How to increase acceptance of an RSV vaccine? Explain the FDA’s vaccine approval process

PHILADELPHIA – A new study finds that people are more likely to recommend that a pregnant family member or friend get vaccinated to protect the infant from RSV illness if they are shown a chart outlining the rigorous process a vaccine undergoes to be approved by the Food and Drug Administration (FDA).

The experiment was conducted by an Annenberg Public Policy Center (APPC) team as part of a May 31-June 6, 2023, nationally representative panel survey on RSV, vaccination, and maternal health. Researchers found that 57% of those in a group exposed to a flowchart of the FDA vaccine approval process (see Appendix 1) were very or somewhat likely to recommend the RSV vaccine to a pregnant family member or friend, compared with 40% of those in a control group not shown the chart. Those in a third group, informed about the risks of RSV, were also more likely (58%) to recommend the vaccine (see graphic).

RSV, or respiratory syncytial virus, is the leading cause worldwide of lower respiratory tract infections in babies. Virtually all children get an RSV infection by the age of two. Though typically mild, the highly contagious RSV virus can cause serious illness, hospitalization, and even death among infants and the elderly.

The FDA has not yet approved an RSV vaccine for pregnant people. The FDA approved RSV vaccines by Pfizer and GSK for adults 60 and older and is considering the Pfizer vaccine for pregnant people, which would activate antibodies that would be passed on to the infants to protect them in their first six months. Separately, on Aug. 3, the Centers for Disease Control and Prevention (CDC) recommended another form of preventive treatment against RSV, a monoclonal antibody injection for infants under eight months old and some older babies at risk of severe illness.

“Over the years the FDA and CDC have developed a sophisticated review system designed to protect the integrity of the data as well as the independence of the analysis on which the vaccination vetting and approval process relies,” said Kathleen Hall Jamieson, director of the Annenberg Public Policy Center and director of the survey. “The public would be well served if the press were to remind the public of this review process when a new vaccine is announced and vigilantly monitor it to ensure that it is doing its intended job well.”  

Survey and study data on RSV

The study is part of a new white paper from the Annenberg Public Policy Center of the University of Pennsylvania that looks at misconceptions about vaccination during pregnancy. “Reducing susceptibilities to misconceptions about vaccination during pregnancy: RSV” is the second in a series of Vaccine Communication and Fact-Checking Toolkit reports produced in partnership with Critica, a nonprofit organization that seeks to improve public understanding and acceptance of scientific evidence and counteract health- and science-related misinformation.

The report contains survey data from the Annenberg Science and Public Health knowledge survey (ASAPH) of U.S. adults, first empaneled in April 2021 and conducted for APPC by the independent market research firm SSRS. The 11^th wave of the panel, in which the experiment was embedded, was with 1,601 U.S. adults and fielded May 31-June 6, 2023. It has a margin of sampling error (MOE) of ± 3.3 percentage points at the 95% confidence level.

Correcting or contextualizing problematic claims about RSV or vaccination

The report “Reducing susceptibilities to misconceptions about vaccination during pregnancy: RSV” addresses ways to correct or contextualize misleading or false claims about maternal vaccination in general and vaccination against RSV among those who are pregnant in particular. These include misleading claims about the need for an RSV vaccine and unsupported claims about treatments that should be considered as options. Other examples include:

• Distortions about the safety of an RSV vaccine for pregnant individuals
• Distortions about vaccine ingredients
• Distortions about the effects of the RSV vaccine

Recommendations

The report makes a series of recommendations for public health officials and others who communicate with the public about health about ways to minimize public susceptibility to misinformation about RSV and vaccination, including:

• Visually represent the effects of RSV and offer clear and accurate information about the risks and benefits of vaccination compared with the likelihood of infection and its risks.
• The CDC should create a webpage that complements existing information on RSV but focuses on vaccination during pregnancy.
• Pre-emptively communicate about the changing nature of science by including caveats indicating that the guidance on RSV vaccination will be updated as more is learned about the vaccine.
• Increase public understanding of the FDA review process.

The report and the experiment

To read more about these findings and recommendations:

• Download the report here
• Download Appendix 1 with the experiment on RSV
• Read FactCheck.org’s Q&A on the RSV vaccines for older adults.
• Read FactCheck.org’s Q&A on the RSV maternal vaccine to protect infants
• Download the current version of the FDA vaccine approval chart from FactCheck.org

The experiment was designed by Patrick E. Jamieson, Ph.D., director of APPC’s Annenberg Health and Risk Communication Institute, the data analyzed by research analyst Shawn Patterson, Ph.D., and the chart created by FactCheck.org’s managing editor, Lori Robertson.

Some of the research included in the report was conducted as part of a grant from the Robert Wood Johnson Foundation. The views expressed in the report do not necessarily reflect the views of the Foundation.

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The Annenberg Public Policy Center was established in 1993 to educate the public and policy makers about communication’s role in advancing public understanding of political, science, and health issues at the local, state, and federal levels.

Critica is a nonprofit organization whose mission is to develop and test new methods of advancing public acceptance of scientific evidence, counteracting scientific misinformation, and promoting the use of scientific evidence in public policymaking.

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