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This page describes the recommendations as published in August 2024. Check CDC's current RSV vaccine guidance before acting on them.

Respiratory syncytial virus (RSV) is a major cause of respiratory illness and hospitalization among older adults in the United States each fall and winter. On June 21, 2023, CDC's Advisory Committee on Immunization Practices (ACIP) issued its first recommendation for adults: people 60 and older may receive a single dose of RSV vaccine after talking it over with a clinician — "shared clinical decision-making." The 2023–2024 season was the first under that advice, and by spring 2024 an estimated 20%–25% of U.S. adults 60 and older had been vaccinated.

On June 26, 2024, ACIP voted to change course.

The 2024 recommendation

  • All adults 75 and older should receive a single dose of RSV vaccine.
  • Adults 60–74 at increased risk of severe RSV disease should receive a single dose.
  • Anyone already vaccinated should not get another dose.

It applied to all three vaccines approved by the Food and Drug Administration (FDA) for adults 60 and older: GSK's Arexvy, Pfizer's Abrysvo and Moderna's mResvia, which FDA approved on May 31, 2024.

For adults 60–74, increased risk meant:

  • chronic cardiovascular disease, such as heart failure, coronary artery disease or congenital heart disease (isolated hypertension did not count);
  • chronic lung or respiratory disease, such as chronic obstructive pulmonary disease, emphysema, asthma, interstitial lung disease or cystic fibrosis;
  • end-stage renal disease, or dependence on hemodialysis or other renal replacement therapy;
  • diabetes with chronic kidney disease, neuropathy, retinopathy or other end-organ damage, or treated with insulin or an SGLT2 inhibitor;
  • neurologic or neuromuscular conditions that impair airway clearance or cause respiratory muscle weakness, such as poststroke dysphagia, amyotrophic lateral sclerosis or muscular dystrophy;
  • chronic liver disease, such as cirrhosis;
  • chronic hematologic conditions, such as sickle cell disease or thalassemia;
  • severe obesity (body mass index of 40 or more);
  • moderate or severe immune compromise;
  • living in a nursing home;
  • other conditions or risk factors a clinician judges would raise the risk of severe viral respiratory disease — for example frailty, a suspected undiagnosed chronic condition, or living in a remote or rural community where moving a severely ill patient to a higher level of care is difficult.

A patient's own word was enough. Pharmacists, nurse practitioners and other qualified vaccinators could decide eligibility on clinical judgment without paperwork, and were told not to turn anyone away for lack of documentation; the report asked that the same allowance carry into administrative procedures such as reimbursement policies.

The evidence

mResvia (Moderna). A phase 2/3 trial enrolled 36,685 immunocompetent adults 60 and older from November 2021 to December 2022, and a phase 1 trial added safety data on 106 adults aged 65–79. Over a median of 3.7 months after vaccination, one dose was 78.7% effective against RSV lower respiratory tract disease with two or more symptoms and 80.9% against disease with three or more. Over all follow-up, a median of 18.8 months, those figures were 47.4% and 48.4%, with protection higher in the first 12 months than in the next 12. The trial was not large enough to measure protection against hospitalization or death. Severe reactogenicity events were more common than with placebo, but serious adverse events were not, and no Guillain-Barré syndrome (GBS), other inflammatory neurologic events, myocarditis or pericarditis occurred within 42 days.

Arexvy and Abrysvo. Four observational studies of the first season after vaccination found effectiveness against RSV hospitalization of 75% to 82% in the general or immunocompetent population, similar for both vaccines and for ages 60–74 and 75 and older. The vaccines also protected adults with certain immunocompromising conditions and with end-stage renal disease.

Safety signals. An FDA analysis of Medicare beneficiaries 65 and older compared GBS in the 42 days after vaccination with days 43–90. The results did not clearly show an increased risk but could not rule one out; the cases had not yet been confirmed against medical records, and a fuller analysis was under way. The Vaccine Safety Datalink also flagged immune thrombocytopenia after Arexvy, but record review found that most cases began before vaccination; with only four cases starting in the 21 days after the shot and one in the following 21 days, no link could be confirmed.

Benefits against risks. A model estimated that, per million doses over two seasons, the hospitalizations, intensive care admissions and deaths prevented would exceed the possible vaccine-related GBS cases, though the balance varied by age and risk group.

Why ACIP changed the advice

In 2023 the evidence had gaps: the trials of Arexvy and Abrysvo could not show protection against hospitalization or death and included few frail participants or people over 75, and a handful of GBS cases in the trials might or might not have been chance. Shared decision-making was meant to weigh each person's risk, but clinicians found it confusing and slow, and after a season, coverage among adults with chronic conditions was only modestly higher than among those without.

A risk-based recommendation for 60–74-year-olds could leave some at-risk people unvaccinated. But with a possible GBS risk after the protein subunit vaccines, and no post-approval safety data yet for mResvia, ACIP concluded the benefits did not clearly outweigh the potential harms for 60–74-year-olds without risk factors. It stressed that clinicians should still be free to vaccinate patients they judge to be at increased risk even if they fit no named category, and that patients should be told the benefits and risks, including the possible GBS risk with the protein subunit vaccines.

Clinical guidance

  • RSV vaccine may be given at the same visit as other adult vaccines.
  • One dose protects for at least two RSV seasons; ACIP would decide later whether more doses are needed.
  • Vaccination can happen at any time of year but helps most in late summer or early fall, before RSV season — August to October in most of the continental United States.
  • Report clinically significant adverse events to the Vaccine Adverse Event Reporting System (1-800-822-7967), even when it is unclear whether the vaccine caused them.

Adults 50–59

FDA approved Arexvy on June 7, 2024, for adults 50–59 at increased risk of RSV lower respiratory tract disease. ACIP judged the evidence insufficient to vote on that age group and asked first for updated safety analyses in adults 60 and older — including the full-season FDA analysis with chart-confirmed GBS — more data on how long protection lasts and on response to revaccination, and immune-response data in people with immunocompromise.

Sources

  • Britton A, Roper LE, Kotton CN, et al. "Use of Respiratory Syncytial Virus Vaccines in Adults Aged ≥60 Years: Updated Recommendations of the Advisory Committee on Immunization Practices — United States, 2024." MMWR 2024;73(32). The report's social-media image is not reproduced.
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Licence: CC0 1.0 (public domain) · Adapted from www.cdc.gov

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