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ACIP Endorses RSV Vaccine for At-Risk Adults 50 and Up


Committee also adds another option for a pentavalent meningococcal vaccine

by
Joyce Frieden, Washington Editor, MedPage Today

The CDC’s Advisory Committee on Immunization Practices (ACIP) voted 14-0, with one abstention, on Wednesday to recommend that high-risk patients ages 50 to 59 be vaccinated for respiratory syncytial virus (RSV), and also added a new option for meningococcal vaccination.

“I don’t think I can say it enough, but [we need] more studies in moderate-to-severe immunocompromised patients who are at highest risk for RSV disease,” ACIP member Mini Kamboj, MD, of Weill Cornell Medical College, in New York City, said after she voted for the recommendation. This is “a call to action,” she said.

There are currently three vaccines approved for RSV; two of them — GSK’s Arexvy and Pfizer’s Abrysvo — are protein subunit vaccines, while Moderna’s mResvia is a messenger RNA vaccine. All three vaccines are approved for use in the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults ages ≥60 years. In addition, Arexvy is approved for prevention of LRTD caused by RSV in adults ages 50 to 59 years who are at increased risk for the disease; this group includes those with chronic diseases such as cardiovascular disease or end stage renal disease; those who are immunocompromised; and those who reside in a nursing home.

Abrysvo also is approved for prevention of LRTD caused by RSV in adults ages 18 to 59 years who are at increased risk, and for immunization in pregnancy at 32 to 36 weeks’ gestational age for the prevention of LRTD caused by RSV in infants from birth through 6 months. Moderna has applied for an indication for mResvia in the 18-to-59-year age group, and the FDA is expected to make a decision on that application by June 12.

Last June, ACIP unanimously recommended that all adults ages ≥75 years and adults ages 60 to 74 years who are at increased risk of severe RSV disease receive a single dose of RSV vaccine; the committee did not endorse one vaccine over another. That vote supplanted the committee’s earlier recommendation that adults ages 60 and older may receive RSV vaccination “after engaging in shared clinical decision making with their healthcare provider.”

Shared decision making also came up during Wednesday’s meeting, with ACIP member Jane Zucker, MD, MSc, of the SUNY Downstate School of Public Health in New York City, wondering whether it should be included in the 50-to-59 recommendation. “I’m not a great fan of that option — it would make the recommendation for 50 to 59 be different than 60 to 74 which I would not particularly like to do,” she said. “But I guess what’s weighing on me is that there clearly are people in that 50-to-59-year age group — for example, lung transplant patients, hematopoietic stem cell transplant patients — that would clearly benefit from having access to this vaccine. And so I’m trying to think through where I would land” on whether shared decision making should be an option.

Zucker asked whether ACIP’s RSV work group had discussed shared decision making. ACIP chair Helen Keipp Talbot, MD, who is also a member of the work group, said that they had. “There was a huge disparity in uptake when we had shared clinical decision making for those over 60, and one of the reasons to move the vote down to 50 was to lessen disparities,” said Talbot, of Vanderbilt University, in Nashville, Tennessee. “So the concern about a shared clinical decision making would be that it would worsen the disparities that we’re seeing.”

Committee members also expressed skepticism about the idea that revaccination for RSV would be useful. Susan Gerber, MD, medical director at GSK, presented data from a study of 872 people showing an increase in RSV titers after revaccination with Arexvy at 36 months. “Robust humoral and cellular immune responses were observed for revaccination with Arexvy, including for individuals with certain comorbidities,” she said.

ACIP member Noel Brewer, PhD, of the University of North Carolina in Chapel Hill, asked why the company stratified the revaccination results into four quartiles. “One way of interpreting is that only some people should get a second dose,” he said. “Another way of interpreting is there’s an actual benefit that’s clearly meaningful for all four groups.”

“Not having a complete understanding of correlative protection and just looking at the data as it is, we do see in our quartile data that there are no systematic trends that were observed in association with demographic characteristics or comorbidities between different quartiles upon revaccination,” Gerber said. “We did also see similar humoral immune responses observed by comorbidity status and by frailty.”

Brewer tried again. “Are you saying we should only give the vaccine again to the people in the lowest quartile? That’s what I’m trying to understand.”

“We did not see any differences in those quartiles between trends with respect to demographics or — ” Gerber said, but Brewer interrupted her. “You’re kind of not answering my question,” he said. In the end, the committee voted to recommend that “RSV vaccination is recommended as a single dose only. Persons who have already received RSV vaccination are NOT recommended to receive another dose.”

The committee also voted unanimously to recommend that GSK’s pentavalent MenABCWY (Penmenvy) meningococcal vaccine “may be used when both MenACWY and MenB are indicated at the same visit.” The recommendation would apply to “healthy persons ages 16 to 23 years (routine schedule) when shared clinical decision making favors administration of MenB vaccine; and persons ages ≥10 years who are at increased risk for meningococcal disease (e.g., because of persistent complement deficiencies, complement inhibitor use, or functional or anatomic asplenia).” Committee members approved a similar recommendation for the Vaccines For Children program.

Penmenvy, which was licensed on Feb. 14th, is the second pentavalent meningococcal vaccine approved for sale in the U.S. The other is Pfizer’s Penbraya, which was licensed in October 2023.

ACIP recommendations are not considered final until they are published in the Morbidity and Mortality Weekly Report.

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    Joyce Frieden oversees MedPage Today’s Washington coverage, including stories about Congress, the White House, the Supreme Court, healthcare trade associations, and federal agencies. She has 35 years of experience covering health policy. Follow

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