The CDC advisory panel that helps set US vaccine policy said the use of RSV shots should be expanded to more adults, recommending the shot for all people 75 and older and for those aged 60 to 74 at risk of severe disease.
The agency’s Advisory Committee on Immunization Practices (ACIP) unanimously voted for the new guidance. The CDC’s sign-off, which came two hours after the meeting, broadens previous advice that said adults 60 and older should get vaccinated using “shared clinical decision-making” — meaning a conversation with a healthcare professional about their risks.
“[W]e get to see more RSV vaccination,” ACIP chair Helen Keipp Talbott said following the vote.
It’s a win — albeit a somewhat incremental one — for the three RSV vaccine manufacturers: GSK, Pfizer and Moderna. ACIP’s recommendations are critical for insurance coverage, with health plans required to cover vaccinations that fall within the guidance.
The committee declined to make a recommendation on vaccination for people aged 50 to 59, a group for whom GSK had pushed to expand coverage. The UK-based pharma is currently the only company whose vaccine is approved for that age group after the FDA approved the expanded label earlier this month. Pfizer’s vaccine is under review for the same age group as well, after reporting data in April. It could get an answer later this year, according to a company spokesperson.
CDC advisors were presented with real-world evidence showing that both GSK and Pfizer’s vaccines had similar efficacy as demonstrated in previous clinical trials, and risk-benefit profiles that supported their use in the now-endorsed age groups. Namely, the reduced burden of hospitalizations and deaths far outpaced the risk of Guillain-Barré syndrome.
The efficacy data appeared to top Moderna, which earlier in the day shared new data that showed its vaccine was roughly 50% effective at preventing both severe and less severe disease. The figure was roughly 5 percentage points less than the efficacy of Pfizer and GSK’s protein-based options.
Stephane BancelThe CDC didn’t exclude Moderna’s shot from its recommendation, however, voting to recommend its usage with the others. And at a separate event in Cambridge, MA, CEO Stéphane Bancel said that it was unfair to make product-versus-product comparisons because of the context of each trial.
“If you look at what happened for the two other vaccines, they were running in a season that, in my opinion, was not a real season,” Bancel said, attributing the characterization to the fact that those RSV seasons were concurrent with the Covid-19 Omicron wave. “Everybody went home and masked.”
Bancel also said he believes Moderna’s prefilled syringe “is going to be a big differentiation,” citing pharmacist feedback the company has received.
Major products for vaccine makers
The vaccines quickly raked in hundreds of millions of dollars for GSK and Pfizer after they were each approved in May 2023. GSK reported £1.24 billion ($1.33 billion) in sales in 2023, while Pfizer added $890 million in global revenue last year. GSK has estimated £3 billion ($3.8 billion) in peak revenue.
ACIP members coalesced around the new, wider guidance in part because “shared clinical decision-making” has been an arbitrary measure that’s hard to implement, some experts explained.
“People find it befuddling,” said panel member Camille Kotton, a clinical director in the infectious disease division at Massachusetts General Hospital.
Others, including Denise Jamieson, dean of the Carver College of Medicine at the University of Iowa, were concerned that while it’s easier policy to implement, changing the language for patients 60 to 74 may in fact restrict access to patients who don’t have a chronic medical condition that would fall into CDC’s qualification. Jamie Loehr, a 62-year-old family medicine doctor in Ithaca, NY, said he himself wasn’t vaccinated because he didn’t have any known risk factors and was confident in that decision.
Members of the committee’s RSV working group said that the list of chronic conditions was purposely broad, so that many patients would likely be covered, should they want a vaccine. Despite the update, members conceded that a risk-based recommendation would be more difficult to institute than a universal one.
Matthew Daley, a senior investigator at Kaiser Permanente Colorado, said he’s learned that the committee’s recommendations “settle over time.”
“It takes us a little while to get there, and that’s hard,” Daley said. “But I think that’s OK, because that’s in the setting of some uncertainty.”
Editor’s note: This story was updated following CDC’s adoption of ACIP’s recommendations and to include a quote from ACIP chair Helen Keipp Talbott. Nicole DeFeudis contributed reporting.