Will new approvals, stronger recommendations improve RSV vaccine uptake?
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Last fall and winter, older adults and pregnant women in the United States had a chance to receive the world’s first approved vaccines for respiratory syncytial virus.
Like with a handful of other shots, the CDC recommended that adults aged 60 years or older consider getting an RSV vaccine based on “shared clinical decision-making” — a designation the CDC uses when it believes an individual may benefit from a vaccine but that broad vaccination of a group is unlikely to have a population-level impact. Months later, the CDC made a stronger recommendation for pregnant women, recommending they all get vaccinated against RSV.
After decades of RSV vaccine development, the approvals and recommendations were seen as landmark events in preventive medicine. Uptake was low, however — not unusual for first-year approvals, experts told Healio. But they noted several other factors, including lack of education about the vaccines, low awareness and the fact that the CDC stopped short of recommending that all older Americans get one of the shots.
“My opinion is that shared clinical decision-making does not work,” Kenneth Schmader, MD, a professor of medicine at Duke University, said in an interview.
Schmader represents the American Geriatrics Society on the work group that counsels the CDC’s Advisory Committee on Immunization Practices (ACIP) on RSV vaccines.
“True shared clinical decision-making requires first off that the clinician knows all about the benefits and risks of the vaccines, and there's a lot to know,” he said. “Eighty percent of these vaccines are given at the pharmacy, requiring pharmacists to know a lot about the nuances of the vaccine, to be able to communicate that information to an individual, and then there's the person who is thinking about getting vaccinated and has to take all that into account in a short time in busy settings.”
A little more than a year later, the ACIP changed its mind, voting last week to strengthen the recommendation to say that all patients aged 75 years or older — and all patients aged 60 to 74 with an increased risk for severe RSV — should get one of the vaccines.
Those recommendations and several other developments, including the approval of the first messenger RNA vaccine for RSV, have changed the landscape of RSV vaccination going into the next respiratory diseases season. We checked in with some experts to get their thoughts on the developments over the last year and whether they will have an impact on RSV vaccine uptake.
‘Vetted five ways from Sunday’
Data have shown that uptake of the vaccines was lower than what experts would have liked to see but not necessarily lower than what they would have expected.
“By the time vaccines are licensed, they've been vetted five ways from Sunday,” C. Buddy Creech, MD, MPH, director of the Vanderbilt Vaccine Research Program, said in an interview. “But these haven't yet been given to millions of individuals. Because of this, some people are going to wait and not be the first in line at the pharmacy or their health care provider to get that vaccine.”
According to the CDC, as of May 11, an estimated 24.4% of eligible adults aged 60 years or older reported having received an RSV vaccine. Coverage was highest among white patients (26.8%) and lower among Black (20.9%), Asian (19.1%), Pacific Islander or Native Hawaiian (16.1%) and Hispanic (14.7%) patients.
Moreover, survey results presented in May at the National Foundation for Infectious Diseases’ Annual Conference on Vaccinology Research showed that only 17.7% of older adults reported that a health care worker asked to discuss RSV vaccination at their most recent visit, and only 22.3% recommended one of the shots.
“It's a new vaccine. Providers and patients had to get used to it — and, of course, providers have to stock it,” Healio | Infectious Disease News Editorial Board Member William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center and past medical director of the NFID, said in an interview.
“The whole system of making the vaccines available to people is something that was just getting started, and you can't have great expectations that first year,” Schaffner said.
Months after the FDA approved GSK and Pfizer’s RSV vaccines for older patients, it also approved Pfizer’s shot for pregnant women to protect infants during their first 6 months after birth. Uptake was even lower than it was among older patients despite early indications that patients who were expecting a baby were open to getting an RSV vaccine.
In a survey conducted in March 2023 — before any approvals — 54% of those expecting a baby indicated they were “very likely” to receive an RSV vaccine. The percentage rose to 63% if respondents believed RSV infection was serious and likely but dropped to 35% if they felt RSV infection was not serious.
Real-world data showed that uptake was much lower. According to data available from the CDC, as of January 31, RSV vaccine coverage among pregnant women was just 17.8%.
“This is typical for a new vaccine,” Schmader said. “There are some early adopters but then it takes a while for [uptake to increase]. I don't think that means anyone squandered the fact that vaccines have been approved. Some people actually got them, and that’s a great start.”
Another mAb hits the market ...
Another possible reason for the low uptake among pregnant women was the availability of two monoclonal antibody (mAb) shots that can be given to infants to protect them against RSV, including the newly approved nirsevimab. These options may have “sounded better than vaccination during pregnancy,” Creech said.
