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The Pfizer-BioNTech COVID-19 vaccine, now marketed as Comirnaty, was granted full FDA approval on Monday, but when could vaccines developed by Johnson & Johnson and Moderna win full approval?
A J&J spokesperson told Fox News that the company “plans to file for a Biologics License Application (BLA) with the FDA later in 2021.”
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Meanwhile, Moderna announced on June 1 it started a rolling admission process with the FDA for full approval of its COVID-19 vaccine for use in people aged 18 and older. (Its announcement came several weeks after Pfizer-BioNTech’s May 7 announcement the companies were seeking approval.) A Moderna spokesperson told Fox News that the company expects to complete the submission in August.
The BLA is the next step following emergency use authorization (EUA). The FDA granted Moderna’s COVID-19 vaccine emergency approval for individuals aged 18 and older in December, and the J&J vaccine was granted emergency approval in February.
In a call with reporters Monday, Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, detailed the FDA’s review of Pfizer’s BLA. The FDA completed the review in just over three months, or some 40% faster than usual.
The process of fully authorizing a vaccine takes about six to eight months, but the FDA completed the process for approving Pfizer’s vaccine in just a little over three after filing its BLA and testing 44,000 trial participants 16 years old and older. Currently more than 204 million people have been vaccinated with Pfizer-BioN-Tech.
This Jan. 24, 2021, file photo shows a vial of the Pfizer vaccine for COVID-19 in Seattle, Wash.
(Ted S. Warren/ AP Photo)
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Pfizer’s application built on previously submitted pre-clinical and clinical data, information relating to the manufacturing process, vaccine quality data and site inspections. Likewise, Moderna CEO Stéphane Bancel previously noted the company was in the process of submitting additional late-stage trial data for FDA review.
Emergency approval, issued to all three companies, comes when there are serious, threatening diseases that have no other alternative, and the vaccines must first meet the FDA’s safety and efficacy standards before they receive an EUA.
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Officials are hoping that the full approval of a vaccine will ease hesitancy, and as more people roll their sleeves to receive shots, it lessens the opportunity for the virus to further mutate.
Clinical trials are underway for children under 12, who cannot yet receive any COVID-19 vaccines because regulators are awaiting data regarding safety, efficacy and dosing.
Fox News’ Kayla Rivas contributed to this report.
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