“This is an exciting time for RSV prevention,” an editorialist writes in reviewing new options for reducing the hospitalizations and deaths associated with infections of respiratory syncytial virus (RSV). FDA has approved RSVpreF (ABRYSVO) by Pfizer and RSVPreF3 (Arexvy) by GSK for the prevention of lower respiratory tract disease (LRTD) caused by RSV in people aged 60 years and older.
“The [Advisory Committee on Immunization Practices (ACIP)] support for a shared decision-making recommendation in those aged 60 to 64 years was unanimous, but the vote was split for those aged 65 years and older, with some members favoring a universal recommendation for that age cohort and others favoring shared clinical decision making,” the writer explains. “The lack of a booster effect with RSVPreF3 was concerning. It is unclear whether this means that a single vaccine dose is effective for at least 2 years without ability to boost, suggesting that perhaps we should vaccinate only those at highest risk for severe RSV in the next few years. Other concerns related to underenrollment of frail and older adults with chronic conditions, exclusion of immunocompromised patients, and low rates of RSV hospitalizations in both vaccine and placebo groups. Trials in the highest-risk groups are not yet planned. However, with FDA approval and an ACIP recommendation, the companies producing vaccines do not have a major impetus to conduct such trials. Data from such trials might allow the ACIP to broaden the recommendation to everyone in specific age cohorts or with specific conditions rather than relying on shared decision making. Postmarketing data would be less likely to be sufficiently robust to engender public and regulatory confidence in a broad recommendation.”