FDA to authorize Pfizer’s Covid-19 vaccine for 12-to-15-year-olds by early next week, official says

The US Food and Drug Administration is poised to authorize Pfizer/BioNTech’s coronavirus vaccine in children and teens ages 12 to 15 by early next week, a federal government official tells CNN.

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 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.

ROME, ITALY - MARCH 25: A healthcare worker of the Italian Army prepares doses of the Pfizer/BioNTech (Comirnaty) COVID-19 vaccine at the military citadel of Cecchignola, on March 25, 2021 in Rome, Italy. At the request of the European Commission, Italian security forces discovered 29 million does of the AstraZeneca vaccine at a Catalent factory. Meanwhile European public trust dwindled with reported side effects of the AstraZeneca vaccine, a prosecutor in Italy is investigating possible manslaughter after a naval office died hours after being inoculated with the AstraZeneca vaccine. (Photo by Antonio Masiello/Getty Images)

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The FDA is currently reviewing data submitted by Pfizer to support the extended use. 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 vaccine is currently authorized in the US for emergency use in people 16 and older.

Before issuing the EUAs for the three authorized coronavirus vaccines, 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-to-15-year-olds, the FDA has told CNN.

“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 last week.

Doctors at Cincinnati Children's Hospital started vaccinating volunteers as young as 12 last week (October 16-20) as part of Pfizer's Phase 3 Covid-19 vaccine trial. Abhinav, 12, was one of them.

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“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.”

A US Centers for Disease Control and Prevention advisory committee known as the Advisory Committee on Immunization Practices will schedule a meeting for after any FDA decision to extend the EUA to new age groups. ACIP will advise CDC on whether to recommend use of the vaccine in 12-to-15-year-olds, and then CDC Director Dr. Rochelle Walensky will decide whether the agency will recommend its use in the new age group.

Covid-19 vaccines for younger children

Pfizer said Tuesday morning it expects to submit for FDA emergency use authorization for its Covid-19 for children ages 2 to 11 years old in September. The vaccine safety and efficacy study in children age 6 months to 11 years old is ongoing.

“We expect to have definitive readouts and submit for an EUA for two cohorts, including children age 2-5 years of age and 5-11 years of age, in September,” Pfizer CEO Alert Bourla said Tuesday during a call with investors.

Bourla said the readout and submission for children 6 months to 2 years is expected in the fourth quarter of 2021.

Moderna is also testing its vaccine in children as young as 6 months and expect to ask the FDA for EUA covering infants and children later this year.

Extending EUA to younger children will be a different from what’s happening with older children and young teens, the federal government 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 government official said. “For the younger children, we almost certainly will consider more strongly going to an advisory committee meeting.”

CNN’s Naomi Thomas contributed to this story.