FDA Authorizes Pfizer-BioNTech and Moderna Booster Vaccines for All Adults

Today, the US Food and Drug Administration (FDA) authorized the Pfizer-BioNTech BNT162b2 booster shots for all adults 18 and older.

The updated recommendations state adults who received a regimen of Pfizer-BioNTech or Moderna are eligible for either mRNA booster 6 months after their second dose, and adults who received Janssen are eligible for a Pfizer-BioNTech or Moderna booster 2 or more months after their original shot.

This approval was eagerly anticipated, as immunity from the Pfizer-BioNTech vaccine wanes after 6 months and breakthrough infections among fully vaccinated persons are becoming more common.

The decision comes before a day-long meeting of the Advisory Committee on Immunization Practices (ACIP), in which they will debate recommending the CDC approve booster shots for all adults. If the CDC acquiesces, booster doses could be available as soon as this weekend.

Pfizer-BioNTech originally submitted a request for Emergency Use Authorization (EUA) to administer its booster to all adults on November 9. Never far behind, Moderna requested EUA for their COVID-19 vaccine booster shortly after.

Because the FDA previously approved heterologous boosters, people 18 years of age and older who were vaccinated with 2 doses of an mRNA (Pfizer-BioNtech or Moderna) or 1 dose of Janssen (Johnson & Johnson) are eligible for a Pfizer-BioNTech booster.

Studies suggest getting a booster with a different mRNA than one’s original vaccine can actually increase immune response.

The FDA and US Centers for Disease Control and Prevention (CDC) were pressured to examine the data and make an official recommendation in a timely manner, as many Americans were receiving booster doses regardless of whether they met the previous approval guidelines.

Additionally, differing guidelines across the 3 vaccines led to some people at high risk for severe or fatal COVID-19 disease, due to comorbidities or a weakened immune system, to be confused whether they were eligible for a booster.

Before this approval, Pfizer-BioNTech and Moderna were only authorized to administer boosters to adults 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.

Experts emphasized that the highest priority is administering doses to the unvaccinated, including in low- and middle-income countries, to build herd immunity. However, preventing breakthrough infections among vaccinated individuals with waning immunity is a vital step toward controlling the COVID-19 pandemic.