If You Got Moderna, the FDA Has a Major Booster Update for You

This comes ahead of the agency's meeting to approve or decline additional shots for this vaccine.

Millions of Pfizer recipients are getting additional shots right now, following the U.S. Food and Drug Administration's (FDA) and Centers for Disease Control and Prevention's (CDC) decision to approve a booster dose of that vaccine for certain groups of people at the end of September. Moderna and Johnson & Johnson recipients have been warned to hold off on seeking out additional shots, however, since the FDA and CDC advisory committees have not yet authorized a booster for either of those two vaccines, nor have they suggested mixing and matching Pfizer with them. The FDA's committee is set to vote on whether or not to approve Moderna's booster proposal on Oct. 14, but the agency just spoke out about Moderna boosters in a new report.

RELATED: If You Got Moderna, These Are the 3 Reasons to Wait for a Booster.

Ahead of the scheduled meeting this week, FDA scientists have declined to take a stance on backing Moderna booster shots. The agency released a 45-page document on Oct. 12, detailing Moderna's argument for an additional dose, reporting on its safety and efficacy, and analyzing the need for it. According to the FDA, Moderna submitted an amendment to its emergency use authorization on Sept. 3 to include a third, half-dose booster shot, which would be administered six months after the second dose. Moderna has cited data on the rate of breakthrough infections and the declining levels of neutralizing antibodies produced by its vaccine six to eight months after that second dose as reasons for boosters.

"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 FDA said in its analysis, adding that "concerns have been raised that declining neutralizing antibody titers or reduced effectiveness against symptomatic disease may herald significant declines in effectiveness against severe disease."

But overall, the agency says that the available data shows that Moderna and the other authorized COVID vaccines "still afford protection against severe COVID-19 disease and death" across the U.S. "There are many potentially relevant studies, but FDA has not independently reviewed or verified the underlying data or their conclusions," the agency said in its report, declining to take a stance on whether or not it would approve a Moderna booster.

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The FDA also similarly did not take a stance on Pfizer's booster shots in its report released ahead of the meeting where the agency's advisory committee voted on the booster, CNBC reported. The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) ultimately chose to recommend third shots of the Pfizer vaccine for those most at risk of COVID, scaling down the pharmaceutical company's original proposal to offer a booster to anyone 16 and older, as long as it had been six months since their last shot.

Moderna is only asking the FDA to approve its booster shots for the same groups it approved the Pfizer booster for: those 65 and older, and those under 65 who are at high risk of severe COVID for medical, institutional, or occupational reasons. But unlike Pfizer, Moderna has not argued that its vaccine's effectiveness is waning against severe COVID or hospitalization. Existing data appears to show that the Moderna vaccine continues to be effective in that regard, which significantly distinguishes Moderna's application from Pfizer's, per The New York Times.

A CDC study published on Sept. 24 found that Moderna's vaccine has remained the most protective against hospitalization, even amid the Delta surge. After analyzing nearly 3,700 patients in 21 different hospitals from March to August, researchers found that Moderna was 93 percent effective against hospitalization, while Pfizer and Johnson & Johnson were 88 and 71 percent effective, respectively. Pfizer's efficacy also dropped to 77 percent after just four months, while Moderna's did not decline.

"The benefit of a booster dose must be weighed against potential risk," the FDA concluded in its report. "It is currently not known if there will be an increased risk of myocarditis/pericarditis or other adverse reactions after a booster dose of the Moderna COVID-19 vaccine. These risks and associated uncertainties have to be considered when assessing benefit and risk."

RELATED: Dr. Fauci Just Gave an Update on Getting a Booster of a Different Vaccine.

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