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FDA panel says J & J booster is safe. But is it suboptimal?

ABC 10 News KGTV
ABC 10 News KGTV
 2021-10-16
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SAN DIEGO (KGTV) -- People who got the Johnson and Johnson COVID vaccine are one step closer to getting a booster shot after a vote Friday by an advisory panel to the Food and Drug Administration.

The agency’s Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend allowing boosters for every J & J recipient 18 and older. These boosters should be given at least two months after the initial immunization.

However, the elephant lingering in Friday's virtual meeting room was that a J & J booster administered at two months might not offer optimal protection. Representatives for the company argued for a longer interval, but committee members felt J & J had insufficient data to back it up.

On top of that, a new study from the National Institutes of Health released this week suggests J & J recipients might be better off getting a booster from a different company.

VRBPAC is an influential group of outside experts, but the final decision on boosters will be left to regulators at the FDA. The Centers for Disease Control and Prevention will also weigh in next week, potentially offering more nuanced recommendations regarding which groups should seek out the first boosters.

The panel’s recommendation is a lot different than the one issued the day prior for recipients of the Moderna vaccine. In that case, the committee recommended a booster for high-risk individuals only given six months after the initial immunization.

The language closely mirrors the recommendation issued for Pfizer last month: people 65 and up, adults with underlying conditions, and people at risk of exposure from their job.

“There’s lots of moving parts here. It is very complicated,” said Dr. Mark Sawyer, a pediatrician and vaccine expert at Rady Children’s Hospital who serves as a voting member of VRBPAC.

Dr. Sawyer said boosters for J & J have been more complicated than the others because the company presented less data to support its application. The company turned over many of the critical studies within the last two weeks. In an unusual move, the FDA convened the meeting of VRBPAC experts before its staff could independently review many of J & J’s submissions.

Independently reviewing all the data might take another month, said Dr. Peter Marks, who oversees the FDA’s vaccine division. Many committee members felt boosters could not wait.

This week, final results from J & J’s clinical trial revealed protection against mild disease waned to just 42 percent four months after the single-shot vaccine.

A booster improved protection to 75 percent effective against moderate cases. The company said booster shots were 100 percent effective in preventing severe cases of COVID-19, but the results were from a study with roughly one-third of the volunteers of the initial clinical trials.

Dr. Sawyer said regulators were also facing public pressure.

“As everyone knows, we approved booster doses for Pfizer last month. And in the meantime, everyone who got Moderna and Johnson and Johnson was saying, ‘Hey, what about me?’” he said.

Committee members felt confident J & J presented enough evidence to show a booster given at two months was safe and it improved the immune response, he said.

Representatives for the company argued that a six month interval should produce more durable protection from the virus. That conclusion was based on data from 17 volunteers.

“The trouble is the company didn’t present hardly any data on six months,” said Dr. Sawyer. “They presented a lot of data on an interval of two to three months.”

Committee members were also briefed on a new study organized by the National Institutes of Health on the benefits of mixing and matching booster brands, particularly for J & J recipients.

People who got one dose of J & J followed by another dose of J & J produced four times as many virus-fighting antibodies. But J & J recipients who got a Moderna booster saw a 76-fold surge in antibody production, the study found.

Dr. Sawyer said the study is so new, regulators need more time to analyze it. VRPBAC was briefed on the study after voting on J & J's booster.

“Basically, we have to work with what science we have at the time,” Sawyer said.

He says next week, the CDC should release more granular guidance spelling out which J & J recipients should get a booster right away of J & J.

A few weeks from now, he said we’ll get more guidance indicating which people might want to consider a different brand.

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