FDA Expands Emergency Use Authorization for Pfizer-BioNTech COVID-19 Vaccine to Include Adolescents Aged 12–15

Today, the U.S. FDA announced the approval of an expanded Emergency Use Authorization (EUA) for the BNT162b2 COVID-19 vaccine, jointly developed by Pfizer and BioNTech, to include protection against COVID-19 in adolescents aged 12 to 15 years.

BNT162b2 is an mRNA-based COVID-19 vaccine. It demonstrated 95% efficacy in preventing infection in clinical trials involving adults and older adults, and real-world effectiveness following vaccination has also exceeded 90%. However, this vaccine had previously received FDA authorization only for individuals aged 16 years and older.

In a Phase 3 clinical trial involving 2,260 adolescents aged 12 to 15 years, 18 symptomatic COVID-19 cases were identified in the placebo group (n=1,129), whereas no symptomatic COVID-19 cases were observed in the vaccine group (n=1,131). Furthermore, one month after the second dose, the geometric mean titer (GMT) of neutralizing antibodies induced by BNT162b2 in this population was 1,239.5, meeting the non-inferiority criterion compared with the GMT of 705.1 previously achieved in individuals aged 16 to 25 years.

Meanwhile, BNT162b2 demonstrated good tolerability in this adolescent population, with side effects comparable to those previously observed in the 16-25-year-old population.

This vaccine should not be administered to individuals with a known history of severe allergic reactions (including anaphylaxis to any component of the vaccine).

Note: The original text has been abridged.

References:

[1] Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic. Retrieved May 10, 2021, from https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use?utm_medium=email&utm_source=govdelivery

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