroad, and how they would pay to be medically transported to another hospital if they or a family member was seriously ill and hospitalized, but wanted or needed care at a more advanced or specialized hospital or one closer to home. Often, international travelers are not aware of health threats that they may encounter in countries they plan to visit that are different than those we face in the U.S.

Just as you would plan the itinerary for your travels, one should plan ahead for the unexpected, especially, if you will be traveling with young children or persons who are at high risk for health problems. Most calls I receive for help when people are away from home are actually cases in which no one imagined the family member would suffer a serious illness and is now hospitalized in another country, where the hospital is demanding cash payments, the family member is having to pay for their own extended lodging, and no one understands what is wrong with their family member. These are heart-breaking situations.

Additionally, people who might decide that under normal circumstances that their health is excellent and therefore they would pass on certain vaccines such as influenza or COVID-19 (not something I would advise, yet I understand that many people do think like this) should reconsider when travel is involved. First, it is always disappointing when you have looked forward to a trip, visiting family or a vacation, and likely spent a lot of money arranging it, to then get sick. That disappointment can turn to fear when the illness is severe enough that medical attention is needed and you are away from home and uncertain as to where to turn.

Second, if you are visiting friends and family, even if you do not become severely ill, you now may be the source for infecting a young child or an elderly person who very well might become severely ill. I have read heart-wrenching stories of people who did not take precautions, became ill and may have merely experienced a cold-like illness, but realize they likely infected a parent or grandparent or other family member who developed severe illness, required hospitalization, and in some cases died.

Finally, it can certainly be a desperate situation to be trying to find health care for a child or other family member at night, on a weekend or on a holiday even in the U.S., not to mention when you are away from home and not familiar with the health care system in the city you are visiting and, in the case of international travel, don’t speak their native language.

Here are my tips and recommendations:

Domestic Travel within the U.S.

  • Check with your doctor’s office to make sure you and all the family members who will be traveling with you are up-to-date with all your immunizations. In addition to the regularly scheduled immunizations:
    • Most everyone over 6 months of age should get the influenza vaccine. Those who are 65 years and older should get the high-dose flu vaccine.
    • Everyone over 6 months of age should also consider getting a COVID-19 updated booster shot (or your first, if you have never received one).
    • If you are traveling with a child under the age of 1 or if any travelers are over the age of 60, be sure to check with their doctors as to whether they should get the RSV vaccine.
  • If you want to check your immunizations for yourself, if you have received them all from a single health care provider, they may be listed on that provider’s patient portal if they have one (e.g., myChart if the provider is on the Epic electronic health record system). But, if you received some of these vaccines from a pharmacy or if you have received them from a number of providers who are not all on Epic, you can get a complete list of the vaccines you have received and the dates you received them by downloading the free app Docket https://docket.care/, as long as the providers who gave you the vaccines participate in and report to the Idaho Immunization Reminder Information System (IRIS). That app will also indicate if you are due for certain vaccines.
  • If any of the travelers have multiple medical conditions, an unusual medical condition and/or take medications on a regular basis, consider printing out a list of those medical conditions and medications.

You might be surprised to know how many patients I have seen who tell me, “I take a small white pill for my blood pressure, and a big yellow pill for ….” First of all, these descriptions don’t narrow down the range of possibilities of medications much and rarely will a description like that inform us as to the dosage of the medication. Further, patients might often call a capsule a pill, when a doctor or pharmacist would not. So, be sure to list the name of the medication (if you have the generic and the brand name, provide both, but either one will be fine if you don’t), the dosage and the unit (e.g., most pills you take probably are measured in milligrams, referred to as “mg” following the number, but children often take solutions of medications and they are sometimes labeled with the dose (e.g., 250 mg), but other times with the volume (e.g., my youngest grandson spent the night with me this week and I had to give him his medication and the direction was to give 1.88 cc or ml).

It is fine if you don’t know what the abbreviation on the bottle stands for because the doctors and pharmacists will, but in some cases the dose and the volume can be the same or close numbers, therefore, we want to make sure we know what abbreviation follows the number because that will tell us whether we are looking at the dose or the volume to be administered). Finally, be sure to write down how often you are taking the medication– e.g., twice daily, at bedtime, with meals, or as needed.

  • If you are high risk for severe disease with COVID-19 (see https://www.cdc.gov/coronavirus/2019-ncov/your-health/risks-getting-very-sick.html for factors that increase your risk for severe disease) or traveling with someone who is, now that Paxlovid is approved by the FDA, you may wish to discuss with your physician whether you are a candidate for Paxlovid (anti-viral medication) if you get infected while away from home, and if so, whether your physician will prescribe it so that you can take the medication with you. Given the need to start Paxlovid soon after detection of infection, and the challenges you may face while out of town in getting a medical evaluation and a prescription for the medication in a timely manner over the holidays, and if out of the country, the fact that Paxlovid may not be available, having the medication to take with you may come in handy. However, do not take the medication unless and until you have a positive test for COVID-19.
  • Consider whether you should purchase a family medical evacuation/air transport plan. (see below under international travel). While you may think this would only be needed for international travel, consider what you would do if you were out of state and a family member became very ill and required a prolonged hospitalization.
  • I recommend that you carry medication in your carry-on bag rather than your luggage. First, probably everyone who is reading this has had the experience of lost luggage. Therefore, if you are not going to take all of your medication in your carry-on, at least carry an extra day or two of medication in the event your luggage is delayed. Further, some medications can be temperature sensitive and lose effectiveness if exposed to extremes of temperature for an extended period of time. Cargo bay temperatures can get as low as 45 degrees Fahrenheit. If you do plan to pack medications in your luggage, be sure to check with your pharmacist whether that might create any problems.
  • I also recommend packing a few days of extra medication just in case your plans change or there are unforeseen weather events or other circumstances that would delay your return home.
  • It may be prudent to take an adequate supply of at-home COVID tests with you that would allow you to test each person who is traveling with you. There are still significant transmission levels of the SARS-CoV-2 virus, and transmission levels may be higher during the holidays.

Every household still has the opportunity to order 4 free at-home rapid antigen tests (2 boxes each containing 2 tests) if you have not already ordered them in the past two months. You can order these free tests at https://special.usps.com/testkits while supplies last.  I am not sure you will receive yours in time for your holiday travel, but it is worth a try, and even if not, these can be used to replenish your current supply.

If you already have a supply of tests, check the expiration dates to make sure that the tests are current. However, the FDA has recently extended the expiration dates for a number of home tests based on more testing since the agency issued their authorization for the tests. So, before tossing any of your current tests in the trash, check the FDA’s website at https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests#list to see if your test’s expiration date has been extended.

If you are out of tests and don’t receive your free tests in the mail in time, you can find tests at most pharmacies and many grocery stores. You may be glad you traveled with some tests if there is significant transmission wherever it is you are traveling to, as pharmacy inventory can quickly be exhausted when there is sudden demand. Plus, it is not fun to have to be contacting multiple stores to find out which has tests when you are not feeling well.

