The drug maker Pfizer said on Friday that it had submitted an application to the Food and Drug Administration to authorize its coronavirus vaccine for emergency use, setting in motion an accelerated regulatory process that could allow the first Americans to get a vaccine by the middle of December.
Pfizer and its German partner, BioNTech, announced Wednesday that the vaccine was safe and 95 percent effective, and that it also worked well in older people and in preventing severe Covid-19.
Another front-runner, Moderna, said on Monday that its vaccine, which uses similar technology, was 94.5 percent effective and that the company also expected to apply soon for emergency authorization.
The two vaccines use a synthetic version of coronavirus genetic material, called mRNA, to program a person's cells to churn out many copies of a fragment of the virus.
An emergency authorization would allow limited groups of Americans to get the vaccines before the F.D.A. has completed the typical monthslong approval process, but agency officials have made clear through new guidelines that their bar for emergency authorization will be high.
In a video message Friday, Pfizer's chief executive, Dr. Albert Bourla, 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 emergency use authorization for our Covid-19 vaccine is now in the F.D.A.'s hands."
Both of the companies' vaccine candidates began large human trials on the same day, July 27, leading the pack of six vaccines the federal government has invested in through its crash vaccine development program, Operation Warp Speed.
If the two vaccines are authorized for emergency use, federal and company officials have said there could be enough doses to immunize about 20 million Americans before the end of the year, a group that would most likely include health care workers and nursing home residents. There are an estimated 17 million to 20 million health care workers in the United States, and about a million people living in nursing homes.
After lowering expectations for how many millions of vaccines they can produce this year, the companies expect to ramp up their manufacturing early next year. Like with other kinds of vaccines, mass producing them for the coronavirus has proved to be a complex and delicate process requiring sterile conditions and precise control of temperature and humidity. The mRNA technology has also never been commercially manufactured. If other vaccines are also authorized, hundreds of millions of doses could be available by the spring, according to federal officials.
Both Pfizer and Moderna have arranged deals with the government so that the vaccines will be free to Americans and distributed according to plans worked out between the federal government and the states. CVS and Walgreens also have federal deals to begin immunizing nursing home residents. On Tuesday, Alex M. Azar II, the secretary of the Department of Health and Human Services, said that 99 percent of the country's nursing homes had signed up to be part of the program.
Regulators at the F.D.A. plan to take about three weeks to review Pfizer's vaccine before an outside panel of experts meets to review the application the second week of December. That meeting has been scheduled for Dec. 10.
Understand Vaccine and Mask Mandates in the U.S.
- Vaccine rules . On Aug. 23, the Food and Drug Administration granted full approval to Pfizer-BioNTech's coronavirus vaccine for people 16 and up, paving the way for an increase in mandates in both the public and private sectors. Private companies have been increasingly mandating vaccines for employees. Such mandates are legally allowed and have been upheld in court challenges.
- Mask rules . The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of vaccination status, wear masks in indoor public places within areas experiencing outbreaks, a reversal of the guidance it offered in May. See where the C.D.C. guidance would apply , and where states have instituted their own mask policies . The battle over masks has become contentious in some states, with some local leaders defying state bans .
- College and universities. More than 400 colleges and universities are requiring students to be vaccinated against Covid-19. Almost all are in states that voted for President Biden .
- Schools . Both California and New York City have introduced vaccine mandates for education staff. A survey released in August found that many American parents of school-age children are opposed to mandated vaccines for students, but were more supportive of mask mandates for students, teachers and staff members who do not have their shots.
- Hospitals and medical centers . Many hospitals and major health systems are requiring employees to get a Covid-19 vaccine, citing rising caseloads fueled by the Delta variant and stubbornly low vaccination rates in their communities, even within their work force.
- New York City . Proof of vaccination is required of workers and customers for indoor dining, gyms, performances and other indoor situations, although enforcement does not begin until Sept. 13. Teachers and other education workers in the city's vast school system will need to have at least one vaccine dose by Sept. 27, without the option of weekly testing. City hospital workers must also get a vaccine or be subjected to weekly testing. Similar rules are in place for New York State employees.
- At the federal level. The Pentagon announced that it would seek to make coronavirus vaccinations mandatory for the country's 1.3 million active-duty troops "no later" than the middle of September. President Biden announced that all civilian federal employees would have to be vaccinated against the coronavirus or submit to regular testing, social distancing, mask requirements and restrictions on most travel.
The agency typically, though not always, follows the advice of its advisory committees. If committee members reach a consensus about the effectiveness of Pfizer's vaccine, the company could receive emergency clearance by mid-December.
Because Moderna is also on the verge of submitting its vaccine for review, the outside panel could review the company's vaccine soon after Pfizer's.
Pfizer said on Friday that the company has begun regulatory submissions in Australia, Canada, Europe, Japan and Britain, and that it plans to apply in other countries "in the immediate future."
Inside the F.D.A., Pfizer's application will be reviewed by the agency's Center for Biologics Evaluation and Research, which has organized large teams of medical and compliance officers, epidemiologists and statisticians to dig into thousands of pages of data about the safety and effectiveness for each vaccine, as well as information on how companies plan to safely and consistently manufacture large batches of the product.
The process could take longer if the reviewers come across errors, or if they need to ask for additional data. Regulators expect the manufacturing data to spur intense deliberation, as companies have scrambled to turn over that information in time.
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