FDA clears Moderna's RSV vaccine for use in people aged 18 to 59
'RSV poses a serious health risk to adults with certain chronic conditions, and today's approval marks an important step forward in our ability to protect additional populations from severe illness from RSV,' Moderna CEO Stéphane Bancel, said in a statement.
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The approval was a welcome win for the Cambridge-based company, which has faced several setbacks of late due to deep distrust of its messenger RNA vaccine platform among supporters of health secretary Robert F. Kennedy Jr.
A number
The next step in the vaccine's path to expanded use has already been cleared. At a meeting in April, the Center for Disease Control and Prevention's expert vaccines panel, the Advisory Committee on Immunization Practices, voted to recommend use of RSV vaccine
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At the time of the vote, only two of the three licensed RSV vaccines — Pfizer's Abryso and GSK's Arexvy — were licensed for use in adults under the age of 60. The committee's recommendation was worded in such a way as to include any RSV with a license for use in this age group, so should, in theory, apply as well to the Moderna vaccine now that the age extension has been endorsed by the FDA.
But that ACIP recommendation is currently in limbo. A recommendation from the advisory body must be approved by the CDC director or the secretary of the Health and Human Services Department in order to come into force. There is currently no CDC director and in the nearly two months since ACIP endorsed the recommendation, Kennedy has chosen not to sign off on it. He did, however, approve three other recommendations the committee made related to use of chikungunya vaccines.
Without a recommendation from the ACIP that has been accepted by the CDC director or the health secretary, the vaccine can be administered to an individual in the new age group, but health insurers do not have to cover its cost.
Kennedy
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Late last month Moderna
The company said it will have mRESVIA available in the U.S. for both younger adults at increased risk — the ages 18 to 59 cohort — and adults aged 60 and older for the 2025-2026 respiratory virus season.
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