(Reuters) – Pfizer Inc and BioNTech once again requested the U.S. Food and Drug Administration on Tuesday to authorize booster doses of their COVID-19 vaccine for 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 expert 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 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 the boosters prevent hospitalizations and deaths and that emerging data indicates they can slow mild infections as well.
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.
(Reporting by Manas Mishra in Bengaluru; Editing by Vinay Dwivedi)
