FDA expands GSK’s Arexvy approval to high-risk adults aged 18-49

UK—British pharmaceutical company GSK has received approval from the US Food and Drug Administration to expand the use of its respiratory syncytial virus vaccine, Arexvy, significantly broadening the product’s market potential in the United States.

The regulatory green light allows the company to offer Arexvy as a preventative measure for non-pregnant adults aged 18 to 49 who face an increased risk of developing RSV-associated lower respiratory tract disease.

The FDA based its approval decision on data from a global Phase IIIb clinical trial demonstrating Arexvy’s effectiveness in the younger adult population.

The study confirmed that the vaccine’s immune response in patients aged 18 to 49 matched the protective levels observed in adults aged 60 and older in a separate Phase III study.

Market evolution and competition

Arexvy entered the market in 2023 as the first RSV vaccine to receive regulatory approval in the United States, initially targeting only adults aged 60 and older.

GSK subsequently secured permission to expand the vaccine’s use to the 50-59 age category before obtaining this latest approval for high-risk younger adults.

Since Arexvy’s initial launch, the competitive landscape has intensified considerably.

Both Moderna and Pfizer have brought their own RSV vaccines to market, with mRESVIA and Abrysvo receiving regulatory approval for use across the entire high-risk adult population.

Sales projections and market dynamics

Analysts at GlobalData predict that all three RSV vaccines will experience declining sales in the coming years due to shifting attitudes toward vaccination across the United States.

Despite this anticipated downturn, the research firm expects Pfizer’s Abrysvo to capture the largest market share among the three competitors by 2030, generating approximately USD1 billion in revenue.

GlobalData forecasts that GSK’s Arexvy will produce USD938 million in sales during 2030, while Moderna’s mRESVIA will bring in USD502 million during the same period.

GSK plans to submit additional applications for Arexvy to regulatory authorities in multiple countries, aiming to expand the vaccine’s commercial presence beyond the American market.

Changing vaccine policy landscape

The expanded approval for Arexvy comes amid significant shifts in US vaccine policy.

In January 2023, the Centers for Disease Control reduced the routine childhood immunization schedule from 18 vaccines to 11, removing the RSV vaccine along with six other shots from the recommended list.

US Health Secretary Robert F. Kennedy Jr. has announced plans to further trim the childhood vaccine schedule by removing seven of the 11 remaining vaccines currently recommended for routine administration.

Regulatory environment under scrutiny

Changes in vaccine policy extend to the FDA’s evaluation processes as well.

The agency’s Center for Biologics Evaluation and Research initially declined to review Moderna’s seasonal influenza vaccine, mRNA-1010, citing concerns about the supporting clinical trial’s design.

However, the FDA reversed this position after Moderna filed an appeal, agreeing to proceed with the review.

The Arexvy approval follows recent leadership changes at the FDA, as Commissioner Marty Makary announced that Vinay Prasad would be stepping down from his position leading the Center for Biologics Evaluation and Research for the second time in his career.