A certain number of tests per month are covered under many insurance plans, so if you go to the pharmacy itself to make the purchase, they can determine your insurance coverage for the tests https://www.cms.gov/how-to-get-your-at-home-OTC-COVID-19-test-for-free.

Many of the COVID-19 tests are also sensitive to temperature extremes, so I also recommend that you place these in your carry-on luggage rather than your checked bags. Keep in mind that the most important thing in in relying on the result of an at-home COVID-19 is the control line (often indicated by a “C” on the test strip where the line should appear) showing up. If it does not show up, discard the test and get another one.

  • It also may be advisable to take a supply of over-the-counter fever-reducing medicines, cold-symptom relieving medicines, and high-quality masks with you. Be aware that there have been shortages in many parts of the country of children’s over-the-counter medicines from time-to-time, and this will be worse if there are significant levels of COVID-19, RSV, influenza and other respiratory viruses circulating. Also keep in mind that some pharmacies and grocery stores may have reduced business hours on the holidays.
  • You would be well advised to wear a high-quality mask in airports and at least while boarding the aircraft and deplaning. While airplanes generally do have good ventilation and filtration of air, we have a number of well-documented transmissions of SARS-CoV-2 on flights, even to passengers who are not seated close to the index case. Further, keep in mind that ventilation is poor prior to the captain turning the engines on and they are frequently off during boarding. In addition, sometimes the captain will turn the engines off on the tarmac if there is going to be a significant delay in order to conserve fuel. It only takes seconds for the virus to transmit to a passenger when another passenger walks by who is infected, and the passenger may not even be aware that he or she is infected.
  • Make a plan. Check with your doctor and your children’s doctors’ offices about (1) what their holiday hours will be and (2) whether someone will be available to help you if you or your child gets sick when the office is closed and you are out of town. However, you also need to plan ahead for emergency rooms and hospitals in the area where you will be staying in case the medical issue cannot be handled over the phone and requires urgent attention.

Beware that some urgent care clinics may not be open on holidays or may have limited hours. Also beware that emergency rooms are often extremely busy during the height of respiratory virus season (including during the holidays) and may also have reduced staff on the holidays. Therefore, there may be significant delays. Remember that many of the people in the emergency room are likely there for respiratory infections, so you will be wise to wear a high-quality mask at all times other than when the physician is examining your nose or throat, when they are obtaining a sample from you for testing or in the event that they need to place oxygen on you. Since waits can sometimes be many hours, you may want to take your next dose of medications with you.

  • Know where to go for medical attention. Identify one or more urgent care centers near where you will be visiting. Check their website to verify days and hours of operation and check to see if they have reduced hours of operation on the holidays. If yours or your child’s illness does not seem to be severe, urgent care centers will likely be your best bet in that wait times are generally shorter and co-pays through your insurance are likely to be less than for an emergency room visit.
  • Have a plan in the event of an emergency. In some parts of the country, the high volumes of illness, the increase in injuries that we see this time of year, and the reduced staffing due to illness and holiday scheduling will lead to the overwhelming of ERs and to delays in EMS response times. Therefore, know where the nearest hospital is, and if you have small children, where the nearest pediatric hospital is.

If there is more than one hospital near where you will be visiting for the holidays, you can check with your doctor to see if he or she is familiar with them and can make a recommendation. If not, there is no single best source to identify the highest quality hospitals in your area, so I use a couple of websites.

The first is the LeapFrog Hospital Safety Grades https://www.hospitalsafetygrade.org/search?findBy=state&zip_code=&city=&state_prov=ID&hospital=, which I use to get a sense of the hospital’s commitment and efforts towards ensuring patient safety. You can search hospitals by state to allow you to compare. I strongly prefer hospitals with an “A” grade for patient safety, but there may not be one near where you will be staying.

I then look at quality scores and awards, and I like the HealthGrades website for this: https://www.healthgrades.com/find-a-hospital. When you go to this webpage, type in hospitals and the city and state you will be visiting. The hospitals in that area should pop up in descending order of overall quality. When you click on the hospital, you will see recent quality awards, if any. Then, given that you most likely would need a hospital for a respiratory illness, you can click under the areas of pulmonary (lung diseases) and critical care (how well the hospital, its doctors, nurses and therapists perform in caring for patients in the intensive care unit) to see how that hospital’s quality outcomes are.

Another indicator of the best hospitals that I use is Magnet status – a very difficult to achieve status, and even more difficult to maintain, for excellence in nursing that has been correlated with quality of care. You can go to https://www.nursingworld.org/organizational-programs/magnet/find-a-magnet-organization/ and scroll down to select the state you are visiting, and the list of Magnet designated hospitals and the years in which they have been redesignated, if applicable, will appear.

Of course, if you did not plan your choice of hospital in advance and you have an emergency, just go quickly to your nearest hospital.

  • Plan for an extended wait time in the ER and the potential that you or your child might have to be admitted to the hospital. Given the back-up in hospitals and the extraordinary time that you may have to spend in the ER with your child or family member even if they are not admitted, plan for who will care for your other children on short notice while you are at the hospital, especially if you or a family member must be admitted as an inpatient?
  • Who will care for any pets you traveled with if you are tied up in the ER or hospital for more than a day?

International Travel

  • Check with your doctor’s office to make sure you and all the family members who will be traveling with you are up-to-date with all your immunizations. In addition to the regularly scheduled immunizations:
    • Everyone over 6 months of age should get their influenza vaccine. Those who are 65 years and older should get the high-dose flu vaccine. There won’t be significant influenza activity in the southern hemisphere during our upcoming holiday if that is your destination, however, you will face exposure risks while at airports and on airplanes on the way.
    • Everyone over 6 months of age should also consider getting a COVID-19 updated booster shot (or your first, if you have never received one). There are some countries that are having significant surges in COVID-19 at the present time, (e.g., Australia, Germany and Sweden), but like the U.S., most countries are no longer reporting their cases. Consider that the country you are traveling to may have higher transmission rates than the U.S. at the time you travel, so take steps to protect yourself.
    • If you are traveling with a child under the age of 1 or if any travelers are over the age of 60, be sure to check with their doctors as to whether they should get the RSV vaccine.
  • If you want to check your immunizations for yourself, if you have received them all from a single health care provider, they may be listed on that provider’s patient portal if they have one (e.g., myChart if the provider is on the Epic electronic health record system). But, if you received some of these vaccines from a pharmacy or if you have received them from a number of providers who are not all on Epic, you can get a complete list of the vaccines you have received and the dates by downloading the free app Docket https://docket.care/, as long as the provider who gave you the vaccine participates in and reports to the Idaho Immunization Reminder Information System (IRIS). That app will indicate if you are due for a vaccine and list the vaccines that you have already received and the date received.
  • Travel Agent – optional

If you are using a travel agent to plan international travel, ask for any information they can provide you as to vaccines you will need, documentation of vaccines any of the countries you are traveling to might require, restrictions on medications you can take with you to those countries (see below), as well as medical care resources in the cities you will be visiting.

