Pfizer-BioNTech Submit Request for EUA for COVID-19 Booster Doses for All Adults

Pfizer-BioNTech submitted their request for an expanded Emergency Use Authorization (EUA) to administer its “booster” COVID-19 vaccine doses to all adults 18 years and older today.

The Food and Drug Administration (FDA) is likely to approve the EUA in compliance with the Biden Administration’s initiative to provide booster doses (a third shot for mRNA Pfizer-BioNTech and Moderna recipients or a second shot for Janssen/Johnson & Johnson recipients) to all adults over 18 years of age.

President Biden initially planned to make boosters available to all adults by September 20, 2021, but health experts criticized these plans due to limited evidence that healthy adults require a booster dose and a preference to prioritize allotting doses to countries with low vaccination rates.

The FDA and the Advisory Committee on Immunization Practices (ACIP) are motivated to act fast on issues of vaccine approval, as many concerned Americans are already receiving an additional dose regardless of whether they meet the booster guidelines.

COVID-19 cases are on the decline, but numerous studies have shown that immunity granted by 2 doses of the Pfizer-BioNTech vaccine wanes significantly after 6 months, reigniting calls for boosters for all eligible adults.

Additionally, health officials say some eligible populations are confused whether they fit one of the specific approved categories and may wait too long to get a potentially lifesaving COVID-19 booster.

Currently, Pfizer-BioNTech is authorized under EUA to provide booster doses to people 65 years of age and older, people 18-64 who are deemed at high risk for severe COVID-19 disease (including the immunocompromised), and people 18-64 with jobs that put them at high risk for COVID-19 contraction.