FDA approves expanded use of Moderna's RSV shot, but uncertainty remains
The Food and Drug Administration (FDA) expanded the approval of Moderna's RSV vaccine late Thursday to include individuals 18-59 years of age who are at increased risk for severe illness from respiratory syncytial virus, the company said.
The vaccine was previously only licensed for adults aged 60 years and older.
'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, Moderna's CEO, said in a statement.
The expanded approval was a much-needed win for the company, which has experienced setbacks due to Trump health officials' distrust of messenger RNA-based (mRNA) vaccines.
The Department of Health and Human Services (HHS) recently canceled more than $750 million in contracts for Moderna to develop and test mRNA vaccines to protect against pandemic flu.
Moderna's RSV shot was the first non-COVID-19 mRNA vaccine to be approved in the United States.
The Centers for Disease Control and Prevention's (CDC) independent vaccine panel, the Advisory Committee on Immunization Practices (ACIP), previously voted to recommend an RSV vaccine for adults aged 50 to 59 who have medical conditions that increase their risk of severe illness from the virus.
But the recommendation needs to be endorsed by the CDC director for it to take effect; there currently is no CDC director. Susan Monarez, who had previously been acting director, is awaiting Senate confirmation and isn't allowed to serve as acting director at the same time.
HHS Secretary Robert F. Kennedy Jr. has the power to endorse the recommendation in the absence of a CDC director, but he has not signed off on it since the committee voted more than two months ago. He has also not acted on the other recommendations from the same meeting, including the use of a meningitis vaccine.
He endorsed the panel's recommendations for chikungunya vaccines in May.
Without an officially accepted ACIP recommendation, insurers don't have to cover the vaccine for the expanded population.
Kennedy fired all 17 members of ACIP earlier this week, arguing a 'clean sweep' was needed to purge conflicts of interest and help restore trust in vaccinations and public health.
On Wednesday, he named eight handpicked replacements, including some vocal vaccine critics. A scheduled late June meeting is still expected to occur.
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