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It’s a big step toward US approval of the Biontech and Pfizer corona vaccine – an advisory committee to the US FDA has already given the green light. The FDA itself could soon follow suit.
The corona vaccine from Mainz company Biontech and its US partner Pfizer has overcome a major hurdle with its request for emergency approval in the US After hours of discussion, an advisory committee to the US FDA was He ruled in favor of granting emergency approval for the application to people over 16 years of age.
In the meeting held via video link, 17 of the experts voted in favor of admission, four voted against. There was one abstention. The final decision on emergency approval rests with the FDA itself and is expected in the next few days. The recommendation of the advisory committee is not binding, but the authority generally follows the recommendations of the experts. It would be the first corona vaccine approved in the United States.
Biden praises the recommendation
US President-elect Joe Biden described the committee’s recommendation as “a bright light at an unnecessarily dark time.” In the country of around 330 million inhabitants, more than 15 million people have already been infected by the corona virus. About 290,000 people have died from the Sars-CoV-2 pathogen since the pandemic began. In absolute terms, that is more than in any other country in the world.
“I would like to thank the FDA Advisory Committee for recognizing the critical role that our vaccine can play in fighting the ongoing pandemic,” Biontech co-founder Ugur Sahin said, according to the statement. “Today’s positive discussion and vote confirm the potential of our candidate vaccine to protect people against this deadly and devastating disease.”
FDA emphasizes: safety is a top priority
The Biontech and Pfizer vaccine is already approved in the UK, Canada, Bahrain and Saudi Arabia. An application for emergency approval is currently under consideration in the EU and a decision can be expected this year. The results of the phase III study of the vaccine, which were also published Thursday in the renowned trade journal “New England Journal of Medicine,” show an effectiveness of 95 percent.
FDA chief Stephen Hahn said the meeting of the advisory committee, made up of scientists, doctors, and employees of government and pharmaceutical companies, was an “important step.” “At this time of great urgency, FDA employees feel a responsibility to complete the review process as quickly as possible,” Hahn said, but emphasized the top priority of safety. “I can assure you that no vaccine will be approved in the United States that FDA staff would not safely administer to their own families.” The American company Moderna has also applied for emergency approval from the FDA, and the advisory committee plans to discuss this next Thursday.
