Moderna will test new COVID shot against placebo, RFK Jr. says

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Moderna Inc. has agreed to do a placebo-controlled trial of its new COVID vaccine that was recently approved by U.S. regulators, Health and Human Services Secretary Robert F. Kennedy Jr. said Tuesday.

In a post on X, Kennedy said he wanted to “address those of you who have anxieties” about the Food and Drug Administration’s limited approval of Moderna’s vaccine, which was cleared for a narrower segment of the population than prior shots.

Moderna declined to comment. As a condition for approving the new shot, the FDA required a future placebo-controlled study in adults ages 50 to 64 without high-risk conditions, according to agency documents.

Kennedy said that “the FDA will monitor and collect data throughout the trial for every adverse outcome” and “scrutinize every aspect of the trial.”

Under Kennedy, U.S. health agencies have taken steps to limit who can get COVID vaccines, arguing there’s a lack of evidence for repeat doses. The FDA indicated last month it would no longer approve COVID booster shots for healthy adults and children without new studies.

Moderna’s second-generation vaccine was approved for all adults 65 and older, as well as anyone 12 and over who has at least one risk factor for severe disease. The company’s older COVID shot had previously been approved for people 12 years of age and older regardless of their underlying health.

Requiring vaccine makers to test their shots against a placebo group is unusual and has raised ethical concerns. Giving people an inert substance when a vaccine exists can potentially expose them to preventable illness. Moderna’s new COVID vaccine, which will be sold under the name mNexspike, was tested against its older COVID shot, called Spikevax.