Monday , January 25 2021

FDA: “Decision to approve Pfizer vaccine from December 10 …”



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The U.S. Food and Drug Administration (FDA) plans to approve the “Pfizer” vaccine against coronavirus in the weeks leading up to its December 10 general meeting, CNN reported.

“It’s going to be a few weeks. That can be day to week,” said Dr. Peter Marx, director of the U.S. Center for Food and Drug Administration’s Biological Assets Assessment and Research.

“It may be in a few days, but our goal is to make sure it’s safe within a few weeks,” he added.

As I said, it is still not possible to specify when the approval for emergency use will arrive, because it must be “done properly”.

“Of course, we will work to do that as soon as possible,” Dr. Marx said.

The FDA’s Advisory Committee on Vaccines and Related Biological Products, a panel of independent experts, is scheduled to meet on Dec. 10 to review the application for emergency use submitted by Pfizer.

So far, Pfizer is the only company to have applied to the FDA in the US.

The FDA’s surrender began on July 27 in the United States and is based on the results of a third-phase clinical trial of the Pfizer vaccine, which registered more than 43,000 volunteers.

Recent research has shown that the coronavirus vaccine is 95% effective in preventing infections, even in older adults, and does not cause serious side effects, said Pfizer and BioNTech.

The vaccine cannot be distributed until the FDA has granted the EEBA, as presented by the U.S. Centers for Disease Control and Prevention.

Vaccinations will begin in the United States in the “second half of December,” according to the director of the National Institute of Allergy and Infectious Diseases, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.


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