FDA Approves COVID-19 Vaccine Extension to Teens

In May, the FDA approved Pfizer's COVID-19 vaccine for an extension to teens aged 12 to 15. This is the first vaccine for those under 16.

On May 10, the United States Food and Drug Administration (FDA) approved an expansion of the Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine for individuals aged 12 to 15. This extension to teens will allow them the chance to receive both doses of the Pfizer vaccine just in time for their summer vacation.

Expanding the Protective Bubble

Now that most adults who want to receive the COVID-19 vaccine have already been fully or partially vaccinated, vaccinating adolescents and children is the next step in the ongoing return-to-normal. Safely vaccinating youths will help students return to in-person school in the fall without posing a risk to their teachers or fellow classmates.

Safety and Efficacy

“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D., during a national press conference on May 10. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”

Discussion of whether the vaccine should be made available to this younger group began in early April when Pfizer initially applied for the expansion. The company cited its Phase 3 clinical trial, in which 2,260 adolescents in the 12 to 15 age range received either the Pfizer vaccine or a placebo shot. Of the 2,000+ who received the real vaccine, there were no cases of COVID-19, compared to the 18 adolescents who received placebo injections. The study remains in progress and will track participants until 2023 to monitor long-term protection.

Other Producers

All three U.S.-approved COVID-19 vaccine producers – Pfizer, Moderna, and Johnson & Johnson – have begun testing the safety and efficacy of their vaccinations on children and teens in recent months. Currently, Pfizer is the only shot approved for those under age 16. The company expects to expand its patient base to those age 11 and younger this fall. Moderna began a two-phase trial in mid-April. The company is currently in Phase 1, which includes 3,000 participants aged 12 to 17. Johnson & Johnson is in the beginning phases of their research on patients aged 15 and younger.


We hope this information on Pfizer’s vaccine extension to teens is helpful to you.

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