CHMP decision levels the playing field for GSK's RSV jab

GSK's respiratory syncytial virus (RSV) vaccine Arexvy should have its label expanded to make it an option for all adults aged 18 and over, extending its current approval in people aged 50 and over, according to the EMA's human medicines committee.

The recommendation by the CHMP should now result in approval of Arexvy in the broader age range in February next year, and will put the shot on equal footing in the adult population with Pfizer's Abrysvo and Moderna's mResvia, which are both already approved for use in the 18 and over age group.

Arexvy is a key growth product in GSK's vaccines business, contributing £251 million ($286 million) in sales in the third quarter, up 36% on the prior year and driven by demand outside the US, which has seen weak demand following changes to immunisation recommendations and a regulatory environment that is viewed as increasingly anti-vaccine.

Pfizer reported that total third-quarter sales of Abrysvo fell 22% to $279 million, although ex-US sales increased 75%. Its shot is the one that is also approved for use in pregnancy to protect infants from birth up to six months of age. Moderna, meanwhile, recorded sales of just $2 million for mResvia in the same period.

Arexvy was the first RSV vaccine approved in Europe for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults, initially in the over 60s and then in people aged 50 to 59 in individuals considered at elevated risk of RSV disease.

RSV causes hundreds of thousands of hospitalisations in the EU annually, particularly in infants under five and older adults, leading to significant healthcare costs, lost productivity, and deaths.

According to a 2023 paper published in the Journal of Infectious Diseases, an average of 158,000 adults aged 18 and over are hospitalised in the EU due to RSV infections each year, which the authors concluded was an important finding in "a condition considered in the past to be primarily a disease of young children."

While serious disease in younger adults is rare, the risk is increased by underlying chronic conditions, such as obesity, diabetes, chronic obstructive pulmonary disease (COPD), heart failure, chronic kidney disease, and asthma.

"Today's positive CHMP opinion is an important step towards bringing more options to prevent severe RSV disease for adults in Europe," said Sanjay Gurunathan, head of vaccines and infectious diseases R&D at GSK.

"GSK is dedicated to increasing access to our vaccines in broader adult populations and we continue to drive innovation to help make it easier for healthcare professionals to offer protection against severe RSV disease," he added.