On Thursday, an advisory committee to the U.S. Centers for Disease Control and Prevention declined to endorse an RSV vaccine for young people, arguing that current guidelines are “adequate.”
The CDC’s Advisory Committee on Immunization Practices (ACIP) says that respiratory syncytial virus (RSV) vaccination should only be recommended for adults 75 and older and seniors 60 to 74 who are at risk for severe disease. He asserted that it was. The commission’s RSV working group determined that “the benefits of RSV vaccination outweigh the risks” for these people.
For people under 60, ACIP argues that existing data “does not motivate immediate policy expansion.” According to the committee, recent evidence is “conclusive” that certain components of the RSV vaccine are associated with the risk of Guillain-Barre syndrome, a rare but serious side effect in which the immune system attacks peripheral nerves. This shows that their sexuality is on the rise. This safety signal, the committee argues, confounds benefit-risk calculations for younger adults, whose risk of severe RSV disease is generally lower than older adults.
ACIP said it “continues to evaluate recommendations” for RSV vaccination. “Developing RSV vaccine policy for adults under 60 years of age requires careful consideration of the balance of public health benefits and risks in this population,” the advisers said in a presentation Thursday.
By keeping these age limits in place, ACIP hurt GSK, Moderna, and Pfizer. Analytics firm Airfinity predicted in an October 2024 report that these restrictions could reduce RSV’s annual revenue to just $1.7 billion by 2030, compared to previous estimates of $4.6 billion. This is a 64% decrease from the US dollar.
GSK’s Alexvy, which became the industry’s first FDA-approved RSV vaccine in May 2023, was given the green light for use in adults aged 50 to 59 in June 2024.
On Thursday, GSK announced Phase IIIb data showing that a single dose of Alexby elicited a “strong immune response” in adults aged 18 to 49 and may have an acceptable safety profile. . CSO Tony Wood said these findings suggest Arexvy “could help extend protection to more adults at risk of RSV disease.” said.
Pfizer’s Abrysvo was also initially approved for adults 60 and older, but earlier this week won regulatory approval for use in younger adults, allowing it to be used in adults 18 to 59 who are at high risk for RSV disease. It’s now possible.
Moderna’s mResvia is a relative newcomer to the RSV market, winning FDA approval in May 2024. The mRNA shot is intended for adults 60 and older.
GSK is the current RSV market leader. In December 2023, CEO Emma Walmsley said at an investor event that Alexby had won most of its retail vaccinations in the U.S. and was on track to be a big hit. .
Meanwhile, Reuters reported that Pfizer’s Abrisvo has largely disappointed in the market, Chief Financial Officer David Denton said at a press conference in November 2023. By the end of 2023, Arexvy had sales of nearly $1.6 billion, while Abrysvo’s sales were only $515 million.
