GSK Wins First-Ever FDA Approval for an RSV Vaccine

Syringe pulling vaccine from a vial

Pictured: Syringe pulling vaccine from a vial / Adobe Stock, weyo

The FDA gave the greenlight on Wednesday to Arexvy, a vaccine developed by GlaxoSmithKline to prevent lower respiratory tract disease caused by respiratory syncytial virus in people aged 60 and older.

It’s the first-ever RSV vaccine to be approved in the United States, though Pfizer’s product is also making its way toward regulatory review.

The FDA gave GSK’s candidate Priority Review last November, while Pfizer won this designation in December. The agency is expected to decide on Pfizer’s candidate later this month.

RSV is a common respiratory viral infection that usually carries mild symptoms. However, the disease is more likely to become severe in young children and older adults. Biopharma companies have focused on these two vulnerable populations in developing vaccine candidates.

“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening . . .”

The virus kills roughly 14,000 older adults in the U.S. annually.

GSK declined to state what the vaccine will cost. On the first-quarter earnings call on April 26, GSK Chief Commercial Officer Luke Miels outlined a pricing range roughly between $60 and $185, according to Endpoints News.

The total market for RSV vaccines is estimated at $5 billion to $10 billion, according to analysts who spoke to Reuters.

“[The market for this vaccine] is viewed as something that is Shingrix-like at scale,” Phil Dormitzer, GSK’s global head of vaccines R&D, told Endpoints News, referencing its shingles vaccine that brought in $3.8 billion last year. “We expect this to be a tremendously important vaccine both for public health and for the company.”

In briefing documents provided in advance of a March 2023 adcomm recommendation, GSK presented efficacy numbers for its candidate, with a vaccine efficacy of 82.6% in preventing RSV-induced lower respiratory tract disease (LRTD) in adults aged 60 years and older. The vaccine was even better at preventing severe LRTD in patients 70 to 79 years old.

The committee’s decision on GSK’s candidate came one day after the same group decided there were sufficient data to support Pfizer’s RSV vaccine in older adults.

“I’d be shocked if one was substantially better,” Jason McLellan, a protein researcher at the University of Texas at Austin who led the research on the RSV protein used in these vaccines, told Endpoints. “I think they’re both very similar and both will work well.”

Lisa Munger is a senior editor at BioSpace. You can reach her at Follow her on LinkedIn

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