Learning about FDA vax approval process quells fears

Information about the Food and Drug Administration’s vaccine approval process makes people more likely to recommend the RSV vaccine for pregnant family members or friends, a survey shows.

Researchers conducted the experiment as part of a May 31 to June 6, 2023, nationally representative panel survey on RSV, vaccination, and maternal health. Researchers found that 57% of those in a group shown a flowchart of the FDA vaccine approval process 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.

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 GSK and Pfizer 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 August 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,” says Kathleen Hall Jamieson, director of the Annenberg Public Policy Center at the University of Pennsylvania 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.”

The study is part of a new white paper 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 US adults, first empaneled in April 2021 and conducted for APPC by the independent market research firm SSRS. The 11th wave of the panel, in which the experiment was embedded, was with 1,601 US 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.

The report 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.

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.
• Preemptively 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.

Source: Penn

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