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10/21/2021

FDA authorizes Moderna, J&J COVID-19 booster shots, clears mix-and-match brands

The FDA plans to further assess the benefits and risks of the use of booster doses in additional populations, and update the healthcare community and public in the coming weeks.
Sandra Levy
Senior Editor
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The Food and Drug Administration authorized booster shots of Moderna’s two-dose COVID vaccine and Johnson & Johnson’s single dose shot.

The agency also authorized the use of each of the available COVID-19 vaccines as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine.

A single booster dose of the Moderna COVID-19 vaccine may be administered at least 6 months after completion of the primary series to individuals:

  • Age 65 years old and older;
  • Ages 18 to 64 years old at high risk of severe COVID-19
  • Ages 18 to 64 years old with frequent institutional or occupational exposure to SARS-CoV-2

The Moderna COVID-19 single booster dose is half of the dose that is administered for a primary series dose. 

[Read more: White House details COVID-19 vaccine plan for children ages 5 to 11 years old]

“Today’s actions demonstrate our commitment to public health in proactively fighting against the COVID-19 pandemic,” said acting FDA commissioner Janet Woodcock. “As the pandemic continues to impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent COVID-19, including the most serious consequences of the disease, such as hospitalization and death. The available data suggest waning immunity in some populations who are fully vaccinated. The availability of these authorized boosters is important for continued protection against COVID-19 disease.”

A single booster dose of the Janssen (Johnson and Johnson) COVID-19 Vaccine may be administered at least 2 months after completion of the single-dose primary regimen to individuals age 18 years old and older. 

The agency clarified 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 to individuals ages 18 to 64 years old with frequent institutional or occupational exposure to SARS-CoV-2.

[Read more: FDA authorizes COVID-19 booster for certain immunocompromised individuals]

“The amendments to the emergency use authorizations to include a single booster dose in eligible populations are based on the available data and information and follows the input from the members of our advisory committee who were supportive of the use of a booster dose of these vaccines in eligible populations,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

Marks added, “We are also taking action today to include the use of mix and match boosters to address this public health need. We will work to accrue additional data as quickly as possible to further assess the benefits and risks of the use of booster doses in additional populations and plan to update the healthcare community and public with our determination in the coming weeks.”

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