FDA Expected To Authorize Pfizer Vaccine For 12-To-15-Year-Olds
By Jason Hall
May 4, 2021
CNN reports the emergency use authorization vaccine for children and teens is expected to be authorized by early next week, a federal government official confirmed.
The FDA will need to amend the emergency use authorization for the vaccine, but the official, who was not authorized to speak and requested anonymity, told CNN the process is expected to be straightforward as the FDA is currently reviewing data submitted by Pfizer supporting the extended use of the vaccine.
Pfizer reports a clinical trial involving 2,260 participants age 12-to-15 showed the vaccine had a 100% efficacy and was well tolerated. The company's COVID-19 vaccine is currently authorized in the United States for emergency use in individuals age 16 or older.
The FDA had previously held meetings of its independent Vaccines and Related Biological Products Advisory Committee to review data and vote on whether the three authorized coronavirus vaccines -- including Pfizer, Moderna and Johnson & Johnson -- would be recommended for emergency use.
However, the FDA confirmed to CNN that it will not take those measures in extending emergency use to 12-to-15-year-olds.
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