Date :Saturday, November 21st, 2020 | Time : 08:38 |ID: 182774 | Print

Pfizer and BioNTech apply for FDA emergency use authorization for coronavirus vaccine

SHAFAQNA – Two American and German pharmaceutical companies on Friday submitted to the US Food and Drug Administration for emergency use authorization for their coronavirus vaccine candidate.

Following the success of clinical trials on the joint vaccine of the American companies “Pfizer” and the German company “BioNTech” against the new generation of Corona virus (Covid-19), this alliance today (Friday) an official application for a vaccine production license Submitted to the US Food and Drug Administration (FDA).

President of the European Commission Ursula von der Leyen, told on a news conference on Thursday that It is possible that the union will issue a license for the joint vaccine of the two companies, as well as the vaccine made by the American company “Moderna” against the corona virus, before the end of next month (next six weeks).

“If everything goes well, the European Medicines Agency (EMA) may grant a conditional marketing license from the middle of December,” von der Leyen said and noted that there are daily consultations to synchronize their evaluation of Corona vaccines.

Pfizer and BioNTech say final analysis shows coronavirus vaccine is 95% effective with no safety concerns and based on the results of the final tests and the absence of any dangerous side effects, they announced that they might receive approval from the US and European regulators for the emergency use of the vaccine within the next month.

This news is translated by Shafaqna English.

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