ACIP Makes Changes to Adult RSV Vaccine Recommendations

All adults ages 75 years and older should receive a single dose of any respiratory syncytial virus (RSV) vaccine, and adults ages 60 to 74 years who are at increased risk of severe RSV disease should receive a vaccine, according to a unanimous 11-0 vote by the CDC’s Advisory Committee on Immunization Practices (ACIP).

Also, people who have already received the RSV vaccine are not recommended to receive a booster, based on data that showed another dose did not improve outcomes.

These recommendations supplant the current recommendation that adults ages 60 and older may receive RSV vaccination after engaging in shared clinical decision-making with their healthcare provider.

There are currently three RSV vaccines available for use in older adults — GSK’s adjuvanted RSV prefusion F protein-based vaccine (Arexvy), Pfizer’s unadjuvanted, bivalent RSV prefusion F protein vaccine (Abrysvo), and Moderna’s mRNA-1345 vaccine (mRESVIA).

Since the ACIP issued the first RSV vaccine recommendation for adults in 2023, the shared decision-making recommendation has proven problematic in clinical practice, Camille Kotton, MD, chair of the ACIP’s Adult RSV Work Group, told the committee. “We have learned from feedback from healthcare providers that having shared decision-making conversations is not simple,” she said. “Unlike a universal recommendation where there’s a clear call to vaccinate, with shared clinical decision-making the call to action is to discuss with a healthcare provider — a less clear message.”

The recommendation also clarified that although the vaccine is universally recommended for those 75 and older, adults 60 to 74 who are not at increased risk of severe disease do not need to receive an RSV vaccine.

Who exactly is at high-risk for severe disease? The committee offered a list of chronic medical conditions associated with risk for severe RSV disease — such as lung disease, cardiovascular disease, moderate or severe immune compromise, diabetes mellitus with end-organ damage, severe obesity, and other systemic diseases — that will be provided by the CDC.

Benefits Still Outweigh Risks?

The benefits of the RSV vaccine in older adults continue to outweigh the small documented risk of Guillain-Barre syndrome that was linked with the vaccine, Michael Melgar, MD, co-lead of the Adult RSV Work Group, said in a presentation. “Bottom line, preventable outcomes far exceed potential cases of Guillain-Barre syndrome for both [GSK and Pfizer] vaccine products,” Melgar commented during an overview of vaccine benefits and risks.

Earlier in the day, James Donahue, PhD, DVM, MPH, of the Marshfield Clinic Research Institute in Wisconsin, presented recent surveillance data from Vaccine Safety Datalink that revealed a small statistical signal for immune thrombocytopenic purpura (ITP) with the GSK vaccine. Upon review, most cases were determined to not be new cases that emerged after RSV vaccination. However, ongoing chart review is planned.

No Recommendations for RSV Vaccination in Adults Ages 50-59

The committee decided there was not enough data on benefits versus risks to recommend for or against the use of GSK’s Arexvy vaccine in people ages 50 to 59 years at risk for severe RSV-associated disease, according to Amadea Britton, MD, co-lead of the Adult RSV Vaccine Work Group. On June 10, the FDA expanded the approval of Arexvy to include at-risk adults in this age group.

“This does not mean that the Work Group feels that RSV disease in this age group is unimportant,” she said. “This opinion is also not a recommendation against the use of the RSV vaccine in adults aged 50 to 59 years. Rather, the Work Group believes more information is needed to make a population-level policy.”

In other meeting news, the ACIP also voted unanimously to recommend that the combined diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, Haemophilus influenza type b conjugate and hepatitis type B vaccine (DTaP-IPV-Hib-HepB) (Vaxelis) should be included with PRP-OMP (PedvaxHIB) in the preferential recommendation for American Indian and Alaska Native infants based on the Haemophilus influenzae type b (Hib)Hib component.

Previously, Vaxelis did not have a preferential recommendation for these infants because it contains PRP-OMP in a lower amount than PedvaxHIB, and post-dose 1 immunogenicity data were not previously available, Melgar explained.