An emergency authorization request for the Covid-19 vaccine developed by the Pfizer / BioNTech alliance should be filed in the United States on Friday, the US government announced on Thursday.
“Pfizer’s partner BioNTech has announced that it intends to file an emergency clearance request with the FDA tomorrow,” the US Medicines Agency, said US Secretary of Health Alex Azar during a press conference at the White House.
“We expect Moderna to make this request soon as well,” he added, of this American company also in the ranks to develop and widely distribute a vaccine against Covid-19.
An emergency authorization is a temporary or conditional authorization granted to respond to an emergency situation such as a pandemic. It can be revoked or modified if new data on efficacy or safety appear later.
These words of the American minister confirm those of the leaders of the two companies.
“The documents will be finalized today or tomorrow, and submitted to the FDA,” Ugur Sahin, CEO of BioNTech, told AFP on Thursday.
The CEO of Pfizer had for his part said Tuesday that an authorization request would be filed very soon in the United States.
Pfizer, an American pharmaceutical giant, and BioNTech, a small German biotechnology company, announced on Wednesday that their vaccine was 95% effective in preventing Covid-19, according to full results from their large-scale clinical trial.
The FDA has not said how long it will take to review data on vaccine efficacy and safety, the two main criteria.
Moncef Slaoui, the scientific manager of Operation Warp Speed, mounted by President Donald Trump to vaccinate the American population, said on Monday that the green light would undoubtedly come in December.