FDA says RSV vaccines must come with Guillain-Barré warning
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Key takeaways:
- The FDA will require RSV vaccines to carry a warning about Guillain-Barré syndrome.
- Federal vaccine advisors expressed concern about a potential association between the shots and the rare disorder.
The FDA is adding a warning about Guillain-Barré syndrome to the respiratory syncytial virus vaccines manufactured by GSK and Pfizer based on data that suggest there may be a link between the shots and the rare disorder.
The agency said the benefits of receiving one of the vaccines still outweigh the risks.
“FDA has determined that the overall body of evidence suggests increased risks of [Guillain-Barré] with Abrysvo and Arexvy, but that available evidence is insufficient to establish a causal relationship,” the FDA said in a press release.
The agency said it approved safety labeling changes for GSK’s Arexvy and Pfizer’s Abrysvo after a postmarketing observational study demonstrated a potential risk for Guillain-Barré syndrome (GBS) within 42 days of receiving one of the shots and based on an analysis of clinical trial data and reports to the Vaccine Adverse Event Reporting System (VAERS).
The FDA approved the two vaccines in May 2023 for people aged 60 years or older. Soon after, the CDC recommended that older patients consider receiving one.
The CDC strengthened that recommendation last June to say all adults aged 75 years or older should get vaccinated against RSV, and that adults aged 60 to 74 years with risk factors should also get one of the shots, but it no longer recommended vaccination for low-risk adults aged 60 or older.
In deliberating its recommendations for the shots, the CDC’s Advisory Committee on Immunization Practices discussed data suggesting there was an increased risk for GBS. Although it said an initial analysis did not provide “clear, conclusive” evidence for the risk, the ACIP concluded that an elevated GBS risk for older adults who received the vaccine “could not be ruled out.”
In October 2024, FDA researchers presented data to the ACIP from the 2023-2024 respiratory season that suggested an increased risk for GBS from the vaccines among adults aged 65 years or older. The researchers noted that the results were consistent with data from earlier clinical trials and VAERS.
The FDA also analyzed Medicare claims from beneficiaries aged 65 years or older who received one of the vaccines between May 2023 and July 2024 and identified an increased risk for GBS within 42 days of vaccination — roughly nine excess cases per million doses of Abrysvo and roughly seven excess cases per million doses of Arexvy among people aged 65 years and older, according to the agency.
The decision, the FDA said, was “based on the totality of data from clinical trials, reports to VAERS and the results of self-controlled cases series analyses in an observational study conducted by FDA that suggest increased risks of GBS with Abrysvo and Arexvy.
“FDA has further determined that the benefits of vaccination with Abrysvo and Arexvy continue to outweigh their risks,” the agency added.
GBS is a rare disorder that can cause nerve damage and lead to muscle weakness or paralysis, the FDA noted. RSV is a major cause of hospitalization among older adults, particularly those aged older than 75 years. The shots made by GSK and Pfizer were the first RSV vaccines ever approved globally after decades of development.
References:
- Britton A, et al. MMWR Morb Mortal Wkly Rep. 2024;doi:10.15585/mmwr.mm7332e1.
- CDC. Evaluation of Guillain-Barré syndrome (GBS) following respiratory syncytial virus (RSV) vaccination among adults 65 years and older. https://www.cdc.gov/acip/downloads/slides-2024-10-23-24/05-RSV-Adult-Lloyd-508.pdf. Published Oct. 24, 2024. Accessed Jan. 8, 2025.
- FDA requires Guillain-Barré syndrome (GBS) warning in the prescribing information for RSV vaccines Abrysvo and Arexvy. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-requires-guillain-barre-syndrome-gbs-warning-prescribing-information-rsv-vaccines-abrysvo-and. Published Jan. 7, 2025. Accessed Jan. 8, 2025.
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