FDA approves GSK's RSV vaccine for high-risk adults ages 50 to 59, expanding the vaccination's reach

The Food and Drug Administration on Friday approved GSKRespiratory syncytial virus vaccine for adults aged 50 to 59 years who’re at increased risk seriously ailing from the possibly deadly virus.

The vaccine, called Arexvy, is the primary FDA-approved vaccine to guard this population against RSV. The agency first approved GSK's vaccine for patients in May 2023 60 and olderwho’re more vulnerable to severe cases of the virus.

RSV causes hundreds of hospitalizations and deaths amongst seniors annually, based on Data from the Centers for Disease Control and Prevention. But the virus may cause serious illness in adults ages 50 and older – and even younger – with underlying chronic diseases similar to asthma, diabetes and heart failure.

About 13 million Americans between the ages of fifty and 59 are at high risk of severe illness from RSV, Phil Dormitzer, head of vaccine research and development and infectious disease research at GSK, said in an interview.

“On the one hand, it's useful because it obviously allows you to meet the medical needs of that age group,” Dormitzer told CNBC, “but it's also nice for pharmacists to have a single vaccine that they can administer to a larger population, which makes it simpler.”

GSK's vaccine is not going to yet reach this latest group of patients. A CDC advisory panel will vote on recommendations for GSK's vaccine later in June, together with a rival vaccine from Pfizer and a newly approved vaccine from Modern.

The FDA’s expanded approval could help GSK maintain its dominant position within the RSV market in the autumn and winter, when the virus typically spreads further within the US The British pharmaceutical company's vaccine generated sales of around £1.2 billion last 12 months, surpassing the 890 million US dollars (about £699 million) of revenue generated by Pfizer’s vaccine.

GSK Chief Commercial Officer Luke Miels said on a conference call in May that the corporate stays “very confident“that Arexvy can achieve peak annual revenues of over £3 billion over time.

Dormitzer said GSK had success within the last RSV season, but noted that the corporate will at all times “take the competition seriously.”

He said Arexvy had shown strong efficacy in patients with pre-existing conditions.

In a late-stage study, a single dose of the vaccine in high-risk adults ages 50 to 59 elicited an immune response no worse than that seen in people ages 60 and older.

An earlier late-stage study on this older age group found that vaccination was almost 83% effective in stopping lower respiratory tract disease attributable to RSV and about 94% effective in stopping severe disease.

According to GSK, the security data in adults aged 50 to 59 years were also consistent with the information in adults aged 60 and over. Side effects included fatigue, headache and muscle pain, most of which were mild to moderate.

A single dose of GSK’s vaccine was only barely less effective in adults aged 60 and over after two virus seasons, showing 67.2% effectiveness against lower respiratory tract disease. Dormitzer said the corporate will test the vaccine's effectiveness over three RSV seasons to see if it may well provide even longer protection.

GSK can also be studying Arexvy in other patient groups to expand the vaccine's reach in the long run. The company expects to announce study data in two different patient groups during 2024: people aged 18 to 59 who’re at increased risk of severe RSV infection and adults with weakened immune systems.

Dormitzer added that the corporate can also be expanding the vaccine's reach in other countries. Regulators in Europe, Japan and other regions are currently reviewing GSK's application to expand Arexvy's approval to incorporate high-risk patients ages 50 to 59.

GSK's vaccine has been approved in nearly 50 countries, an organization spokesperson told CNBC.

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