FDA expands approval of Moderna's RSV vaccine to some adults under age 60
The U.S. Food and Drug Administration expanded its approval of Moderna's respiratory syncytial virus (RSV) vaccine on Thursday to include adults under the age of 60 at increased risk of the disease.
Previously, the vaccine, known as mRESVIA, had been licensed for use for those aged 60 and older.
Approval for mRESVIA came after Moderna conducted a late-stage clinical trial showing the vaccine helped boost immune responses in younger adults.
More than one-third of adults between ages 18 and 59 have at least one underlying condition that puts them at increased risk of RSV, according to Moderna.
"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," Stéphane Bancel, CEO of Moderna, said in a press release. "We appreciate the FDA's review and thank all the participants in our clinical trial as well as the Moderna team for their dedication to protecting people against RSV."
Although the FDA approves vaccines and may expand approvals for certain age groups, the Centers for Disease Control and Prevention sets recommendations regarding who should get vaccines and when.
Currently, the CDC recommends RSV vaccination only for those aged 75 and older and for those aged 60 and over at increased risk.
The CDC's independent vaccine advisory committee will need to vote to recommend that the new age group be eligible for the shot, followed by a final recommendation from the director of the CDC.
Earlier this week, Kennedy removed all 17 sitting members of the committee and replaced them with eight new members. It remains unclear how the new members of the panel will decide to approach recommendations for the RSV vaccine.
As of Friday, the CDC director role remains vacant and Health and Human Services Secretary Robert F. Kennedy Jr. has been making final recommendations. In an April meeting, the prior advisory committee voted to recommend RSV vaccination for those aged 50 to 59 with increased risk of disease, but Kennedy did not adopt the recommendations.
Instead, it appears Kennedy plans to have the new committee re-discuss the recommendations for RSV vaccination as well as discuss HPV and COVID vaccinations in their meeting scheduled to be held between June 25 and June 27
Moderna's RSV vaccine is based on mRNA technology, which some of the new members have expressed skepticism about, especially in relation to COVID-19 vaccines.
Despite availability, RSV vaccination has been lagging. As of April 26, the latest date for which CDC data is available, an estimated 47.5% of adults aged 75 and older and 38.1% of adults aged 60 to 74 with a high-risk condition reported ever having received an RSV vaccine.
