Tell FDA what you think about RSV shots for pregnant moms

Our Stand: at-a-glance

• FDA’s advisory committee, VRBPAC, will meet May 18, 2023, to discuss Pfizer’s RSV (Respiratory syncytial Virus) shot for pregnant women and infants.
• Virtually all children get RSV by 2 years of age. The vast majority have mild cases that don’t require hospitalization, and confers natural immunity to boot.
• According to international experts, 99% of infant mortality from RSV happens in resource-limited countries,[i] not places like the U.S.
• CDC says RSV causes approximately 58,000 hospitalizations and 100-500 deaths in children under 5 [ii] (A glance at the source data makes one curious about whether the death rate is overestimated because data about influenza, pneumonia, and RSV overlap.[iii])
• On May 3, 2023, the FDA approved an RSV vaccine for older adults, made by GSK (formerly known as GlaxoSmithKline).
• VRBPAC voted unanimously that GSK data met the stated goals for effectiveness, and 10-2 that data showed it was safe for use. One voting member, Dr. Griffin, wanted to make sure it was on record that the VRBPAC “yes” vote was to answer the questions posed, but wasn’t the same as voting for licensure: “I don’t think necessarily everyone who voted yes thinks that the vaccine should be licensed at this point. So, I just want to say that. Yeah, I think it’s a great study. I think the sponsor did a great job, I would be more comfortable with more data, more years of data.”[iv]
• The FDA did not approve the competing Pfizer RSV vaccine, Abrysvo. The advisory committee wanted more data, specifically more data reflecting the targeted age group, along with increased efficacy preventing hospitalizations and deaths.[v] The reason for this is because with RSV, infection itself is not the problem since most of the time infection is mild; the danger is in complications that arise.
• Pfizer’s Abrysvo is the vaccine to be considered for pregnant moms and infants on May 18, 2023. Will the FDA approve this vaccine for pregnant women, even though VBRPAC wanted more data for the same vaccine in older Americans?
• The FDA has already approved Nirsevimab, a long-acting monoclonal antibody to treat RSV in infants. So is the risk of a vaccine with a history of serious side effects in decades of clinical trials the appropriate way to approach RSV for American babies?
• Researchers have been attempting to create an RSV vaccine for decades. All attempts to date had been unsuccessful because the vaccines intensified the disease, even causing deaths in some trials.
• Pfizer stands to gain a lot of money from this vaccine. As SHF reported previously, the market for RSV is huge and wide open. Evaluate Pharma, which provides “commercial intelligence” and “financial services” for “pharma assets, reports, “consensus forecasts Arexvy and Abrysvo [the RSV vaccines] selling $1.8 billion and $1.2 billion respectively in 2028.”[vi]
• Both the FDA and the CDC have patented technologies that support the making of RSV vaccines, which have been available for private license within the last decade. If any RSV vaccine researchers purchased that technology, what financial benefits might the FDA see from licensure? Americans must demand transparency here.
• The ACIP is already planning to meet in June 2023 to determine whether to recommend the shot. If the RSV shot is put on the childhood vaccine schedule, the manufacturers will be immune from liability for any injury or death (even manufacturing defects) due to the 1986 Act. Do we want a vaccine with one of the most dangerous clinical trial histories to be free from liability if a pregnant mother or their child is harmed or dies after getting this shot?
• The FDA’s advisory panel wanted more data before the RSV vaccine was approved for older Americans. Do you think they will find adequate data for shots in pregnant women, if they didn’t find it enough for the older population?

Take action today by telling the FDA the risk of RSV shots for pregnant women does not outweigh the stated benefits. For more information on the RSV vaccine, please read our article linked here or in the button below.