A request of emergency approval of the COVID-19 vaccine developed by the Pfizer / BioNTech alliance could be presented on Friday in the United States, the government announced Thursday.
“Pfizer’s partner, BioNTech, announced that it intends to submit an emergency request for approval” of its vaccine tomorrow (Friday) to the US drug regulatory agency (FDA), said the US Secretary of Health, Alex Azar, at a press conference at the White House.
Earlier, BioNTech co-founder, Ugur Sahin, said earlier to AFP in an interview by Zoom: “The documents will be finalized today (Thursday) and tomorrow and presented to the FDA.”
And Pfizer’s CEO had said Tuesday that an application for authorization would be filed in the United States very soon.
US pharmaceutical giant Pfizer and BioNTech, a small German biotech company, announced Wednesday that their vaccine was effective in a 95% for the prevention of covid-19, based on the full results of its large-scale clinical trial.
Secretary Azar added that the US government “hopes” that Modern, a US company that is also competing to develop and distribute a COVID-19 vaccine, “submit soon” its application for approval.
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 the efficacy or safety of the substance subsequently emerge.
For its part, the FDA did not say how long it would take to review the efficacy data and vaccine safety, the two main criteria.
Moncef Slaoui, the chief scientist appointed by President Donald Trump to lead the operation to vaccinate the American population, said Monday that the green light will likely come in December.