The clinical trials of the experimental vaccine against COVID19 from the American company Moderna, one of the most advanced, will not produce results before November 25 at the earliest, according to his boss on Wednesday, who therefore excludes any commercialization before the presidential election November 3.
“We will have enough safety data on November 25 to be able to apply for an emergency authorization from the FDA (Federal Medicines Agency), provided that the safety data are good, that is to say that the vaccine is considered safe, ”said Stéphane Bancel, CEO of Moderna, at a conference organized by the Financial Times.
Moderna is, with pharmaceutical companies Pfizer and Johnson & Johnson, in phase 3 of clinical trials in the United States, a phase where the experimental vaccine or a placebo is randomly injected into tens of thousands of volunteers, in order to verify that the vaccine is safe and effective. The phase 3 trial of the AstraZeneca / Oxford vaccine is currently on hold in the country.
Donald Trump has repeatedly said he hopes for a vaccine before the November 3 election, raising concern among public health experts about possible political pressure on the regulatory process.
A single laboratory, Pfizer, expects results by the end of October, a few days before the poll, which would allow the company to immediately file an application for authorization with the FDA. The trial protocol provides for interim analysis of the data relatively early, relative to the others.
But scientists, biostatisticians and clinical trial experts have warned of the risks of such rapid approval, preferring to test the vaccine for a few more months in order to be certain of its effectiveness and possible side effects, especially since any vaccine would be probably ultimately administered to hundreds of millions of people.