Pfizer and BioNTech applied for emergency use authorization of Coronavirus vaccine and submitted their application to the US Food and Drugs administration on Friday.
The joined firms become the first vaccine providers to seek regulatory clearance in America.
“It is with great pride and joy and even a little relief that I can say that our request for emergency use authorization for our Covid-19 vaccine is now in the FDA’s hands,” Pfizer CEO Albert Bourla said in a video shared on Friday.
Albert Added, “This is a historic day, a historic day for science and for all of us. It took just 248 days to get from the day we announced our plans to collaborate with BioNTech to our FDA submission day”, and said, “We have operated at an extraordinary speed in our clinical development program, from concept to regulatory filing, while always maintaining our focus on safety.”
The submission is based on three Phase clinical trials, which started on July 27th, with 43,000 thousand volunteers enrolled in the process.
The final analysis indicates 95% effectiveness in the drug with no serious side effects even in older people.
Emergency use authorization allows products to be utilized under specific conditions before all evidence is available for approval.
Another U.S based pharmaceutical company, Moderna’s vaccine shows 94.5% effectiveness and is most like to submit their application for EUA.
Coronavirus’s global spread has made many nations evident to economical disasters and threatened human life on earth.