Key takeaways:
- The FDA has approved the world’s first vaccine for Respiratory Syncytial Virus (RSV) for adults aged 60 and up, made by GSK.
- The single-dose shot was found to lower the risk of symptomatic illness by 83% and of severe illness by 94% in a late-stage clinical trial.
- The approval of the RSV vaccine is a major milestone in public health and will help protect older Americans from the virus.
The Food and Drug Administration (FDA) has approved the world’s first vaccine for Respiratory Syncytial Virus (RSV), a shot for adults aged 60 and up, made by pharmaceutical giant GSK. This marks a major public health achievement in the prevention of a potentially life-threatening disease.
The FDA’s decision follows a wide majority vote in favor of the safety and efficacy of GSK’s Arexvy vaccine at an advisory meeting in March. The single-dose shot was found to lower the risk of symptomatic illness by 83% and of severe illness by 94% in a late-stage clinical trial.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement that the approval reflects the agency’s commitment to facilitating the development of safe and effective vaccines for use in the United States.
The development of a vaccine for RSV has been a long time coming, with researchers attempting to develop one for roughly 60 years. Dr. Phil Dormitzer, GSK’s senior vice president and global head of vaccines research and development, said the company is already manufacturing doses and expects to make them available to the public this fall.
The approval of the RSV vaccine is a major milestone in public health and will help protect older Americans from the virus. It is a testament to the dedication of researchers and the FDA in their commitment to providing safe and effective vaccines.
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