New ACIP Recommendations for RSV Vaccines Aim to Solve Challenges With Shared Clinical Decision-Making

The CDC has published a report that summarized evidence considered following the recently updated Advisory Committee on Immunization Practices (ACIP) respiratory syncytial virus (RSV) recommendations, along with clinical guidance for the use of RSV vaccines among individuals 60 years and older. The report was published in the Morbidity and Mortality Weekly Report (MMWR) and aimed to clarify the individuals at highest risk for RSV and reduce barriers for clinical shared decision-making from previous recommendations.¹

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On June 21, 2023, ACIP released the first RSV vaccine recommendation that said all adults aged 60 years and older should receive a single-dose RSV vaccine, based on shared clinical decision-making with a health care provider. Following the recommendation, the release provided that in the spring of 2024, 20% to 25% of US adults aged 60 years and older were estimated to have received an RSV vaccine with either of the FDA approved immunizations, Arexvy (GSK) or Abrysvo (Pfizer). Additionally, in May 2024 the FDA also approved mRESVIA (Moderna), intended to prevent RSV-associated lower respiratory tract disease (RSV-LRTD) in adults 60 years and older.¹

Following a review of data assessing the safety and efficacy of all 3 vaccines in randomized, observer-blind, placebo-controlled clinical trials, the ACIP Work Group for RSV prevention has met monthly since July 2023 to provide updates for vaccination recommendations. In June 2024, a year after the initial release of recommendations, ACIP issued updated recommendations for a single dose of any FDA-approved RSV vaccine for adults 75 years and older and for adults 60 to 75 years who are at increased risk for severe RSV. The updated recommendations replaced the previous suggestions that emphasized shared clinical decision-making.^1,2

According to the CDC, shared clinical decision-making presented drawbacks, resulting in new age-based recommendations for adults aged 75 years and older and risk-based recommendations for individuals aged 60 to 74 years. The authors noted that the 2023 recommendation of shared clinical decision-making for RSV vaccination was suggested due to uncertain protection against RSV-associated hospitalization or death. Despite both vaccines displaying tolerability, a small population of individuals experienced Guillain Barré syndrome (GBS).³ Because of this, the recommendation of shared clinical decision-making allowed the patient and provider to assess risk before receiving a RSV vaccine. However, health care providers noted that this shared decision can often be confusing, time consuming, and difficult to implement, emphasizing the importance of updating the reccomendations.¹

“These updated recommendations are intended to maximize RSV vaccination coverage among persons most likely to benefit, by clarifying who is at highest risk and by reducing implementation barriers associated with the previous shared clinical decision-making recommendation,” said the study authors in a news release.¹

However, ACIP acknowledged that the risk-based recommendation for adults aged 60 to 74 years could result in a decrease of vaccinations among individuals at increased risk, compared to an age-based recommendation for this population. The authors noted that based on recent evidence, the benefits of RSV vaccination did not significantly outweigh potential harms among adults aged 60 to 74 years that did not have risk factors for severe disease, leading ACIP to make the recommendation.¹

“ACIP also stressed that research regarding RSV risk factors is ongoing, so providers should continue to have flexibility in offering RSV vaccine to patients they assess to be at increased risk for severe disease even if they do not fall into an explicitly named risk category. As with all vaccines, patients should be informed of the benefits and risks of RSV vaccination; for protein subunit RSV vaccines, this information includes potential risk for GBS,” said the study authors, in a news release.¹

REFERENCES

1. Use of Respiratory Syncytial Virus Vaccines in Adults Aged ≥60 Years: Updated Recommendations of the Advisory Committee on Immunization Practices — United States, 2024. CDC. News release. August 15, 2024. Accessed August 30, 2024.

2. Ferruggia K. ACIP Releases Updated RSV Recommendations. Pharmacy Times. News release. July 5, 2024. Accessed August 30, 2024. https://www.pharmacytimes.com/view/acip-releases-updated-rsv-recommendations.

3. Ferruggia K. CDC Evaluates Concerns of Guillain-Barré Syndrome Following RSV Vaccination. Pharmacy Times. News release. June 17, 2024. Accessed August 30, 2024. https://www.pharmacytimes.com/view/cdc-evaluates-concerns-of-guillain-barr-syndrome-following-rsv-vaccination.