Should every American older than 18 get a booster?
Should a 22 year old, healthy man who got 2 doses of Moderna (100 x2) get another 50 of Moderna?
On 11/19/21 the US FDA authorized a booster for any American older than 18 year olds who have had 2 doses of Pfizer or Moderna vaccination. Peter Marks says that this action will “eliminate confusion about who may receive a booster dose.”
Ironically, it creates confusion. The USA is now a global outlier, as I will detail below. The US FDA’s decision making, specifically for Moderna, contradicts other leading health authorities and raises serious doubt about the agency’s judgement, and whether it remains free from political tampering.
Worse, the action introduces fundamental questions of benefit & harm. Consider a healthy 22 year old American man who has had already taken 2 doses of Moderna. The FDA is now authorizing this man to receive a 50 ug booster shot of Moderna. Is that in his best interest? All of society?
Simply put: the FDA cannot know that the benefits to such a man outweigh the risk. The FDA does not even know the benefits to this man & broader society outweigh the risks. The FDA is playing a dangerous game with vaccine perception.
Why do I say this? Right now, it is clear that Moderna has a higher rate of myocarditis than Pfizer. Given the presence of a safer alternative, peer nations have rapidly curtailed the use of Moderna. A partial list:”
Oct 6, Sweden & Denmark paused Moderna for anyone under 30. (In Denmark under 18 can request Moderna)
Nov 9, France advises against Moderna in anyone under 30
Nov 10, Germany recommends Pfizer to anyone under 30 or pregnant women
In a slightly younger age group, for the same concern, other nations: Denmark, Norway, Taiwan, South Africa all recommend only 1 dose of mRNA vaccine (for now)
Yet, here in the USA for an 18-30 year old healthy man, we are now authorizing receipt of a third dose of Moderna. Let’s consider efficacy and safety.
Thus far, the Pfizer press release as to the results of the booster RCT show a reduction in symptomatic virus/ infection. No one was hospitalized in either group—so we have no data boosters reduce hospitalizations. No one died in either group—so again no data. Only 2 people had oxygen sats less than 93% in the control arm. A larger sample size is needed to identify the numerical risk difference for that endpoint, if it exists. All that can be said for sure, right now, is boosters reduce symptomatic covid19. There is not enough information to know how this risk reduction interacts with the age of the recipient.
But, given this is an endemic virus, eventually having sars-cov-2 and some mild symptoms is likely inevitable in your life. The bar for boosters must be showing that one is less likely to get very sick from the virus, not that mere symptomatic covid is reduced, and that has not (yet) been demonstrated.
We do not know the rate of myocarditis after dose 3 Pfizer. Preliminary data from Israel show that it is less than dose 2, but it is not zero. We do not know the rate of myocarditis from dose 3 of Moderna. It will definitely be larger than zero, and likely larger than Pfizer, but this is not yet known.
In order to determine net benefit, one has to balance efficacy and safety. Do boosters lower hospitalizations in anyone under 30, under 40? We have no idea, and it is an uphill task to do that. Rates of hospitalization in healthy, non obese vaccinated people in this age group are very low, and particularly low with Moderna’s 2 dose series, even in the face of delta.
For that reason, any myocarditis greater than zero that results in hospitalization may offset any gains from boosting. Even a little dose 3 myocarditis could result in boosting being net harmful, particularly for young, healthy men. If a subset of myocarditis has long term problems, it will be a serious problem.
Simply put, the FDA has no reliable data to know for sure that boosting--particularly Moderna dose #3 for someone who had 2 doses already—and particularly among healthy young men provides a health benefit. It is possible to be net harmful. That is simply not good enough for the agency.
Sars-cov2 spread in the population
Although everyone thinks boosting is necessary to change the epidemic trajectory, this claim is highly speculatory and not supported by robust evidence. Given the nature of the claim—just how uncertain it is—vaccine decisions must be made at the individual person health level and not based on wishful thinking of population spread. We simply don’t know what boosting might or might not do, and the broader sequelae.
The best person on twitter
The best person thinking about this issue on twitter is Walid Gellad.
Here is Walid pointing out that no one knows the safety risk with Moderna
Are current booster recs confusing?
The idea that we need to have the same policies for Pfizer & Moderna because anything less is confusing is a profoundly stupid thing to say. Nations around the world are constructing different policies for these 2 products given the different risk benefit profile (as they should!), and the citizens of Sweden, Norway, Denmark, UK, South Africa, and Taiwan are all not jumping off buildings distraught by the mental complexity of it.
Second, there is already complexity in this space. J&J has different rules/ guidance. There are different doses by age (5-11 vs 12 and up) for Pfizer. Pfizer and Moderna have different doses themselves (30 vs. 100 x 2 then 50).
I frankly think it is intellectually dishonest to say that we need 1 size fits all booster recommendations because otherwise it is “confusing.” Finally, they have no direct evidence that the confusion exists. It is just an empty talking point.
What is really going on?
Allow me to outline what I think is really going on here. First, remember the top 2 FDA officials—Marion Gruber and Phil Krause—have resigned and would have left the agency by now per prior news reports. Next remember….