FDA panel recommends COVID-19 vaccine trials

Coronavirus

COLUMBUS, Ohio (WCMH)–On Thursday, a committee within the FDA began their review of the COVID-19 vaccine trial data from Pfizer.

Their recommendation for Emergency Use Authorization is the first step in vaccine approval Local medical experts explain it’s the first chance to learn more about the virus.

“One of the things I’ve learned is, when you get the vaccine, you may feel off-kilter for 24-hours or so. Especially after the second dose,” said Dr. Joseph Gastaldo from OhioHealth, after tuning into the review.

Experts site nearly 70% of all recipients will feel side effects at the injection site. From pain, to fatigue, and even fever. Some recipients could experience more serious reactions.

“When you look at what’s actually in a vaccine, there are many, many things in there that there are going to be some rare people that have allergies or allergic reactions to rare things in them,” Dr. Gastaldo said.

This is not an unexpected fallout for infectious disease experts.

“As we vaccinate more millions and millions of people, we’re going find people who have severe allergies to them,” Dr. Gastaldo warns.

When the FDA began the review, those experts said that one major area of focus would be the side effects and adverse reactions from people who received an injection. Not everyone actually received the vaccine. An equal number of participants received a placebo but still reported similar side effects.

“Look at fatigue. You have after people got dose one, 40% of people had complaints of fatigue. And also in the placebo after dose one, 33% of people had complaints of fatigue,” Dr. Gastaldo describes of the data. “Headache. In the vaccine, 41% had complaints of headache, and 33% had complaints in the placebo group.”

Meaning some of the side effects could be what doctors call psychosomatic, which is a reaction in the recipients mind.

“That’s why we need to do random controlled trials. They don’t know if they got the placebo or not, they don’t know that. Their blinded. We want that to happen. We don’t want to introduce anything to that,” Dr. Gastaldo said.

As the committee takes an in-depth look at those reactions in the trial data, doctors shoulder the responsibility of preparing the public with what to expect.

“I think that’s up to us at public health, to educate our patients about this vaccine, the process for making this vaccine and how effective and safe this vaccine it is,” said Dr. Mysheika Roberts from Columbus Public Health.

Knowing the community’s faith is needed in the vaccine, as whole, to return to a pre-pandemic way of life.

“I’ve been saying for a while we need 60-80% of our population to either be vaccinated or to be previously exposed in order to have herd immunity,” Dr. Roberts said.

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