  • Travel Medicine Clinic – optional    At least 6 weeks prior to travel

You can do the necessary research for yourself (see below), but I personally like the ease of going to a travel medicine clinic (the one my family uses is https://www.stlukesonline.org/communities-and-locations/facilities/clinics/st-lukes-clinic–travel-medicine-and-immunizations, but you can research other options in your area. Saint Alphonsus also has a travel medicine clinic https://www.saintalphonsus.org/specialty/travel-medicine/). During your travel medicine consultation, they will identify all the vaccines you might need for the countries you are traveling to, administer those vaccines and give you vaccine certificates for any countries that require them. Travel medicine clinics may be an especially good option if the people traveling are at high medical risk or if you need a vaccine that is not commonly available in most doctor’s offices or pharmacies, such as yellow fever vaccine. In addition, they can identify health threats in those countries such as infections transmitted by mosquitos, ticks or fleas and provide you with information as to how to avoid or minimize those exposures.

You also can consider public health departments that offer travel medicine services, however, many don’t and some have discontinued these services with the onset of the COVID-19 pandemic, so be sure to check their websites (e.g., Central District Health no longer offers this service) to see if they do offer the service and to schedule an appointment.

If you are uninsured or may experience high out of pocket expenses for vaccines, many public health departments will have immunization hotlines (e.g., in Ada and Boise Counties 208-327-7400, Valley County 208-634-7194, and Elmore County 208-587-4407) that you can call to get information as to the immunizations they offer (they may also list these on their websites, e.g., you can go to https://cdh.idaho.gov/hl-immunizations-adults.php for the list of vaccines offered through Central District Health) and schedule an appointment to receive your necessary vaccinations.

There are programs available to cover the cost of many vaccines (but not those that would not be routine vaccines in the U.S.) for those who are uninsured or for those with insurance plans that are not ACA-qualified plans for which the insured is required to make an out-of-pocket payment. For example, the Vaccines for Children program https://www.cdc.gov/vaccines/programs/vfc/index.html will cover the cost of all routine vaccines for children who are uninsured, including the COVID-19 vaccines, and the Bridge Access Program will cover the costs for COVID-19 vaccines for uninsured adults.

  • Go to the CDC’s travel website and enter the name of the country or countries that you will be visiting. https://wwwnc.cdc.gov/travel/destinations/list. This will provide you with any travel health notices, including particular health risks in those countries and alerts relating to disease outbreaks. That site will also list recommended and required vaccinations for travelers to those countries. While most countries are no longer requiring COVID tests, immunization records of COVID-19 vaccines or quarantine for travelers, foreign countries can often make changes very quickly in response to outbreaks in their own countries, and so it is best to check to be sure there is no requirement that might catch you by surprise, and depending on the country you are traveling to, there might be requirements related to other diseases.

Pay particular attention to the section entitled “Healthy Travel Packing List,” especially if you plan to travel with medications and/or medical supplies. Some countries require medications to be in their original, labelled prescription bottles rather than in a pill box organizer. There are some over-the-counter and prescription medications that are perfectly fine to travel with inside the U.S., but are outlawed in certain other countries, and could even land you in prison. People are often surprised that certain cold medicines and over-the-counter medications to treat diarrhea are outlawed in certain countries. Be sure to check with the U.S. Embassy website https://www.usembassy.gov/ for each country you will be visiting to ensure that you are permitted to travel with the medications you plan to take with you, as well as any restrictions regarding syringes needed to administer those medications or any other medical supplies you plan to take to ensure they are permitted and that you have any required medical documentation. Also, be mindful of dosage limits. For example, diphenhydramine (commonly sold under the brand Benadryl) is available in the U.S. in 25 mg tablets and capsules. However, at least one country makes it illegal to have this medication in more than 10 mg formulations.

There are currently 31 countries that have circulating poliovirus (see https://wwwnc.cdc.gov/travel/notices/level2/global-polio for a complete list). Be sure that you have been fully vaccinated, and keep in mind that if you are traveling with a young child under the age of 6, that child may not yet be fully vaccinated against polio under the current schedule of vaccines. Therefore, check the immunization records yourself for IPV or inactivated polio vaccine to be sure your child has had a total of four shots. If not, check with your pediatrician’s or family medicine physician’s office as to the risks for the child or if the child is old enough to receive the 4th shot before you depart. If adults will be traveling to one of the 31 countries listed above, check with your physician or travel medicine clinic to determine whether you should receive a one-time IPV booster prior to your travel.

  • There are currently 39 countries that have been experiencing outbreaks of measles. You can check the current list of those countries at https://wwwnc.cdc.gov/travel/notices/level1/measles-globe. Measles is the most contagious virus that we know of, and exposure can occur more than an hour after the infected person leaves a room and a susceptible person enters.

If an adult becomes infected with the rubeola (measles) virus who has not had measles and has not been vaccinated against measles, there is a significant chance for severe illness that would require hospitalization. I promise you that you do not want to be hospitalized overseas, and obviously, this situation will be worse if you are the only adult traveling with a young child without someone to care for the child if you need to be hospitalized. Further, if the child you are traveling with is under the age of 6, he or she may not yet have been fully vaccinated against measles. Therefore, be sure to check the vaccination record for the child or talk to the child’s physician to determine whether the child is fully vaccinated, and if not, whether the child is old enough to be given the second dose of vaccine (called MMR for measles, mumps and rubella) at least two weeks prior to your departure.

  • If any of the travelers have multiple medical conditions, an unusual medical condition and/or take medications on a regular basis, consider printing out a list of those medical conditions and medications. You might be surprised to know how many patients I have seen who tell me, “I take a small white pill for my blood pressure, and a big yellow pill for ….” First of all, these descriptions don’t narrow down the range of possibility of medications much. Further, patients might often call a capsule a pill, when a doctor or pharmacist would not.

Be sure to list the name of the medication (if you have the generic and the brand name, provide both, but of the two, the generic name is likely to be most helpful to health care professionals in another country), the dosage and the unit (e.g., most pills you take probably are measured in milligrams, referred to as “mg” after the number, but children often take solutions of medications and they are sometimes labeled with the dose (e.g., 250 mg), but other times with the volume (e.g., my youngest grandson spent the night with me this week and I had to give him his medication and the direction was to give 1.88 cc or ml). It is fine if you don’t know what the abbreviation on the bottle stands for because the doctors and pharmacists will, but in some cases the dose and the volume can be the same or close numbers and we want to make sure we know what abbreviation follows the number because that will tell us whether we are getting the dose or the volume to be administered. Be sure to write down how often you are taking the medication– e.g, twice daily, at bedtime, with meals, or as needed.

If you are not traveling to an English-speaking country, be sure to have a copy of the list of medical problems and medications that is translated into the native language for that particular country. Google and Adobe can both be used to translate your document into the language(s) of the country(ies) you are visiting. However, medical jargon is not always accurately translated, so it can be helpful to ask someone who speaks that language to review the translated version to make sure it accurately reflects what you meant to write. There are also some professional services that offer this service that you can find online. It also may be that the translation services department of your local hospital would be willing to review the document for you.

