The U.S. FDA approved the use of Moderna’s and Janssen’s COVID-19 vaccines as a booster dose after their primary versions are completed.
On Thursday the U.S. Food and Drug Administration (FDA) approved the use of the Moderna and Janssen (Johnson & Johnson) COVID-19 vaccines as a booster dose after their primary versions are completed.
The FDA amended the emergency use authorizations (EUAs) for both vaccines in certain groups. The Moderna vaccine would be allowed as a booster six months after for all ages 65 years and up. It will also be allowed for those ages 18 to 64 and at high risk for severe COVID-19, and those aged 18 to 64 who are frequently exposed to SARS-CoV-2 due to their occupation or lifestyle. Meanwhile, the Janssen (Johnson and Johnson) vaccine would be allowed two months after for ages 18 years and older.
Both vaccines join Pfizer-BioNTech’s COVID-19 vaccine, which, until recently, was the only one allowed to administer a booster dose. Pfizer-BioNTech’s vaccine is approved to be given six months after the primary series is completed to those aged 18 to 64 years and are frequently exposed to the virus.
“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,” said Janet Woodcock, M.D., the acting FDA commissioner, in a statement.
Moderna’s EUA for the booster dose is based on results from a successful clinical trial that evaluated its efficacy and safety on 149 participants. Janssen’s EUA is based on data of 39 participants who participated in a large clinical trial that also looked into its efficacy and safety.
In addition, the FDA also approved the use of heterologous or mixed booster doses for currently available and FDA-authorized vaccines. This means that a single booster shot of any available COVID-19 vaccine can be used following the completion of primary doses of another vaccine brand. Eligible recipients are the same as those indicated in the respective booster vaccines.
The decision to allow vaccine mixing is based on positive clinical data from the Vaccines and Related Biological Products Advisory Committee and National Institute of Allergy and Infectious Diseases’ evaluation. The FDA said the benefits of administering a heterologous dose outweigh the known potential risks in eligible groups.
The Centers for Disease Control and Prevention will release guidelines soon after a meeting with their Advisory Committee on Immunization Practices. It is also contingent on the CDC director’s formal recommendation.
