The US Food and Drug Administration (FDA) has given approval for the first-ever vaccine to combat respiratory syncytial virus (RSV). Developed by GlaxoSmithKline (GSK), the vaccine, named Arexvy, is intended for use in adults aged 60 and above. RSV is the primary cause of hospitalisations for infants and young children in the US, with an estimated 58,000 to 80,000 admissions annually for those under five. The virus is also responsible for more than 177,000 hospitalisations among older adults and 14,000 annual deaths.
The efficacy of the vaccine was determined in clinical trials, with the results showing that Arexvy was 82% effective at preventing lower respiratory tract illness caused by RSV. This statistic increased to 94% for individuals with more than one underlying medical condition. The shot could help to reduce hospitalisations and deaths in the upcoming RSV season, which can cause mild, cold-like symptoms, but also kills up to 10,000 seniors and a few hundred children under the age of five each year.
GSK has millions of doses of the vaccine on hand, and is scheduled to meet with the US Centers for Disease Control and Prevention’s vaccine advisory committee in June. The regulatory body will determine potential vaccinations schedules for eligible individuals aged over 60. The shot has also been granted approval for use by the European Union.
Other RSV vaccines and treatments in development by other drug companies are presently under review by regulatory agencies, including monoclonal antibody nirsevimab by Sanofi and AstraZeneca, and RSVpreF, developed by Pfizer for both pregnant people and older adults. Although there have been a range of RSV vaccines in development for years, GSK won the competition unexpectedly ahead of the likes of Pfizer, having demonstrated a highly effective Arexvy efficacy of 82.6% in preventing confirmed lower respiratory tract disease caused by RSV.
The FDA’s approval of the Arexvy vaccine is a notable victory in the fight to protect vulnerable people against RSV. Pharmaceutical analysts have predicted that the global market for RSV vaccines will be worth more than $10bn by 2030, while GSK has forecast $2.5bn in peak sales for its RSV vaccine. Arexvy’s efficacy in patients aged 60 and above is compelling, with GSK’s late-stage trial establishing that it had an efficacy rating of 82.6% overall and was effective at preventing severe lower respiratory tract disease in 94% of participants. The vaccine is expected to be priced above $120 per shot.
The global RSV epidemic is a seasonal virus mostly occurring in the fall and winter, and typically causes mild, cold-like symptoms. However, older adults with diabetes or heart or lung disease are at greater risk of severe illness, meaning that it results in 60,000 to 160,000 hospitalisations annually for those over 65 in the US, plus 6,000 to 13,000 deaths. With the approval of the Arexvy vaccine, there is hope that these numbers can be dramatically reduced. If the vaccine is approved for use in the US and Europe, GSK stated that it could be authorised for use as early as next year and would be rolled out to seniors aged 60 and above.
In conclusion, the approval of the Arexvy vaccine is a significant development in fighting respiratory syncytial virus and protecting vulnerable groups from severe symptoms. Arexvy’s impressive efficacy rating in late-stage trials makes it a standout in a highly competitive field of vaccine development. With the potential to significantly reduce hospitalisations and deaths, and a large market expected for RSV vaccines, GSK’s success bodes well for public health and scientific breakthroughs.
