FDA Expands Use Pfizer-BioNTech COVID-19 Vaccination with Young People

The U.S. Food and Drug Administration (FDA) made a move today to lower the age range that can now access the Pfizer-BioNTech BNT162b2 COVID-19 mRNA-based vaccine product. Moreover, the Gold Standard regulatory agency also condensed the time period between the first two doses and the boosters for individuals 12 and over. The FDA shared on their website that individuals aged 12 to 15 are now able to access booster doses of the BNT162b (Comirnaty) under the ongoing emergency use authorization (EUA).

They referred to “real-world data from Israel” associated with safety data from over 6,300 individuals aged 12 through 15 years who received a booster dose of the vaccine at least five months post completion of the primary two-dose vaccination series.

Changes to Interval

Young people age 12 and up can now access the booster five months (previously 6 months) after the second dose, thus supporting a third booster dose for children age 5 to 11 who are at risk—such as immunocompromised, at a minimum of 28 days post the second dose as part of the primary inoculation.

Peter Marks, MD, Ph.D., director of the FDA Center for Biologics Evaluation and Research declared, “Based on the FDA…

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TrialSite Staff


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