FDA Approves World's First RSV Vaccine

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Facts

  • On Wednesday, the US Food and Drug Administration (FDA) approved Arexvy, the world's first Respiratory Syncytial Virus (RSV) vaccine for adults 60 and older.1
  • The approval of Arexvy, developed by GlaxoSmithKline, is based on the FDA's analysis of data from a phase III clinical trial in which the vaccine's single-dose shot reduced the risk of lower respiratory tract disease caused by RSV by nearly 83%.2
  • Though the efficacy data on Arexvy is reportedly sufficient for approval, the FDA has acknowledged potential safety issues over Guillain-Barre syndrome — a rare neurological disorder that can result from the shot.3
  • Before the vaccine can be rolled out to the public, the US Centers for Disease Control and Prevention (CDC) must vote in favor to recommend its release. The advisory committee is scheduled to convene in June.4
  • GSK's vaccine is one of several RSV vaccines under review by the FDA, including Pfizer's RSVpreF. The FDA has asked Pfizer to conduct a safety study on the risk of Guillain-Barre syndrome if its vaccine is approved.5
  • According to the CDC, RSV leads to approximately 60K–160K hospitalizations and 6K–10K deaths among adults 65 and older each year. Among children younger than 5, the CDC reports that it causes an estimated 58K–80K hospitalizations and 100–300 deaths per annum.6

Sources: 1BBC News, 2GSK, 3USA Today, 4New York Post, 5CNBC, and 6CDC.

Narratives

  • Narrative A, as provided by Nature. The approval of the world's first RSV vaccine is a tremendous opportunity to help address a critical public health need. The development of Arexvy is a breakthrough that will save many lives by preventing millions from contracting a highly contagious, life-threatening disease.
  • Narrative B, as provided by Washington Post. It is essential to adequately assess this shot's efficacy and potential association with Guillain-Barré before releasing it for public use. Moreover, additional research is needed to determine if it can be given seasonally, like flu shots, and how effective it will be for RSV patients undergoing specific treatments, such as chemotherapy or organ transplants.

Predictions