FDA Advisor Board Notes for Oct 26 age 5-11 EUA

The Board voted on this question:

“Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech Covid-19 vaccine when administered as a 2-dose series (10 nano grams each dose, 3 weeks apart) outweigh its risks in use for children 5-11 years of age?”

Vote Result: 17 Yes and 1 abstained.

A few thousand children were in the study for Oct 26 meeting. June 1, 2021 was when the clinical trial started for this age group. The dose was reduced to 1/3 the amount compared to the adult dose.

The Board asked

  1. Why weren’t more studies done on people that already had Covid?
  2. Will this benefit people if they already have antibodies?
  3. Why weren’t more studies done on how long the vaccine will give protection?
  4. Why weren’t more studies done on if it will prevent transmission?
  5. Why aren’t we collecting data on shedding?
  6. Does the shot prevent severe disease?
  7. If they had the Delta infection, will getting the vaccine of the old Coronavirus give more or less immunity?
  8. Can we just approve it to certain groups?

The Board assumes

  1. More studies will be done to fill in the gaps of information such as various ethnicities or special groups and long-term effects.
  2. As an Emergency Use Authorization, any red flags that are raised by the data collected in the future will be used to recall dangerous shots that have significant side effects.
  3. Parents will be allowed to choose whether or not to have their children vaccinated based on the health of the child and the situation in the home.
  4. Safety systems are in place to identify the rare adverse events.

The Board was worried that

  1. Without a way to test their antibodies parents won’t be able to assess the benefit compared to the risks to make the best decision.
  2. Policy makers will make mandates or requirements without regard to child health or family situations.
  3. We will see an evolution of the virus and we may need to modify it for variants.
  4. The risks can’t be measured because they are seeing myocarditis in older age groups, but haven’t seen it in this age group. They can’t predict all the possible risks.
  5. If they try to approve it for some subset other groups including low income may not have access to the vaccine.

Some issues that were raised were:

Parents want to know if there is an adverse reaction, will our Pediatrician know about the possible adverse events? FDA and CDC have a passive reporting system and also Vaccine Safety Link and Sentinel Best Systems are more active to monitor things like myocarditis. The CDC safety team is devoted to understand the adverse events. 25-30% of people that were vaccinated are included in the safety system to be monitored. There is also a clinical safety team that the doctors can ask about rare adverse events and the team will research the issue further. Some problems with the reporting are: Emerging safety signals are hard to detect. There is a lag between when the information is sent and when it is posted.

What will the ACIP do with the FDA approval? It will look at other variables to look at who would benefit from the vaccine and who should get the vaccine. FDA looks at Safety and Effectiveness. ACIP looks at how it will impact certain populations. How will the FDA discussion impact the ACIP discussion? ACIP can limit further but can’t expand beyond what the FDA allows.

On one hand many people are eager because they’re so frightened of COVid-19. On the other hand, there are many indications that we shouldn’t be so worried about this age group at this time. 68% of children hospitalized with COVid-19 had comorbidities. Many kids have immunity already. 40% of kids are reported to already have had COVid-19. There have not been any deaths from myocarditis for this age group. Most risks are reduced as the dose is one-third the amount that is given to adults. 94 kids in this age group died of COVid-19. (I don’t know out of how many.) If severe outcomes become a problem, the FDA can pause the distribution of the vaccine.

Affects on families and schools were part of the FDA’s consideration.


  1. The best way to protect most kids’ health may be to do nothing, but it’s important for those kids that are at high risk to have access to a vaccine.
  2. Hopefully the vaccine companies will continue to improve their vaccines to be more effective and cause less harm. We hope studies will be ongoing.
  3. Hopefully the 3-week interval or a lower dose version will be looked at for other age groups.
  4. Mandates weren’t immediate for adults. Hopefully there will be plenty of time for research before schools and governments will issue any mandates.
  5. Hopefully much more information will be available before this is approved as part of the routine shot schedule.

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