FDA votes to approve Pfizer vaccine for children ages five and up

Published: Nov. 1, 2021 at 4:16 PM AKDT
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FAIRBANKS, Alaska (KTVF) - The FDA has voted to approve the use of the Pfizer COVID-19 vaccine for children ages five to eleven.

According to Dr. Lisa Rabinowitz, Staff Physician with Public Health on the Alaska COVID-19 Vaccine Task Force, the approval from the FDA will now be passed along to the CDC for further approval.

“Currently we are in the middle of that process,” Dr. Rabinowitz explained. “The FDA advisory panel met and did vote to extend the Emergency Use Authorization for Pfizer for that 5 to 11 age group. That was then approved by the FDA. Now that goes to the CDC. Tomorrow and the next day, the 2nd and 3rd, the ACIP, Advisory Committee on Immunization Practices, will meet, review all the data that they have and decide if they want to give a recommendation to administer to that age group.”

Dr. Rabinowitz continued, “If they do come up with a recommendation, then that goes to the head of the CDC to either accept that recommendation, deny it or make an alteration to it. So, potentially in the next day or so we should have information on that pediatric age group for that vaccine.”

The studies conducted by Pfizer included thousands of children with promising results.

“From the preliminary data that we saw that Pfizer has released the study was on 2,268 children, they saw great vaccine efficacy, and very safe,” Dr. Rabinowitz elaborated. “So, in specifically the studies, we didn’t see any myocarditis, heart inflammation or allergic reactions; but with a study this size we wouldn’t necessarily see those rare complications. So they continue to look at data internationally to look at that data. The effectiveness for symptomatic disease was 90.7% for that age group, and side effects looked similar or even better to that next age group up.”

Originally the vaccine was approved for the most vulnerable populations, and over time opened up to more populations. With young children there are a variety of factors that had to be considered before approval according to Dr. Rabinowitz.

“They really started with the highest risk group, so 65 and older we know is just a huge risk factor for that,” Dr. Rabinowitz remarked. “In most clinical trials, they do pregnant women and pediatrics second just because it is an important population, a protected population that we like to be extra safe with. The other consideration is that sometimes in this lower age group they have to change the dosing of these vaccines, and so that also takes longer times with the trials to try the different doses. So, it’s really a safety thing, making sure we have all the adult data before we even move on to that pediatric population.”

And for now, other vaccines like Moderna are still testing and data collecting for children in the same age groups.

“Moderna has submitted data for that teen group that they’re looking at,” Dr. Rabinowitz continued. “I think they’re being very cautious in terms of rare side effects, expanding some of their trials to get more enrollees to look closer. I think there’s going to be lots of data coming out as we learn more about how kids are affected by COVID. We’re starting to see some of the data come out on long term long-COVID, and how that affects kids. That can be 7 to 10% of kids even in the most recent studies. Then we have had over 500 kids in the U.S. with MIS-C (multisystem inflammatory syndrome in children), 16 of those in Alaska, which is an inflammatory condition that can happen after. So, I think looking at the complications from COVID, and weighing the risk benefits of the vaccine is one of the most important things we do

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