Pfizer seeks emergency FDA approval for Covid-19 vaccine

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Drugmaker Pfizer said on Friday it had submitted a request to the Food and Drug Administration to authorize its coronavirus vaccine for emergency use, triggering a fast-track regulatory process that could allow the first Americans to obtain a vaccine by mid-December. .

Pfizer and its German partner, BioNTech, announced on Wednesday that the vaccine is 95% safe and effective, and that it also works well in the elderly and in preventing severe Covid-19.

Another frontrunner, Moderna, said on Monday that its vaccine, which uses similar technology, was 94.5% effective and that the company also plans to apply for emergency clearance soon.

Both vaccines use a synthetic version of the genetic material of the coronavirus, called mRNA, to program a person’s cells to make many copies of a fragment of the virus.

An emergency clearance would allow limited groups of Americans to obtain the vaccines before the FDA has completed the typical month-long approval process, but agency officials have made it clear through new directives that their emergency clearance bar would be raised.

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The two companies’ vaccine candidates began large human trials on the same day, July 27, leading the six-pack of vaccines the federal government has invested in as part of its vaccine development program. crash, Operation Warp Speed.

If both vaccines are cleared for emergency use, federal and company officials said there could be enough doses to immunize about 20 million Americans by the end of the year, a group which would most likely include healthcare workers and residents of nursing homes. There are approximately 17-20 million healthcare workers in the United States, and approximately one million people live in nursing homes.

After lowering expectations for how many millions of vaccines they can produce this year, companies plan to ramp up manufacturing early next year. As with other types of vaccines, mass production for the coronavirus has proven to be a complex and delicate process requiring sterile conditions and precise temperature and humidity control. MRNA technology has also never been commercially manufactured. If other vaccines are also licensed, hundreds of millions of doses could be available by spring, according to federal officials.

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Pfizer and Moderna have both made deals with the government to make vaccines free to Americans and distributed according to plans developed between the federal government and the states. CVS and Walgreens have also entered into federal agreements to begin vaccinating nursing home residents. On Tuesday, Alex M. Azar II, secretary of the Department of Health and Human Services, said 99% of nursing homes across the country had signed up to be part of the program.

FDA regulators plan to take about three weeks to review Pfizer’s vaccine before an external panel of experts meets to review the application in the second week of December. This meeting is scheduled for December 10.

The agency generally, but not always, follows the advice of its advisory committees. If committee members reach consensus on the effectiveness of the Pfizer vaccine, the company could receive emergency clearance by mid-December.

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Because Moderna is also close to submitting its vaccine for review, the external committee could review the company’s vaccine soon after Pfizer’s.

Pfizer and BioNTech said on Friday the companies had also submitted documents to regulatory agencies in the United Kingdom and the European Union, which have an ongoing submission process. Emergency requests to other countries will also be submitted within days, the companies said.

Within the FDA, Pfizer’s request 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 delve into the thousands pages of data on the safety and efficacy of each vaccine, as well as information on how companies plan to safely and consistently manufacture large quantities of products.

The process may take longer if reviewers encounter errors or need to request additional data. Regulators expect manufacturing data to spark intense deliberation as companies have strived to get this information out on time.

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