FDA Update: Agency Approves First Respiratory Syncytial Virus Vaccine
On May 3, the U.S. Food and Drug Administration (FDA) approved Arexvy, a vaccine for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in individuals 60 years and older. Arexvy is the first vaccine for RSV approved for use in the U.S.
The agency is requiring GlaxoSmithKline Biologicals "to conduct a postmarketing study to assess the signals of serious risks for Guillain-Barré syndrome and [acute disseminated encephalomyelitis]… the company has committed to assess atrial fibrillation in the postmarketing study," as well.
For more information, access the FDA website.
Keywords: ACC Advocacy, Respiratory Syncytial Virus Vaccines, Biological Products, United States Food and Drug Administration, Respiratory Syncytial Viruses, Respiratory Tract Diseases
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