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According to agency officials, CNN reports, the US Food and Drug Administration (FDA) intends to make a decision on approving the “Pfizer” coronavirus vaccine within weeks of the key meeting scheduled for December 10.
“It will be a matter of weeks. This can be from day to week,” said Dr. Peter Marx, director of the American Food and Drug Administration’s Center for Assessment and Research of Biological Assets.
“It’s possible it could be in a few days, but our goal is to make sure it’s safe within a few weeks,” he added.
As he said, it is not yet possible to give the exact dates when the approval for urgent use will arrive, because it has to be “done right”.
“Obviously we will work to do this as soon as possible,” said Dr Marx.
The FDA Advisory Committee on Vaccines and Related Biological Products, a group of independent experts, will meet on December 10 to discuss an emergency use application submitted by Pfizer.
So far, Pfizer is the only company to request the EUA from the FDA.
The FDA’s yield is based on the results of a phase three clinical trial of the Pfizer vaccine, which began in the United States on July 27 and enrolled more than 43,000 volunteers.
The final analysis of the study showed that the coronavirus vaccine is 95 percent effective in preventing infections, even in the elderly, and did not cause serious side effects, companies “Pfizer” and “BioNTech” said.
The vaccine cannot be distributed until the FDA issues the EUA, according to a presentation 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 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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