Alliance Urges FDA and CDC Committees to Avoid Unnecessary Delays in Getting RSV Vaccines to Older Adults

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) convened today to discuss and make recommendations on the safety and effectiveness of vaccines for respiratory syncytial virus (RSV). Alliance Senior Vice President of Health Education and Advocacy Lindsay Clarke gave public comment stressing the importance of RSV vaccination for older adults:

Good afternoon. Thank you to the committee for this opportunity to comment. My name is Lindsay Clarke and I am the Senior Vice President of Health Education & Advocacy at the Alliance for Aging Research. The Alliance receives some industry funding for non-branded health education campaigns on older adult vaccination. 

One of the campaigns that I lead at the Alliance is the Our Best Shot campaign. Over the years this campaign has produced dozens of educational resources focused on raising awareness about the importance of vaccines in older adults, how they work, which ones are recommended by the CDC’s Advisory Committee on Immunization Practices, how the Medicare program covers vaccines, and more. The educational resources have included a focus on influenza, pneumonia, shingles, and COVID and this past year we produced an educational film on RSV in older adults, emphasizing to viewers that RSV is not just a pediatric disease. We know that the reported 14,000 deaths and 177,000 hospitalizations in older adults each year due to RSV are likely underestimated due to under testing and reporting of the disease.

We also know that in those older adults who are infected with RSV but don’t have serious complications, they can still pass the virus on to vulnerable children and infants in their lives.

In addition to adults ages 65 and older, adults ages 60 to 64 living with asthma, congestive heart failure, or chronic obstructive pulmonary disease (COPD) are at high risk for RSV-related hospitalizations and deaths. Studies from the CDC and others presented at the ReSViNET conference last week demonstrate that a higher proportion of adults ages 60 to 64 who were hospitalized and/or experienced severe outcomes due to RSV were Black, Hispanic, or American Indian/Alaskan Native. These racial and ethnic differences are critical for the FDA and CDC to recognize as they consider labeling and vaccine administration recommendations by age. Earlier—and higher—rates of asthma, congestive heart failure, or COPD in communities of color due to structural racism leads to earlier RSV onset and higher risk of hospitalization and severe outcomes, including deaths. We ask both agencies to heed the still-raw lessons of COVID-19 and work together to collect and analyze data by race/ethnicity as well as age to better ensure RSV vaccine equity—and equity for all other vaccines. Additionally, please do not layer on a shared clinical decision-making recommendation for this vaccine as a utilization management technique. It is not needed and will only reinforce known disparities.   

Effective vaccines for RSV in older adults clearly have the potential to make a tremendous impact and save tens of thousands of lives. We call on the CDC’s Advisory Committee on Immunization Practices to meet and vote on recommendations within a week or two of any FDA approval and to publish their recommendations in the MMWR without delay. While respiratory surges are no longer limited to the traditional cold and flu season, we know that the surges of influenza, COVID, pneumonia, RSV, and other respiratory illnesses continue to flood and overwhelm our healthcare system in the Fall and Winter months. That gives us six months to approve, recommend, and start administering these vaccines, while simultaneously educating older adults and clinicians about their benefits and availability.

Lastly, we urge the Federal government to make sure that the safety of co-administering multiple vaccines like RSV and influenza, COVID, or pneumonia is clearly communicated. We know from our education and outreach that misinformation about the safety of receiving multiple vaccines at once persists, and clear communication from the FDA, CDC and other agencies is critical in the distribution of reliable and trustworthy information on vaccination, and specifically on coadministration.

We are excited by the fact that RSV vaccines could be available for older adults before the start of this year’s cold and flu season. While general awareness and prevention will remain a priority for the Alliance, we look forward to being able to encourage older adults and all adults at high-risk to receive an RSV vaccine to protect themselves and their loved ones.

Thank you again for this opportunity.

The VRBPAC Meeting continues on March 1. Visit the FDA’s VRBPAC page to listen to the live meeting or view materials and recordings.