We are all feeling our way on how to handle COVID-19. Expert recommendations on vaccines, vaccine mandates, treatments, social distancing, etc. will keep changing as more information emerges, as new variants evolve, as new treatments and vaccines are developed, and generally as we learn from our collective experience. This post consists of current consolidated responses to some of the comments on my posts How we think about COVID-19 vaccine mandates and “The Real Anthony Fauci.” I appreciate everyone’s engagement on this issue.
Responses to Political Comments
Let’s stay away from labels.
People opposed to vaccine mandates come from a lot of different places. Some are vaccinated but do not believe in mandating vaccines. Others are hesitant to get vaccinated themselves. Some of those who are personally hesitant about vaccines have experienced illness or injury which the health care system failed to cure or actually caused. They have experienced real trauma, their faith has been broken and they are struggling to put together a world view in which they can feel safe and move forward. I admire the bravery in these people, even though I disagree with them about vaccine mandates and some of them are very critical of me. Others have somehow come to a broader cynicism about American leaders in all fields; I’m willing to keep working to earn their trust. The only people who disappointment me in this conversation are the handful of public figures who have discovered that they can build a following by willfully spreading misinformation.
Remember the health care workers.
For me, the central motivation to vaccine mandates right now is to protect our health care system and our health care workers. COVID-19 vaccines reduce the probability of hospitalization for serious illness (and the FDA views this as true net of any risks of side-effects, see below). Right now our health care system is nearing collapse in many places. That is a human tragedy for patients with all ailments, but especially for the health care workers who have chosen to put themselves on the front lines (read fresh observations here). At least for now, broader vaccination is the only realistic route to reducing hospitalizations (see below regarding alternative outpatient cures).
We do respect bodily autonomy.
No one in public life today is advocating that people be physically forced to submit to injections. That would be a direct physical violation. Vaccine mandates do not force vaccination, they just impose civil consequences for non-vaccination. That is a meaningful distinction. The Mayor’s vaccine mandate is a completely common-sense measure. For their own good, people who are not vaccinated should not be entering crowded indoor spaces like restaurants, theaters and gymnasiums. And they should not be adding to the crushing burden on our health care system by taking those risks.
I do not support denying health care to unvaccinated people.
Some have urged that unvaccinated people be denied COVID-19 treatment or be forced to pay for their own COVID-19 treatment. I do not support that. The unvaccinated person is taking a higher risk of illness. But personal choices affect risk for many illnesses and injuries. The health care system cannot be in the business of blaming people. I support the several public and private vaccine mandates we have in Massachusetts, but I do not support denying care to unvaccinated people, regardless of why they are unvaccinated. I am profoundly grateful to the heroic doctors and nurses who labor every day to rescue us from our worst mistakes.
We will only go so far.
Vaccine mandates are not the tip of the spear. They are not a step down a slippery slope to fascism. They are a limited public policy measure introduced in the face of a public health crisis. Reasonable people can disagree as to the balance to strike between public health concerns and personal liberty (e.g., Klingsworth) and that balance will evolve, but this is still America: Individual liberty will remain a core value.
Responses to Science Comments
In responding to the comments about the science and medicine which some people made, I am not suggesting that I personally possess scientific or medical expertise. I am just identifying broadly (if not universally) respected scientific sources that speak to the comments.
Are the COVID-19 vaccines really vaccines?
Sure, in the sense that they strengthen immunity against a disease. It is true that they are different from traditional vaccines. As the CDC explains, the COVID-19 mRNA vaccines don’t contain any portions of a microorganism. Rather they include mRNA that teaches cells to produce a fractional part of a protein which, in turn, teaches our immune system to recognize COVID-19 viruses.
How does the CDC define a vaccine and why did the definition change?
In 2020, the CDC’s web educational materials defined a vaccine as a “product that produces immunity therefore protecting the body from the disease.” That is a good and clear definition. Protection does not imply 100% protection — many vaccines are less than 100% effective; the flu vaccine being a familiar example. At some point recently, the CDC’s web educational materials changed the definition of vaccine to something that contains “a suspension of live (usually attenuated) or inactivated microorganisms (e.g. bacteria or viruses) or fractions thereof administered to induce immunity and prevent infectious diseases and their sequelae.” The definition change does seem awkward and inconsistent with how the COVID-19 mRNA vaccines work, but I don’t see the definition imperfection as having any policy implications. A comparison of the current glossary to the July 2020 glossary reveals a couple of dozen minor changes that also seem insubstantial.
Where are the safety studies for the COVID-19 vaccines?
All of the vaccines that have been offered to the general public have been through clinical trials in which they were evaluated both for efficacy and for safety. That is the process which forms the basis of FDA approval. The documentation of the FDA approval process is voluminous and much of it is publicly available. See the document collections for Pfizer, Moderna, Johnson & Johnson. The risk of adverse events related to the vaccine is a central focus of the review process and the ultimate judgment call that the FDA makes before approving use is whether the benefits outweigh the risks.
Is anyone looking at long term consequences of COVID-19 Vaccines?
