FDA Vaccine Panel Recommends Pfizer-BioNTech Vaccine for Kids Ages 5-11

 

The U.S. Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee met today to discuss and make recommendations on an emergency use authorization (EUA) for the Pfizer–BioNTech vaccine for children 5 through 11 years of age. They voted on recommending it, 17 voting yes with one abstaining.

In documents prepared for the meeting, the vaccine demonstrated 90.7% effectiveness for the children in this age group. In more than 2,200 children in the study, 1,500 received the active vaccine. In the entire group, only 19 were diagnosed with COVID-19. Of the three children who had been vaccinated who came down with COVID-19, there were few, mild symptoms, for example, cough, sore throat and headache.

The remaining 16 were unvaccinated and had more symptoms, including 10 who presented with fevers. There were no severe cases or deaths in either group. There were no cases of myocarditis, which has been seen in males in the older adolescent groups, though myocarditis is rare and can also be caused by SARS-CoV-2 and other viral infections.

During the panel hearing the subject of myocarditis was a consistent topic. Several people who testified at the panel who were opposed to authorization during a public comment period, cited side effects, arguing the benefits do not outweigh the risks.

“It’s always nerve-wracking, I think, when you are asked to make a decision for millions based only on studies of a few thousand children,” said Paul Offit, a member of the committee and a pediatrician at Children’s Hospital of Philadelphia. He said he was “reassured” by the lack of myocarditis cases in this age group during the clinical trial.

Another member, Amanda Cohn, medical officer with the U.S. Centers for Disease Control and Prevention (CDC), and a voting member of the FDA panel, said that the number of children in the Pfizer-BioNTech trial was similar to numbers used to approve other childhood vaccines.

“I don’t want to minimize the risk,” Cohn told the committee. “At this moment, based on the totality of the evidence, the benefits do outweigh the risk. We have incredible safety systems in place to monitor for the potential for myocarditis in this age group and we can respond quickly. To me, the question is pretty clear. We don’t want children to be dying of COVID, even if it is far fewer children than adults, and we don’t want them in the ICU.”

It will now move to the CDC. In the event that both agencies support the data, children this age would be likely to be able to receive their first shots in early November.

Anthony Fauci, chief medical advisor for the White House and director of the National Institute of Allergy and Infectious Diseases (NIAID), told ABC’s “This Week,” “If all goes well, and we get the regulatory approval, and the recommendations from the CDC, it’s entirely possible, if not, very likely, that vaccines will be available for children from 5 to 11 within the first week or two of November.”

The Pfizer-BioNTech vaccine will be dosed in children of this age at one-third the dose adults are given. In the U.S., there are about 28 million children ages 5 to 11, and the Biden Administration has acquired enough doses to vaccinate all of them. The shots will be free. They will be distributed to pediatricians, family physicians, hospitals, health clinics and pharmacies. Schools in some states are planning to offer vaccines.

In a poll by the Kaiser Family Foundation in September, only about a third of parents with children ages 5-11 were willing to vaccinate their children immediately, with another third planning to “wait and see,” although the survey didn’t say exactly what they were waiting to see. A third, then, do not plan to vaccinate their children, which is consistent with U.S. overall COVID-19 vaccination rates in the U.S.

Children in this age group are much less likely to die of COVID-19 than older adults. However, pediatricians still urge parents to have their children vaccinated. The kids in this age group can still become very sick, and they can also spread the virus to other people. In the U.S., according to the American Academy of Pediatrics, more than 6 million children have tested positive for COVID-19. The AAP also indicated that 131,000 new cases were reported in children in the week ending October 14. Children represent about a quarter of all weekly diagnosed COVID-19 cases in the U.S.

Now that the FDA panel has made their recommendation, the FDA will make a decision in the next day or two, then it goes to the CDC’s vaccine advisory group, which plans to meet November 2 and 3 to discuss the vaccine.

Rochelle Walensky, director of the CDC, told NBC’s “Meet the Press” on Sunday, “In my mind, the most important thing right now as we work to get our cases down, as we work to get our children vaccinated, is that we continue the masking to keep our kids in school.”

Overall, U.S. COVID-19 cases are dropping. According to Johns Hopkins University, the seven-day average as of October 24 was 72,843, about 10,000 less than the week before. The seven-day average of daily COVID-19 deaths was 1,690.

Ashish Jha, the dean of the Brown University School of Public Health, told CNN last week, “Kids need to get vaccinated because it’s going to be good for them. It’s going to protect them. Obviously, it’s also going to add population immunity to a broader population. … It is going to be one more important step towards getting to the end of this pandemic.”

Yesterday, October 25, Moderna announced interim data from a Phase II/III trial that demonstrated its COVID-19 vaccine was well-tolerated and create a strong immune response in children ages 6 to 11. That study included more than 4,700 children and studied two 50-microgram doses of the vaccine shots 28 days apart. The standard dose for adults is 100 micrograms. It expects to submit data to the FDA and other global regulators “in the near term.”