This is a first major step towards the authorization of a vaccine against Covid-19 in the United States.
The U.S. Medicines Agency (FDA) Vaccine Advisory Committee voted Thursday, December 10, after a day of hearings, to recommend authorizing the Pfizer / BioNTech vaccine.
The recommendation was adopted by a majority of 17 votes of the expert group, against three votes against and one abstention.
This opinion is non-binding, and the green light for marketing has not yet been given.
The FDA will decide in the coming days.
But the outcome is clear and the vaccine should begin to be administered in the United States early next week in hospitals and nursing homes, the US Minister of Health said on Wednesday.
The vaccine was found to be safe, without serious side effects, and 95% effective after two doses in preventing Covid-19, the disease caused by the coronavirus.
The first dose seems to start to protect after ten days, but less well than with the booster three weeks later.
Allergy warning
“The immune responses elicited by mRNA (messenger RNA) are similar to those of natural infection. But of course, the mRNA vaccine is non-infectious and cannot cause disease,” summarized Kathrin Jansen, Chief Vaccine Officer. at Pfizer, during a question-and-answer session with the committee.
Experts have debated at length the risk of allergy after two cases of severe reactions in the UK.
In the United States, a warning will accompany the vaccine, announced the FDA's Marion Gruber: it will not be recommended for people with a known allergy to any of its ingredients.
But committee member Paul Offit stressed the need to reassure the tens of millions of people allergic to eggs or peanuts.
With AFP
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