RSV Vaccines for Senior Adults Linked to Guillain-Barré Syndrome
- by Rishma Parpia
- Published March 11, 2024
- Risk & Failure Reports
On Feb. 29, 2024, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) presented a preliminary analysis that showed that 23 adults over the age of 65 who received a respiratory syncytial virus (RSV) vaccine developed Guillain-Barré syndrome (GBS).1 When a person develops GBS, including after an infection or vaccination, the body attacks the peripheral nerves. GBS symptoms begin with muscle weakness and numbness or tingling in different parts of the body and recovery can be complete or paralysis of one or more limbs can occur, including full body paralysis, which can lead to death.2
The CDC’s analysis evaluated preliminary rates of GBS following one dose of either GSK plc’s RSVPreF3+AS01 (AREXVY) vaccine or Pfizer, Inc.’s RSVPreF (ABRYSVO) vaccine and compared it to the rates of GBS in an historical control group.
The data used in the study was collected from the Centers for Medicare & Medicaid Services (CMS) administrative claims and enrollment information that was derived from CMS Medicare Shared Systems Data (SSD). The population studied included CMS Medicare Beneficiaries over age 65 years and older enrolled in Medicare Fee-for-Service.
The study period for the ABRYSVO RSV vaccine was from May 31, 2023 to Dec. 2, 2023 and for AREXVY from May 3, 2023 to Dec. 2, 2023. The people who were used as part of the analysis either had one dose of ABRYSVO or AREXVY after the CDC’s RSV vaccine authorization and prior to the data through Dec. 2, 2023.3
Increased Risk of GBS Observed for Both RSV Vaccines
The analysis showed an elevated risk of GBS, with 13 cases of GBS following one dose of ABRYSVO and less than 11 cases of GBS following a dose of AREXVY.4
According to the data, in the 21-day period following vaccination, the rate of GBS among seniors who received ABRYSVO was 4.6 per 1 million vaccine doses and 1.1 per 1 million vaccine doses for those who received AREXVY.5
Data from the U.S. Food and Drug Administration (FDA) also illustrated a higher- than-expected number of GBS cases being reported in RSV vaccine recipients. Tom Shimabukuro, MD, director of the Immunization Safety Office at the CDC said:
Taken together, these data suggest a potential increased risk [of GBS after RSV vaccinations].6
Health officials at the CDC were aware that cases of GBS had been identified in clinical trials prior to the approval for public use, and that there were surveillance systems in place monitoring any new cases.7
Pfizer and GSK Representatives Pledge to Investigate the Reported GBS-RSV Link
Representatives of Pfizer and GSK attended the ACIP meeting and made a statement noting that a safety signal for a vaccine is a complicated process to resolve. Reema Mehta, Head of Risk Assessment and Management at Pfizer said:
Pfizer is committed to the continuous monitoring and evaluation of the safety of Abrysvo and is conducting four safety studies to look into the possibility of vaccine-related GBS.8
Mehta added that Pfizer will conduct four different safety studies to investigate the incidence of GBS following RSV vaccination.9
GSK representatives said that the current data on GBS is limited and uncertain. A spokesperson from the company said that the vaccine maker intends to initiate a controlled epidemiological study to evaluate the GBS link to the RSV vaccine and is the process of currently developing the study. They stated:
Patient safety is our highest priority, and we will continue to monitor diligently all safety data reported in the ongoing RSV older adult clinical trials and in post-marketing pharmacovigilance systems.10
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