Thoughts on the New CDC Guidance

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

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

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

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

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

Factors weighing in favor of this guidance:

1. The CDC is quite right that the vaccines currently authorized in the U.S. are extremely effective, at least against the wild-type virus and B.1.1.7 (the UK variant). At this time, we do not have conclusive data, but it is believed that these vaccines are somewhat less effective at preventing infection by P.1 (Brazil variant) and B.1.351 (South Africa variant), though there is some evidence and it is thought very likely that these vaccines will prevent severe outcomes and death in persons infected with the variants of concern that we have identified.

• A growing body of evidence suggests that fully vaccinated people are less likely to have asymptomatic infection and potentially are less likely to transmit the infection to others than those who are unvaccinated.

• Relaxation of the restrictions on fully vaccinated individuals may promote more vaccine hesitant individuals to go ahead and get vaccinated. (There is also a counter-argument below).

Concerns:

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

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

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

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

• As I said, my concern is less about the guidance than the timing. The FDA and CDC has just opened up vaccinations to children age 12 and above. The UK variant (B.1.1.7) is now the most prevalent variant in the U.S. Children play a much greater role in the transmission of this variant than they did in the transmission of the forms of the virus we dealt with for the past year. It seems to me that it would have been advantageous to continue our precautions for another 6 weeks to allow time for more Americans to be vaccinated, including this newly eligible age group. In fact, I think the CDC could have modified their guidance to allow states to implement this new guidance once a target of state residents over the age of 12 (e.g., 70%) were vaccinated to serve as an added inducement for vaccinations of their citizens.

• Another disconcerting aspect to the timing of this guidance was that the CDC only officially recognized airborne (aerosol) transmission days before this new guidance. Airborne transmission is the reason for greater concern of transmission of the virus indoors as opposed to outdoors. It then is slightly concerning that having just recognized this mode of transmission so recently, the CDC could conclude that vaccinated individuals were safe without masks indoors. They may be, I just wish that they would have explained why they came to that conclusion, if they did. For example, based on the new guidance, teachers could now go mask-less indoors in schools all-day long, surrounded by 30 – 40 students who are unvaccinated. That would not be something I would recommend based on the studies I have seen.

• I am thrilled that we have such effective vaccines. Preventing people from becoming severely ill or dying is a huge accomplishment, but our long-term success in managing this pandemic is reducing the transmission of the virus so that we avoid the long-term consequences and costs of infection and so that we prevent new variants from arising that might threaten the effectiveness of our vaccines. A central question that I believe that the CDC should have answered for themselves before issuing this guidance was whether this guidance would slow the transmission of the virus. I’m not sure of the answer, but I fear it will not.

• As I listened to Dr. Walensky, the Director of the CDC, respond to questions about the guidance, it is clear that much of the guidance is provided with the expectation that persons will be honest and exercise concern for others and continue to follow the recommendations for masking and physical distancing if unvaccinated. I will let my readers assess how likely they think that is based upon what we have witnessed in the past year.

• While the CDC offers the position that this new guidance may be an incentive for unvaccinated Americans to get vaccinated, and I certainly think that is possible, I think it is also possible that it may do the exact opposite. Given that we currently do not have good ways to determine whether persons are vaccinated or unvaccinated in most circumstances, one does have to wonder whether this new guidance has just eliminated a possibly important motivator for those who are hesitant to get vaccinated in that they can just show up to businesses or events unmasked, unvaccinated and without the need for physical distancing. There is a counter-argument to be made that in fact, this has actually provided another motivator for unvaccinated persons to get vaccinated because unvaccinated persons were previously protected by restrictions that required masking, distancing and gathering size limits, but now will be subjected to much greater risk.

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

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

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

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

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

Call to action:

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