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The U.S. Drug Agency has set stricter criteria than the White House would like to urgently approve any future vaccines against the Covid-19 epidemic, making it impossible to issue any licenses before the US presidential election. November 3.
Vaccine manufacturers will have to wait at least two months before injecting the last dose in Phase III clinical trials before submitting a marketing request as requested by the agency. The United States Food and Drug Administration (FDA). In a document posted on its website on Tuesday, but the three experiments currently underway in the United States began successively in late July (Moderna. Pfizer) and late September (Johnson & Johnson). The first two require two doses three to four weeks apart.
Vaccines must show at least 50% effectiveness in preventing Covid-19, while the US Medicines Agency requires that any trial include at least five severe cases of Covid-19 in the placebo group, as the The goal of the vaccine is to prevent the most dangerous forms of the disease.
“The US Food and Drug Administration is committed to ensuring that the process of scientific evaluation and development of Covid-19 vaccines is as open and transparent as possible,” said Stephen Hahn, director of the US agency. USA, in a tweet.
And the US media indicated that the director of the US agency won a power struggle that he had been waging for several weeks with the White House to impose these standards.
US President Donald Trump condemned the decision, tweeting Tuesday night that these new rules “make it more difficult to produce vaccines quickly. It will be approved before the day of the presidential elections. It is a new political attack! He specifically mentioned Han.
For his part, Eric Topol, one of the scientists who used to pressure the US Drug Administration not to give in to Trump’s pressure, wrote: “This day is equivalent to declaring the independence of the Food and Drug Administration.” .
This regulatory document appears to hold back the ambitions of Pfizer, whose boss has repeatedly claimed that its clinical trial will contain enough data by the end of October to match Trump’s hopes. On the other hand, Moderna said that it is betting on the date of the end of November.
Source: French press agency
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