FDA OKs Booster of Pfizer’s/BioNTech’s COVID-19 Vaccine in Certain Groups

By Miranda Greenberg -

September 23, 2021

The US Food and Drug Administration (FDA) has authorized for emergency use a booster dose of Pfizer’s/BioNTech’s COVID-19 vaccine for certain populations.

The single booster dose, to be administered at least six months after completion of the primary series, has been authorized for:

  • individuals 65 years of age and older;
  • individuals 18 through 64 years of age at high risk of severe COVID-19; and
  • individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19, including severe COVID-19.

As a next step, the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to discuss a potential recommendation for the use and rollout of boosters to the US population.

Pfizer and BioNTech continue to supply their COVID-19 vaccine, including volumes sufficient for boosters, under their existing supply agreement with the US government, which continues through April 2022.

Other updates

In addition, Pfizer and BioNTech report results from a Phase II/III trial that showed a robust neutralizing antibody response to their COVID-19 vaccine in children five to 11 years of age who received a two-dose regimen of 10 µg administered 21 days apart. That is a lower dose than the 30-µg dose used for people 12 and older.

Pfizer and BioNTech plan to share these data with FDA, European Medicines Agency EMA), and other regulators with plans for near-term submission for emergency use and conditional marketing authorization respectively to the FDA and EMA.

Topline readouts for the other two age cohorts from the trial, children two to five years of age and children six months to two years of age, are expected in the fourth quarter of this year (2021).

Source: US Food and Drug Administration, Pfizer (booster), Pfizer (results from Phase II/III trial), BioNTech (booster), and BioNTech (results from Phase II/III trial)