Sex: U
Vaccine: RSV
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barré Syndrome; This serious case was reported by a consumer and described the occurrence of guillain barre syndrome in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barré Syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported.   It was unknown if the reporter considered the guillain barre syndrome to be related to Arexvy.     It was unknown if the company considered the guillain barre syndrome to be related to Arexvy.   Additional Information: GSK receipt date: 14-MAR-2024 It was reported on 29th February, 2024, the Centers for Disease Control and Prevention's (CDC) presented a preliminary analysis that showed that 23 adults over the age of 65 who received a respiratory syncytial virus (RSV) vaccine developed Guillain Barre syndrome (GBS). The CDC's analysis evaluated preliminary rates of GBS following one dose of either GlaxoSmithKline RSVPreF3 plus AS01 (AREXVY) vaccine or Pfizer, RSVPreF (ABRYSVO) vaccine and compared it to the rates of GBS in an historical control group. The population studied included Beneficiaries over age 65 years and older enrolled in insurance Fee for Service. The study period for the Abrysvo RSV vaccine was from May 31, 2023 to December 2, 2023 and for Arexvy from May 3, 2023 to December 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 Decemeber 2, 2023. 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. 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. Data from the Food and Drug Administration (FDA) also illustrated a higher than expected number of GBS cases being reported in RSV vaccine recipients. Safety Office at the CDC said that taken together, these data suggest a potential increased risk (of GBS after RSV vaccinations). 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. Pfizer and GlaxoSmithKline Representatives Pledge to Investigate the Reported GBS RSV Link. Representatives of Pfizer and GlaxoSmithKline attended the ACIP meeting and made a statement noting that a safety signal for a vaccine is a complicated process to resolve. Head of Risk Assessment and Management at Pfizer said that Pfizer will conduct four different safety studies to investigate the incidence of GBS following RSV vaccination. GlaxoSmithKline representatives said that the current data on GBS was 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 link to article here. Pfizer was committed to the continuous monitoring and evaluation of the safety of Abrysvo and was conducting four safety studies to look into the possibility of vaccine related GBS. 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.