WASHINGTON | The US Medicines Agency (FDA) on Tuesday set stricter criteria than those desired by the White House to urgently approve any future vaccine against COVID-19, making any authorization before the November 3 presidential election 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.
The vaccines will need to show at least 50% effectiveness in preventing 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 reports. Americans won a standoff of several weeks with the White House to impose these criteria.
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! ”Denounced Donald Trump in the evening, directly mentioning Mr. Hahn on Twitter.
“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 Donald Trump’s administration.
This regulatory document seems to pull 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.