Federal vaccine advisers have recommended that adults 60 years and older may receive a single dose of a newly licensed respiratory syncytial virus vaccine using shared clinical decision-making, creating the first U.S. pathway toward routine adult use of vaccines against a virus that causes tens of thousands of hospitalizations among older Americans each year.

The Advisory Committee on Immunization Practices reached the recommendation Wednesday after reviewing two recently approved products, GSK’s Arexvy and Pfizer’s Abrysvo. The committee ultimately used the same shared-decision framework across adults 60 and older, rather than issuing a blanket recommendation that everyone in the age group should be vaccinated. The June meeting summary shows the panel wrestling with differences in risk by age and health status, the prices of the vaccines, uncertainty about duration of protection and limited post-licensure safety experience.

Two first-in-class vaccines arrive together

The Food and Drug Administration approved GSK’s Arexvy on May 3 for prevention of lower respiratory tract disease caused by RSV in adults 60 and older, calling it the first RSV vaccine approved in the United States. Pfizer’s Abrysvo followed later in May. Both approvals rested on large randomized trials showing substantial reductions in RSV lower respiratory tract disease during the first season after vaccination.

RSV is often associated with infants, but older adults and people with cardiopulmonary disease, immune compromise or frailty can also develop severe illness. CDC estimates reviewed by the committee place the annual U.S. burden among older adults at roughly 60,000 to 160,000 hospitalizations and 6,000 to 10,000 deaths, although the exact burden varies by season and surveillance method.

GSK’s clinical program, summarized for ACIP in a June 21 presentation, evaluated its protein-based vaccine with an adjuvant in adults 60 and older. Pfizer presented data for its bivalent prefusion F vaccine in a separate briefing. The studies differ in design and endpoints, so direct comparison of headline efficacy percentages is not straightforward, but both products showed protection against medically significant lower respiratory tract illness.

Why advisers chose “may receive” rather than “should receive”

The central policy debate was not whether the vaccines work, but how broadly they should be recommended. ACIP initially considered a stronger recommendation for people 65 and older and a shared-decision approach for those 60 to 64. Members then moved toward shared clinical decision-making for the older group as well. According to the meeting summary, the panel voted 9-5 on the revised policy for adults 65 and older and 13-0, with one abstention, for adults 60 to 64.

Under shared clinical decision-making, vaccination is neither a default recommendation for everyone nor a prohibition for people without a named risk factor. CDC’s proposed clinical considerations say the discussion can include an individual’s risk of severe RSV, underlying conditions, age, living situation, preferences and the characteristics of the vaccine. People in long-term-care facilities or with chronic heart or lung disease may have more potential benefit than healthy adults at the younger end of the eligibility range.

The approach also reflects evidence gaps that will narrow only after real-world use. The first licensed vaccines are entering the market without years of post-marketing safety surveillance, and the duration of protection is not yet fully established. Whether revaccination will eventually be needed is also unresolved.

Benefit, safety and cost all entered the vote

ACIP’s evidence-to-recommendations process considers more than efficacy. A CDC framework presentation reviewed the balance of desirable and undesirable effects, certainty of evidence, feasibility, equity and acceptability. The committee also reviewed possible safety signals, including small numbers of inflammatory neurologic events observed during development programs, while emphasizing that trial numbers are too limited to characterize very rare risks with precision.

Cost was unusually prominent in the discussion. An independent economic analysis led by University of Michigan researchers modeled vaccination under different assumptions about price, duration of protection, disease burden and vaccine performance. Because RSV risk rises substantially with age and underlying illness, cost-effectiveness varies depending on whom the program targets and how long protection lasts.

A separate CDC comparison of economic models examined how assumptions used by manufacturers and public-health analysts affect projected value. Those discussions helped push some members away from an age-only universal recommendation and toward a policy that permits clinicians and patients to prioritize vaccination where expected benefit is greatest.

Implementation will look different from childhood vaccination

For many Medicare beneficiaries, the new RSV products are expected to be covered through Medicare Part D rather than the physician-administered Part B pathway. That makes pharmacies an important distribution channel and creates practical questions about counseling, reimbursement and coordination with other fall vaccines. ACIP members discussed whether RSV vaccines can be given during the same visit as influenza or COVID-19 vaccines and reviewed coadministration data presented by manufacturers.

The vaccines are expected to be available before the next respiratory-virus season, but Wednesday’s advisory vote is not yet the final CDC recommendation. The ACIP recommendation must still be reviewed and endorsed by the CDC director before becoming official agency guidance. As of Saturday, that step has not occurred, so clinicians and pharmacies are preparing for a policy that remains one administrative action short of implementation.

FDA licensing and CDC recommendation serve different functions. FDA determines whether a vaccine’s evidence supports approval for a stated indication. ACIP and CDC decide how a licensed vaccine should be used in the population. That is why both Arexvy and Abrysvo can already be FDA-approved while the national recommendation is still being finalized.

A new tool for an old respiratory threat

The arrival of adult RSV vaccines closes a long development gap. Researchers have pursued RSV vaccination for decades, but scientific setbacks delayed successful products. Advances in understanding the virus’s prefusion F protein created a more effective target and helped produce the current generation of candidates.

Now the question moves from whether an adult RSV vaccine can be licensed to how it should be used. ACIP’s answer is deliberately individualized. A healthy 60-year-old and an 82-year-old with chronic lung disease do not face the same baseline risk, and the “may receive” language is intended to preserve that distinction while making vaccination available to both after discussion with a health professional.

The policy will also generate evidence. Once millions of doses are potentially administered, surveillance systems can better assess rare adverse events, effectiveness against hospitalization, durability across seasons and patterns of uptake. Those data could support a stronger, narrower or otherwise revised recommendation in the future.

For the 2023-2024 season, however, the committee has established the basic direction: the first two adult RSV vaccines should be available to people 60 and older through shared clinical decision-making, with the greatest expected benefit among those most vulnerable to severe respiratory disease. The remaining step is formal CDC endorsement before that recommendation becomes national guidance.