CDC’s advisers on Wednesday narrowed the recommended age group for RSV vaccines to adults 75 and older. They also recommended scrapping the shared decision-making model, where provider and patient together determine what healthcare decision is best, claiming the model creates “barriers” to vaccination.
U.S. health officials on Wednesday changed their recommendations for respiratory syncytial virus (RSV) vaccines in older adults, narrowing the recommended age group for the shots to adults 75 and older.
The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) also recommended that among people ages 60 to 74, only those who have an increased risk of severe RSV due to medical conditions should get the shot.
The recommendations replace the previous recommendation that all adults 60 and older may take the shot after consulting with their provider.
The committee also recommended that adults who already received an RSV shot should not receive any type of booster, based on data showing an additional shot did not improve RSV-related outcomes.
ACIP members declined to recommend GSK’s Arexvy RSV vaccine for people ages 50 to 59 at risk for severe RSV, even though the U.S. Food and Drug Administration in June expanded Arexvy’s approval to include that group.
“You shouldn’t vaccinate people who really don’t need the vaccine,” committee member Dr. Oliver Brooks told the group.
The new recommendations may cut the possible U.S. market for RSV shots in 2024-25 from $93 million to about $55 million, Reuters reported.
CDC Director Mandy Cohen accepted the committee’s recommendations, making it the government’s updated guidance for doctors.
Growing evidence of RSV vaccine injuries
Before voting on the changes, the committee discussed the growing evidence of adverse events associated with the RSV vaccine, including the documented risk of Guillain-Barré syndrome (GBS).
GBS is a rare disorder in which the body’s immune system attacks its own nerves. Symptoms can range from brief weakness to paralysis.
ACIP’s Dr. Matthew Daley assured other committee members that GBS is rare.
However, Children Health Defense research scientist Karl Jablonowski, Ph.D., who provided ongoing commentary on the meeting on CHD.TV’s live blog, noted that the presenter was “dancing around the fact that incidence of GBS for RSV is 1 one 47,500, [in data presented] where even for the COVID-19vaccines it was 1 in 700,000.”
Dr. Michael Melgar, co-lead of the Adult RSV Work Group, said the benefits of the shots still outweigh the risks.
There are currently three FDA-approved RSV vaccines on the market. Last year GSK’s (Arexvy) and Pfizer’s (Abrysvo) RSV prefusion F protein-based vaccines were approved by the FDA for adults ages 60 and up, and the two companies have been competing for market share.
The FDA approved Moderna’s mRNA RSV vaccine (mRESVIA) earlier this month for the same age group, with no input from its advisory committee.
James Donahue, DVM, Ph.D., MPH, of the Marshfield Clinic Research Institute in Wisconsin also presented recent surveillance data from the CDC’s Vaccine Safety Datalink analysis revealing a safety signal for immune thrombocytopenic purpura — an illness that can lead to bleeding and bruising — with the GSK RSV vaccine.
Eliminating the shared clinical decision-making model
The new recommendations eliminate the “shared clinical decision-making” model, where a provider and patient work together to determine what healthcare decision is best for the patient based on a person’s individualized risk factors, values and preferences.
The model, a key element for the practice of personalized medicine, is in place for four other adult vaccines.
The committee said the model was difficult and confusing to implement and a universal recommendation is simpler.
Dr. Camille Kotton, chair of the Adult RSV Work Group, said, “We have learned from feedback from healthcare providers that having shared decision-making conversations is not simple,” she said. “Unlike a universal recommendation where there’s a clear call to vaccinate, with shared clinical decision-making the call to action is to discuss with a healthcare provider — a less clear message.”
NBC News said the shared decision-making model is “a likely reason that fewer than 25% of older Americans have gotten a shot.”
Jablonowski told The Defender that in its original recommendation, the committee used shared decision-making as “an escape.” Because there weren’t enough data to support a recommendation for universal vaccination, the committee put the responsibility on the physicians, he said.
Now that they have more data, they are taking the decision out of the hands of the patient and provider, he said.
“The presenter summarized shared clinical decision-making as inconvenient and less clear than a standing recommendation,” Jablonowski blogged. Shared clinical decision-making “is a cornerstone of personalized medicine. US taxpayers have spent billions, probably hundreds of billions of dollars on personalized medicine research. She is really arguing that personalized medicine does not apply to vaccinations.”
In Thursday’s meeting, the CDC’s Lakshmi Panagiotakopoulos, M.D., MPH, also criticized the model while discussing the COVID-19 vaccines. “Shared clinical decision-making would create barriers to vaccination, may not effectively target those higher at risk, and would likely increase inequities in vaccine access,” she said.
Committee member Denise Jamieson, M.D., MPH, also expressed her concern that not enough providers would recommend optional vaccines strongly unless there were universal recommendations.
