The Food and Drug Administration (FDA) has expanded the Emergency Use Authorizations (EUA) for both the Pfizer-BioNTech and Moderna COVID-19 vaccines to include a booster dose in individuals 18 years of age and older who have completed a primary vaccination series with any other authorized or approved COVID-19 vaccine.

Previously, the booster dose authorization only extended to individuals 65 years of age and older, as well as to people 18 to 64 years old at high risk of severe COVID-19 or those with frequent institutional or occupational exposure to SARS-CoV-2.

In individuals who received the Pfizer-BioNTech or Moderna COVID-19 vaccines, a booster dose may be administered at least 6 months after completion of the primary series. While the Pfizer-BioNTech booster dose level remains the same, the Moderna COVID-19 booster dose level is 50µg (0.25mL), lower than the primary series dose.

Both Companies provided data demonstrating waning neutralizing antibody titers approximately 6 months after completion of the primary series, particularly against variants of concern, indicating a need for a booster dose to maintain a high level of protection.

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Updated fact sheets with additional information are now available for the Pfizer-BioNTech and Moderna COVID-19 vaccines.


  1. Pfizer and BioNTech receive expanded US FDA Emergency Use Authorization of COVID-19 vaccine booster to include individuals 18 and older. News release. November 19, 2021.
  2. Moderna announces FDA authorization of booster dose of COVID-19 vaccine in the US for adults 18 years and older. News release. November 19, 2021.

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