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Moderna and Pfizer announced progress in testing covid-19 vaccines in recent days – AFP
The application for emergency approval of the covid-19 vaccine developed by the Pfizer / BioNTech association will be submitted in the United States on Friday, the United States government announced on Thursday (20).
“Pfizer partner BioNTech has announced that it intends to submit an emergency approval request” for its vaccine tomorrow (Friday) to the United States Drug Regulatory Agency (FDA), “US Health revealed Alex Azar, at a press conference at the White House.
Earlier, BioNTech co-founder Ugur Sahin told AFP in an interview with Zoom: “The documents will be finalized today (Thursday) and tomorrow and will be sent to the FDA.”
Pfizer’s chief executive revealed on Tuesday that an authorization request would be submitted in the United States very soon.
US pharmaceutical giant Pfizer and BioNTech, a small German biotech company, announced Wednesday that their vaccine has shown 95% efficacy in preventing COVID-19, according to the full results of its large-scale clinical trial.
Secretary Azar added that the US government “hopes” that Moderna, a US company that also competes to develop and distribute a vaccine against covid-19, “soon” submits its application for approval.
An emergency authorization is a temporary or conditional authorization granted to respond to an emergency, such as a pandemic. It can be revoked or modified if new data on the efficacy or safety of the substance become available.
In turn, the FDA did not say how long it would take to review the vaccine’s efficacy and safety data, 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 go-ahead is likely in December.
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