Vaccination

FDA Approves World's First RSV Vaccine

MAY 4 2023·Updated MAY 5 2023

Story

Image credit: cnn

The 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.
BBC News
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%.
GSK
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.
USA Today
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.
New York Post
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.
CNBC
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.
CDC

Sources Split

LEFT

CENTER

RIGHT

ESTAB
CRIT

CENTER

PRO
ESTAB

The Spin

Narrative A

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.

Nature

Narrative B

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.