Introduction
The FDA has issued a new requirement for GSK’s Arexvy and Pfizer’s Abrysvo RSV vaccines: a warning about the potential risk of developing Guillain-Barré syndrome (GBS). GBS is a rare neurological condition that can cause paralysis, and this warning comes after the FDA conducted a postmarketing observational study
Why Its Important
●Increased Risk: The study found an increased risk of GBS within 42 days of receiving the RSV vaccine. For adults aged 65 and older, the FDA estimates about nine cases of GBS per million doses of Pfizer’s Abrysvo and seven cases per million doses of GSK’s Arexvy.
●Not a Causal Relationship: It’s important to note that while the study suggests an increased risk, the FDA has stated that there is insufficient evidence to establish a causal relationship between the vaccines and GBS.
●Benefits Outweigh Risks: Despite this potential risk, the FDA maintains that the benefits of vaccination with Arexvy and Abrysvo still outweigh the risks. In fact, the FDA noted that each million of RSV vaccine doses administered could prevent nearly 10,000 hospitalizations in adults aged 60 and older.
●Vaccine Usage: Initially approved for adults 60 and older, the CDC now recommends these vaccines primarily for those 75 and older, and those 60 and older with high-risk medical conditions, because of the potential link to GBS.
●Safety Profile: GSK has reported that over 9 million people in the U.S. have received Arexvy and that it has an overall acceptable safety profile.
What it means for Patients?
People in the recommended age groups or those who have high-risk medical conditions, need to discuss the risks and benefits of the RSV vaccine with their healthcare provider. While there is a slight increased risk of GBS, the vaccines have also been proven to prevent hospitalizations from RSV. This new warning on the label will help individuals and their doctors make informed decisions about vaccination.
