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.
- 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. https://www.businesswire.com/news/home/20211119005441/en/Pfizer-and-BioNTech-Receive-Expanded-U.S.-FDA-Emergency-Use-Authorization-of-COVID-19-Vaccine-Booster-to-Include-Individuals-18-and-Older.
- 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. https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-fda-authorization-booster-dose-covid-19.