First request for authorization of a vaccine against Covid-19 in the United States

Just ten months after the sequencing of the new coronavirus, the American pharmaceutical group Pfizer and its German partner BioNTech on Friday asked the United States Medicines Agency (FDA) to authorize their vaccine against the disease caused by the virus, Covid-19 , the first manufacturers to do so in the United States or Europe.

The request had been expected for several days, following the publication of the results of the clinical trial carried out since July on 44,000 volunteers in multiple countries, and according to which the vaccine would be 95% effective in preventing Covid-19, without side effects. serious.

Pfizer confirmed to AFP that it had officially filed the file with the FDA on Friday.

The U.S. agency announced the same day that a public meeting of its vaccine advisory committee would be held on December 10 to consider the request.

The opinion of this committee is advisory. The decision whether or not to authorize the vaccine will then be up to FDA scientists, and could be made as early as the first half of December.

Europe could follow in the second fortnight, according to the President of the European Commission, Ursula von der Leyen. Another vaccine, by the American company Moderna, as effective, is on the heels of Pfizer.

Donald Trump’s government is already planning to vaccinate 20 million people at risk in December, then 25 to 30 million per month. In Europe, countries are also getting organized: Spain, for example, wants to vaccinate “a very substantial part of the population” in the first semester.

The speed of these developments is unprecedented in the history of vaccines. It took an average of eight years of development for vaccines licensed in the last decade in the United States.

BioNTech only offered its groundbreaking messenger RNA technology to Pfizer in March, when the world was going through its first lockdown. The first volunteer received the vaccine on April 23 in Germany, in the first phase of the trials. Phase 3, the last, began on July 27 and recruited from 44,000 participants on several continents.

Half of these volunteers received a placebo, the other half the experimental vaccine, without knowing which one. They lived their lives normally, with the same cautionary advice as the rest of the population.

Gradually, with the outbreak of the pandemic in the United States in the fall, the number of Covid-19 cases jumped in the placebo group – but not in the vaccinated group.

Of 170 cases among the participants, 162 were in the placebo group, and 8 in the treated group, according to press releases from the manufacturers. The statistic is clear: a vaccinated person was 95% less likely to catch Covid-19 than an unvaccinated person.

Better still, the vaccine seems effective in preventing severe forms of the disease, and it would be as effective in young people as in those over 65.

– Dose rush –

Another reassuring fact: the side effects were limited to fatigue in 3.8% of participants after the second dose, and headaches (2%), all of which were surmountable. No serious side effects, according to companies.

The follow-up took place over two months, a period which makes it possible to identify the vast majority of side effects: historically, 90% of side effects appear within 40 days, according to Moncef Slaoui, senior manager of the “Warp Speed” operation. “launched by Donald Trump.

Experts from US and European regulators will now verify this data, announced with fanfare, 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.

The FDA is committed to doing so transparently, recognizing that many Americans are suspicious. In October, 42% said they would refuse to be vaccinated, according to a Gallup poll.

At this stage, it is not known how long the protection will last. “At least a year, if not a lot more,” Ugur Sahin, CEO of BioNTech, told AFP. Only time will confirm this.

This should not prevent states from rushing for the product. Hundreds of millions of doses have been reserved. The alliance thinks it can manufacture 1.3 billion next year, enough to ensure a “normal winter”, but in 2021, according to Ugur Sahin.

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