In Unusual Move, US FDA Invites Pfizer to Request COVID-19 Vaccine Approval for Infants and Toddlers
Child COVID vaccinations – now the FDA has invited Pfizer to submit for approval of vaccines for under-5s.

What does the FDA know that we don’t? Hopefully a lot.

Without offering much detail, the FDA yesterday afternoon asked Pfizer to send over a rolling submission to amend its Covid-19 vaccine Emergency Use Authorization to include children 6 months to under 5 years of age.

The tricky part in making such a request is that last month, Pfizer announced that its vaccine (a 3 µg dose for the youngest population) had performed better in the 6- to 24-month-old population, than in children ages 2-4 – that is as compared to the results of the vaccine among 16- to 25-year-olds, in which high efficacy was demonstrated.

But the company wants to test a third jab for all of the under-5s to see if it will even out the results somehow for older tots. And it doesn’t seem to be changing its tune, even with this latest FDA request.

“Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” Pfizer CEO Albert Bourla said in a statement.

No safety concerns were identified in that prior analysis of the 3 µg dose data among children 6 months to under 5 years of age, Pfizer said.

While the FDA often requests that companies provide additional safety or efficacy data (usually before a new drug or vaccine is approved or authorized), the agency rarely requests a specific submission, but acting FDA commissioner Janet Woodcock said this is a priority right now for the agency.

But others are not so sure:

“I don’t think authorizing two doses in children ages 2 to 4 years of age where effectiveness in this age group hasn’t been confirmed is going to convince the majority of parents to vaccinate their children,” Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s vaccine office, told STAT News. “If the vaccine in this age cohort is a three-dose vaccine, FDA should review the data from the three-dose series before authorizing the vaccine.”

See ENDPOINTS News: FDA takes a rare step and asks Pfizer to submit a COVID-19 vaccine EUA for the youngest children.

Image Credits: Quinn Dombrowski.

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