For older adults, the fall arrival of new vaccines against respiratory syncytial virus (RSV) will provide their first protection against potentially life-threatening respiratory disease. But the addition of another immunization will also complicate the already crowded vaccine season for physicians, with shared decision making and some uncertainty regarding whether the new vaccines should be administered with other shots.
Earlier this year, FDA officials approved two vaccines to treat RSV, which can cause as many as 160,000 hospitalizations and 10,000 deaths annually among adults ages 65 years and older, according to data published July 21 in Morbidity and Mortality Weekly Report (MMWR).
The CDC's Advisory Committee on Immunization Practices (ACIP) recommended in June that adults ages 60 years and older may receive a single dose of an RSV vaccine, using shared clinical decision making. The vaccines, which are supposed to be available in early fall, will be the latest recommended for older adults before year's end, along with influenza and the newest COVID-19 vaccine, which an FDA committee has recommended should be targeted against the Omicron XBB.1.5 variant. (The FDA approved one of the RSV vaccines for pregnant women Aug. 21, and ACIP is expected to meet soon to discuss its recommendations.)
Shared decision making requires physicians to invest additional time, along with the other medical issues they need to address, but they should still make a strong case with their older patients, said Jason M. Goldman, MD, FACP, ACP's liaison representative to ACIP and an internal medicine physician in Coral Springs, Fla.
“We are probably underdiagnosing the amount of RSV that is truly out there,” Dr. Goldman said. “It's incumbent upon us as primary care physicians to be recommending these life-saving vaccines to our patients, especially those who are most vulnerable and have the most risk. This is just as important as recommending the mammogram, colonoscopy, managing their diabetes, hypertension, and everything else.”
Increasingly, RSV has been recognized as a worrisome virus in adults as well as children, as better testing has become available, said William Schaffner, MD, MACP, a professor of infectious diseases at Vanderbilt University School of Medicine in Nashville, Tenn. “What we've learned in the last 20 years is that RSV actually causes as much serious respiratory illness in adults as does influenza in most seasons,” he said. “Both of these viruses have been out circulating.”
Dr. Goldman agreed, noting he only realized how common RSV is in recent years, when he began to test with a panel that detects an array of viruses, including SARS-CoV-2 and RSV. Previously a patient would come into the office with viral symptoms and would be advised to take acetaminophen, drink fluids, and rest up.
“We didn't know what specifically it was,” Dr. Goldman said. “How much RSV are we writing off as ‘just a virus,’ when it's actually RSV that could have been prevented?”
Earlier this year, federal officials approved two vaccines, Abrysvo, made by Pfizer, and Arexvy, by GlaxoSmithKline. The vaccines, according to CDC officials, have “demonstrated moderate to high efficacy” in preventing symptomatic RSV disease over two consecutive seasons in adults ages 60 years and older.
In clinical trials over two RSV seasons, one dose of Abrysvo and one dose of Arexvy prevented 84.4% and 74.5% of RSV disease, respectively, as well as 81% and 77.5% of disease that required medical attention, according to data published in MMWR. Neither study was sufficiently powered to determine if the vaccines prevented hospitalization or death.
Physicians should feel comfortable with using whichever vaccine is in stock, said Amesh Adalja, MD, FACP, an infectious diseases physician and senior scholar at the Johns Hopkins Center for Health Security in Baltimore. “In general, I would think of them as interchangeable when talking to patients,” said Dr. Adalja, who also is on the speaker's bureau for GlaxoSmithKline. “What's important is getting one of them into a high-risk patient's arm.”
During the clinical trials, six cases of inflammatory neurologic events were identified, including Guillain-Barré syndrome, federal officials noted in MMWR. But it's unclear whether the cases were due to random chance. Until postmarketing surveillance clarifies “the existence of any potential risk, RSV vaccination in older adults should be targeted to those who are at highest risk for severe RSV disease,” they wrote.
These uncertainties contributed to ACIP's decision to not universally recommend the new vaccines, said Vidya Sundareshan, MD, MPH, FACP, Chair of ACP's Immunization Committee and a professor and chief of infectious diseases at Southern Illinois University School of Medicine in Springfield. “That's really the reason why this recommendation for shared clinical decision making was made, to allow more flexibility for providers and patients when they consider getting this vaccine,” she said.
Patients face a higher risk for severe disease if they have underlying medical conditions, including lung disease, cardiovascular disease such as congestive heart failure, diabetes, and liver disorders, among other conditions listed in MMWR.
At the ACIP meeting, several committee members raised concerns about the need for more data among adults in their 70s and older, as well as those living in long-term care facilities, said Dr. Schaffner, who watched the June meeting virtually. The clinical trials also didn't include any immunocompromised individuals, according to the MMWR authors. But that shouldn't preclude any of these groups from getting an RSV vaccine “using shared clinical decision-making given the potential for benefit,” they wrote.
At this point, it's unknown how long the vaccine's protection will last, according to data presented at the ACIP meeting. The cost wasn't available at the June meeting, but company spokespeople later confirmed that the list prices will be $280 per dose for GlaxoSmithKline's Arexvy and $295 per dose for Pfizer's Abrysvo, not including any discounts or other price reductions.
