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The Pfizer-BioNTech COVID-19 vaccine, now marketed as Comirnaty, received full FDA approval on Monday, but when could vaccines developed by Johnson & Johnson and Moderna gain full approval?
A spokesperson for J&J told Fox News that the company “plans to file a Biologics License Application (BLA) with the FDA later in 2021.”
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Meanwhile, Moderna announced on June 1 that it has started an ongoing admissions process with the FDA for full approval of its Covid-19 vaccine for use by persons 18 years of age and older. (Its announcement came weeks after Pfizer-BioNTech announced on May 7 that the companies were seeking approval.) A Moderna spokesperson told Fox News the company plans to complete the submission in August. .
The BLA is the next step after Emergency Use Authorization (EUA). The FDA granted emergency approval of Moderna’s COVID-19 vaccine for people aged 18 and older in December, and the J&J vaccine received emergency approval in February.
On a call with reporters on Monday, Dr. Peter Marks, director of the 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, about 40% faster than usual.
The full vaccine authorization process takes about six to eight months, but the FDA completed Pfizer’s vaccine approval process in just over three after filing its BLA and testing 44,000 participants in the vaccine. trial aged 16 and over. Currently, more than 204 million people have been vaccinated with Pfizer-BioN-Tech.
This file photo from Jan. 24, 2021 shows a vial of the Pfizer vaccine for COVID-19 in Seattle, Wash.
(Ted S. Warren / AP Photo)
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Pfizer’s app is based on pre-submitted preclinical and clinical data, manufacturing process information, vaccine quality data, and site inspections. Likewise, Moderna CEO Stéphane Bancel previously indicated that the company is in the process of submitting additional late-stage trial data for FDA review.
The emergency approval, issued to the three companies, comes when there are serious and threatening diseases that have no other alternative, and the vaccines must first meet the standards for safety and effectiveness of the FDA before receiving an EUA.
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Officials hope that full vaccine approval will ease the hesitation, and as more people roll up their sleeves to receive vaccines, it reduces the possibility for the virus to mutate further.
Clinical trials are underway for children under 12, who cannot yet receive any COVID-19 vaccine as regulators await data regarding safety, efficacy and dosage.
Kayla Rivas of Fox News contributed to this report.
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