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FDA advisers set to make decision on Pfizer vaccine booster shot this Friday

Published: Sep. 14, 2021 at 7:35 PM EDT|Updated: Sep. 14, 2021 at 7:51 PM EDT
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CHARLESTON, S.C. (WCSC) - President Joe Biden said last week that the country has purchased enough doses of the COVID-19 vaccine to make booster shots available for Americans soon.

But there are still questions about when and for whom these booster shots will be approved for use.

Those answers should arrive Friday, when a group of Food and Drug Administration advisers is scheduled to meet to discuss a booster for the Pfizer-BioNTech vaccine, the first manufacturer to seek booster dose approval.

Doctors with the South Carolina Department of Health and Environmental Control will be watching that meeting closely.

“I think that recommendation for an additional dose of vaccine or a booster dose of vaccine is coming. It’s not going to surprise us,” said Dr. Jonathan Knoche, a medical consultant for DHEC.

Knoche said science is showing that antibodies to protect people from COVID start to wear off at some point after getting vaccinated, so people will need a booster shot to rebuild those antibody levels, as they do with other vaccines.

“Obviously, we don’t want to make a recommendation that’s not in step with what the federal government is saying, based on their review of the data and the literature, and we don’t want to recommend a booster dose too soon, when it wouldn’t be as effective as waiting for the right time period, so I think we’re really trying to make the best recommendation based on science,” he said.

In August, a group of medical leaders from the federal government released a statement, saying boosters would be available for all Americans by the week of Sept. 20, and people would be eligible for the shot starting eight months after receiving their second dose.

But since then, scientific reviews and studies have come out, saying boosters might not be necessary just yet, including one published Monday in The Lancet, an international medical journal.

Its writers include World Health Organization officials and two outgoing FDA regulators, who wrote, “Even if some gain can ultimately be obtained from boosting, it will not outweigh the benefits of providing initial protection to the unvaccinated,” making the argument that shots should first go to areas in the world where the vaccine is scarce or not yet available.

In an address to the nation last week, Biden said scientists from the FDA and Centers for Disease Control and Prevention will make the final call on when and for whom boosters become available.

“As soon as they are authorized, those eligible will be able to get a booster right away in tens of thousands of sites across the — sites across the country for most Americans, at your nearby drug store, and for free,” the president said.

DHEC’s guidance for people who are confused about this back-and-forth is to wait to see what comes out of Friday’s meeting.

“We need to figure out at which point a booster would be appropriate and not sort of jump the gun when you’re not optimizing your body’s immune system response,” Knoche said.

Third doses of the COVID vaccine have already been approved and are currently available for people with moderately to severely weakened immune systems, including, but not limited to, people being treated for cancer and those who have received organ transplants.

Doctors have said third doses are needed for that group of immunocompromised people because their bodies likely did not develop the full immune response after two shots that people with stronger immune systems did, so they need a third dose to reach that baseline level of protection in the first place.

Knoche said the likelihood of a booster being approved and needed for the COVID vaccine should not cast doubt on the vaccine’s effectiveness, as he said studies have found it to be safe and highly effective.

“We get boosters all the time. We go get out tetanus booster,” he said. “You know, so I just think we need to see what the optimal timeframe is for the general public.”

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