The American Medicines Agency (FDA) set Tuesday, October 6 more stringent criteria than those desired by the White House to urgently approve any future vaccine against Covid-19, making any authorization before the presidential election of November 3 unlikely. .
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Vaccine makers will have to wait at least two months after injecting the last dose in Phase 3 clinical trials before submitting a marketing application, the FDA asks in a document posted online.
However, the three ongoing trials in the United States began at the end of July (Moderna, Pfizer) and the end of September (Johnson & Johnson) respectively, and the first two require two doses spaced three or four weeks apart.
Mark of independence
The vaccines will have to show an efficacy of at least 50% to prevent Covid-19, and the FDA requires that any trial have at least five severe cases of Covid-19 in the placebo group, the aim of the vaccine being to prevent the forms severe disease.
"The FDA is committed to ensuring that the process for the development and scientific evaluation of Covid-19 vaccines is as open and transparent as possible,"
tweeted FDA chief Stephen Hahn, who reported to media Americans won a standoff of several weeks with the White House to impose these criteria.
"Today marks a declaration of independence for the FDA,"
tweeted Eric Topol, one of the scientists who pressured the FDA not to give in to the administration of Donald Trump.
This regulatory document seems to be pulling the rug out from under Pfizer's feet, whose boss has repeatedly said that his clinical trial would have enough data by the end of October, which corresponded to Donald Trump's hope.
Moderna, on the other hand, had already said to count on the end of November.
These new rules
"make it harder to create vaccines quickly
(for them to be)
approved before presidential election day."
It's a new political attack! ”
, reacted the American president in the evening, by directly mentioning Stephen Hahn on Twitter.