Advisory committee meeting on Pfizer vaccine EUA request

Coronavirus

The committee will recommend the EUA be approved by the Food and Drug Administration (FDA) or not

COLUMBUS, Ohio (WCMH) – Thursday is an important day for Pfizer’s request for an Emergency Use Authorization (EUA) for its COVID-19 vaccine. The Vaccines and Related Biological Products Advisory Committee (VRPAC) will meet to discuss the request. The meeting is open to the public and can be viewed online.

“This is really of historical importance and it’s something I think a lot of people will have interest in,” said Dr. Joseph Gastaldo, an infectious disease expert with Ohio Health.

The committee will recommend the EUA be approved by the Food and Drug Administration (FDA) or not. The FDA makes the final decision on EUA approval, which Dr. Gastaldo explained is then followed by steps at the (CDC).

“What’s happening [Thursday] is a sub group within the FDA consisting of experts who are independent from the federal government will review with a fine-tooth comb all of the data from the Pfizer study,” said Dr. Gastaldo. “In addition they will also review the manufacturing process. They’re going to evaluate the efficacy and more importantly the safety of the vaccine.”

Pfizer and Biontech reported their two dose vaccine is 95% effective in clinical studies. Efficacy is one of many aspects of the vaccine discussed in a report made public Tuesday by the FDA. The report is about fifty pages long and will be reviewed by the VRBPAC. Dr. Gastaldo has also read the report.

“My cliff note review of the 50 pages released from the FDA show the vaccine is very effective
in preventing people from getting sick from this virus. In addition the vaccine is pretty safe,” he said. “Yes, when people get vaccinated they could feel off kilter for 24 hours. They may have a sore arm, they may have fatigue. That’s your body’s way of getting the immune response from the vaccine.”

Dr. Gastaldo expects the Pfizer vaccine will be approved for EUA.

“I feel confident in saying once those processes happen we will be giving vaccines as soon as possible in our communities,” he said.

According to Ohio’s vaccination plan, the state is expecting to get almost 100 thousand doses of the Pfizer vaccine next week.

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