The CDC and American Academy of Pediatrics both recommend a single dose of nirsevimab for infants aged younger than 8 months born during or entering their first RSV season, and all infants and children aged 8 through 19 months who are at an increased risk for severe RSV disease and entering their second RSV season, including those recommended by the AAP to receive the other mAb, palivizumab.
The AAP continued to recommend palivizumab for eligible infants who could not access nirsevimab — there was a shortage — but noted that children who have received nirsevimab should not receive palivizumab in the same RSV season.
RSV is the leading cause of hospitalization among infants in the U.S.
“The landscape of RSV protection for infants is the best it’s ever been,” Lori Handy, MD, MSCE, attending physician in infectious diseases and associate director of the Vaccine Education Center at The Children’s Hospital of Philadelphia, told Healio.
According to the CDC, as of March, more than 41% of people with an infant aged younger than 8 months reported that the infant had received nirsevimab — a rate that may have been even higher with improvements in cost, insurance reimbursement and supply, Handy suggested.
“Now that we are entering the second season and have some preliminary data on the effectiveness of nirsevimab, providers are in a better position to provide a strong recommendation for RSV immunization — either vaccination of the pregnant person or passive immunization of the baby with a monoclonal antibody,” she said.
Seeing which option ultimately is more popular — getting vaccinated during pregnancy or immunizing the infant with an mAb — will be “something to watch,” Creech said.
“They're both recommended for prevention of RSV in infancy, but we don't yet know how that shakes out in the opinion of those who are pregnant,” he said. “If all things were equal — cost, ease of administration and receipt — which one wins out? We just don't know.”
... followed by an mRNA vaccine
Experts also considered that the recent approval of a third RSV vaccine for older people could help increase uptake.
In late May, the FDA approved Moderna's mRNA vaccine to protect adults aged 60 years or older against lower respiratory tract disease caused by RSV. It became the third vaccine approved for RSV but the first using mRNA technology. It is the first approved mRNA vaccine that does not target COVID-19.
“It is difficult to compare the three [RSV] vaccines directly because the trials for each were done very differently with different endpoints and different periods of follow-up after vaccination,” David O. Freedman, MD, professor emeritus of infectious diseases at the University of Alabama at Birmingham, told Healio.
However, in terms of preventing significant disease in the short term, Moderna’s vaccine appeared “roughly equivalent” to the Pfizer and GSK shots, Freedman said.
Whether the availability of a third vaccine will increase uptake remains to be seen, experts said.
“Two issues may play against Moderna’s mRNA vaccine: First, people do remember the short-term local effects — a day or two of fever, malaise, etc. — with mRNA COVID-19 vaccines, even if no comparison of side effects of the three RSV vaccines have been done,” Freedman said. “Second, mRNA vaccines are perceived to be short lived because of all the boosters that have been recommended with COVID. Moderna really needs strong second-season data to prove this is not an issue with their RSV vaccines.”
Schaffner also acknowledged that the country, “as a consequence of COVID and its introduction to the mRNA vaccine,” is divided on the technology.
“I'm just not sure how that's going to play,” he said.
Ryan C. Maves, MD, professor of medicine and anesthesiology at Wake Forest University School of Medicine, noted a reason to be optimistic.
“It is worth recalling that over 80% of U.S. adults have received at least one dose of an mRNA vaccine — well over 90% of those over the age of 50 years,” he told Healio. “So, we shouldn’t overstate the importance of vaccine hesitancy regarding mRNA vaccines. I think that having a third option is a good thing, and I suspect the number of people who will avoid RSV vaccines solely because of mRNA technology are probably not likely to pursue RSV vaccines in general.”
New recommendations
According to the CDC, RSV causes up to 160,000 hospitalizations and 10,000 deaths every year in the U.S. among people aged 65 years or older.
In its June 26 meeting, the ACIP voted unanimously to recommend RSV vaccination for all people aged 75 years or older and patients aged 60 to 74 years with risk factors for severe RSV disease. CDC Director Mandy Cohen, MD, MPH, signed off on the recommendations, making them official.
The ACIP clarified that only people who have not already received an RSV vaccine should get a shot. Adults aged 60 to 74 years who are not at an increased risk for severe RSV disease are no longer included in the recommendations.
The CDC said it would publish clinical considerations describing medical conditions and other risk factors for severe RSV disease for providers to reference. Online, the agency lists cardiopulmonary disease, kidney disorders, liver disorders, neurologic or neuromuscular conditions, hematologic disorders, diabetes and moderate or severe immune compromise as risk factors for severe RSV in adults aged 60 years or older.
Schaffner said the risk-based approach “is not a lot easier than shared clinical decision-making.”
“It's really shared clinical decision-making in sheep's clothing,” he said in an interview after the vote. “It's as difficult for doctors and pharmacists as shared clinical decision-making.”
