Drug maker Pfizer said Friday it had filed an application with the Food and Drug Administration for its emergency coronavirus vaccine, initiating an accelerated regulatory process that could allow the first Americans to get a vaccine by mid-December .
Pfizer and its German partner BioNTech, Announced Wednesday that the vaccine was safe, 95 percent effective, and that it also worked well in the elderly and in preventing severe Covid-19.
Another front runner, Moderna, said on Monday The vaccine, which uses similar technology, was 94.5 percent effective, and the company also expected to apply for an emergency clearance soon.
The two vaccines use a synthetic version of the coronavirus genetic material called mRNA to program a person’s cells to make many copies of a fragment of the virus.
Emergency clearance would allow limited groups of Americans to get the vaccines before the F.D.A. has completed the typical month-long approval process, but the agency officials have made this clear new guidelines that their bar for emergency authorization will be high.
In a video message Friday Pfizer’s managing director, Dr. Albert Bourla, calling it a “historic day” said: “With great pride and joy – and even a little relief – I can say that our emergency authorization application for our Covid-19 vaccine is now in the hands of the FDA. “
The companies’ two vaccine candidates began large-scale human trials on the same day, July 27, leading the pack of six vaccines the federal government has invested in as part of its crash vaccine development program, Operation Warp Speed.
If the two emergency vaccines are approved, federal and corporate officials have stated there could be enough doses to immunize about 20 million Americans before the end of the year. This group would most likely include healthcare professionals and nursing home residents. There is an estimated one 17 million to 20 million healthcare workers in the United States and about a million people live in nursing homes.
After lowering expectations for the number of millions of vaccines they can produce this year, companies assume they will ramp up production early next year. As with other types of vaccines, mass production for the coronavirus has been proven a complex and delicate process requires sterile conditions and precise control of temperature and humidity. The mRNA technology was never made commercially either. If other vaccines are also approved, hundreds of millions of doses could be available by spring, according to federal officials.
Both Pfizer and Moderna have made agreements with the government so that the vaccines are free to Americans and distributed according to plans worked out between the federal government and the states. CVS and Walgreens also have federal agreements to begin immunizing nursing home residents. On Tuesday, Alex M. Azar II, Secretary of the Ministry of Health and Human Services, said that 99 percent of the country’s nursing homes had signed up for the program.
Regulators at the F.D.A. The Pfizer vaccine review is planned to take about three weeks before an outside panel of experts meets to review the application in the second week of December. This meeting is scheduled for December 10th.
The Agency usually, although not always, follows the advice of its advisory committees. If the committee members agree on the effectiveness of the Pfizer vaccine, the company could receive emergency clearance by mid-December.
With Moderna also close to submitting its vaccine for review, the outside panel could review the company’s vaccine shortly after Pfizer’s.
Pfizer said Friday that the company has started filing filings in Australia, Canada, Europe, Japan and the UK, and that it plans to apply in other countries “in the near future”.
Within the FDA, Pfizer’s application is being reviewed by the agency’s Center for Biologics Evaluation and Research, which has organized large teams of health professionals and compliance officers, epidemiologists, and statisticians to search thousands of pages of data on the safety and effectiveness of each vaccine. as well as information on how companies plan to safely and consistently manufacture large batches of the product.
The process can take longer if reviewers encounter errors or need to request additional data. Regulators expect the manufacturing data to encourage reflection as companies have tried to get this information out in a timely manner.