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Monday, January 18, 2021

Panel votes to recommend FDA approval of Pfizer’s COVID-19 vaccine

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Late day Thursday, a government advisory panel gave their nods for the use of Pfizer’s COVID-19 vaccine, allowing for the Food and Drug Administration (FDA) to grant the approval for the vaccine.

In a 17-4 vote with one absent vote, the committee of health experts concluded that the vaccine appears safe and effective for emergency use in people 16 and older.  Inoculation for the vaccine will likely become the first approved in the U.S. to beat the virus that’s has caused the deaths of nearly 300,000 Americans.  

The FDA is expected to follow the recommendation from its expert advisers. Depending on how fast the agency signs off, hospitals and other organizations could begin administrating the vaccine within days for some health care workers and nursing home residents.

The nod came despite questions from several members about whether teenagers with 16 and 17-year-old, should be included in the recommendation since the risk to those age groups are low and there wasn’t much data about them in the vaccine trial. 

Ultimately, the panel voted on the question put forth by the FDA, which included teens between 16 and 17.  Pfizer has asked for emergency use authorization for its two-dose vaccine in people aged 16 to 85.

“The American public demands and deserves a rigorous, comprehensive and independent review of the data,” said the FDA’s Dr. Doran Fink. “We expect a high bar for efficacy,” he added.

Among the topics discussed whether individuals with “significant” allergic reactions may not be able to get vaccinated.

Two people who received the COVID-19 shot in England on Tuesday suffered severe allergic reactions to it.

Pfizer reps told the panel that, while they’re aware of the British reports, they haven’t seen any signs of allergic reactions in their trial of the vaccine.

The FDA said that the results of Pfizer’s large, ongoing study showed that the vaccine — developed with Germany’s BioNTech — was more than 90 percent effective across a large swath of people and that no major safety problems were uncovered.

“The data presented in the briefing report were consistent with what we heard before and are really exciting,” said Dr. William Moss, head of Johns Hopkins University’s International Vaccine Access Center.

“Nothing that I see would delay an emergency use authorization.”

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