Drug maker Pfizer said on Friday it had submitted a request to the Food and Drug Administration to allow the coronavirus vaccine for use in emergencies, triggering an accelerated regulatory process that could allow early Americans to get a vaccine by mid-December. .
Pfizer and its German partner, BioNTech Announced Wednesday The vaccine was 95 percent safe and effective, and that it also works well in the elderly and in the prevention of severe Covid-19.
Another, modern runner, He said on Monday That its vaccine, which uses similar technology, was 94.5 percent effective and that the company also expects to soon apply for emergency permission.
The two vaccines use an artificial copy of the genetic material of the Coronavirus, called mRNA, to program a person’s cells to make many copies of a portion of the virus.
The emergency authorization would allow limited groups of Americans to obtain vaccines before the FDA completes the model approval process, which takes months, but agency officials explained by New tips That their bar for emergency permission would be high.
In the Friday video message, Pfizer CEO Dr. Albert Burla described it as a “historic day,” and said: “It is with great pride and joy – and even with a bit of relief – I can say that our request for permission for an emergency use of the Covid-19 vaccine is now in the hands of the FDA. . “
Both companies’ vaccine candidates began large human trials on the same day, July 27, spearheading a package of six vaccines that the federal government invested in through its rapid vaccine development program, Operation Warp Speed.
If the vaccines are authorized for emergency use, federal and company officials have said there may be enough doses to immunize about 20 million Americans before the end of the year, a group that is likely to include health care workers and nursing home residents. There is an estimate 17 million to 20 million healthcare workers In the United States, and About a million people Living in nursing homes.
After lowering expectations about how many millions of vaccines they can produce this year, companies expect to ramp up their manufacturing early next year. As with other types of vaccines, it has been shown to be mass produced for the Coronavirus A complex and delicate process It requires aseptic conditions and careful control of temperature and humidity. The mRNA technology was also not commercially synthesized. If other vaccines are licensed as well, hundreds of millions of doses could be available by spring, according to federal officials.
Pfizer and Moderna have arranged deals with the government so that the vaccines are free to Americans and are distributed according to plans established between the federal government and the states. CVS and Walgreens also have federal deals to start vaccinating nursing home residents. On Tuesday, Alex M. announced. Azar II, Secretary of the Department of Health and Human Services, That said, 99 percent Of the country’s nursing homes have signed up to be part of the program.
Regulators at the FDA plan to take about three weeks to review the Pfizer vaccine before an outside panel of experts meets to review the application in the second week of December. This meeting is scheduled for December 10.
The agency usually follows, though not always, the advice of its advisory committees. If panelists reach consensus about Pfizer’s vaccine effectiveness, the company may receive an emergency clearance by mid-December.
Since Moderna is also close to submitting its vaccine for review, an external committee can review the company’s vaccine shortly after Pfizer has been vaccinated.
On Friday, Pfizer said the company had started filing regulatory applications in Australia, Canada, Europe, Japan and Britain, and that it plans to apply in other countries “in the near future.”
Within the FDA, Pfizer’s request will be reviewed by the agency’s Center for Biological Assessment and Research, which has organized large teams of medical officials, compliance officers, epidemiologists and statisticians to dig into thousands of pages of data about the safety and effectiveness of each vaccine, along with information on how to plan Firms to safely and consistently manufacture large quantities of the product.
The process may take longer if reviewers encounter errors, or if they need to request additional data. Regulators expect the manufacturing data to spur intense debate, as companies scramble to deliver that information in a timely manner.