New York- In documents released Tuesday morning, Moderna argued that the Food and Drug Administration should authorize a half dose of its coronavirus vaccine as a booster shot for recipients at least six months after the second dose, citing evidence from that the potency of the vaccine against infection decreases over time. The agency noted in its own analysis that, overall, the available data shows that Moderna and the other vaccines “still provide protection against severe illness and death from Covid-19 in the United States.”
Moderna cited the rate of progressive infections, “real-world evidence of reduced effectiveness against the Delta variant” and decreasing levels of neutralizing antibodies in his vaccine six to eight months after a second dose. The company said its clinical trial studies showed that a third injection raised antibody levels higher than those that had been before the second dose.
The documents were released by the FDA ahead of a two-day meeting of the agency’s advisory committee, scheduled for Thursday and Friday. In its own briefing for the committee, also released Tuesday, the FDA summarized the data without taking a position.
The committee is expected to vote on whether to recommend emergency authorization of the Moderna and Johnson & Johnson vaccine boosters. While panel votes are not binding, regulators generally follow them.