The US Food and Drug Administration will be able to skip the time-consuming advisory process for deciding authorization of coronavirus vaccines for older children and teens, a government official told CNN Thursday, but it will likely undertake a lengthier review for younger children.
Vaccine maker Pfizer has applied for emergency use authorization for its coronavirus vaccine for teens and children ages 12 to 15. The FDA will have to amend the emergency use authorization (EUA) for the vaccine, but the process should be straightforward, said the official, who was not authorized to speak about the process publicly and requested anonymity.
Extending EUA to younger children is a different matter, the official said.
“In the older group of children if there is nothing exceptional, if everything looks very similar to adults, the feeling is that it is not necessary to take this to an advisory committee meeting,” the official said. “For the younger children, we almost certainly will consider more strongly going to an advisory committee meeting.”
Pfizer and Moderna both are testing their vaccines in children as young as 6 months and expect to ask the FDA for EUAs covering infants and children later this year.
More context: The FDA is currently reviewing data submitted by Pfizer to support extending the EUA to younger teens. Pfizer said at the end of March that a clinical trial involving 2,260 12-to-15-year-olds showed its efficacy is 100% and it is well tolerated.
The company said the vaccine-elicited strong antibody responses one month after the second dose, exceeding those demonstrated in people ages 16 to 25 in previous trials. The vaccine is currently authorized in the US for emergency use in people ages 16 and older.
Before issuing the EUAs for the three authorized coronavirus vaccines – made by Pfizer/BioNTech, Moderna and Johnson & Johnson – the FDA held meetings of its independent Vaccines and Related Biological Products Advisory Committee to review the data and vote on whether to recommend EUA. That will not happen in extending EUA to 12-15-year-olds, the FDA said.
“While the FDA cannot predict how long its evaluation of the data and information will take, the agency will review the request as expeditiously as possible using its thorough and science-based approach,” the FDA said in an email to CNN on Thursday.
“Based on an initial evaluation of the information submitted, at this time, the agency does not plan to hold a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on this request to amend the EUA for the Pfizer-BioNTech Covid-19 Vaccine, which was discussed and recommended for authorization at a VRBPAC meeting in December 2020. As with all FDA-authorized Covid-19 vaccines, we are committed to transparency with this EUA review process.”
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