FDA Approves First Vaccine for Respiratory Syncytial Virus

First doses will be available in the Fall. 

British drugmaker GlaxoSmithKline (GSK) announced this week that the Food and Drug Administration (FDA) has approved their respiratory syncytial virus (RSV) vaccine for use in patients 60 and over, a demographic that is particularly vulnerable to the virus. RSV can be fatal for elderly individuals, and the Centers for Disease Control (CDC) estimates that the virus kills 14,000 adults aged 65 and older each year. 

“Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. 

Now that the FDA has approved the vaccine, named Arexvy, the CDC needs to conduct a review to see how it should best be dosed. GSK Plc says that a single dose of the vaccine will provide protection for two years and will likely be priced at $120 per shot. Late-stage scientific trials for Arexvy found the vaccine to be about 94% effective against severe manifestations of RSV and about 83% effective against RSV in general.

As the Lord Leads, Pray with Us…

  • For Director Marks as he heads the Center for Biologics Evaluation and Research.
  • For FDA Commissioner Calliff as he oversees the approval process of medications and treatments.

Sources: Reuters, Axios, Newsmax


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