first vaccine authorization application filed in the United States

Only ten months after the sequencing of the new coronavirus, the US pharmaceutical group Pfizer and its German partner BioNTech requested this Friday the US Drug Agency (FDA) to authorize its vaccine against Covid-19. They are the first manufacturers to do so in the United States or Europe.

The request had been expected for several days, after the publication of the results of the clinical trial carried out since July 44,000 volunteers in various countries. Based on these trials, the vaccine is 95% effective with no serious side effects. Pfizer confirmed to AFP that it officially submitted the file to the FDA on Friday. United States and Europe could authorize the vaccine from December.

Another vaccine, from the Modern American company, so effective, is on the heels of Pfizer, like the government of Donald Trump already plans to vaccinate 20 million people at risk in December, after 25 to 30 million per month.

Europe is also organizing

In Europe, countries are also organizing themselves: Spain, for example, wants to vaccinate “a very substantial part of the population” in the first semester. In France, the government is already anticipating the arrival of a vaccine and its distribution, to avoid having the shortage we experienced with masks last spring. 1,500 million euros have already been budgeted For the purchase of vaccines, millions of doses have been reserved for pre-order and five contracts have already been finalized.

Next step: experts from European and US regulators will now verify data from clinical trials, to certify that the vaccine is safe and effective. As a first step, the FDA will grant, like Europe, a conditional authorization, linked to the health emergency, and probably restricted to certain groups. Children will not initially be part of it.

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