The CDC’s vaccine advisors on Thursday maintained that respiratory syncytial virus immunization is only recommended for adults aged 75 and older, and in seniors 60 to 74 years who are at risk of severe disease.
On Thursday, a panel of advisors to the U.S. Centers for Disease Control and Prevention declined to endorse respiratory syncytial virus vaccines for younger adults, insisting that current guidelines are “appropriate.”
The CDC’s Advisory Committee on Immunization Practices (ACIP) affirmed that respiratory syncytial virus (RSV) shots should only be recommended for adults 75 years and older, and seniors 60 to 74 years who are at risk of severe disease. The committee’s RSV working group determined that for these populations “the benefits of RSV vaccination outweigh risks.”
For those aged 60 and younger, the ACIP maintains that existing data have not “motivated an immediate policy expansion.” Recent evidence provide “increasing certainty” that a specific component of the RSV vaccines is associated with the risk of Guillain–Barré syndrome, a rare but severe side effect where the immune system attacks peripheral nerves, according to the panel. This safety signal muddies the benefit-risk calculation for younger adults, in whom the risk of severe RSV disease is generally lower than in seniors, the committee contends.
The ACIP said it “continues to evaluate recommendations” for RSV vaccination. “Developing RSV vaccine policy in adults <60 years will require careful consideration of the balance of public health benefits and risks in this population,” the advisers wrote in Thursday’s presentation.
In maintaining these age restrictions, the ACIP delt a blow to GSK, Moderna and and Pfizer. In an October 2024 report, analytics company Airfinity projected that these limitations could cut RSV annual revenues to just $1.7 billion by 2030—a 64% reduction from a prior estimate of $4.6 billion.
GSK’s Arexvy—which became the industry’s first FDA-approved RSV shot in May 2023—was greenlit for use in adults aged 50 to 59 in June 2024.
On Thursday, GSK unveiled Phase IIIb data showing that a single dose of Arexvy could elicit a “robust immune response” in adults aged 18 to 49 years, with an acceptable safety profile. CSO Tony Wood said that these findings suggest that Arexvy “could help expand protection to more adults at risk from RSV disease.”
Pfizer’s Abrysvo, which was also originally approved for adults aged 60 and older, won regulatory go-ahead for a younger adult population earlier this week, allowing its use in adults 18 through 59 years who are at increased risk of RSV disease.
Moderna’s mResvia is a relative newcomer to the RSV market, winning the FDA’s approval in May 2024. The mRNA shot is indicated for adults aged 60 and older.
GSK is the current RSV market leader. In December 2023, CEO Emma Walmsley said in an investor event that Arexvy was on-track to blockbuster status, having captured most of retail vaccinations in the U.S.
Pfizer’s Abrysvo, meanwhile, has largely had a disappointing market showing, CFO David Denton said in a November 2023 conference, as reported by Reuters. By the end of 2023, Arexvy had brought in nearly $1.6 billion, while Abrysvo’s sales sat at $515 million.
