FDA Requires RSV Vaccine Labels to Include Guillain-Barré Syndrome Risk
On Jan. 7, 2025, the U.S. Food and Drug Administration (FDA) mandated and approved changes to the safety labeling for the Prescribing Information of two Respiratory Syncytial Virus (RSV) vaccines: Abrysvo (manufactured by Pfizer)1 and Arexvy (manufactured by GlaxoSmithKline Biologicals).2 This label change update is being required to inform both the public and health care […]
Moderna Halts RSV Pediatric Vaccine Trial After Five Infants Hospitalized
On Dec. 11, 2024, the U.S. Food and Drug Administration (FDA) announced that clinical trials for Moderna’s pediatric mRNA RSV vaccines have been paused due to safety concerns. The recent phase 1 trials of two experimental respiratory syncytial virus (RSV) vaccines for infants not only failed to provide adequate protection but may have worsened respiratory […]
WHO Names 17 Pathogens as Top Priorities for Global Vaccine Development
A new World Health Organization (WHO) study published in eBioMedicine last week highlights 17 viral and bacterial pathogens that are major sources of endemic disease around the world and that WHO officials believe should be urgently prioritized for vaccine development. The study marks the WHO’s first global effort to systematically prioritize endemic pathogens with epidemic […]
CDC Narrows RSV Vaccine Guidelines Due to Safety Concerns
The U.S. Centers for Disease Control and Prevention (CDC) has recently narrowed its original recommendations for the respiratory syncytial virus (RSV) vaccine, citing concerns over the risk of a side effect that can lead to paralysis or death. The recommendations originally stated adults over the age of 60 should receive the vaccine, but updates in […]
Guillain-Barré Syndrome ‘More Common Than Expected’ in Early RSV Vaccine Trial
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 […]
RSV Vaccines for Senior Adults Linked to Guillain-Barré Syndrome
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 […]
