PHILADELPHIA (KYW Newsradio) -- A panel of doctors and health experts from the Philadelphia area and around the country is meeting Thursday to review Pfizer’s COVID-19 vaccine. There will then be a vote on whether or not to recommend it for FDA approval for emergency use. This is a major final hurdle before Americans can start getting the shots.
The all-day meeting began at 9 a.m. Two committee members have ties to the area: Dr. Paula Annunziato, vice president and therapeutic area head of vaccines clinical research at Merck, which is based in North Wales, Pa., and Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
The independent panel will go over data from Pfizer, which worked with German-based BioNtech, to see if there are any red flags. FDA scientists and top Pfizer officials will make presentations. At the end of the day, the panel will send recommendations to the FDA.
"After we receive their recommendations, we'll incorporate that into our decision and we hope, shortly thereafter, once we have the recommendations, to make our own decision," FDA Commissioner Stephen Hahn said.
Hahn says the entire process is being guided by experts who have American safety at the top of their minds.
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Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, speaking to Harvard’s School of Public Health on Wednesday, said the process is trustworthy because independent experts are involved.
“When a vaccine is deemed to be safe and effective by the FDA, the American public needs to appreciate that that process of that decision was ... independent of the administration, independent of the drug companies,” Fauci said.
And if the FDA does give final approval to Pfizer or the other drugmakers, Fauci said, "I can promise you that I will take that vaccine myself and I will recommend that my family does that."
A topic that will likely come up during the meeting is the news from United Kingdom officials that two health care workers had allergic reactions after getting shots as the nation began its rollout of the vaccine. Those cases led to U.K. regulators updating their guidance.
“Any person with a history of a significant allergic reaction to a vaccine, medicine or food (such as previous history of anaphylactoid reaction or those who have been advised to carry an adrenaline autoinjector) should not receive the Pfizer BioNtech vaccine,” the U.K’s Medicines and Healthcare products Regulatory Agency said on Wednesday.
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There were no known cases of allergic reactions among the tens of thousands of patients who are participating in the clinical trials. Offit, who was on KYW Newsradio Wednesday morning, said British officials may have jumped the gun.
“It’s an unfortunate situation, and I think it scared people unnecessarily. I think the smarter thing to have done would have been to have allergists review the data on these two patients to find out what specifically about that vaccine was causing an allergic reaction,” Offit said.
“The safety and benefits of this vaccine outweigh any theoretical risks at this point.”
Pfizer, which is touting its vaccine to be 95% effective, said trials show mild side effects in patients, including fatigue, headache and soreness at the site of the injection.
If the FDA grants emergency use authorization, some Americans could start getting vaccinated as early as next week. The panel will meet again next Thursday to focus on the Moderna vaccine.