US Advisory Panel Votes To Expand Recommendation For Pfizer, GSK's RSV Vaccines For Older Adults Below 60 Years

On Wednesday, the Advisory Committee on Immunization Practices (ACIP) voted to expand its recommendation for the use of respiratory syncytial virus (RSV) vaccines approved for adults 50-59 years of age at increased risk of RSV-associated lower respiratory tract disease (LRTD).

In June 2024, ACIP postponed a vote on a recommendation for adults aged 50-59 at increased risk for RSV-LRTD until additional data becomes available.

The update includes Pfizer Inc.’s (NYSE:PFE) Abrysvo (Respiratory Syncytial Virus Vaccine), which the U.S. Food and Drug Administration approved in October 2024 for the prevention of RSV-associated LRTD in adults aged 18 to 59 at increased risk of severe disease.

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The recommendation also includes GSK plc’s (NYSE:GSK) Arexvy in adults aged 50-59 who are at increased risk for severe RSV disease.

This expands on ACIP’s previous vote in June 2024 to recommend RSV vaccines for adults aged 60-74 who are at increased risk and all adults aged 75 and older.

Arexvy is indicated for the prevention of LRTD caused by RSV in individuals 60 years of age and older and individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV.

According to the CDC, between 15,000 – 20,000 RSV-associated hospitalizations occur annually in U.S. adults aged 50 – 59 years.

A systematic review of studies in the U.S. shows that RSV is estimated to cause 42,000 hospitalizations each year in adults aged 50-64 years old.

GSK said the ACIP considered results from a phase 3 trial evaluating the immune response and safety of GSK’s RSV vaccine in adults aged 50-59, including those at increased risk for RSV-LRTD due to certain underlying medical conditions compared to older adults aged 60 years and older where efficacy has been demonstrated after a single dose of GSK’s RSV vaccine.

The updated recommendation does not benefit Moderna Inc’s (NASDAQ:MRNA) mRNA-based RSV vaccine mRESVIA (mRNA-1345), which is currently approved for adults over 60 years.

William Blair notes Moderna shared Phase 3 data for mRNA-1345 in high-risk adults aged 18-59 at its 2024 R&D Day event and has since submitted an application to the FDA for regulatory approval using a priority review voucher. The FDA has accepted Moderna’s application and has assigned a PDUFA goal date of June 12, 2025.

Analyst Myles R. Minter highlights the Phase 3 trial of mRNA-1345 in over 1,000 high-risk individuals between ages 18 and 59. mRNA-1345 demonstrated non-inferior immunogenicity compared to adults age 60 or older for neutralizing antibodies against both RSV-A and RSV-B and a tolerable safety profile.

“If approved on time, we believe mRESVIA could be added to the updated age group recommendation during the scheduled June 25-26, 2025, ACIP meeting,” Minter said.

Price Action: PFE stock is up 1.07% 22.28, MRNA stock is down 2.30% at $24.62, and GSK stock is up 1.74% at $35.98 at the last check on Thursday.

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