RSV Vaccine Recommendations Expanded, New Shots Approved in CDC Panel's Latest Guidance

The pharmaceutical industry received significant updates from the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP), with expanded recommendations for respiratory syncytial virus (RSV) vaccines and approvals for new shots targeting meningococcal disease and chikungunya virus.

RSV Vaccine Eligibility Broadened

In a reversal of its previous stance, the ACIP has expanded its recommendation for RSV vaccines to include adults aged 50 and older who are at risk of developing severe RSV-linked lower respiratory tract disease (LRTD). This decision potentially opens up the market to an additional 13 million eligible patients, according to GSK's chief scientific officer Tony Wood.

The expanded guidance comes as welcome news for GSK and Pfizer, whose RSV vaccines Arexvy and Abrysvo saw significant sales declines following last year's narrower recommendation. GSK's Arexvy experienced a 51% drop in sales from £1.2 billion to £590 million, while Pfizer's Abrysvo revenue fell 15% from $890 million to $755 million.

The CDC reports that between 15,000 and 20,000 RSV-associated hospitalizations occur annually in the U.S. among adults aged 50 to 59, with those suffering from chronic obstructive pulmonary disease (COPD), asthma, heart failure, and diabetes at increased risk.

New Vaccine Approvals and Recommendations

Meningococcal Vaccine

The ACIP endorsed GSK's 5-in-1 meningococcal vaccine Penmenvy for inclusion in the adolescent vaccination schedule. The vaccine is recommended for individuals aged 16 to 23, as well as for children aged 10 to 15 who are at increased risk. Penmenvy was also unanimously approved for the Vaccines for Children (VFC) program, ensuring free doses for eligible children.

Approved by the FDA in February, Penmenvy offers a convenient alternative to separate administration of two shots covering five meningococcal serogroups. It will compete with Pfizer's pentavalent vaccine Penbraya, which was launched in 2023.

Chikungunya Vaccine

Bavarian Nordic's chikungunya vaccine Vimkunya received ACIP approval for individuals aged 12 and older traveling to countries with active outbreaks of the mosquito-borne virus. The committee also recommended considering the vaccine for those traveling to countries without current outbreaks but with elevated risk for U.S. travelers, as well as for laboratory workers potentially exposed to the virus.

Vimkunya, approved by the FDA in February, addresses a significant global health concern, as chikungunya virus transmission to humans has been documented in over 50 countries within the past five years.