The Food and Drug Administration (FDA) authorized the use of a booster dose of Pfizer’s COVID-19 vaccine Wednesday for the elderly and populations especially vulnerable to COVID-19.
The FDA amended the Emergency Use Authorization (EUA) for the Pfizer vaccine to allow for a booster dose for individuals aged 65 years and older, or anyone aged 18 and older who are at high risk of severe COVID-19 or whose “frequent institutional or occupational exposure” to COVID-19 puts them at high risk.
UPDATE: The FDA grants emergency use authorization for the Pfizer booster for 65 and up and for people whose health or occupation puts them at risk. Statement just released: pic.twitter.com/DJR5ToRr45
— Natalie Brand (@NatalieABrand) September 23, 2021
The FDA’s Vaccines and Related Biological Products Advisory Committee voted 16-2 against Pfizer’s request that boosters be approved for all Americans aged 16 and over on Sept. 17. The panel did vote 18-0 to recommend approval for seniors and individuals at high risk, which is ultimately the recommendation the agency followed.
The FDA fully approved Pfizer’s COVID-19 vaccine Aug. 23, and President Joe Biden promised that boosters would be available to all Americans by late September. The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices is meeting Wednesday and Thursday to discuss whether to recommend boosters to certain populations. The first day of the meetings were held prior to the FDA’s approval.
Some countries, including Israel, have already been administering boosters to their populations. Evidence presented to the FDA shows that the booster doses are generally safe and provide additional protection, particularly to vulnerable populations, as vaccine efficacy wanes six to eight months after administration. (RELATED: Fauci Flips On Boosters, Now Says It’s Not A ‘Mistake’ For FDA To Limit Recommendations)
Two top vaccine officials at the FDA announced their resignations in August, reportedly due to disagreements with the Biden administration’s push for widespread boosters. The two officials signed a letter Sept. 13 arguing that booster doses aren’t needed for the general population at this time.