Washington: The Food and Drug Administration (FDA) set the stage Tuesday for a new round of decisions on which Americans should get coronavirus booster shots, releasing a review of data suggesting that an additional half-dose of Moderna’s vaccine at least six months after the second dose increased antibody levels. But the agency did not take a position on whether an additional shot was necessary.
An independent advisory panel of experts will examine the available data on both Moderna and Johnson & Johnson boosters in a two-day meeting later this week. Votes are scheduled on whether to recommend emergency authorization of boosters for both vaccines. While the panel’s votes are not binding, the F.D.A. typically follows them.
In documents released Tuesday, Moderna argued that a third injection is needed because the potency of its vaccine wanes over time, with levels of neutralizing antibodies falling six to eight months after a second dose. The company also cited “real world evidence of reduced effectiveness against the Delta variant,” although the F.D.A. noted that the studies diverge on whether Moderna’s protection weakened over time against symptomatic infection or against the Delta variant.
The company did not argue that a booster was necessary to prevent severe disease or hospitalization, but concentrated its arguments on preventing infection and mild to moderate disease.