The Food and Drug Administration has authorized expanded access to COVID-19 vaccines and will allow for mix-and-match booster shots in eligible groups.
In a late Wednesday announcement, the agency said it has amended Emergency Use Authorizations for Moderna’s and Johnson & Johnson’s coronavirus drugs to allow for the use of a single booster dose under the following guidelines:
Moderna’s shot may be administered at least 6 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
- 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
Janssen (Johnson & Johnson) COVID-19 vaccine may be administered at least 2 months after completion of the single-dose primary regimen to individuals 18 years of age and older.
Clinicians can either match a booster to the one used in the primary vaccination or use a different available COVID-19 vaccine, FDA stated.
The agency also confirmed that a single booster dose of the Pfizer-BioNTech COVID-19 vaccine may be administered at least 6 months after completion of the primary series. Eligible individuals include those 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.
“The available data suggest waning immunity in some populations who are fully vaccinated,” said Acting FDA Commissioner Janet Woodcock, M.D. “The availability of these authorized boosters is important for continued protection against COVID-19 disease.”
The decision to allow mix-and-match doses of the authorized COVID-19 vaccines was made in part to expand booster access to more individuals, FDA officials said.
“The agency will continue to assess data on the benefits and risks of booster dose use and expects to update the clinicians and the public in the coming weeks,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research
