Infectious Diseases: New Therapeutics

Respiratory Syncytial Virus Vaccine - An important Public Health intervention: Focus on Adults

On June 26, 2024, new ACIP and CDC recommendations significantly changed the landscape for deciding which adults should receive an RSV vaccine. View the Evidence to Recommendations Framework for RSV Vaccination in Adults Aged 50 59 years, 60 74 years, and 75 years and older. This is an excellent resource that illustrates the ACIP deliberation process. Also, view a comprehensive list of the ACIP slides and documents from the June 26th ACIP RSV meeting.

Summary:
The ACIP and CDC considered 3 models for vaccine policy making: 1) universal recommendations, 2) risk-based recommendations, and 3) shared clinical decision making (SCDM). Interestingly, one of the outcomes of that meeting is that the new recommendations for use have narrowed, resulting in fewer patients likely to receive an RSV vaccine. Previously, RSV vaccination was recommended for all adults age 60 and greater. Universal recommendations are no longer recommended for those ages 60-74. Previous recommendations been replaced by a risk-based approach for this age group.

Key points from the ACIP meeting include:

Risk-based policy recommendations are favored over SCDM approaches in adults ages 60-74, therefore, adults ages 60 to 74 with a higher risk of severe disease due to underlying medical conditions should receive a single lifetime dose of an RSV vaccine
Universal-based policy recommendations were made for all adults age 75 and older. This group should receive a single life-time dose of an RSV vaccine.
- The transition from SCDM to a universal recommendation among adults 75 years and older and a risk-based recommendation among adults aged 60–74 years and is intended to:
  - Clarify the “call to action”, minimizing the burden of SCDM.
  - Maximize vaccination among persons most likely to benefit among whom there is now real-world evidence of protection.
  - Minimize vaccination among persons least likely to benefit while additional safety data accrue.
SCDM remains an option for at risk patients ages 50-59 and clinicians can opt to treat with Arexvy; however, the costs to patients may be higher if insurance does not provide coverage. Just days before the ACIP meeting, the FDA had approved the Arexvy vaccine for this age group when patients are at higher risk for severe disease.
- In an 11-0 vote, the ACIP Expert Committee voted to not make any recommendation on use of the Arexvy vaccine in adults ages 50 to 59, saying they did not have enough data with which to make a broad policy recommendation.
- Importantly, this opinion is NOT a recommendation against the use of RSV vaccine in adults aged 50 59 years.
For adults ages 60 years and older who remain unvaccinated, ACIP encourages timing of RSV vaccination to be given in the late summer and early fall to optimize public health benefits
RSV vaccination is recommended as a single lifetime dose. Persons who have already received RSV vaccination are NOT recommended to receive another dose.
Safety - uncertainty remains regarding the magnitude of potential risk of Guillain Barre syndrome (GBS). The GBS signal continues to warrant close attention and additional follow-up.
Three RSV vaccines are now FDA approved for adult use in the US. In addition to the 2 protein-subunit based vaccines (Arexvy and Abrysvo), the mRNA-based RSV vaccine will be marketed under the trade name MRESVIA and was FDA approved on June 14th for use in adults age 60 and older.
- Interestingly, the FDA labeling for MRESVIA is silent on whether the patient should have an underlying risk factor that puts them at higher risk of severe disease; however, the ACIP’s analysis supported use in the 60-74 age group when patients had a higher risk of severe disease.
- View the approved MRESVIA labeling (package insert), the Summary for Basis of Approval, the FDA approval letter, and supporting documents here.
When an RSV vaccine is indicated in adults, ACIP did not find evidence that supports preferential use among the 3 available products.

The significant changes in recommendations are intended to be a more clear “call to action” and should not daunt the efforts of providers to vaccinate all high risk patients. Public health providers, Boards of Health, and immunizing pharmacists should take steps now to understand the new recommendations and the 3 vaccines commercially available and prepare for the upcoming vaccination season.

Posted July 2, 2024