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FDA Advisory Panel Votes to Recommend Emergency use of Pfizer Vaccine, Probably Leading to Final Approval this Week

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The vote is one of the final steps towards authorization of a vaccine.

Posted: Dec 10, 2020 4:54 PM

NBC News- An independent panel of experts has overwhelmingly voted in favor of recommending that the Food and Drug Administration authorize Pfizer's Covid-19 vaccine for emergency use in people ages 16 and older.

The vote Thursday afternoon was split 17 in favor of the authorization, four against, with one person abstaining from the vote. Though the FDA is not obligated to go along with the panel's recommendation, it is widely anticipated that the regulatory agency will indeed authorize the Pfizer vaccine for emergency use, and do so promptly.

"Our plan is to take their recommendations into account for our decision-making and make a decision shortly thereafter," FDA Commissioner Dr. Stephen Hahn said Thursday on the "TODAY" show. "It really depends upon the complexity of the issues discussed, but we intend to act quickly."

The United States would be the fourth country to move forward with Pfizer's vaccine. Canada approved the vaccine Wednesday, and the United Kingdom began administering the shots this week. Bahrain has also granted access to the vaccine.

Data so far indicate the vaccine is safe and 95 percent effective across a variety of age and racial groups and ethnicities, when given in two doses, about three weeks apart.

Outside experts have been unusually effusive with praise for Pfizer's vaccine work.

"The trial results are impressive enough to hold up in any conceivable analysis," Dr. Eric Rubin, an immunologist at the Harvard T.H. Chan School of Public Health wrote in an editorial published Thursday in the New England Journal of Medicine, where he serves as the editor-in-chief.

"Most vaccines have taken decades to develop, but this one is likely to move from conception to large-scale implementation within a year," he wrote. "This is a triumph."

While Thursday's vote is seen as a positive step toward combating the coronavirus pandemic, it comes amid alarming increases in people dying of Covid-19. On Wednesday, that number reached a new high, surpassing 3,000 deaths in a single day, according to an NBC News tally.

The shots are known to come with some side effects, including fever, fatigue, headache and muscle and joint pain. Two people in the U.K. were reported to have severe allergic reactions after receiving the shot.

Dr. Paul Offit, a VRBPAC member and vaccine researcher at the Children's Hospital of Philadelphia, urged continued studies to learn more about the potential for allergic reactions to the vaccine, and to assure those who have severe allergies in general.

The matter needs "careful observation to prove that this is not going to be a problem. You've got tens of millions of people who are not going to get this vaccine because of the comments that were made" by health officials in the U.K.

"We need to offer people some solace," Offit said. "This issue is not going to die until we have better data."

Such reactions are partially why clinical trials of Pfizer's vaccine will continue. Its safety and effectiveness will also continue to be scrutinized, even after shots start going into arms.

During Thursday's meeting, Dr. Nancy Messonnier, director for the National Center for Immunization and Respiratory Diseases at the CDC and head of the agency's work on Covid-19 vaccines, outlined the various tracking platforms and databases that will watch for any potential adverse events or problems possibly related to the vaccine.

"On Day One of the Covid-19 vaccine program, systems will be in place to monitor the safety of vaccine recipients," she said. Those systems will include tried-and-true monitoring databases, such as the Vaccine Adverse Event Reporting System, as well as a new CDC database called V-SAFE, which uses text messaging and online surveys to check in with people who have received the vaccine to identify potential safety issues.

Another consideration moving forward is one of ethics: Should those who participated in clinical trials, but received the placebo, be offered the real vaccine?

Pfizer has said those participants should be offered the vaccine, but many purists of the scientific process urge the trials to continue as is to collect as much safety and efficacy data as possible.

What's more, experts say, additional information on the vaccine's effects on pregnant women, young children and those who are severely immunocompromised will be needed moving forward.

The FDA's advisory panel is scheduled to meet again virtually Dec. 17 to consider a similar Covid-19 vaccine, made by Moderna. In November, the company released preliminary results from its Phase 3 trial, which showed the vaccine is nearly 95 percent at preventing symptomatic illness.

Additional details from Moderna are expected to be released publicly before next week's meeting.

Elsewhere in the pipeline, vaccines from AstraZeneca and Johnson & Johnson are continuing with Phase 3 trials, with results likely after the New Year.

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