Follow up of clinical trial participants continues. Risk profiles are periodically updated with information from that follow up as authorization scope is revisited. See the document collections for Pfizer, Moderna, Johnson & Johnson. Note that long term follow up also has the potential to reduce estimated risks of the vaccine, because as adverse events occur in the placebo control group, it can be determined that the vaccine was not the cause of those events.
How effective are the COVID-19 vaccines?
As much as 95% effective — based on the initial trials. Effectiveness at the 95% level means that in a population context in which X of out of 100,000 unvaccinated people get symptomatic COVID, the symptomatic COVID count among the vaccinated will be 5% of X per 100,000. As time goes, by the immunity fades at an unknown rate (hence boosters). And, as new variants emerge, the effectiveness may go down. Still, according to recent results from Denmark, unvaccinated people who get Omicron are 6 times more likely to end up hospitalized than vaccinated people who get Omicron.
How come some vaccinated people are getting breakthrough infections?
Protection is not 100% so some breakthrough is expected. Yet, in a Massachusetts study released in December 2021, people who were unvaccinated were 31 times more likely to get symptomatic/identified COVID than those who were vaccinated and boosted. See also this research summary from the CDC. The data in the preceding two links mostly reflect the behavior of the Delta variant.
With the highly infectious Omicron variant, infection will be more widespread, but those who are vaccinated will still be less likely to become hospitalized even when they get infected. Dr. Fauci’s summary appears below:
I think, in many respects, Omicron, with its extraordinary, unprecedented degree of efficiency of transmissibility, will, ultimately, find just about everybody. Those who have been vaccinated and vaccinated and boosted would get exposed. Some, maybe a lot of them, will get infected but will very likely, with some exceptions, do reasonably well in the sense of not having hospitalization and death.
Unfortunately, those who are still unvaccinated are going to get the brunt of the severe aspect of this, and although it is less severe on a case by case basis, when you quantitatively have so many people who are infected, a fraction of them, even if it’s a small fraction, are going to get seriously ill and are going to die, and that’s the reason why it will challenge our health system.Dr. Fauci interview of January 11, 2022 with Center for Strategic and International Studies.
Can vaccinated people transmit the virus?
The latest posted CDC science brief is dated September 2021, before Omicron. At that point, the ambiguous summary was:
[V]accinated people who become infected with Delta have potential to be less infectious than infected unvaccinated people. However, more data are needed to understand how viral shedding and transmission from fully vaccinated persons are affected by SARS-CoV-2 variants, time since vaccination, and other factors, particularly as transmission dynamics may vary based on the extent of exposure to the infected vaccinated person and the setting in which the exposure occurs. Additional data collection and studies are underway to understand the extent and duration of transmissibility of Delta variant SARS-CoV-2 in the United States and other countries.CDC Science Brief Downloaded on January 12, 2022, but last updated September 15, 2021.
With Omicron’s infectiousness we have to expect that the results will be worse. Most believe the Omicron wave is going to reach a lot of people. At this point, the central motivation for vaccination may not be to avoid infection but rather to reduce the consequences of infection. See Dr. Fauci’s comment above.
What about natural immunity for people who have had COVID-19?
Getting the disease provides some protection from reinfection, but the protection offered by vaccines is stronger and the protection available from the combination of natural immunity and vaccinated immunity is stronger still. The same caveats as to lapse of time and variants apply to both natural immunity and vaccination. See this explainer from Johns Hopkins or this explainer from the CDC.
What about nutraceuticals and off-label treatments for COVID-19?
Right now, vaccines remain the main evidence-based strategy for reducing the risk of hospitalization from COVID. There is hope that better treatment options will emerge.
The National Institutes of Health publish extensive treatment guidelines which summarize the available evidence on various currently available strategies for treating COVID. Those evidence-based guidelines offer no support for supplements like Vitamin C, Vitamin D, Zinc, or for off-label drugs like Ivermectin and Hydrochloroquine.
Is blood clotting a risk from mRNA vaccines?
No. There does not appear to be a risk of clotting from the Pfizer and Moderna mRNA vaccines. Clotting has been a rare side effect with the Johnson & Johnson and AstraZeneca vaccines which are based on a viral vector instead of mRNA. Blood clots can be a complication of COVID-19 itself, and the overall cost-benefit analysis for the viral vector vaccines is still positive, but not as positive as the mRNA vaccines, Pfizer and Moderna.
What about vaccinating people under 18 — do the benefits outweigh the risks?
Yes. CDC continues to recommend that everyone ages 5 years and older get vaccinated for COVID-19 using the Pfizer vaccine.
Myocarditis is an apparent slight risk for young men receiving the Pfizer and Moderna vaccines. The CDC, having reviewed this risk against the benefits continues to recommend Pfizer vaccination for children over 5. The issue got lengthy analysis in the FDA’s recent decision to extend booster eligibility to 16 and 17 year olds for the Pfizer vaccine — the FDA noted that most vaccine-related myocarditis cases resolve with “conservative management.” The benefits of vaccination depend heavily on the prevalence of disease — the Omicron spike moves the needle towards vaccination. Yet, the risk of myocarditis in young men may be higher for the Moderna vaccine than for the Pfizer and the FDA has delayed its decision to authorize Moderna for children 12-17.