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November 20, 2020 Pfizer and BioNTech have confirmed that today they will file the request for emergency use authorization (an accelerated procedure) with the Food and Drug Administration (Fda, the American food and pharmaceutical market supervisory authority) for mRNA, the vaccine candidate for Covid-19.
The companies plan to send authorization applications to other regulatory agencies around the world.
As a company note reads, this could pave the way for vaccine use in the United States on people at highest risk as early as mid-December.
Pfizer and BioNTech let it be known that the request submitted to the FDA is based on the results of phase 3 trials, which show that the vaccine is effective in 95% of cases.
"Our work to make a safe and effective vaccine available has never been more urgent, as we continue to see an alarming rise in Covid-19 cases globally," said Albert Bourla, Pfizer's chief executive, noting that "Filing the application in the US is a milestone in our journey to distribute the vaccine around the world. We now have a more complete picture of the vaccine's efficacy and safety, which gives us confidence in its potential."
Bourla said work continues "with the FDA and regulators globally to obtain authorization for the vaccine candidate as soon as possible."
According to Ugur Sahin, CEO of BioNTech, today's request is "a crucial step" and that, "as a German company, headquartered in Germany, in the heart of Europe, our interaction with the EMA is of particular importance. constantly provided data as part of the review process ".
Pfizer and BioNTech have already started the authorization process in various parts of the world (for example with the EMA and the British authorities) and plan to further expand the number in the coming days.
The companies have specified that the vaccine has not yet been given the green light for distribution in any state.