RSV Vaccine Market: Smaller and a Bit More Crowded

Going into the 2024-25 respiratory virus season, the market for the adult respiratory syncytial virus (RSV) vaccine has gotten smaller as a result of Centers for Disease Control and Prevention(CDC) recommendations that tightened the age criteria for those who should get vaccinated.

Meanwhile, the FDA has approved a third RSV manufactured by Moderna, which is being marketed as mRESVIA. The FDA had previously approved GSK’s Arexvy and Pfizer’s Abrysvo, both of which were approved in May 2023.

In June, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted to recommend that all adults 75 and older receive an RSV vaccine. That recommendation, which became CDC official policy on June 26, replaced a recommendation that adults 60 years of age and older could consider receiving a RSV shot using shared clinical decision-making with a provider.

ACIP did recommend RSV vaccination in one group of younger adults: Those ages to 60 to 74 years of age and older who are at increased risk of severe RSV disease. There are large numbers of people in that category, though, which the CDC says includes those with cardiovascular disease (heart failure, coronary artery disease but excluding isolated hypertension), lung disease (chronic obstructive pulmonary disorder, asthma, interstitial lung disease), diabetes with end-organ damage (such as diabetic nephropathy), severe obesity (a body-mass index of 40 or greater) and several other conditions. The CDC also deems frailty and residing in a nursing home as risk factors for severe RSV.

The CDC also says that RSV vaccination is recommended as a single, lifetime dose only, so those who were vaccinated last year when the shot was first available do not need to get vaccinated.

A RSV work group presentation to the ACIP said that feedback from healthcare providers was that “having SCDM [shared clinical decision-making] is not simple in practice. unlike a universal recommendation where there’s a clear call to action to vaccinate.”

The committee also heard a presentations modeling the cost-effectiveness of the RSV vaccinations and the risks of Guillain-Barré syndrome. The cost-effectiveness research, a summary of three models presented by Ismael R. Ortega-Sanchez, Ph.D., of the CDC’s National Center for Immunization and Respiratory Diseases, suggested that universal vaccination at age 75 and older would cost between $51,000 and $66,000 per quality-adjusted life year (QALY) saved and that vaccinating those in the 60-74 age group at risk of having a severe case of RSV would cost between $61,000 and $89,000 per QALY saved.

Another presentation to the committee modeled the effect of vaccinating a million people 75 and older over two RSV seasons. For Arexvy, it showed 4,300 hospitalizations would be prevented, 630 intensive care unit (ICU) admissions and 610 deaths with 3 cases of Guillain-Barré syndrome. For Abrysvo, the model projected that there would be 3,800 hospitalizations prevented, 540 ICU admissions and 540 deaths with 16 cases of Guillain-Barré syndrome.