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 for people 18 years of age and older who have a primary vaccination course with each other approved or approved COVID-19 vaccine.
Previously, the approval of the booster dose only extended to people aged 65 and over and to people aged 18 to 64 at high risk of severe COVID-19 or people with frequent institutional or occupational exposure to SARS-CoV-2.
Individuals who have received the Pfizer BioNTech or Moderna COVID-19 vaccine can be given a booster dose for at least 6 months after completing the primary series. While the Pfizer-BioNTech booster dose remains the same, the Moderna COVID-19 booster dose is 50 µg (0.25 ml), which is lower than the dose in the primary series.
Both companies provided data showing declining neutralizing antibody titers, particularly against variants of concern, around 6 months after the primary series was completed, suggesting that a booster dose is needed to maintain high levels of protection.
Updated leaflets with additional information are now available for the Covid-19 vaccines Pfizer-BioNTech and Moderna.
- Pfizer and BioNTech Receive Expanded U.S. FDA Emergency Clearance Boosting COVID-19 To Include People 18 Years Old and Over. Press release. November 19, 2021. https://www.businesswire.com/news/home/20211119005441/en/Pfizer-and-BioNTech-Receive-Expanded-US-FDA-Emergency-Use-Authorization-of-COVID-19-Vaccine -Booster-to-Include-Individuals-18-and-older.
- Moderna announces FDA approval of a booster of the COVID-19 vaccine in the United States for adults 18 years and older. Press release. November 19, 2021. https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-fda-authorization-booster-dose-covid-19.