The FDA today approved the pneumococcal 15-valent conjugate vaccine for the prevention of invasive pneumococcal disease in infants and children.
Today, Merck announced the US Food and Drug Administration (FDA) approval of an expanded indication for its pneumococcal 15-valent conjugate vaccine (Vaxneuvance; Merck) 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, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks of age and older. This approval follows the December 2021 FDA Priority Review acceptance of Merck’s supplemental application.
Invasive pneumococcal disease (IPD) is an infection caused by the bacterium S. pneumoniae, or pneumococcus, according to the press release announcing the approval. 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—infection in the blood—and meningitis—infection of the coverings of the brain and spinal cord—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.
This FDA 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 the release. 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 release.
“Despite decreases in incidence of invasive pneumococcal disease in children, certain key serotypes continue to cause serious illness that can lead to death in children under the age of 5, with serotypes 3, 22F, and 33F responsible for more than a quarter of all invasive pneumococcal disease cases in this population,” said Steven Shapiro, DO, chairman, Department of Pediatrics, Jefferson Abington Hospital, and investigator for the PNEU-PED trial. “With the robust clinical data supporting Vaxneuvance and this FDA approval, Vaxneuvance will be an important new option to help advance protection for children.”
The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to meet today on the use of the pneumococcal 15-valent conjugate vaccine in pediatric populations.
US FDA approves Merck’s Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for the prevention of invasive pneumococcal disease in infants and children. Merck. Published June 22, 2022. Accessed June 22, 2022. https://www.merck.com/news/u-s-fda-approves-mercks-vaxneuvance-pneumococcal-15-valent-conjugate-vaccine-for-the-prevention-of-invasive-pneumococcal-disease-in-infants-and-children/