A view shows the headquarters of GlaxoSmithKline in London, England, January 17, 2022.
Hannah McKay Reuters
The Food and Drug Administration on Friday extended its approval GSKThe respiratory syncytial virus vaccine is for adults ages 50 to 59 who are at increased risk of getting sick from the virus that causes it.
The shot, called Arexvy, is the first vaccine cleared by the FDA to protect this population against RSV. The agency first approved GSK’s jab in May 2023 for patients 60 and over, who are more susceptible to severe cases of the virus.
RSV causes thousands of hospitalizations and deaths among the elderly each year, according to data from the Centers for Disease Control and Prevention. But the virus can also cause severe illness in adults 50 and older — or younger — with chronic conditions such as asthma, diabetes and congestive heart failure.
About 13 million Americans aged 50 to 59 are at risk of severe disease from RSV, Phil Dormitzer, GSK’s head of vaccine research and development and infectious disease research, said in an interview.
“It’s useful because, of course, you can meet the medical needs of that age group,” Dormitzer told CNBC, “but it’s also good for pharmacists to have a single vaccine that they can give to a larger population, so it gives them simplicity.”
The GSK shot has yet to reach that new patient population. An advisory panel for the CDC will vote later in June on a recommendation for GSK’s vaccine, along with competing shots from Pfizer and the newly approved jab of Modern.
The expanded FDA approval could help GSK maintain its dominance in the RSV market later this fall and winter, when the virus is typically more prevalent in the US. £699 million) in the revenue that the Pfizer vaccine raked in.
GSK Chief Commercial Officer Luke Miels said in an earnings call in May that the company remains “very confident” that Arexvy can bring in more than £3 billion in peak annual sales over time.
Dormitzer said GSK has been successful in the last RSV season, but noted that the company will always “take a lot of competition.”
They said Arexvy showed strong efficacy in patients with medical conditions.
In late-stage trials, a single dose of the shot produced an immune response in high-risk adults aged 50 to 59 that was no worse than that seen in people 60 and older.
A previous late-stage trial in an older age group found the shot was nearly 83% effective in preventing lower respiratory tract disease caused by RSV and about 94% effective in preventing severe disease.
Safety data in adults aged 50 to 59 is also consistent with data in adults 60 and above, according to GSK. Side effects include fatigue, headache and muscle pain, among others, which are usually mild to moderate.
The dose of one shot of GSK was only slightly less effective in adults 60 and above after two viral seasons, showing an efficacy of 67.2% against lower respiratory tract diseases. Dormitzer said the company will test the vaccine’s efficacy over three RSV seasons to see if it can provide longer protection.
GSK is also studying Arexvy in other groups of patients to expand the scope of the shot in the future. The company is expected to announce trial data later in 2024 on two separate groups of patients: people aged 18 to 59 who are at risk of severe RSV, and adults with weakened immune systems.
Dormitzer added that the company is also expanding its range of shots in other countries. Regulatory agencies in Europe, Japan and other regions are reviewing GSK’s application to expand Arexvy’s approval to high-risk adults aged 50 to 59.
GSK’s shot is approved in nearly 50 countries, a company spokesperson told CNBC.