Finally, keep in mind that not all medications you are taking may be available in that country, and even if they are, they may go by a different name. So, when traveling to a non-English speaking country, add what you take the medication for to the list since they may need to change you to a medication that is available in their country.

  • It also may be advisable to take a supply of over-the-counter fever-reducing medicines, cold-symptom relieving medicines, and high-quality masks with you. You are unlikely to be familiar with the over-the-counter medications in other countries, and if it is a non-English speaking country, you may have difficulty reading the labels and understanding the instruction for use and dosing of the medications.
  • If you are high risk for severe disease with COVID-19 (see https://www.cdc.gov/coronavirus/2019-ncov/your-health/risks-getting-very-sick.html for factors that increase your risk for severe disease) or traveling with someone who is, now that Paxlovid is approved by the FDA, you may wish to discuss with your physician whether you are a candidate for Paxlovid (anti-viral medication) if you get infected while away from home, and if so, whether your physician will prescribe it so that you can take the medication with you. Given the need to start Paxlovid soon after detection of infection, and the challenges you may face while out of town in getting a medical evaluation and a prescription for the medication in a timely manner over the holidays, and if out of the country, the fact that Paxlovid may not be available, having the medication to take with you may come in handy. However, do not take the medication unless and until you have a positive test for COVID-19.
  • When traveling to a non-English speaking country, strongly consider identifying a website or app (e.g., Google translate) on your iPhone that you can use to translate to and from that country’s native language, or you can certainly purchase hand-held devices that will translate speech as well. This can be important if you need to request medical services and need directions or help, and this can be invaluable if you are in an urgent care clinic or emergency room and need to communicate to the health care providers and no translator is available.
  • If you need to travel with medical devices (e.g., a CPAP machine, a nebulizer, etc.) that require electrical power, be sure that the country you are traveling to uses the same kind of plugs and outlets as the U.S. (many don’t), or you may need to take a converter with you. Here is a website you can use to determine the different electrical standards countries use https://www.worldstandards.eu/electricity/plug-voltage-by-country/ and I found a helpful picture guide to the different types of plugs here https://www.skyscanner.net/news/international-travel-plug-adapter-guide. You likely can find converters at stores like Walmart or quite a number of options online. Keep in mind that if you are taking a cruise, the plug outlets are likely to be the ones used by the country of origin of the ship rather than the country you are traveling to. Be sure to check with the cruise line or your travel agent.
  • Consider whether you should purchase a family medical evacuation/air transport plan. I have unfortunately been called a few times over my career by a distressed family member, most often a spouse of someone who very unexpectedly became severely ill and required a prolonged hospitalization. While insurance may cover part or all of the hospitalization abroad, unlike in the U.S. where hospitals accept most insurance plans and don’s submit bills until after discharge from the hospital, foreign hospitals often require cash payments on a daily or weekly basis. Further, not that American doctors aways do a good job of explaining what is wrong with the family member, but I am often told that family members abroad don’t get to talk to the doctor regularly or don’t understand what the doctor is saying. For these, and other reasons, these family members are often desperate to have the patient transported home to a local hospital or at least to a different hospital in an English-speaking country or one with greater capabilities to treat their loved one.

Unfortunately, when patients are very ill, they need to be transported with a medical team that can care for the patient in air and handle any emergencies that might occur en route. Travel more than 150 miles requires a jet. These transports are very expensive (in my experience, even relatively short transports are in excess of $10,000.00. Overseas transports will obviously be far more expensive.

Most often, your medical insurance will only cover air transport if it is not possible for your family member to get the needed care at the hospital where they are. Issues with communication or the hospital requiring cash up front would generally not qualify for coverage under many insurance policies, nor would a request to transport the patient so that you can be closer to home, where there is more family support and doctors who have previously cared for the patient.

Therefore, you may wish to purchase a medical evacuation/transport plan. I have a plan that costs less than $400 per year to cover all members of my household. If you wish to purchase a plan, it is important to understand that not all of these plans are the same, and there are some important questions you should ask prior to purchasing your plan.

Most plans that I reviewed will only provide transportation to the nearest suitable U.S. hospital. For example, if your family member was hospitalized in Mexico, you would most likely be transported to a hospital in South Texas or Southern California, which may feel like a big improvement, but may still be far from home, may cause difficulties for your children who need to get back to school, and is almost certain to be far away from other family and friend support, all while incurring ongoing lodging costs for yourself away from home. There are plans that will cover transportation back to Boise or whatever your nearest local hospital that has the capacity and capability to care for your family member is located.

Another factor in your choice of plan would be whether they will guarantee your ability to fly back with your family member. Many plans will indicate that they may accommodate a family member with a patient, but don’t guarantee it. Obviously, it can be distressing for both family members to be separated from each other, and it is always more difficult for the receiving hospital and doctors when there is no family member available to provide information. Similarly, not all plans will ensure that your luggage will be accommodated on the flight. That may seem like a minor detail, but there are a lot of headaches and expense when you have to arrange for your luggage to be flown to the city you are being transported to and then from that airport to wherever you will be staying, all while you are worried about the welfare of your family member.

Finally, another thing that I like about my plan is that even if my wife and I are travelling domestically, if we were out of state and I wanted to get her back to Boise or she wanted to transport me, this plan would cover that transport.

  • You would be well advised to wear a high-quality mask in airports and at least while boarding and deplaning. While airplanes generally do have good ventilation and filtration of air, we have a number of well-documented transmissions of SARS-CoV-2 on flights, even to passengers who are not seated close to the index case. Further, keep in mind that ventilation is poor prior to the captain turning the engines on, and often the engines are not on during boarding. Sometimes the captain turns the engines off on the tarmac if there is going to be a significant delay in order to conserve fuel. It only takes seconds for the virus to transmit to a passenger when another passenger walks by who is infected, and that passenger may not even be aware that he or she is infected.
  • I recommend that you carry medication in your carry-on bag rather than your luggage. First, probably everyone who is reading this has had the experience of lost luggage. Therefore, if you are not going to take all of your medication in your carry-on, at least carry an extra day or two of medication in the event your luggage is delayed. Further, some medications can be temperature sensitive and lose effectiveness if exposed to extremes of temperature for an extended period of time. Cargo bay temperatures can get as low as 45 degrees Fahrenheit. If you do plan to pack medications in your luggage, be sure to check with your pharmacist whether that might create any problems.
  • I also recommend packing at least a few days of extra medication just in case your plans change or there are unforeseen weather events or other circumstances that would delay your return home.
  • It may be prudent to take an adequate supply of at-home COVID tests with you that would allow you to test each person who is traveling with you. There are still significant transmission levels of the SARS-CoV-2 virus, and transmission levels may be higher during the holidays.

Every household still has the opportunity to order 4 free at-home rapid antigen tests (2 boxes each containing 2 tests) if you have not already ordered them in the past two months. You can order these free tests at https://special.usps.com/testkits while supplies last.  I am not sure you will receive yours in time for your holiday travel, but it is worth a try, and even if not, these can be used to replenish your supply.

