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