The US Food and Drug Administration (FDA) has expanded approval of Moderna’s respiratory syncytial virus (RSV) vaccine to include younger adults at risk, though its still uncertain whether the shot will be recommended for broader use in the national immunisation schedule.
Moderna’s vaccine, known under the brand name mRESVIA, became the first non-Covid-19 messenger RNA-based (mRNA) vaccine to be approved in the US in May 2024. Until now, the vaccine was licensed for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older.
The expanded approval now includes individuals aged 18 to 59 who are at risk of RSV.
This approval was supported by results from Moderna’s Phase III study (NCT06067230), which demonstrated the vaccine’s immune response worked just as well in this age group compared to the existing approved age group of 60 years and older.
Infants and older adults remain the most vulnerable age groups to RSV, though over one-third of adults between 18 and 59 years of age have at least one underlying condition that puts them at increased risk of developing a severe form of the disease.
“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,” said Stéphane Bancel, Chief Executive Officer of Moderna.
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By GlobalDataModerna said it plans to have mRESVIA available for both both younger adults and older adults in the US in time for the 2025-2026 respiratory virus season. This usually begins around November and peaks in the mid-Winter months.
mRESVIA is the second approved product in the US for Moderna, along with its Covid-19 vaccine Spikevax. The pharma company has been seeking outside investment to fund late-stage trials for further infectious disease vaccine candidates, amid a strategy to diversify its portfolio.
Vaccines under political pressure
Whilst the label expansion reflects an easing in regulatory tension surrounding mRNA vaccines under the Trump administration, FDA approval does not automatically mean shots enter national immunisation schedules.
That is instead decided by the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP).
The CDC currently recommends the vaccine for adults aged 75 and older, as well as for adults aged 60 to 74 who are at increased risk of infection. In April, the CDC’s ACIP recommended the use of approved RSV vaccines in at-risk adults aged 50 to 59.
This week, US health secretary Robert F Kennedy (RFK) Jr axed the entire ACIP panel of experts, replacing members with vaccine sceptics and individuals with no prior public health strategy experience. The reshuffle has raised concerns about the future of the US immunisation schedule and the scope of vaccine recommendations.
“Investor focus will likely shift to the CDC’s ACIP’s next meeting, which is scheduled to proceed on June 25-27,” said William Blair analyst Miles Minter in a research note.
“This will be the first time for investors to see the refreshed ACIP in action and will be important for sentiment in the vaccine sector, which continues to decline in our view. Ultimately, we see the biggest headwind to the RSV vaccination market as restrictive ACIP recommendations that do not include re-dosing potential,” Minter added.
Moderna gains on Pfizer
The label expansion sees Moderna catch up with Pfizer, which already has an RSV vaccine approved for adults aged 18 years and over. Like mRESVIA, Pfizer’s Abrysvo has the requirement of increased disease risk for those between 18 and 59, whilst anyone above the age of 60 is eligible for the jab. Pfizer still has a market advantage, however, with Abrysvo the only vaccine product approved for infants. It also gained FDA approval a year before mRESVIA, giving it first to market advantage.
GSK also has an FDA-approved vaccine in the form of Arexvy, though its label only covers those at risk in individuals aged between 50 through 59 years, along with the standard indication of ages 60 and over.
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