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GSK gets FDA nod for adult respiratory syncytial virus (RSV) vaccine

The FDA has granted accelerated approval for an intravenous drug to treat Alzheimer's Disease, according to a statement.

HQ Team

May 4, 2023: After nearly half a century of research, the first vaccine against respiratory syncytial virus (RSV) has been approved by the U.S. Food and Drug Administration (FDA).

The FDA has approved GSK Plc’s Arexvy vaccine for adults aged 60 and above to be given as a single shot. The vaccine will be available by August 2023, according to a statement released by the company.

The US FDA approval is based on GSK’s landmark positive pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial data.

GSK’s vaccine showed overall efficacy of 82.6% and was about 94% effective against severe lower respiratory tract disease associated with an RSV infection among participants aged 60 and older in its late-stage trial.

Leading pharmaceutical companies such as Pfizer, Moderna and  Bavarian Inc, all have been racing to gain approval for this disease that can be fatal for infants and the elderly. GSK has drawn ahead with its approval and will able to tap into this multi-billion-dollar market estimated to surpass $10 billion by 2030. Credit Suisse analysts expect $2.5 billion in peak sales for GSK’s RSV vaccine for older adults.

Vaccine frequency

Chief Commercial Officer Luke Miels of GSK said the vaccine would be priced above $120 per shot. A full marketing and pricing strategy will be drawn once data from a study proves that the shot protects against RSV for two seasons.

CDC’s panel of advisors on immunization will be meeting in June to decide the frequency of the injection.

The U.S. Centers for Disease Control and Prevention (CDC) said the last season for RSV started in June and peaked in November. The August release date will help combat the peak season for the disease

RSV and respiratory illness

RSV is a lower respiratory illness that does not cause much harm in healthy adults, but the virus can lead to pneumonia or bronchiolitis in clinically vulnerable people with comorbidities. Older people and infants are particularly at risk.  According to government estimates, RSV is responsible for 14,000 deaths in adults aged 65 and older and 500 infants annually in the United States.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) too has issued a positive response to the vaccine. A final European regulatory decision is anticipated in the coming months, while regulatory reviews are ongoing in Japan and several other countries.


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