Merck's Pneumococcal Vaccine Expanded for Wider Use in Children

The FDA and the CDC’s Advisory Committee on Immunization Practices (ACIP) Wednesday gave positive decisions on an expanded indication for Merck’s pneumococcal 15-valent conjugate vaccine (Vaxneuvance).

The FDA and the CDC’s Advisory Committee on Immunization Practices (ACIP) Wednesday gave positive decisions on an expanded indication for Merck’s pneumococcal 15-valent conjugate vaccine (Vaxneuvance).

First, the FDA approved the vaccine to include children aged 6 weeks through 17 years old. The active immunization is now indicated for the prevention of invasive disease caused by Streptococcus Pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in those ages.

Invasive pneumococcal disease (IPD) is an infection caused by the bacterium S. pneumoniae, or pneumococcus. Of the approximately 100 different types of S. pneumoniae, a smaller number of serotypes are responsible to IPD in children including serotypes 3, 22F, and 33F, among others.

Examples of IPD include bacteremia and meningitis, which can result in long-term neurological complications. IPD can lead to hospitalization or death and children under the age of 2 are particularly vulnerable.

The FDA accepted the company’s supplemental application under Priority Review last December. The approval is based on data from 7 randomized, double-blind clinical studies examining the safety, tolerability, and immunogenicity of the company’s pneumococcal 15-valent conjugate vaccine in infants, children, and adolescents.

Following a 4-dose pediatric series in the pivotal study, it was shown to be noninferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) based on “serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GCMs),” according to a Merck statement.

Additionally, a secondary analysis examining immune responses for the 15-valent vaccine showed that a 4-dose pediatric series were superior to PCV13 for shared serotype 3 and 2 serotypes unique to the pneumococcal 15-valent conjugate vaccine, 22F and 33F. Merck noted that randomized controlled trails assessing clinical efficacy of the pneumococcal 15-valent conjugate vaccine vs PCV13 have not been conducted.

Data supports the use of the vaccine concomitantly with other routine pediatric vaccines commonly administered and its use in special populations like pre-term infants, children living with HIV, or sickle cell disease, according to the company.

Later Wednesday, ACIP unanimously voted to include the vaccine as a recommended option for vaccination in infants and children, including routine use in children under 2 years of age. Additionally, the ACIP unanimously voted to include Vaxneuvance in the Vaccines for Children program.

These provisional recommendations will be reviewed by the CDC director and HHS.