Guillain-Barré Syndrome ‘More Common Than Expected’ in Early RSV Vaccine Trial
- by Natasha Hobley
- Published
- Risk & Failure Reports
Reports of the nervous system disorder Guillain-Barré syndrome (GBS) were “more common than expected” in the older adult population who received the new vaccine for respiratory syncytial virus (RSV). The data, reported by the U.S. Centers for Disease Control and Prevention (CDC), matched trial data reported earlier this year.1
GBS is a “polio-like” inflammatory autoimmune disorder in which a person’s immune system damages nerve cells, which can result in muscle weakness and paralysis of the face, respiratory system and limbs, including full body paralysis and can lead to death. GBS usually develops after an infection and symptoms include numbness and tingling, throbbing pain, heart rhythm problems, high blood pressure, slurred speech, difficulty swallowing and shortness of breath. Most people recover but, in some cases, the nerve damage is permanent.2
Current recommendations state that patients over the age of 60 should talk to their doctor to decide whether they should get the new RSV vaccine. Government officials still say that the benefits of the vaccine outweigh the risks and that they do not plan to change their recommendations.1
The most recent CDC report highlighted 28 cases of RSV vaccine-related GBS and all but one developed symptoms of GBS within 21 days after being vaccinated. Data from the Vaccine Adverse Event Reporting System (VAERS) revealed that there were 1.5 cases per one million in people who received GlaxoSmithKline’s (GSK) Arexvy RSV vaccine, and five cases per one million in people who received Pfizer’s Abrysvo RSV vaccine.
There were 18 reported deaths after RSV vaccinations that were attributed to “a variety of reasons,” two of which were associated with GBS. Other reported causes of death included severe respiratory illness and failure, cardiovascular events, hepatic encephalopathy, RSV infection, and sepsis, among others.3
GBS Long Known to Be a Complication of Vaccination
GBS has long been known to be a complication of vaccination, particularly the influenza and tetanus vaccines, and has also been reported after combination whole cell DPT and acellular DTaP vaccines.4
During an influenza A “swine flu” mass vaccination campaign in the U.S. in 1976, reports of fatal cases of GBS swiftly ended the campaign.5 There is a reported association between GBS and COVID shots—ranging from 0.81 percent to 1.91 cases per 100,000 persons.6
The South African Health Products Regulatory Authority (SAPHRA) confirmed two GBS deaths attributed to Johnson & Johnson/Janssen’s Ad26.COV2.S COVID vaccine in 2022.5 In addition to an association between GBS and viral vectored and DNA COVID vaccines, medical literature reviews have published reports of GBS following mRNA COVID shots.7
RSV Vaccine Granted Fast Track FDA Approval
The U.S. Food and Drug Administration (FDA) fast tracked the approval process of the Pfizer and GSK RSV vaccines for senior citizens. To quality for an accelerated “fast track” path to licensure, pharmaceutical companies must demonstrate their product fills an “unmet medical need,” which is defined as “providing therapy where none exists or providing a therapy which may be potentially better than available therapy.”8
RSV Vaccine Recommended for Pregnant Women, Infants
The Pfizer RSV vaccine has also recently been recommended by the CDC for pregnant women.9 For babies whose mothers did not get as RSV vaccination during pregnancy, the CDC recommends giving the infant a one-dose injection of a monoclonal antibody known as nirsevimab (Beyfortus)—despite 12 infant deaths being reported during clinical trials of the new monoclonal antibody. Two of the infants died from “unknown causes,” while the other 10 deaths were attributed to “underlying disease.”10
In the late 1960s, an RSV vaccine known as formalin-inactivated RSV (FI-RSV) was produced for children by inactivating the RSV virus using formalin, a chemical containing 40 percent formaldehyde. The experimental RSV vaccine was given to children in Washington DC, but 80 percent of them were hospitalized with severe respiratory disease and two children died. Studies found that the vaccine failed to generate enough antibodies to fight off the virus and instead triggered an overactive immune response that led to hospitalization and death.11
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