FDA issues emergency use authorisation for Pfizer-BioNTech vaccine
pharmafile | December 14, 2020 | News story | Sales and Marketing | COVID-19, FDA, US, Vaccine
The US Food and Drug Administration has approved the Pfizer-BioNTech COVID-19 vaccine for emergency use in those aged 16 and older in the US, with the first doses likely to be rolled out this week.
The FDA has determined that the Pfizer-BioNTech jab meets the criteria for issuance of an emergency use approval based on the data currently available, which the administration says provides clear evidence the vaccine may be effective in preventing COVID-19. The data also confirms that the known and potential benefits outweigh the known and potential risks, supporting the use of the vaccine in millions nationwide.
The authorisation follows a trial involving over 43,000 people which found the Pfizer-BioNTech vaccine was effective at preventing coronavirus 95% of the time, as well as an advisory panel last week strongly recommending the vaccine for use in the US.
Emergency approval of the jab is a promising development for those living in the US, where the total deaths from coronavirus is nearing 300,000 – but there remain unanswered questions regarding the logistics of distribution, as well as safety in pregnant women and those with severe allergies.
Dr Peter Marks, Director of the FDA’s Centre for Biologics Evaluation and Research, said in a briefing with reporters that FDA scientists felt “very comfortable” encouraging Americans to get vaccinated, unless they have specific allergies to other vaccines or vaccine ingredients.
FDA Commissioner Dr Stephen M Hahn said: “The FDA’s authorisation for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world.”
“Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorisation,” he added. “The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.”
Darcy Jimenez
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