The CDC panel is taking a slow approach to expanding the use of RSV vaccines

Mproponents of RSV vaccines for older adults saw their plans to expand use hit a significant hurdle Wednesday, when an expert committee that advises the Centers for Disease Control and Prevention on vaccines recommended changes that would likely make fewer older adults eligible for insurance coverage for these products.

In a related move, the Advisory Committee on Immunization Practices chose not to make a recommendation yet on the use of GSK’s Arexvy vaccine in adults aged 50 to 59 years because the committee did not have sufficient data to make such a recommendation. doing. Earlier this month, the Food and Drug Administration approved use of the GSK vaccine for adults in their 50s who are at high risk of developing serious illness if they contract respiratory syncytial virus (RSV). When it was first approved in May 2023, its use was limited to people aged 60 and over.

The decision is a blow to GSK, which is racing to secure market share in a field that now includes two competitors, Pfizer and Moderna. To this end, GSK has used a priority review voucher to expedite its application for an age extension through the FDA approval process. The agency is currently reviewing an application from Pfizer to extend the license for its RSV vaccine, Abrysvo, to adults 18 years and older who have health conditions that put them at risk of serious illness from RSV infection.

STAT contacted GSK for comment, but there was no response at the time of publication.

Without a recommendation for use from the ACIP and the CDC, it is unlikely that insurance companies will cover the cost of the GSK vaccine for those over 50. And at nearly $300 per dose – not including administration costs – these individuals may be reluctant to pay out of pocket.

The final decision on vaccination policy rests with CDC director Mandy Cohen. Late Wednesday, the CDC released a statement echoing the recommendations the ACIP had approved about an hour earlier.

“The CDC has updated its RSV vaccination recommendation for older adults to prioritize those most at risk for severe illness from RSV,” Cohen said in the statement.

In particular, the working group suggested that information is needed on how adults in their 50s with immunocompromising conditions respond to the vaccine — what kind of antibody responses it generates — and more data on whether additional shots will boost any decreased protection. Some data so far suggests that the response to booster shots is not as strong as the response to the first vaccine. ACIP member Sarah Long, a professor of pediatrics at Drexel University College of Medicine in Philadelphia, worried that if boosting isn’t effective, giving the RSV A vaccine too early could squander a resource that could be even more needed later in life.

Long and others on the committee were concerned that, given the possible link to GBS, the risk-benefit ratio for people over 50 might not be more favorable to vaccination than for older adults.

RSV vaccines for older adults are new. The first two, from GSK and Pfizer, were approved last spring and first rolled out in the fall. Initially only allowed for adults 60 and older, the ACIP opted last June not to make a universal recommendation for its use, in the way that everyone is urged to get an annual flu shot. Instead, it suggested that eligible people could get one of the vaccines, but should first talk to a healthcare provider to weigh the risks and benefits of vaccination.

That approach, called shared decision-making, made sense for a committee that has been reluctant to urge everyone 60 and older to get a shot, given concerns that a small number of people getting the Pfizer and GSK vaccines – especially the former – can develop Guillain-Barré syndrome, a form of progressive paralysis from which people normally recover, but after a longer period of hospitalization. There were no reports of Guillain-Barré syndrome among humans in the clinical trials that led to the approval of Moderna’s RSV vaccine, mResvia, which was just approved by the FDA in late May.

Doctors and pharmacists complained about the joint decision-making advice and indicated that they did not always know how to advise patients. There are concerns that the recommendation may have depressed vaccine uptake.

Therefore, the ACIP RSV Working Group proposed amending the recommendation in two ways, both of which were unanimously accepted by the full committee. By a vote of 11-0, the committee recommended that people aged 75 and over should get an RSV shot if they haven’t already had one. Although it is known that the protection of these vaccines decreases over time, it is not yet clear what the optimal frequency for revaccination is. There is currently no recommendation for people who have already been vaccinated to get another RSV shot.

In the second vote, the committee recommended that people ages 60 to 74 who have health conditions that put them at high risk for serious illness from RSV should also get the vaccine. People aged 60 to 74 who do not suffer from any of the health conditions mentioned can still receive the vaccine if they wish. But without an ACIP/CDC recommendation, they would have to pay out of pocket, noted committee chair Helen Keipp Talbot.

The health problems mentioned include lung disease, cardiovascular disease, diabetes with end-organ damage, severe obesity, neurological or neuromuscular disorders, advanced chronic kidney disease, liver disease or blood disorders. Adults ages 60 to 74 who live in long-term care facilities or who are considered vulnerable are also eligible, as are people with moderate or severe immunocompromise.

While some members of the public expressed concerns about the effect the new recommendation could have on vaccination rates in people aged 60 to 74, committee members noted that the science on the use of these products is evolving and that policy on its use will also change. . ACIP member Matthew Daley noted after the votes that perhaps the panel should have added the words “at this time” to the wording of the votes to make that point.