The drug maker Pfizer said on Friday that it was Submitted an application to the Food and Drug Administration To authorize their coronavirus vaccine for emergency use, establishing a speedy regulatory process in motion that may allow the first Americans to receive the vaccine by mid-December.
Pfizer and its German partner, Biotech, Announced on wednesday The vaccine was safe and 95 percent effective, and also worked well in older people and prevented severe Kovid-19. Another front-runner, Modern, Said on monday Its vaccine, which uses similar technology, was 94.5 percent effective and the company expected to apply for emergency authorization soon.
The two vaccines use a synthetic version of a coronavirus genetic material called mRNA, to program an individual’s cells to churn multiple copies of a piece of the virus.
An emergency authority would allow limited groups of Americans to receive vaccines before completing the FDA’s typical months-long approval process. Agency officials have clarified New guidelines Their bar will be higher for emergency authority.
FDA regulators have taken about three weeks to review Pfizer’s vaccine, which spans thousands of pages, before an external panel of experts reviewed the application. The meeting is scheduled for 10 December.
The agency usually, although not always, follows the advice of its advisory committees. If committee members reach a consensus about the effectiveness of Pfizer’s vaccine, the company can obtain emergency approval by mid-December.
Because Modern is also on the verge of submitting its vaccine for emergency approval, external panels can review the company’s vaccine soon after Pfizer.
If both vaccines are authorized for emergency use, federal and company officials have said, there may be enough doses to vaccinate about 20 million Americans before the end of the year, a group that most likely has That would include health care workers and nursing home residents. Have a guess 17 million to 20 million are health care workers In the United States, and Nearly a million people Live in a nursing home.
In a video message on Friday, Pfizer’s Chief Executive Officer, Drs. Albert Borla called it a “historic day” and said, “It is with great pride and joy – and even a little relief – that I can say that our request for an emergency use authority for our Kovid – 19 vaccine is now FDA’s Is in the hands. “
Pfizer said on Friday that the company has begun regulatory submissions in Australia, Canada, Europe, Japan and the UK and has plans to implement it in other countries “in the immediate future”.