FDA set to authorize COVID-19 vaccine for 12- to 15-year-olds as early as next week: Report

The FDA is reportedly poised to authorize Pfizer’s COVID-19 vaccine for children and teenagers ages 12 to 15 years next week, CNN reported Monday.

What are the details?

The outlet, citing a “federal government official,” reported that the FDA is set to authorize the biopharmaceutical company’s vaccine for emergency use.

“The FDA is currently reviewing data submitted by Pfizer to support the extended use,” CNN said. “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.”

In a statement to CNN, a spokesperson for 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.”

“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 [emergency use authorization] for the Pfizer-BioNTech COVID-19 Vaccine, which was discussed and recommended for authorization at a VRBPAC meeting in December 2002,” the agency said. “As with all FDA-authorized COVID-19 vaccines, we are committed to transparency with this EUA review process.”

What else?

Pfizer and Moderna are testing their coronavirus vaccines in children as young as 6 months old.

The outlet’s government source added, “In the older group of children 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. For the younger children, we almost certainly will consider more strongly going to an advisory committee meeting.”

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