If you already have a supply of tests, check the expiration dates to make sure that the tests are current. However, the FDA has recently extended the expiration dates for a number of home tests based on more testing since the agency issued their authorization for the tests. So, before tossing any of your current tests in the trash, check the FDA’s website at https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests#list to see if your test’s expiration date has been extended.

If you are out of tests and don’t receive your free tests in the mail in time, you can find tests at most pharmacies and many grocery stores, and may be better off purchasing them prior to departure rather than searching for them in another country. Moreover, you may be glad you traveled with some tests if there is significant transmission wherever it is you are traveling to, as pharmacy inventory can quickly be exhausted when there is sudden demand. Plus, it is not fun to have to be contacting multiple stores to find out which has tests when you are not feeling well.

A certain number of tests per month is covered under many insurance plans, so if you go to a pharmacy in the U.S. to make the purchase, they can determine your insurance coverage for the tests https://www.cms.gov/how-to-get-your-at-home-OTC-COVID-19-test-for-free.

Many of the COVID-19 tests are also sensitive to temperature extremes, so I also recommend that you place these in your carry-on luggage rather than your checked bags.

I hope this is helpful. I wish you all happy and safe holidays!

Another Public Health Epidemic in the U.S.

Last week, the CDC issued a media release (U.S. Syphilis Cases in Newborns Continue to Increase: A 10-Times Increase Over a Decade | CDC Online Newsroom | CDC) warning of a 10-fold increase in the numbers of congenital syphilis cases resulting from the rapidly accelerating epidemic of sexually transmitted diseases (specifically, gonorrhea and syphilis) in the U.S. (though this problem is not limited to the U.S.).

What causes syphilis and how is the infection transmitted?

Syphilis is a disease that results from infection with a bacterium called Treponema Pallidum. Most often, transmission of this infection occurs with sexual activity, regardless of whether homosexual or heterosexual in nature. Generally, transmission results from direct contact with a chancre, which is a syphilitic sore oftentimes resembling a superficial ulcer. The chancre is typically painless; however, exceptions occur such as when the chancre is located on the anus.

Chancres typically appear on the penis, vagina, anus, rectum, lips or mouth. However, the person who is the source of the infection is not always aware that they have a chancre, and the person who becomes infected may not notice the chancre, especially when it is located inside the sex partner’s mouth, vagina or rectum. Thus, transmission most often occurs during oral sex, vaginal intercourse or anal-receptive sex and the chancre develops at the site where the bacteria (often referred to as spirochetes because of their corkscrew-like appearance under the microscope) are inoculated – i.e, on the lips or in the mouth with oral sex, on the penis with intercourse, on the labia or in the vagina with vaginal intercourse, and on the anus or in the rectum with anal-receptive sex. Of great concern is the potential for a pregnant mother to infect their unborn fetus through placental transfer of the bacteria (see below).

Syphilis can be successfully treated with antibiotics.

What is the natural course of infection if left untreated?

After exposure to Treponema Pallidum from sexual contact with someone who is infected, the incubation period (the time period between exposure and subsequent infection until the disease becomes manifest) can range from 10 days to 3 months, but on average is 3 weeks. The resulting disease is referred to as primary syphilis and is generally recognizable by the development of one or more chancres (multiple chancres are more common in HIV-positive individuals). At this point, the patient is contagious and may remain infectious to others for up to a year if untreated. The patient may have enlarged lymph nodes (which most often are not tender) in the area near the chancre. If a woman becomes infected and is not treated, she can transmit the infection to her unborn baby if she becomes pregnant up to four years later.

Even without treatment, the chancre tends to resolve on its own over the course of 3 – 6 weeks, with or without leaving a small scar behind. However, when the patient is not treated for syphilis, the disease most often progresses to secondary syphilis.

Secondary syphilis occurs between 4 and 10 weeks after the initial chancre of primary syphilis. It is difficult to identify secondary syphilis other than by performing a screening blood test based on the patient being at risk due to unknown or multiple sexual partners or suspicion when a wide range of possible rashes appear.

The classic rash of secondary syphilis is one that does not cause itching and appears on the palms of both hands. The other place I always check is the bottom of the feet. The rash can be very faint, so one has to look closely. Secondary syphilis is the great masquerader and may present with rash over the back, areas of hair loss, a patch on the tongue, or condylomas (wart-like skin lesions) over the genital areas (though they can occur in the mouth) that are typically white or gray in color. These rashes can easily be confused with other diseases and conditions.

Some patients will have symptoms during secondary syphilis, such as fever, headache, muscle aches, fatigue, and even weight loss. However, many patients do not report symptoms. The symptoms will resolve with or without treatment. However, if not treated, the disease will most often then progress to latent syphilis, and in some cases, to tertiary syphilis.

Latent syphilis can only be detected with a blood test. There are no rashes or symptoms to suggest that infection is present. The latent stage can last many years.

The dreaded consequences of untreated syphilis are the potential for transmission to an unborn child and the development of the next phase of syphilis called tertiary syphilis. Tertiary syphilis can affect the brain (severe headaches, confusion, dementia, weakness, paralysis), nerves (numbness and loss of sensation), eyes (pain, redness, blurred vision or even loss of vision), heart, blood vessels, liver, bones and/or joints. It also can be fatal.

What is congenital syphilis?

An infected pregnant mother can transmit the infection to the developing fetus with potentially severe consequences to the baby. Therefore, testing for syphilis is recommended in all pregnant moms at their first prenatal visit, especially since physical signs of syphilis are often not evident. If the mom has risk factors for acquiring syphilis (drug use, sex worker, multiple sex partners, homelessness, incarceration or sexual partner has been incarcerated), then repeat testing in the third trimester is indicated.

Untreated syphilis during pregnancy sadly can cause the baby to be stillborn (often after 20 weeks) or tragically, to die shortly after birth in as much as 40 percent of pregnancies.

Babies who survive to be delivered can appear to be normal, but then deteriorate several weeks later. Even if the baby survives, developmental delays and seizures may result. Babies can also have wide-ranging signs of congenital syphilis including rashes, bleeding from the nose, anemia, liver enlargement or jaundice, lung and/or kidney problems, among others. These problems tend to manifest within the first two years of life, whereas toddlers with congenital syphilis can develop a number of deformities and loss of hearing after the age of 2 years.

Unfortunately, more than 3,700 babies were born with congenital syphilis in 2022, more than 10 times the number just a decade ago. It is estimated that 90 percent of these cases could have been avoided with early and proper prenatal care and prompt treatment.

If you have unknown or multiple sex partners, please get testing on a regular basis. If you are concerned about anonymity, contact your local health department for confidential STI (sexually transmitted infections) screenings and testing. Keep in mind, you can have more than one STI. My personal record as a physician is diagnosing a patient with 5 STIs at the same time.

If you become pregnant, be sure to get prenatal care right away and on a regular basis.

COVID-19 Liability Cases are Beginning to Make their Way Through the Courts

For some time now, I have raised the potential for liability against employers in lawsuits brought by their employees for failing to provide certain basic protections against infection with the SARS-CoV-2 virus, especially in the case of health care employers. In the specific case of hospitals and nursing homes, we have already seen a number of lawsuits brought by patients or their survivors when the patient was infected by staff or other patients following their admission to the hospital or nursing home.

