FDA panel approves emergency use approval for Pfizer vaccine

ANI | Updated: Dec 11, 2020 6:41 AM IST

Washington [US]Dec. 11 (ANI): A panel of experts advising the U.S. Food and Drug Administration (FDA) recommended emergency approval for the Pfizer-BioNTech Covid-19 vaccine on Thursday.
The FDA’s vaccine advisory panel, made up of independent scientific experts, infectious disease physicians and statisticians, voted 17 to 4, with one member, in favor of emergency clearance for people 16 years of age and older, The New York reported. Times.
The agency is expected to clear the vaccine in a few days, prioritizing healthcare workers and nursing home residents to receive the first shots of the vaccine early next year.
The New York Times reported that with this formal blessing, the nation could finally begin to curb the spread of the virus just as infections and deaths soar, reaching a record high of more than 3,000 deaths a day on Wednesday.
The FDA is expected to grant an emergency use authorization on Saturday, as they are familiar with the agency’s planning, though they cautioned that last-minute legal or bureaucratic requirements could delay the announcement until Sunday or later.
The Pfizer vaccine has been approved for the public in the United Kingdom, Canada, Bahrain, and Saudi Arabia.
The US authorization of Pfizer’s vaccine is expected to be followed soon by one for Moderna’s version, which uses similar technology and has also shown promising results in clinical trials.
Operation Warp Speed, the Trump administration’s multi-billion dollar program to accelerate vaccine development, pre-ordered 100 million doses of the vaccine from Pfizer in July and strongly supported the development and manufacture of Moderna’s vaccine, The New York reported. Times.
However, the US needs to vaccinate about 70 percent of the population to achieve herd immunity, and it will take time, even if the vaccine is widely accepted.
“I think the data was pretty convincing that the benefits greatly outweigh the risks. I wish there had been a little more minority enrollment in the trial. But I think the numbers were enough to make a decision,” said Dr. James Hildreth, a member of the FDA advisory committee told CNN.
“We know that in at least tens of thousands of people tracked for two months, there are no serious adverse events … I think we now know enough to say that this seems to be our way out of this horrible, terrible mess,” said Dr. Paul Offit, another member of the committee.
Meanwhile, Pfizer’s president and CEO said he is pleased that FDA vaccine advisers have voted to recommend that the agency grant emergency use authorization for the company’s coronavirus vaccine in the US. .
“We have been waiting to present our robust data package to the US government’s committee of vaccine experts since we began our efforts to develop a new COVID-19 vaccine earlier this year,” said the President and CEO of Pfizer, Albert Bourla, in a statement. to CNN.
Earlier this week, the UK became the first country in the world to administer the new coronavirus vaccine jointly developed by US drugmaker Pfizer and Germany’s BioNTech in a closely watched inoculation program around the world.
After the UK, Canada became the second country to approve the Pfizer-BioNTech Covid-19 vaccine for its citizens. (AND ME)