A committee of independent advisers to the Food and Drug Administration is meeting Thursday to discuss whether to authorize booster shots of Moderna’s COVID-19 vaccine.

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What You Need To Know

  • A committee of independent advisers to the Food and Drug Administration is meeting Thursday to discuss whether to authorize booster shots of Moderna’s COVID-19 vaccine
  • The Vaccines and Related Biological Products Advisory Committee are listening to presentations from the FDA, Moderna and others before debating and then voting on whether additional doses of the vaccine should receive emergency use authorization
  • The question committee members will ask themselves is whether available data support that a third dose of the Moderna vaccine is safe and effective six months after completion of initial inoculation for people age 65 or older as well as younger adults with underlying medical conditions that put them at high risk of severe COVID-19 and those with occupation exposure
  • The panel will meet again Friday to discuss booster shots of Johnson & Johnson’s vaccine

The Vaccines and Related Biological Products Advisory Committee are listening to presentations from the FDA, Moderna and others before debating and then voting on whether additional doses of the vaccine should receive emergency use authorization to counter waning effectiveness.

The panel will meet again Friday to discuss booster shots of Johnson & Johnson’s vaccine.

The question committee members will ask themselves is whether available data support that a third dose of the Moderna vaccine is safe and effective six months after completion of initial inoculation for people age 65 or older as well as younger adults with underlying medical conditions that put them at high risk of severe COVID-19 and those with occupation exposure.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told members that “separating waning effectiveness from reduced effectiveness against the variants such as the delta variant can be challenging. And … the vaccines are still very effective against serious outcomes, such as hospitalization.”

On Tuesday, the FDA released a mixed analysis of Moderna’s data. Agency scientists found that a 50-microgram third dose – half of what was administered in earlier shots – elevated the level of antibodies at least six months after initial inoculation. However, the data do not clearly demonstrate a booster shot is needed, the scientists said.

“Some real world effectiveness studies have suggested declining efficacy of Moderna COVID-19 Vaccine over time against symptomatic infection or against the Delta variant, while others have not,” the analysis says. “However, overall, data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States.”

In fact, scientists emphasize that all three vaccines used in the U.S. – the ones produced by drugmakers Moderna, Johnson & Johnson and Pfizer-BioNTech – still offer strong protection against severe COVID-19 cases. The issue is how quickly, and how much, protection against milder infection may wane.

The FDA just went through this process last month in deciding whether boosters of the Pfizer vaccine should be green-lit. While it is not required to do so, the agency followed the advisory committee’s recommendation in authorizing the additional doses for people who are 65 or older, are at an increased risk for severe COVID-19 or work in high-risk settings, including health care workers.

In the next step in the process, a panel convened by the Centers for Disease Control and Prevention recommended the shots for people 65 and older as well as those with underlying medical conditions, but not for people with occupational exposure. However, in making the final call, CDC Director Dr. Rochelle Walensky partially split with the advisers by recommending boosters for all three groups.

The CDC advisers are scheduled to meet Oct. 20 to discuss the Moderna and J&J boosters.

Pfizer and Moderna booster shots for immunocompromised people have been approved since August.

The committee will also hear data in the two-day meetings about mixing-and-matching primary vaccines with different boosters. The members also will discuss as a non-voting question whether booster shots should be authorized for all adults.

(this story/news/article has not been edited by PostX News staff and is published from a syndicated feed)

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