It is not surprising that we have not yet seen more lawsuits filed due to the fact that there have been immunity protections offered to hospitals and health care providers by a number of states and, to some extent under federal law, during the early years of the pandemic.

Some of the state legislatures extending limited immunity have allowed those laws to expire, other laws were only in effect during the time the Governor had declared a state of emergency, and in the case of at least one state, the legislature has repealed the immunity provision.

Further, there is some confusion among the courts as to whether federal law (Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 – the “PREP Act”) would extend liability protection to health care providers even in situations where the providers failed to implement or use the countermeasures covered by this law (see below). Much of this law remains in effect under declaration by the Secretary of Health & Human Services; the latest declaration will expire at the end of 2024.

The law does not offer immunity from liability under all situations. For example, an exception stated in the law is death or serious physical injury caused by willful misconduct. (Note that it is the misconduct that must be willful; not that there was intent to cause death or serious injury.) A case involving this situation must be brought in the federal court in Washington D.C.

The act also contemplates that health care providers will make a reasoned decision as to how to deploy covered countermeasures. It appears that even HHS agrees that if a provider fails to act purposefully or fails to make a decision or policy as to how the covered countermeasures are to be deployed, the protections under the act likely do not apply. Further, the defined covered countermeasures in the statute include a number of things, but as to respiratory protection, only respiratory protective devices that are approved by the National Institute for Occupational Safety and Health (“NIOSH”) are covered. By now, all of us have seen many hospital personnel unmasked or merely wearing procedure masks. NIOSH only approves respiratory protective devices (masks and respirators) that are N-95 or greater in quality, thus the use of procedure or surgical masks would not qualify as a covered countermeasure.

Many of the lawsuits brought by patients or their estates allege that the patient contracted COVID-19 because the facility failed to provide its staff with personal protective equipment (“PPE”), failed to teach the staff how to properly use that equipment, or failed to ensure that its staff used the PPE that it had been given. The PREP Act extends its protections to “injuries directly caused by the administration or use of a covered countermeasure[.]” 42 U.S.C. § 247d-6e(a). Thus, the failure to administer or use a covered countermeasure would seem to fall outside of the protections of the statute.

Defendants (health care providers) often seek to remove these cases from state court to federal court in order to avoid state law claims of medical malpractice, ordinary negligence and corporate negligence (which can lead to much larger awards from a jury) by asserting that the immunity provisions of the PREP Act apply and that federal courts have the sole jurisdiction over these cases. In the majority of decisions I can find, plaintiffs have been successful in remanding these cases back to state court under a variety of arguments, including that the PREP Act does not provide for a cause of action (in other words, a basis for bringing a lawsuit) other than the very narrow circumstances of death or serious physical injury resulting from willful misconduct or that the PREP Act does not even apply to the circumstances of the lawsuit.

In a case involving the death of a patient due to COVID-19 while being cared for at a rehab and nursing care facility (Mitchell v. Advanced HCS), the federal district court for the Northern District of Texas remanded the case (i.e., sent it back to state court from federal court) for trial, in large part finding that the PREP Act is an immunity statute, not a statute providing a cause of action (i.e., a basis for a lawsuit) absent the narrow exception stated above. Thus, the state law claims of medical negligence, ordinary negligence and corporate negligence can proceed, and to the extent that the immunity provided under the PREP Act applies, defendants can offer that as a potential defense.

In the case of Grohmann v. HCP Prairie Village, the plaintiff resided in an assisted living facility in order to ensure his safety and care. He contracted COVID-19 while at the facility and it was alleged in the lawsuit that the staff did not seek prompt medical care for his condition contributing to his death two days later. It was further alleged that the employer allowed its employees to work while sick with symptoms of COVID-19 and that the facility failed to train and monitor its staff’s use of PPE to ensure that the virus was not spread among the residents of the facility. It was further alleged that the facility undertook no efforts to isolate those residents with symptoms consistent with COVID-19 and failed to implement an infection control plan to prevent an outbreak of COVID-19 within the facility.

The plaintiff (the estate of Mr. Grohmann) filed their case in state court asserting state law claims of wrongful death, loss of chance of survival, and negligence. The defendant (assisted living facility) sought removal to federal court and the dismissal of all the state law claims based on their claim that the PREP Act was intended by Congress to preempt state law claims.

In deciding these jurisdictional and procedural questions, the federal district court in Kansas first decided that the narrow circumstance that would provide for exclusive federal jurisdiction of death or injury caused by willful misconduct does not apply because the plaintiff did not allege this in his lawsuit. The court then turned to the language in the statue that defines its scope as applying to “injuries directly caused by the administration or use of a covered countermeasure.” The court points out that the phrase “administration or use” is not defined in the statute. So, the court then turns to the  Declaration of the Secretary of HHS which gives effect to provisions of the statute noting that it defines “Administration of the Covered Countermeasure means [1] physical provision of the countermeasures to recipients, or [2] activities and decisions directly relating to public and private delivery, distribution and dispensing of the countermeasures to recipients, management and operation of countermeasure programs, or management and operation of locations for the purpose of distributing and dispensing countermeasures.”  85 Fed. Reg. at 79,197.  

The court then looks to prior decisions of cases involving the PREP Act decided by the federal district court of Kansas. “In eleven related cases, our court held that the PREP Act was ‘inapplicable’ to plaintiffs’ negligence claims where plaintiff’s ‘case is premised on inaction’ and there was ‘no clear allegation that any injury or claim of loss was caused by the administration or use of any covered countermeasure, let alone that the loss arose out of, related to, or resulted from the same.’”  Eaton, 2020 WL 4815085, at *1 n.1, *6–7.  The court went on to write, “Eaton reasoned that ‘the PREP Act addresses the administration or use of covered countermeasures.  There is simply no room to read it as equally applicable to the non-administration or non-use of covered countermeasures.’”  Id. at *8.

The court then went on to cite other federal district courts (including Florida and California) and even state courts (e.g., New York) that have come to the same conclusion.

Acknowledging that the failure to administer or use a countermeasure could still be protected by the PREP Act in the limited circumstance of allocating scarce resources, for example, early in the pandemic when the availability of countermeasures was in short supply and decisions had to be made as to which patients such countermeasures would be offered. In contrast to these rationing kinds of decisions, nonfeasance of simply not using countermeasures that were available would not provide the health care provider with the immunity provided under the statute.

In examining the facts of the present case, the court noted that the “plaintiff alleges that … failures to act directly and proximately caused the alleged harms.  As inEaton, plaintiff here alleges that defendants failed to take various preventive measures to stop the entry, spread, and consequences of COVID-19 within the facility and that defendants’ failure to take those precautions led decedent to contract, develop, and die of COVID-19.”

