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Pfizer is being used for emergency FDA approval for the Covid-19 vaccine



Drugmaker Pfizer said Friday it has applied to the Food and Drug Administration to authorize its coronavirus vaccine for emergency use, triggering an accelerated regulatory process that could allow the first Americans to receive the vaccine by mid-December.

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

Another favorite, Moderna, said on Monday that a vaccine using such technology was 94.5% effective and that the company also expects to apply for an emergency authorization soon.

Both vaccines use a synthetic version of the genetic material of the coronavirus called mRNA to program human cells to shed many copies of a fragment of the virus.

An emergency permit would allow limited groups of Americans to receive the vaccines before the FDA completes its typical months-long approval process, but agency officials have made it clear through new guidelines that their emergency response bar will be high.

In a video message Friday, Pfizer CEO Dr. Albert Burla called it a “historic day” and said: “With great pride and joy – and even a little relief – I can say that our emergency request for Use of our Covid-19 vaccine is now in the hands of the FDA. “

Both companies’ vaccine candidates began large-scale human trials on the same day, July 27, leading a package of six vaccines in which the federal government is investing through its program to develop vaccines against crashes, Operation Warp Speed.

If both vaccines are approved for emergency use, federal officials and companies say 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 workers and homeowners. elderly. It is estimated that there are between 17 and 20 million health 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 increase production early next year. Like other types of vaccines, their mass production for coronavirus has proven to be a complex and delicate process, requiring sterile conditions and precise control of temperature and humidity. MRNA technology has also never been commercially available. If other vaccines are allowed, hundreds of millions of doses could be available by spring, according to federal officials.

Both Pfizer and Moderna have negotiated deals with the government so that the vaccines are free to Americans and distributed according to plans developed between the federal government and the states. CVS and Walgreens also have federal deals to start immunizing nursing home residents. On Tuesday, Alex M. Hazard II, secretary of the Ministry of Health and Social Services, said 99 per cent of the country’s nursing homes had signed up for the program.

FDA regulators 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, though not always, follows the advice of its advisory committees. If committee members reach a consensus on the effectiveness of the Pfizer vaccine, the company could receive an emergency permit by mid-December.

As Moderna is also about to present its vaccine for review, the outer panel may review the company’s vaccine shortly after Pfizer.

Pfizer said Friday that the company has begun filing regulatory documents in Australia, Canada, Europe, Japan and the United Kingdom and plans to apply in other countries “in the near future.”

Inside the FDA, Pfizer’s application will be reviewed by the agency’s Center for Biological Agency Assessment and Research, which has organized large teams of medical and law enforcement officials, epidemiologists and statisticians to dig into thousands of pages of safety data. and the effectiveness of each vaccine, as well as information on how companies plan to safely and consistently produce large batches of the product.

The process may take longer if inspectors encounter errors or if they need to request additional data. Regulators expect production data to stimulate intense discussion as companies struggle to deliver this information on time.


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