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GSK's RSV Vaccine Arexvy Wins FDA Nod for High-Risk Younger Adults
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Key Takeaways
GSK's Arexvy gains FDA approval for adults aged 18-49 years at higher risk of RSV-related LRTD.
GSK said late-stage data showed Arexvy's immune response matched adults 60 , with consistent safety profile.
GSK's Arexvy also won EU expansion to adults 18 while China reviews a filing for use in people aged 60 .
GSK plc (GSK - Free Report) announced that the FDA approved the expanded use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine, Arexvy, in adults aged 18 to 49 years who are at a higher risk of developing lower respiratory tract disease (LRTD).
Arexvy is already approved in the United States for the prevention of LRTD caused by RSV in all individuals aged 60 years and above, as well as for high-risk individuals aged 50 to 59 years.
Year to date, GSK‘s shares have risen 8.8% compared with the industry’s 2.7% growth.
Image Source: Zacks Investment Research
The FDA’s decision was supported by data from a late-stage study, which demonstrated that the immune response generated by Arexvy was comparable to that observed in adults aged 60 years and older. Arexvy’s safety and efficacy profile was consistent with that seen in previously conducted studies of the vaccine.
In January, the European Commission (EC) approved the expanded use of Arexvy for all adults aged 18 years and older to prevent RSV-related LRTD. Previously, the vaccine was approved in Europe for adults aged 60 and older, as well as for those aged 50 to 59 years who are at increased risk of severe disease.
China’s Center for Drug Evaluation has also accepted GSK’s regulatory application for Arexvy for adults aged 60 years and above. If approved, Arexvy would become the first vaccine in China to prevent RSV-related LRTD in this age group. The final decision is expected in 2027.
Other RSV Vaccine Makers in the Market
With the recent FDA approval for younger adults, the GSK vaccine becomes the third FDA-approved RSV vaccine in this age group, joining Pfizer’s (PFE - Free Report) Abrysvo and Moderna’s (MRNA - Free Report) mResvia.
Pfizer’s Abrysvo is approved for the prevention of RSV-associated LRTD in all individuals aged 60 years and above. The vaccine is also approved for pregnant individuals, enabling maternal immunization during pregnancy to protect infants against RSV from birth through the first six months of life. This makes Abrysvo the only RSV vaccine currently approved to protect infants through maternal vaccination during pregnancy.
PFE’s Abrysvo is approved in the United States and Europe for adults aged 18 to 59 years who are at increased risk of RSV-related LTRD.
Moderna’s RSV vaccine, mResvia, is approved by the FDA and the EC to prevent RSV-related LRTD in older adults aged 60 years and above.
In June 2025, the FDA approved MRNA’s mResvia for use in high-risk adults aged 18 to 59 years.
Sales Performance in 2025
Arexvy recorded global sales of £0.6 billion in 2025, up 2% at constant exchange rates (CER), driven by the uptake in ex-U.S. markets, partially offset by declining sales in the United States due to slower market uptake among the 60-plus population and lower market share. Sales increased in ex-U.S. markets, supported by favorable recommendations and reimbursement in Germany and tender volumes in Canada and Spain.
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GSK's RSV Vaccine Arexvy Wins FDA Nod for High-Risk Younger Adults
Key Takeaways
GSK plc (GSK - Free Report) announced that the FDA approved the expanded use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine, Arexvy, in adults aged 18 to 49 years who are at a higher risk of developing lower respiratory tract disease (LRTD).
Arexvy is already approved in the United States for the prevention of LRTD caused by RSV in all individuals aged 60 years and above, as well as for high-risk individuals aged 50 to 59 years.
Year to date, GSK‘s shares have risen 8.8% compared with the industry’s 2.7% growth.
Image Source: Zacks Investment Research
The FDA’s decision was supported by data from a late-stage study, which demonstrated that the immune response generated by Arexvy was comparable to that observed in adults aged 60 years and older. Arexvy’s safety and efficacy profile was consistent with that seen in previously conducted studies of the vaccine.
In January, the European Commission (EC) approved the expanded use of Arexvy for all adults aged 18 years and older to prevent RSV-related LRTD. Previously, the vaccine was approved in Europe for adults aged 60 and older, as well as for those aged 50 to 59 years who are at increased risk of severe disease.
China’s Center for Drug Evaluation has also accepted GSK’s regulatory application for Arexvy for adults aged 60 years and above. If approved, Arexvy would become the first vaccine in China to prevent RSV-related LRTD in this age group. The final decision is expected in 2027.
Other RSV Vaccine Makers in the Market
With the recent FDA approval for younger adults, the GSK vaccine becomes the third FDA-approved RSV vaccine in this age group, joining Pfizer’s (PFE - Free Report) Abrysvo and Moderna’s (MRNA - Free Report) mResvia.
Pfizer’s Abrysvo is approved for the prevention of RSV-associated LRTD in all individuals aged 60 years and above. The vaccine is also approved for pregnant individuals, enabling maternal immunization during pregnancy to protect infants against RSV from birth through the first six months of life. This makes Abrysvo the only RSV vaccine currently approved to protect infants through maternal vaccination during pregnancy.
PFE’s Abrysvo is approved in the United States and Europe for adults aged 18 to 59 years who are at increased risk of RSV-related LTRD.
Moderna’s RSV vaccine, mResvia, is approved by the FDA and the EC to prevent RSV-related LRTD in older adults aged 60 years and above.
In June 2025, the FDA approved MRNA’s mResvia for use in high-risk adults aged 18 to 59 years.
Sales Performance in 2025
Arexvy recorded global sales of £0.6 billion in 2025, up 2% at constant exchange rates (CER), driven by the uptake in ex-U.S. markets, partially offset by declining sales in the United States due to slower market uptake among the 60-plus population and lower market share. Sales increased in ex-U.S. markets, supported by favorable recommendations and reimbursement in Germany and tender volumes in Canada and Spain.
GSK's Zacks Rank
GSK currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.