Defendants try to bring the plaintiff’s claims under the reach of the PREP Act by pointing out some of the countermeasures employed by the facility, such as testing and the use of some PPE. However, the court points out that to bring the plaintiff’s claims under the PREP Act, the defendants would have to show that the “decedent’s death was causally connected to the administration or use of any drug, biological product, or device (i.e. a covered countermeasure).” The court goes on to explain, “The claims here are ‘precisely the opposite:  that inaction rather than action caused the death.’”

The court then remanded the case to state court finding that the plaintiff’s claims do not fall within the scope of the PREP Act.

Having failed to successfully remove cases to federal court and dismiss state law causes of actions, defendants in cases in which a patient was infected while in their care, but defendants failed to use measures to contain the spread of COVID-19 in their institutions, face the potential for significant liability if plaintiffs can prove their cases in court.

I have not yet seen reported decisions of these kinds of cases in state court. My suspicion is that defendants, recognizing the potential liability they are facing, are settling these cases out of court. On the other hand, I am certain there are some cases proceeding to trial for which discovery and identification of expert witnesses has been underway. I’ll update you as I find reports of the outcomes of these cases.

Meanwhile, there is a related case, but with very different facts and issues presented, that was decided by the U.S. Court of Appeals for the Ninth Circuit (this is the court that handles appeals for federal courts in Idaho) earlier this year. The underlying case is one brought by the family of a deceased San Quentin Prison guard (Gilbert Palanco) against the San Quentin Prison, the state of California, the California Department of Corrections and Rehabilitation and certain specific prison officials, including health care providers, after prison guard Palanco was infected with the SARS-CoV-2 virus while on duty and subsequently died from COVID-19 complications. The defendants had asserted limited immunity under California state law, but the district court denied the grant of immunity. Defendants then appealed this decision to the Ninth Circuit Court of Appeals.

Early in the pandemic, prison officials ordered the transfer of 122 prisoners who were determined to be at high risk due to underlying medical conditions from one prison where there was an outbreak of COVID-19 to San Quentin State Prison where there were no known cases of COVID-19. Not surprisingly, this resulted in an outbreak at the San Quentin facility that killed guard Palanco and more than 25 inmates.

According to the panel of judges hearing the case on appeal, “Plaintiffs sufficiently alleged a violation of Polanco’s substantive due process right to be free from a state-created danger, under which state actors may be liable for their roles in creating or exposing individuals to danger they otherwise would not have faced.”

On appeal, the court does not decide the facts of the case, nor does it render a decision as to the underlying lawsuit. Rather, the court assumes that what plaintiffs allege is true for purposes of determining whether in that case, the defendants would be entitled to the immunity provided under law. In so doing, the panel of judges noted that, “the failure to adequately test or screen inmates prior to the transfer, the transfer itself, and the decision to house the inmates in open-aired cells upon arriving at San Quentin, among other things, placed Polanco in a much more dangerous position than he was in before, the danger was particularized and sufficiently severe to raise constitutional concerns, and defendants were aware of the danger that transferring potentially COVID-positive inmates to San Quentin would pose to employees.”

Harmful to their defense was the fact that prior to this event, California Correctional Health Care Services adopted a policy opposing the transfer of inmates between prisons, reasoning that transfers would “carr[y] [a] significant risk of spreading transmission of the disease between institutions.” Further, there was evidence that all of these prison officials and health care providers had been briefed about the dangers of COVID-19, the highly transmissible nature of the virus, and the necessity of taking precautions (such as social distancing, mask-wearing, and testing) to prevent its spread. Defendants were also aware that containing an outbreak at San Quentin would be particularly difficult due to its tight quarters, antiquated design, and poor ventilation.

Adding to the bad facts of the case, most of the 122 transferred inmates had not been tested for COVID-19 in more than three weeks despite the outbreak existing at the time of transfer, none had been screened based upon a review of symptoms, and the inmates were packed onto buses in numbers exceeding the guidelines set out by the Department of Corrections for inmate safety. Inmates who were showing signs of possible infection upon arrival at the San Quentin State Prison were not quarantined. Two days later, when the county public health officer learned of the transfer, prison officials were advised to immediately sequester the transferees, that mixing of the prison populations be restricted to impede spread of disease and that exposed staff and prisoners be required to mask. Unfortunately, prison officials did not heed this advice and asserted that the public health official had no authority over a state-run prison.

Over the ensuing three weeks, San Quentin State Prison went from no cases of COVID-19 to nearly 500. Medical experts issued a report raising concern of a “full-blown local epidemic and health care crisis in the prison and surrounding communities” if not contained. The Prison’s response was also criticized for the failure of staff and prisoners to be provided with PPE even though it was readily available on site. When staff were provided with masks, due to poor training, many wore the masks improperly. The report also cited unacceptable delays associated with testing. Again, prison officials declined to implement any of the recommendations made in the report and declined testing offered for free by one laboratory.

Not surprisingly, the outbreak continued unabated. By July, more than 1,300 inmates and 184 staff had tested positive. Two months later, those numbers had ballooned to more than 2,100 inmates and 270 staff. As of early September, approximately twenty-six inmates and one guard had died of COVID-19.

Guard Palanco was 55 years old and at high risk due to his underlying medical conditions. Part of Palanco’s responsibilities was to transport ill inmates to health care facilities. Despite these risks, he was not provided with PPE.

In reviewing this case on appeal, the panel of judges took all of the facts of the case to be true for determining whether defendants were entitled to immunity under California law. In doing so, the panel held that plaintiffs sufficiently alleged a violation of Polanco’s due process right to be free from a state-created danger. The Fourteenth Amendment of the U.S. Constitution mandates that “[n]o State shall . . . deprive any person of life, liberty, or property, without due process of law.” The court pointed out that under the state-created-danger doctrine, state actors may be liable “for their roles in creating or exposing individuals to danger they otherwise would not have faced.” Liability ensues when state employers affirmatively, and with deliberate indifference, create or expose their employees to a dangerous work environment.

Interestingly, the defendants in this case also argued for immunity under the PREP Act, however, the district court denied the request finding that the PREP Act did not apply.

The court of appeals affirmed the holding of the district court, meaning that the case will now be returned to the district court for trial and the defendants will not be able to assert statutory immunity as a defense.

I have been quite shocked by the lack of infection control measures undertaken by hospitals, as well as their lack of transparency. I don’t know whether this results from poor leadership or disregard for patients under the mistaken assumption that they will have immunity from legal responsibility. However, I encourage health care leaders and boards to consider the court decisions to date to reassess their policies and procedures. Consider carefully cases of high-risk patients that are now at higher risk in a hospital, where they come to for treatment and healing and rely on care from health care professionals, than they would have been at home.

When I was CEO of a hospital and later, a health system, I placed patient and employee safety at the forefront of all my decisions. While I wished we lived in a world where all health care leaders did the right thing because it was the right thing, the realities are far more complex. However, the risk calculations are shifting with these court decisions to date, and I urge boards and leaders to at least proceed with open eyes, being aware of the risks of what I think will soon be a large number of trials and settlements, and all the associated costs, not to mention reputational damage and loss of the public’s trust.

