Two GSK vaccines get US CDC recommendations

(Sharecast News) - GSK announced two important endorsements from the US Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) on Thursday, for its vaccines Penmenvy and Arexvy, potentially expanding protection against meningococcal disease and respiratory syncytial virus (RSV) for millions of Americans. The FTSE 100 pharmaceutical giant said the committee voted to recommend Penmenvy, GSK's newly approved five-in-1 meningococcal vaccine, for individuals over the age of 10.

Penmenvy offers broad protection against Neisseria meningitidis serogroups A, B, C, W, and Y in a single dose.

That, GSK explained, simplifies the existing immunisation schedule, which typically requires separate MenACWY and MenB vaccinations, particularly for adolescents around age 16.

The consolidated approach could reduce the number of injections and improve vaccine uptake.

GSK noted that the recommendation followed the vaccine's Food and Drug Administration (FDA) approval in February, and was expected to support broader adoption when doses become available in the US in the summer.

Penmenvy combines the antigenic components of GSK's established meningococcal vaccines, Bexsero and Menveo.

While MenB remained the leading cause of invasive meningococcal disease among adolescents and young adults, uptake had remained low.

According to 2023 CDC data, fewer than 13% of 17-year-olds completed the recommended two-dose MenB series.

GSK currently manufactures the majority of MenB vaccine doses administered in the US, positioning it to play a central role in expanding protection through Penmenvy.

"We welcome this positive recommendation that can help strengthen disease prevention efforts in the US," said GSK's chief scientific officer Tony Wood.

"Pentavalent vaccines can reduce the number of injections required to help protect against invasive meningococcal disease - especially disease caused by serogroup B.

"Their use could improve immunisation rates among adolescents and young adults in the US, who are at an age with increased risk."

Separately, ACIP also recommended GSK's RSV vaccine, Arexvy, for adults aged 50 to 59 who are at increased risk of severe RSV disease.

That would include individuals with chronic health conditions such as COPD, asthma, heart disease, and diabetes, as well as those in long-term care.

The recommendation broadens eligibility from a previous recommendation covering those aged 60 and older.

GSK said the decision was based on data from a phase three clinical trial showing a strong immune response and safety profile in this younger at-risk group, comparable to that seen in older adults.

RSV was estimated to cause 42,000 hospitalisations annually in US adults aged 50 to 64, with higher risks of severe outcomes among those with underlying conditions.

Both recommendations now awaited final review and approval before being published as official CDC guidance.

"We are pleased with ACIP's recommendation to expand the benefits of RSV immunisation to more than 13 million adults aged 50-59 who are at increased risk for the severe consequences of this virus," Tony Wood added.

"RSV can have a significant impact for those with underlying medical conditions.

"We look forward to helping protect more people with RSV vaccination."

At 0849 BST, shares in GSK were down 1.26% at 1,328.5p.

Reporting by Josh White for Sharecast.com.