a panel of experts which advises the Centers for Disease Control and Prevention on vaccinations, on Wednesday chose not to recommend that all seniors receive a vaccine to protect against RSV.
Instead, the Advisory Committee on Immunization Practices said anyone age 60 and older should be able to get one of the new vaccines — marketed by GSK And Pfizer — if they and their doctors think it would be worth it.
Earlier in the day, the committee appeared poised to vote on a stronger recommendation, one that would have urged all people aged 65 and older to get vaccinated against respiratory syncytial virus. But that recommendation was watered down after a lengthy discussion in which several members of the committee expressed serious concerns about the decisions they were asked to make based on the data the companies provided.
In the end, the committee voted 9-5 to recommend that people 65 and older should “be allowed” to receive an RSV vaccine, based on shared decision-making, a term that usually means a discussion between patients and their doctors. With these vaccines, it could also mean a discussion between patients and their pharmacists, because the RSV vaccines fall under Medicare Part D and as such are administered in pharmacies in most cases. (It is difficult for physicians to be compensated for administering vaccines covered by Medicare Part D.)
The committee voted 13 to zero, with one abstention, to recommend applying the same policy to people aged 60 to 64.
The recommendations now go to CDC Director Rochelle Walensky for her approval. Walensky is expected to approve the recommendations sometime late this week or early next week.
The recommendations are likely to result in lower adoption of the new vaccines than manufacturers anticipated had ACIP voted to accept the stronger “should” recommendation. At some point this spring, a GSK executive predicted that sale of the RSV vaccine could rival that of Shingrix, the company’s highly profitable shingles vaccine.
Both vaccines were approved last month by the Food and Drug Administration for use in people ages 60 and older. But the ACIP Working Group on Adult RSV Vaccination has for some time indicated that it sees no cost-effectiveness argument for recommending that everyone between the ages of 60 and 64 be vaccinated against RSV.
GSK’s vaccine showed an overall vaccine efficacy of 82.6% against RSV lower respiratory tract disease in the first year after vaccination and 77.3% in the middle of the second year after vaccination. Pfizer’s vaccine showed nearly 89% efficacy against RSV lower respiratory tract infection with at least three symptoms in the first year after vaccination, and 78.6% efficacy halfway through a second RSV season.
Michael Melgar, a CDC epidemiologist who co-chairs ACIP’s RSV Adult Vaccine Working Group, cautioned against comparing the two vaccines because the clinical trial designs differed and the two companies aren’t measuring exactly the same results.
The fact that the vaccines appear to protect for at least two years was new information presented at Wednesday’s meeting and credited with a major jump in the estimated price of the GSK vaccine. Prior to this meeting, GSK talked about a per-dose price of about $148. On Wednesday, during a presentation of an economic analysis conducted by the CDC and the University of Michigan, the committee learned that the GSK price estimate had risen to $270.
Both companies resisted strong pressure from the commission to commit to a fixed price, with ACIP members claiming they could not judge the cost-effectiveness of the vaccines without that information.
“None of us buys a car unless we know how much it costs,” says Helen “Keipp” Talbot, a geriatric infectious disease specialist at Vanderbilt University. She urged manufacturers to announce their prices before the committee voted late in the afternoon. Just before the vote, the manufacturers returned with figures, but both mentioned a range.
Leonard Friedland, GSK’s vice president of scientific affairs and public health, said the company’s vaccine, which will be sold under the Arexvy name, will be priced in a “narrow range” of between $200 and $295. Friedland argued that the cost reflects the fact that vaccine coverage will last at least two years. A Pfizer executive told the committee that the company is “in the middle of competitive pricing negotiations” and cannot provide hard cost figures for its vaccine. But she said the Pfizer vaccine, which will go under the brand name Abrysvo, would cost between $180 and $270.
Both companies are expected to bring vaccines to market in time for the next RSV season, which normally falls in the winter. However, since the Covid-19 pandemic, RSV activity has started in late summer and early fall and it is unclear if and when the old pattern of activity will resume.
These are the first vaccines to protect against this virus, which is a leading cause of hospitalization in very young children and the elderly. In older children and adults, RSV infections usually manifest as a cold.
While researchers studying RSV in adults have welcomed the arrival of these vaccines, ACIP experts have been frustrated by the data the companies have presented.
One of their concerns was the fact that the clinical trials that GSK and Pfizer conducted included few adults age 80 and older — the age group most at risk for RSV. People who are immunocompromised and people who live in communal living environments, such as nursing homes, are also at increased risk, but were not included in the studies.
Talbot noted that the committee is being asked to conclude that because the vaccines were effective in the trials – largely in people in their 60s – they will also protect people in these other more vulnerable groups.
“Randomized controlled trials are needed to determine vaccine efficacy in these groups at highest risk for RSV-associated morbidity and mortality,” she argued. “[But] if vaccination is recommended for these groups, clinical trials will no longer be viable for ethical reasons and we have missed the opportunity to obtain the best level of evidence.”
Once a medical intervention has been shown to be effective and recommended for a population, it is no longer ethical to test it in a placebo-controlled trial.
There were also concerns that three people in the clinical trials conducted to test these vaccines developed Guillain-Barré syndrome after being vaccinated, a normally temporary condition in which people experience progressive paralysis.
Some vaccines are associated with a slightly increased risk of GBS. Whether there are any RSV vaccines will only become clear once more people use them, but several members of the committee were clearly concerned by the possibility that there could be a link between these vaccines and GBS.
Committee members were concerned that these vaccines will likely be given at the same time of year as flu and covid shots and it is not yet clear whether giving the vaccines at the same time undermines the immune responses they generate.
Studies of co-administration of Covid and RSV vaccines are ongoing. A study conducted by GSK in which the RSV vaccine was given at the same time as a high-dose flu vaccine – a formulation recommended for older adults – showed that the response to flu was “non-inferior” to what was seen when the flu vaccine was given alone. was administered , with the exception of the response to influenza A H3N2 viruses. Those viruses cause the worst flu illness in seniors and some members of the committee were concerned that co-administration of these vaccines would impair protection against flu.
Since both vaccines appear to provide protection for two RSV seasons, how often older adults should be vaccinated against RSV remains to be seen. Likewise, it is not clear whether immunocompromised people will be protected by these vaccines. Pfizer said it is currently conducting a study to see if one or two doses of vaccine would protect this population.
This story has been updated.