In-Hospital Spread of Epidemic and Pandemic Coronaviruses

When a novel virus (novel means a new virus or new strain of virus to which the population would not be expected to have preexisting immunity, and little, if any, cross-immunity [i.e., immunity to other strains of viruses that might be similar enough to provide some protection against the new strain based upon prior infection or immunization against the prior strain]) emerges in a human population and is sufficiently virulent so as to make individuals uncomfortably sick or severely ill, patients will present to emergency rooms and some will be admitted to the hospital, oftentimes, hours or days before the infecting pathogen is identified.

If the virus is efficiently transmissible and health care workers and organizations have not taken appropriate steps (personal protective equipment [PPE] and air handling), those health care workers, staff, patients and visitors within sufficient proximity to the infected patient may be infected. This is a common problem in third-world countries when outbreaks first occur, and unfortunately, it is not unusual for some nurses and doctors to become severely ill or even die.

In 2014, a patient presented to a Dallas emergency room following international travel with a disease we fortunately do not see in the U.S., except in international travelers, almost always those arriving from an African country. Unfortunately, this patient had an infection with Ebola virus that more often than not results in death. Fortunately, it is not among the most transmissible of viruses that we deal with.

Nevertheless, to understand the potential public health threat of this one patient becoming ill in the U.S., 48 individuals had close contact with him after he became ill, but before he presented to the hospital, and another 76 hospital workers cared for him after he presented to the hospital. Two nurses ended up becoming infected, and of course, there were many health care workers who then were required to care for these two new patients. Thus, one can see how a single infected person could expose hundreds of people directly, and then this can be amplified through other people who have subsequently been infected. This is one way in which disease outbreaks can occur, and, under the right circumstances, an outbreak could lead to an epidemic, or rarely, even a pandemic.

The patient with Ebola unfortunately died from his disease. Fortunately, both nurses recovered.

In Wuhan, China, patients began to be admitted to the hospital in December 2019 with an illness that resembled severe acute respiratory syndrome (SARS), which had created an epidemic in 2002 – 2003, but not with the same virus that had caused these new cases of disease. It would subsequently be determined in early January that this new disease outbreak was being caused by a novel coronavirus, which would subsequently be named SARS-C0V-2 to distinguish it from the SARS-CoV that had caused the 2002 – 2003 disease outbreak. Unfortunately, 3,387 health care workers in China had been infected as of February 24, 2020. Many of them no doubt were infected in caring for patients, however, some number of them likely were infected by colleagues or even outside of the hospital with the emergence of community spread of disease. In the U.S., as well, even with our advance notice of this emerging novel viral pandemic, many health care workers were infected while caring for patients, in some cases due to shortages of PPE, but also from family members, children and other close contacts.

In many ways, we have been fortunate that, in the case of the Ebola exposure in Texas, most of those who were exposed did not become infected, and that in the case of SARS-CoV-2, the case fatality rate was not higher. Nevertheless, both examples demonstrate how quickly a novel virus could spread if highly transmissible, given the number of contacts a sick patient is likely to have, and the multiplier effect that would occur if the infectivity (the proportion of those exposed who will develop infection) was very high.

We know that hospital-based spread of infection was an important factor in both prior novel coronavirus disease outbreaks – SARS-CoV in 2003 (Cooper, B. S. et al. Transmission of SARS in three Chinese hospitals. Trop. Med. Int. Health 14, 71–78 (2009)) and Middle East Respiratory Syndrome coronavirus – MERS-CoV in 2012 (Cowling, B. J. et al. Preliminary epidemiological assessment of MERS-CoV outbreak in South Korea, May to June 2015. Euro Surveill. 20, 7–13 (2015). In the case of SARS, the study of three Chinese hospitals demonstrated that transmission rates were higher within hospitals than within communities. In the case of MERS, in a Korean outbreak of the disease, 75 – 89% of infections could be traced to three nosocomial (within hospital) super-spreading events.

A study published last month (The burden and dynamics of hospital-acquired SARS-CoV-2 in England | Nature) attempted to study the burden (amount of disease) and transmission dynamics (how the virus spread) of SARS-CoV-2 within a hospital in England. They examined data from 356 hospitals (excluding children’s hospitals). The differentiation between patients who were infected in the community versus those who acquired the infection following hospitalization was determined on the basis of the interval from the time of hospital admission to confirmed PCR testing for SARS-CoV-2 infection. Community-onset infections were defined as those with an interval of 2 d or less; an interval of 3–7 d led to a classification of indeterminate healthcare-associated; those with intervals of 8–14 d were classified as probable healthcare-associated; and those with intervals of 15 d or more were classified as definite healthcare-associated. 

This is not merely an issue of academic interest. Widespread transmission of a virus within hospital can impact the public’s health in many ways. The most obvious is that when health care workers are exposed, they may need to be removed from the workforce temporarily in quarantine, even if not ill. Obviously, if those health care workers become ill, they need to be in isolation and also are unavailable to care for patients, at a time when we already have many shortages of health care workers.

Health care workers in quarantine or isolation may, in turn, inadvertently infect household members or close contacts, which can further contribute to spread of the virus in the community and burden hospitals with more infected patients.

Shortages of health care workers then mean increased expenses for hospitals to pay over-time and, if the shortages are severe enough, significant increased costs to hire temporary replacement staff. Overtime work, temporary staff who are working in a hospital that they are new to and perhaps in an area of care that they are less experienced can result in quality-of-care issues. Further concerns for patient safety and quality of care occur when health care shortages are severe enough or the number of patients being admitted are so high as to result in staff being pulled to care for patients from areas where they don’t deal with these kinds of patients on a regular basis or when patients must be overflowed into areas where these types of patients are not normally cared for.

Further, because patients admitted to the hospital for reasons other than the disease outbreak tend to be very young or elderly and/or immunocompromised, patients who become infected while in the hospital (nosocomial infections) tend to have much higher rates of serious disease and mortality than seen in the general population.

The researchers in the study referenced above estimated that between June 2020 and March 2021 between 95,000 and 167,000 inpatients acquired SARS-CoV-2 in hospitals (definite or probable) in England (1% to 2% of all hospital admissions in this period). Further, the evidence demonstrated that patients who themselves acquired SARS-CoV-2 infection in hospital were the main sources of transmission to other patients. Health care workers, on the other hand, were as likely to be infected by fellow health care workers as patients. Once vaccinated, the rate of infection among health care workers dramatically reduced.

All of this demonstrates the importance of early identification and prompt initiation of infection control measures for patients with new hospital-acquired infections and for other patients they may have infected. Further, these studies reinforce the need for measures that reduce transmission from patients with asymptomatic infection in non-COVID-19 hospital areas, including improved ventilation, use of face coverings by patients and staff, increased distancing between beds, minimizing patient movements within and between patient care units and promotion of hand hygiene. The findings also support efforts to prioritize health care workers (HCWs) for COVID-19 vaccination both due to direct protection to HCWs and due to indirect protection offered to patients. Finally, the findings highlight the need to prioritize research into effective methods of reducing hospital transmission of airborne pathogens for which evidence is currently mounting, including patient care unit design and air filtration systems.