Last week, experts on the CDC’s panel that sets vaccine recommendations created new guidance for who should get RSV shots heading into the second-ever season of vaccination for the respiratory disease.
The goals of the Advisory Committee on Immunization Practices (ACIP) were to create clearer advice for older Americans and to make access easier. But in doing so, there are concerns that it may have, paradoxically, left fewer people eligible.
ACIP’s actions have revealed the gap between what vaccine makers wanted and what experts ultimately believed was the best decision for public health. That divide is largely centered around how much involvement a healthcare provider should have in helping people decide whether to get vaccinated, and whether such involvement is efficient or not.
Under the older guidance, anyone 60 and older had to consult a doctor or pharmacist before getting the shot — a process known as shared clinical decision-making.
The big drugmakers behind the shots — GSK, Pfizer and Moderna — had hoped the CDC would shift to what’s known as a universal recommendation, taking the conversation with a healthcare provider out of the picture, and advising that everyone over 60 get the vaccine.
Instead, only adults 75 and older have that recommendation. And for adults 60 to 74 — a population of nearly 56 million, according to the US Census Bureau — the CDC said those people should get vaccinated only if they have at least one chronic health condition, such as severe obesity or lung disease. GSK’s vaccine is also approved by the FDA for adults ages 50 to 59, but the committee declined to make any recommendation there.
Unintended consequences?
Camille Kotton is a clinical director at Massachusetts General Hospital and a member of ACIP, and she voted in favor of the new guidelines (they were unanimously supported by the panel). In an interview after the vote, she told Endpoints News that shared clinical decision-making “doesn’t really work.”
“It requires a kind of a special conversation about a vaccine that people have never heard about before,” she said. She added that a risk-based approach “does actually allow for a lot of people to get vaccine.”
But there are concerns that doing so may have the opposite effect.
After the new guidelines were adopted, shares of each of the vaccine makers fell post-market — GSK and Pfizer fell by single-digit percentage points while Moderna declined 11% — a sign that investors saw the CDC’s action as bad news for the size of the market.
Tyler Van Buren, a senior biotech analyst at TD Cowen, said the firm estimates that the decision shrank the addressable market by up to 40%. A Jefferies note following the vote said it was “more complex than expected.” Leerink Partners said the committee narrowed its recommendations.
In the last RSV season, nearly 24% of Americans 60 and older got vaccinated, including 21% of people that age without a chronic medical condition. Though that rate includes patients who are 75 and older (who are now included in a universal recommendation) some people who got the vaccine last year would conceivably not qualify in the upcoming season.
Big new products
The shots have become major products for the companies. GSK’s vaccine, Arexvy, sold £1.24 billion ($1.33 billion) in 2023. Pfizer lagged slightly, earning $890 million in global revenue last year. Moderna’s shot was approved about a month ago, and the company hasn’t yet reported sales results.
The CDC does consider the costs of vaccinating large numbers of people in comparison to the public health benefit that’s gained. One of the analyses the panel considered found that the cost-effectiveness of vaccinating all Americans 60-74 was more than twice as expensive than vaccinating higher-risk people in the same age group. By focusing on people with health conditions, the panel may have been targeting the vaccine at the group it believes will benefit the most, especially since severe cases of RSV can lead to hospitalization.
Stakeholders also expect the new guidance to help pharmacies, where the vast majority of adults received their shots in the last year, according to a presentation from ACIP’s RSV work group. That totaled more than 10 million vaccinations through April 2024.
Kelly Goode, a pharmacy professor and non-voting member of ACIP representing the American Pharmacy Association, said in an interview that the simpler guidelines are a good thing.
“I think it also then becomes easier for pharmacies to identify patients based on medications that are falling in those risk categories for vaccination,” she said.
Richard Dang, an assistant professor of clinical pharmacy at the University of Southern California, described the update as moving from a soft to hard recommendation.
“It may come off as a stronger recommendation,” he said. For the pharmacies, he believes it should be easier to know who needs a vaccine based on screening forms and medical history, as opposed to needing a longer conversation.
Representatives from the three vaccine manufacturers declined to speak for this story, but sent statements.
“We appreciate ACIP’s simplification of the recommendation by removing shared clinical decision-making,” Moderna said.
GSK said shedding shared clinical decision-making for the 75 and older population “helps make it easier for those at greatest risk to get vaccinated,” referring to the standard as “more complicated.”
Pfizer said the update “reinforces the importance of protecting adults over the age of 60 at increased risk for severe RSV disease.”