FDA backs Moderna booster injection for elderly and high-risk persons

Booster injections of Moderna Inc.’s COVID-19 vaccine should be provided to the elderly and those at high risk of contracting the illness, US regulators’ advisors recommended.

Additional doses of the two-shot messenger RNA vaccine should be made available to persons 65 and older, as well as those 18 and older who are at high risk due to medical or occupational reasons, the Food and Drug Administration’s vaccine advisory council voted 19-0 Thursday.

The booster dosage, which is half of the initial dose, should be administered at least six months after the initial vaccination, the panel said.

The vote comes on the heels of a similar recommendation from the panel for a booster from Pfizer Inc. and BioNTech SE, which was later approved by the agency for use in older, higher-risk individuals. Moderna submitted evidence to the panel demonstrating that their vaccine loses efficacy over time and that a booster shot is both safe and effective at restoring protective antibody levels.

Members of the panel decided that the evidence Moderna offered to support the booster were insufficient, notably the safety statistics for the half-dose booster. However, they determined that it was sufficient in the face of a raging epidemic and evidence that at least some at-risk individuals may acquire major breakthrough cases.

Concerning safety, the specialists were encouraged by the fact that many patients with weakened immune systems had already received a full third dose of Moderna with no obvious side effects.

“These are exceptional times, and we must deal with imprecise data,” Eric Rubin, a panelist from the Harvard T.H. Chan School of Public Health, summarized the sentiments of several panelists.

The FDA will now determine whether to give clearance or not. The agency is not required to adopt the advisory panel’s recommendations and may decide whether to license the booster and for certain groups.

Once the FDA takes action, the baton will be transferred to a separate advisory committee at the Centers for Disease Control and Prevention.

The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention is set to meet Oct. 20 and 21. The group will develop its own booster recommendations and forward them to CDC Director Rochelle Walensky, who will decide whether to accept them or shape her own.

The FDA’s advisory group will meet again on Friday to examine booster injections from Johnson & Johnson, the third firm with an approved COVID vaccine. J&J’s single-shot vaccination has seen far less use than Moderna and Pfizer-vaccines. BioNTech’s

The conference will conclude with a discussion of combining boosters with the various injections used in initial vaccinations.

According to preliminary data from a US government-sponsored experiment announced Wednesday, pairing COVID-19 vaccinations with a different booster generates as many or more antibodies as boosting with the same injection.

Credit: Thelcn