Pfizer Inc and BioNTech once again requested the U.S. Food and Drug Administration (FDA) on Tuesday to authorize booster doses of their COVID-19 vaccine in all adults.
The FDA in September had authorized Pfizer’s boosters for people aged 65 and above, and other individuals at high risk of being infected because of their jobs, after a panel of advisers to the agency rejected Pfizer’s request for authorization of the booster in all individuals aged 16 and above.
The panelists suggested the evidence supporting broad approval was inadequate, and they wanted to see more safety data, especially concerning the risk of heart inflammation in younger people after vaccination.
Moderna’s booster doses have since been cleared for use in a similar group of patients, and a booster shot of Johnson & Johnson’s COVID-19 vaccine has been authorized for use as well. Roughly 25 million Americans had received a booster, as of Monday.
Pfizer and U.S. health officials have argued that boosters prevent hospitalizations and deaths and that emerging data indicates they can slow mild infections as well.
Moderna is likely to file a request with the U.S. FDA to broaden emergency use authorization of its boosters in all adults, CNBC reported on Tuesday, citing sources familiar with the matter, adding that the timing of the filing was not known yet.
Moderna did not immediately respond to a Reuters request for comment.
U.S. President Joe Biden’s administration in August announced plans to roll out booster doses for all adults in September, before the FDA’s advisers had recommended a limited authorization.