The American pharmaceutical group Pfizer and the German company BioNTech officially confirmed on Friday that they would file with the United States Medicines Agency (FDA) an application for marketing authorization for their vaccine against Covid-19 on Friday, becoming the first manufacturers to do so in the United States.
Also read: Covid-19: Pfizer / BioNTech vaccine 95% effective, according to full clinical trial results
The announcement was expected for several days, after the publication of the results of the clinical trial conducted since July on 44,000 volunteers in multiple countries, and according to which the vaccine would be 95% effective in preventing Covid-19 without serious side effects .
The boss of BioNTech told AFP on Thursday that the request would be filed on Friday.
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The demand in the United States represents a critical step in our quest for a Covid-19 vaccine for the world, and we now have a more complete picture of the efficacy and safety of our vaccine, which gives us confidence in its potential,
”said Pfizer CEO Albert Bourla.
The vaccine has also been continuously evaluated for weeks by the European Union, Australia, Canada, Japan and the United Kingdom.
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Companies will be ready to distribute the vaccine within hours of authorization,
" they said in their statement.
Green light in the first half of December?
The FDA has not said how long it will take to review the data, but the US government expects a green light in the first half of December.
Europe could follow quickly: from the second half of December for the European Medicines Agency, according to Commission President Ursula von der Leyen.
Another vaccine, by the American company Moderna, as effective, is on the heels of Pfizer.
Donald Trump's administration is already planning to vaccinate 20 million people in December, then 25 to 30 million per month.
The speed of these developments is unprecedented in the history of vaccines.
Authorized vaccines have taken eight years of development on average over the past 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 has since recruited 44,000 participants on several continents.
Read also: Covid: Can RNA Vaccines Modify Our DNA?
Half of these volunteers received a placebo, the other half the experimental vaccine, without knowing which one.
They have 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 statements from the manufacturers.
The statistic is clear: a vaccinated person was 95% less likely to catch Covid-19 than a non-vaccinated 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.
First, the FDA will grant an authorization for emergency use, a conditional green light, linked to the health emergency, and probably restricted to certain groups.