Moderna's RSV shot gets US nod for use in younger adults
Stéphane Bancel, Moderna's chief executive.
The label for Moderna's respiratory syncytial virus (RSV) vaccine mResvia has been expanded to include adults aged 18 and over in the US, widening its earlier FDA approval for the over-60s only.
The company said it intends to make mResvia available to both younger and older adults in the coming RSV season, which starts in the autumn, as it tries to chip away at a big lead in the marketplace held by rival RSV vaccines from GSK and Pfizer.
Pfizer's RSV shot Abrysvo was cleared by the FDA last October for the 18 to 59 age group, extending its 2023 approval in the over-60s, while GSK's Arexvy is currently indicated in the US for people aged 50 and over.
Meanwhile, news of mResvia's new approval came as GSK said the European Commission had started a review of Arexvy in the over-18 age bracket, setting up a possible go-ahead in the first half of next year. The broader use is also under regulatory review in the US and Japan.
Moderna has been something of a third wheel in the RSV market so far, recording sales of $25 million last year compared to £590 million ($781 million) for Arexvy and $890 million for Abrysvo, which is also cleared as a maternal vaccine to protect newborns and infants from this virus.
Those numbers marked steep declines in sales of the RSV vaccines in the previous year, because of stricter rules on eligibility in the US, which have since been slightly relaxed.
In 2023 – the first year that Arexvy and Abrysvo were approved – it was recommended that they could be used in all adults over the age of 60 if deemed appropriate by their doctor, and sales quickly ramped up to blockbuster levels. That was followed by a much narrower recommendation the following year, however, limiting their use to the over-75s and at-risk people in the 60 to 74 age range, and sales declined.
Use of the vaccines in the 2025-26 season is due to be discussed at a meeting of the CDC's Advisory Committee on Immunisation Practices (ACIP) later this month. However, the recent firing of all the ACIP experts and subsequent replacement by members selected by Health and Human Services (HHS) Secretary Robert F Kennedy Jr, a well-known vaccine sceptic, has sparked concerns about the general direction of vaccination policy under the Trump administration.
"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, Moderna's chief executive.
Earlier this year, Bancel said the priority for Moderna this year is to drive sales of mResvia and the new version of its COVID-19 vaccines Spikevax and lower-dose booster mNexspike, which was approved with limits on who can receive it at the end of May, and introduce additional products from its late-stage pipeline.
The company suffered a setback in the latter regard when it withdrew a marketing application for a combination flu and COVID-19 shot in an acknowledgement that it will need to wait for efficacy data from a phase 3 trial before it will be able to go after FDA approval.
