A 4th dose?

Moderna and Pfizer apply for EUA

Pfizer has requested the FDA grant EUA for a 4th dose of the original mRNA vax for 65 years and up; Moderna has made the same request for 18 and up. Wow!

The only way to know for sure that a 4th dose improves outcomes for people who already had 3 doses is to do a very large randomized trial. Antibody titers cannot be the endpoint— b/c those will definitely be higher. Even mild disease — a scratchy throat— and a positive test result is not enough to justify widespread authorization of the vaccine. You simply don’t know from that endpoint that benefits > risks.

In fact, to persuade anyone of a 4th dose, you must show in an RCT, a reduction in hospitalization (from covid) and/or death (from covid) AND you have to prove that this is also true for 20 year olds, and not driven by 70++ year olds. This is a high bar that I have not seen the companies have cleared.

Walid Gelad puts it this way:

Walid Gellad, MD MPH @walidgellad

For FDA to extend authorization for Moderna *4th* shot to all adults, it has to say that the likely benefits outweigh the known and unknown risks. No one can say this for broad population like all adults age 18+. Pfizer, eg, is asking for just those 65+

washingtonpost.comModerna seeks FDA authorization for a second booster dose of its coronavirus vaccine for all adultsThe company’s request to the Food and Drug Administration is substantially broader than what Pfizer and BioNTech sought earlier in the week.

Will the FDA grant EUA without these data?

I worry the answer is yes

Will hospitals mandate a 4th dose to young employees without these data?

I worry the answer is yes

Is this good regulatory policy?

I know the answer is no

The FDA continues its downward slide towards less and less evidence being used to support costly products given to tens of millions. More is at stake than the current moment. We risk becoming a further medicalized population used to drive corporate profits, while no relevant evidence is generated to guide our actions, and we are along for the ride.