That price tag seems unfortunately high, said Melina Awar, MD, FACP, a hospitalist and an associate professor of clinical medicine at Houston Methodist Hospital, who coauthored an ACP Journal Club commentary about the RSV vaccines in the June Annals of Internal Medicine. “I'm troubled that it's close to $300 a shot,” Dr. Awar said. “Really we should create the least resistant path as possible to encourage our most vulnerable population to get these vaccines that could be lifesaving for them.”
The RSV vaccines will be fully covered for Medicare patients with Part D coverage, Dr. Schaffner said. (The influenza, pneumonia, and COVID-19 vaccines fall under Part B, according to federal officials.) Roughly three-fourths of Medicare recipients have enrolled in Part D drug coverage, but that forces a sizable number of older adults to pay out of pocket if they don't have other coverage, he said.
In addition, physician practices that have not mastered billing under Part D may instead refer patients to a nearby pharmacy, Dr. Schaffner said. “That's going to be one of the limitations of getting this vaccine out to the population that needs it,” he said, adding that physicians might not be as invested in ensuring that their patients get those Part D vaccines versus the ones that they administer under Part B in their offices.
But physicians shouldn't avoid giving the RSV shots for billing-related reasons, Dr. Goldman said. He recommended an online site to process vaccine claims through Medicare Part D. “The Part D [billing] is not an excuse, because there's a workaround,” he said.
As of August, Dr. Goldman said that he was waiting to learn if commercial insurers would cover the RSV vaccines for adults ages 60 to 64 years before stocking them. “Primary care is on such a narrow margin in solo practice that we can't afford to store these vaccines and lose money,” he said, unless there's reasonable expectation of reimbursement.
Regarding coadministration of the fall vaccines, there are already good data showing that the influenza and COVID-19 vaccines can be given simultaneously, Dr. Schaffner said. But to date, there's relatively little research showing that RSV can be administered with other vaccines, he said. One study, published last year in the Journal of Infectious Diseases, indicated that when RSV is given with the flu vaccine, “the immunogenicity of the influenza vaccine was somewhat diminished,” he said.
“Whether that has any clinical significance, we don't know,” Dr. Schaffner said. “But it would tend to make one suggest that the RSV vaccine not be given simultaneously with the others.”
Dr. Schaffner acknowledged that spreading out the vaccines requires scheduling multiple office visits and convincing patients to return for additional shots. However, he added, “There are going to be many patients who may not want to get more than one vaccine at a time anyway.”
More evidence is needed to determine if coadministration impacts vaccine effectiveness, Dr. Adalja said. “Even if the antibody response is lower, does that actually translate into decreased clinical efficacy?” he asked. At this point, there's no reason why physicians shouldn't offer all three immunizations at the same visit, though that approach might boost the likelihood of leaving the patient with a sore arm, he said.
On a practical level, the timing may become naturally staggered, Dr. Adalja said. For instance, the RSV vaccines have been recommended as soon as they become available, while physicians may advise patients to get their influenza vaccine later in the fall, to ensure that it provides coverage through the flu season, he said.
Administering an RSV vaccine with other adult vaccines “during the same visit is acceptable,” the MMWR authors wrote. But they noted that the injections should be separated by at least an inch if possible, and clinicians should consider administering vaccines that are “associated with an enhanced local reaction in separate limbs.”
Fighting vaccine fatigue
The RSV vaccines arrive on the immunization scene at a time when patients haven't particularly embraced other vaccines also recommended for this fall. Last flu season, 47.4% of all adults ages 18 years and older got the shot, up slightly from 45.4% the prior year, according to CDC data. Ongoing protection against SARS-CoV-2 has been weaker, with only 17% of U.S. residents getting a bivalent booster dose by May 2023; uptake among adults ages 65 years and older was higher, with 43.3% getting the shot.
Dr. Awar worries that vaccine-related weariness, including among some physicians, could undercut RSV vaccine buy-in. “The doctors have fatigue from trying to convince and counsel patients to get vaccines for new viruses and health maintenance as well,” she said. “I think that the pandemic contributed to that significant fatigue.”
She suggested that physicians specify what an RSV vaccine can do for vulnerable patients, including its ability to reduce hospitalizations and other consequences, such as needing oxygen or intensive care. Remind patients that they've gotten other vaccines without side effects. If patients are concerned about the small number of neurologic events, make sure they're aware that federal officials will continue to monitor the vaccines for any potential risks, Dr. Awar said. “I've had the most success with our patients when we are very honest about the data,” she said.
By late summer, some of Dr. Sundareshan's patients had already asked when the RSV vaccines would become available. Patients typically split into three groups regarding their vaccine preferences, with roughly one-third not needing any convincing, another third largely resistant, and the remainder on the fence, Dr. Sundareshan said. Immunization works best when a medical practice adopts a team approach, making flyers and other educational materials available, and training front office staff about the importance so they can help talk to patients, she said, noting that ACP posts numerous resources online.
Even in a time-pressed office visit, it's worth devoting a few extra minutes to try to reach those potentially persuadable patients, Dr. Sundareshan said. “Especially if someone is coming in with a history of multiple hospitalizations, etc., I think it's definitely worth having the discussion with patients like that.”