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U.S. FDA Authorizes Mixing & Matching COVID-19 Booster Vaccinations

October 20, 2021 • 6:12 pm CDT
US FDA
(Precision Vaccinations News)

The U.S. Food and Drug Administration (FDA) took action today, expanding the use of a booster dose for COVID-19 vaccines in eligible populations.

This FDA action follows presentations of clinical trial data from the National Institute of Allergy and Infectious Diseases, the Vaccines, and Related Biological Products Advisory Committee discussion of information submitted for consideration, along with the agency's evaluation of the available data.

The FDA determined that the known and potential benefits of using a single heterologous booster dose outweigh the known and potential risks of their use in eligible populations.

The FDA is amending the emergency use authorizations (EUA) for COVID-19 vaccines to allow a heterologous (or "mix and match") booster dose for eligible individuals following completion of primary vaccination with a different COVID-19 vaccine.

  • Specifically, the use of a single booster dose of the Moderna (SpikeVax) COVID-19 Vaccine that may be administered at least six months after completion of the primary series to individuals 65 years of age and older; 18 through 64 years of age at high risk of severe COVID-19; and 18 through 64 years of age with frequent institutional or occupational exposure to the SARS-CoV-2 betacoronavirus.
  • Additionally, the use of a single booster dose of the Janssen (Johnson and Johnson) COVID-19 Vaccine may be administered at least two months after completion of the single-dose primary regimen to individuals 18 years of age and older.
  • Furthermore, to clarify that a single booster dose of the Pfizer-BioNTech (Comirnaty) COVID-19 Vaccine may be administered at least six months after completing the primary 2-dose series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.

The agency encourages health care providers to follow the recommendations that the U.S. CDC will provide following a meeting of the Advisory Committee on Immunization Practices on October 21, 2021, and formal recommendations signed by the CDC's director Rochelle P. Walensky, M.D., MPH.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use and medical devices. 

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