The FDA has mandated new warning labels for two respiratory syncytial virus (RSV) vaccines due to an increased risk of Guillain-Barré syndrome (GBS). The affected vaccines are Pfizer’s Abrysvo and GSK’s Arexvy.
Key Highlights for Patients and Healthcare Providers
- New Safety Warning
- Mandatory GBS risk label for Abrysvo and Arexvy
- Applies to vaccines targeting individuals 65 and older
- Specific Risk Metrics
- Approximately 9 excess GBS cases per million Abrysvo doses
- Approximately 7 excess GBS cases per million Arexvy doses
- What is Guillain-Barré Syndrome (GBS)?
- Rare neurological disorder
- Causes potential muscle weakness
- Can lead to temporary paralysis
- Triggered by immune system response
- FDA’s Balanced Perspective
- Benefits still outweigh potential risks
- No definitive causal relationship established
- Continued vaccine recommendation
Recommended Actions
- Consult healthcare provider before vaccination
- Monitor for neurological symptoms post-vaccination
- Discuss individual risk factors
The FDA has mandated new warning labels for two respiratory syncytial virus (RSV) vaccines due to an increased risk of Guillain-Barré syndrome (GBS)[1][2]. The affected vaccines are Pfizer’s Abrysvo and GSK’s Arexvy[3].
Key Points:
- Warning Requirement: Both vaccines must now include a warning about the potential increased risk of GBS within 42 days following vaccination[1][2].
- Risk Assessment: A postmarketing observational study using Medicare data estimated:
- 9 excess cases of GBS per million doses of Abrysvo
- 7 excess cases of GBS per million doses of Arexvy
among individuals aged 65 and older[2].
- Nature of GBS: Guillain-Barré syndrome is a rare neurological disorder that can cause muscle weakness and, in severe cases, paralysis due to the immune system damaging nerve cells[3][4].
- FDA’s Position: While the evidence suggests an increased risk, the FDA states that available data is insufficient to establish a definitive causal relationship between the vaccines and GBS[2][6].
- Continued Recommendation: Despite the new warnings, the FDA has determined that the benefits of vaccination with Abrysvo and Arexvy continue to outweigh their risks[7].
Healthcare professionals are advised to monitor patients for signs of GBS following vaccination with these RSV vaccines[3].
Citations:
[1] https://www.cidrap.umn.edu/respiratory-syncytial-virus-rsv/fda-requires-guillain-barre-label-warnings-2-rsv-vaccines
[2] https://www.pharmexec.com/view/fda-mandates-updates-prescribing-information-rsv-vaccines-abrysvo-arexvy-increased-guillain-barr-syndrome-risk
[3] https://www.beckershospitalreview.com/pharmacy/fda-mandates-warnings-for-2-rsv-vaccines.html
[4] https://www.usnn.news/fda-mandates-nerve-damage-warnings-for-2-rsv-vaccines/
[5] https://www.biopharmadive.com/news/fda-gbs-warning-rsv-vaccine-label-pfizer-gsk/736776/
[6] https://respiratory-therapy.com/disorders-diseases/infectious-diseases/rsv/fda-mandates-guillain-barre-syndrome-warning-two-rsv-vaccines/
[7] https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-requires-guillain-barre-syndrome-gbs-warning-prescribing-information-rsv-vaccines-abrysvo-and
[8] https://www.fda.gov/safety/medical-product-safety-information/fda-requires-guillain-barre-syndrome-gbs-warning-prescribing-information-rsv-vaccines-abrysvo-and
[9] https://x.com/CAInsiderNews/status/1877468238273196344
[10] https://www.fiercepharma.com/pharma/rsv-vaccines-pfizer-gsk-take-another-hit-fda-label-warning
[11] https://www.reuters.com/business/healthcare-pharmaceuticals/gsk-pfizers-rsv-vaccines-carry-warnings-neurological-disorder-risk-2025-01-07/
Source: Midtown Tribune