Some in the committee voiced concerns that they were “backtracking” by removing adults aged 60 to 74 years without underlying conditions or risk factors from the recommendations.
“It is OK for us to reevaluate vaccines and use them as they are needed. We're one of the few countries that does not do that,” ACIP chair Helen Keipp Talbot, MD, MPH, professor of medicine at Vanderbilt University, responded. “That only lends us credibility in saying, ‘We have reviewed this. This is the right use of medical funds. This is the right way to save lives. This is the right way to reduce risk of vaccines.’”
The ACIP did not hold a vote on whether to recommend RSV vaccination for patients aged 50 to 59 years despite the FDA’s recent decision to extend the approval of GSK’s vaccine for high-risk patients in that age group.
‘You never know what’s going to happen’
Looking ahead, experts said they are hopeful that more RSV vaccines will go into more arms, providing better protection and coverage across the U.S., but that it may take some time to get to there.
What might it take to encourage more people to receive a vaccine?
“A well-publicized RSV outbreak on a couple of massive cruise ships or a massive spike in RSV cases and deaths after the Thanksgiving holiday to sensitize people before the Christmas holiday,” Freedman suggested.
Awareness and advocacy also could help increase vaccination rates.
“Public health authorities have to make patients and physicians aware of these vaccines and their indications, and then physicians and other clinicians need to be advocating for their use in our patients,” Maves said. “Despite the general decrease in faith in public health authorities among the public in the wake of the pandemic, people still trust their doctors.”
Schmader said the very nature of developing vaccines for respiratory viruses is tricky and contributes to one of the things RSV vaccines are lacking — real-world effectiveness data.
“There are seasons, and you never know what's going to happen,” he said. “Some years, there's not a lot of activity, and in others, they’re epidemic, which makes trying to figure out efficacy and effectiveness in these situations challenging.”
He anticipates that more data will become available to better characterize how the vaccines perform among people aged 75 years or older and other high-risk patients, including those who live in nursing homes.
“The fact that we prevented RSV in anybody last year is a testament to decades of work and doing the best we could on short notice,” Creech said. “Now, we're going to be able to see what it looks like this year.”
References:
- CDC. ACIP shared clinical decision-making recommendations. https://www.cdc.gov/vaccines/acip/acip-scdm-faqs.html. Accessed June 26, 2024.
- CDC. ACIP presentation slides: June 26-28, 2024 meeting. https://www.cdc.gov/vaccines/acip/meetings/slides-2024-06-26-28.html. Accessed June 26, 2024.
- CDC recommends a powerful new tool to protect infants from the leading cause of hospitalization. https://www.cdc.gov/media/releases/2023/p-0803-new-tool-prevent-infant-hospitalization-.html. Published Aug. 3, 2023. Accessed June 26, 2024.
- CDC. Respiratory syncytial virus (RSV) vaccination coverage, pregnant persons, United States. https://www.cdc.gov/vaccines/imz-managers/coverage/rsvvaxview/pregnant-persons-coverage-intent.html. Accessed April 24, 2024.
- CDC. RSVVaxView. https://www.cdc.gov/vaccines/imz-managers/coverage/rsvvaxview/index.html. Last reviewed June 21, 2024. Accessed June 24, 2024.
- CDC. Surveillance of RSV. https://www.cdc.gov/rsv/php/surveillance/index.html. Last reviewed June 5, 2024. Accessed June 26, 2024.
- La E. Poster Abstract 23. Presented at: NFID Annual Conference on Vaccinology Research; May 8-10, 2024.
- Moderna receives U.S. FDA approval for RSV vaccine mRESVIA(R). https://investors.modernatx.com/news/news-details/2024/Moderna-Receives-U.S.-FDA-Approval-for-RSV-Vaccine-mRESVIAR/default.aspx. Published May 31, 2024. Accessed June 17, 2024.
- Red Book Online. ACIP and AAP recommendations for nirsevimab. https://publications.aap.org/redbook/resources/25379/ACIP-and-AAP-Recommendations-for-Nirsevimab. Published Feb. 21, 2024. Accessed June 26, 2024.
- Saper JK, et al. Pediatrics. 2024;doi:10.1542/peds.2023-065140.
- Walsh EE, et al. N Engl J Med. 2023;doi:10.1056/NEJMoa2213836.
For more information:
- C. Buddy Creech, MD, MPH, can be reached at buddy.creech@vumc.org.
- Lori Handy, MD, MSCE, can be reached at handyl@chop.edu.
- William Schaffner, MD, can be reached at william.schaffner@vumc.org.
- Kenneth Schmader, MD, can be reached at kenneth.schmader@duke.edu.
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