CDC publishes recommendations on use of RSV vaccines

Adults 60 years of age and older may receive one of two recently approved vaccines for respiratory syncytial virus (RSV), according to the Advisory Committee on Immunization Practices (ACIP).

In May, the FDA approved the first two vaccines for RSV for this age group, one manufactured by GSK and the other by Pfizer. On June 21, ACIP recommended that persons ages 60 years and older may receive a single dose of RSV vaccine, using shared clinical decision-making. The recommendations became official CDC policy on July 21 when they were published in MMWR.

ACIP reviewed data from clinical trials showing that vaccination with a single dose of either RSV vaccine demonstrated moderate to high efficacy in preventing symptomatic RSV-associated lower respiratory tract disease in older adults over two consecutive RSV seasons. While the trials were underpowered to estimate efficacy against RSV-associated hospitalization and death, the evidence suggests that vaccination may prevent considerable morbidity from RSV disease in this age group, ACIP said.

Regarding safety, six cases of inflammatory neurologic events, including Guillain-Barré syndrome, were reported after vaccination in clinical trials, although the vaccines were well tolerated in general, the statement said. “Until additional evidence becomes available from postmarketing surveillance clarifying 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 and therefore most likely to benefit from vaccination,” the statement said. “The recommendation for shared clinical decision-making is intended to allow flexibility for providers and patients to consider individual risk for RSV disease, while taking into account patient preferences.”

The statement said the vaccine should be administered as a single dose, ideally before RSV season begins, although typical RSV seasonality has been interrupted by the COVID-19 pandemic. “For the 2023-24 season, clinicians should offer RSV vaccination to adults aged ≥60 years using shared clinical decision-making as early as vaccine supply becomes available and should continue to offer vaccination to eligible adults who remain unvaccinated,” the statement said. ACIP said that it is acceptable to coadminister the RSV vaccine with other adult vaccines, but this can increase the risk for local or systemic reactions, so clinicians should consider whether the patient is up to date with currently recommended vaccines and whether they will likely return for additional vaccine doses, among other factors.

“As with all vaccines, RSV vaccination should be delayed for persons experiencing moderate or severe acute illness with or without fever,” the statement cautioned. “RSV vaccines are contraindicated for and should not be administered to persons with a history of severe allergic reaction, such as anaphylaxis, to any component of the vaccine.”