Pfizer-BioNTech COVID-19 vaccine to get US-FDA's full approval next week
The United States Food and Drug Administration (FDA) is reportedly set to grant full approval to Pfizer-BioNTech's two-dose COVID-19 vaccine next week, expediting the previous timeline for licensing the vaccine. To note, the vaccine was approved in the US on an emergency use authorization (EUA) license back in December. The company began the process of applying for full approval in May. Here's more.
Reports of the Pfizer-BioNTech vaccine receiving full approval come at a time President Joe Biden's administration is intensifying efforts to get more Americans to receive COVID-19 vaccines. FDA's full approval is expected to persuade more people to take the shot as many were hesitant to receive vaccines approved on EUA basis. Meanwhile, health authorities believe it would help local authorities implement vaccine mandates easily.
While the current vaccines in the US—approved for emergency use—are safe and effective, the Biden administration hopes full approval applying to those aged 16 and above will prompt vaccinations among holdouts waiting for FDA to formally approve the Pfizer shot. A Kaiser Family Foundation survey found 30% of unvaccinated people are more likely to get a fully-approved vaccine than something cleared for emergency use.
After receiving full approval, Pfizer-BioNTech is reportedly planning to request FDA to clear the third dose of its vaccine as a booster shot. Next week, Pfizer would complete submitting data, showing a third dose is safe and effective. Even the Biden administration, earlier on Wednesday, said fully-vaccinated adults should prepare to receive booster shots eight months after taking their second doses, starting September 20.
Bloomberg reported the Pfizer-BioNTech's COVID-19 vaccine—sold under the Comirnaty brand name—would get full approval from the FDA Monday or Tuesday, citing an official familiar with the development. American drug regulators were working on finishing the approval process for the shot by Friday but it was delayed due to a large amount of paperwork and negotiations with the pharma giant, according to New York Times.
The Pfizer-BioTech vaccine has been developed on a nucleoside-modified mRNA platform to deliver a mutated form of SARS-CoV-2's spike protein through lipid nanoparticles. It was developed by American pharmaceutical company, Pfizer, and German biotechnology company, BioNTech. Initially, the gap between its two doses was 21 days, but it was later increased to up to 42 days in the US and four months in Canada.
