antibody levels to SARS-CoV-2 rose by 1.8 times after people received a booster shot.
But the company narrowly missed another threshold set by the advisory panel: The committee hoped to see a fourfold increase in neutralizing antibodies in 88.4% of study participants who got boosters, but the Moderna study observed such a rise in 87.9%, according to the Times.
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One expert in infectious disease was dubious that boosters for younger, healthier Moderna vaccine recipients are necessary.
“The key question to focus on is whether there is evidence of erosion of protection against hospitalization with COVID,” Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security, in Baltimore says. “In those age or risk groups where this has occurred, a booster may be warranted.”
However, he says that “it is unclear what benefit those at low risk for hospitalization gain from a booster, as there is not enough data to show that boosters protect for a significant amount of time against mild breakthrough infections.”
Adalja says that’s especially true for the Moderna product, “as it has been associated with less waning [of protection] than other COVID vaccines.”
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What’s next?
The FDA is not obligated to follow its advisory panels’ decisions, but it typically does.
The FDA still needs to authorize the Moderna booster shot. This will be followed by a weigh-in from the CDC, whose advisory committee will meet on October 20. A rollout of the Moderna booster shot could happen shortly after. Although Moderna’s booster shot is not yet authorized, 1.5 million people have received a third Moderna dose in the U.S. so far, according to the CDC.