23 June 2022 - - The US Food and Drug Administration has approved an expanded indication for US-based pharmaceutical company Merck's (NYSE: MRK) Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) to include children six weeks through 17 years of age, the company said.

Vaxneuvance is now indicated for active immunization 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 six weeks of age and older.

The approval follows the FDA's Priority Review of Merck's supplemental application.

Vaxneuvance is contraindicated for individuals with a severe allergic reaction (e.g., anaphylaxis) to any component of Vaxneuvance or to diphtheria toxoid; see additional Select Safety Information below.

The US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices is expected to meet this week to discuss and make recommendations on the use of Vaxneuvance in pediatric populations.

Invasive pneumococcal disease is an infection caused by the bacterium Streptococcus pneumoniae, or pneumococcus.

While there are approximately 100 different types of S. pneumoniae, called serotypes, a smaller number of serotypes are responsible for IPD in children.

Serotypes 3, 22F and 33F are three of the top five serotypes causing childhood cases of IPD. IPD can lead to hospitalization or death.

Some examples of IPD are bacteremia (an infection in the blood) and meningitis (an infection of the coverings of the brain and spinal cord), which can also result in long-term neurological complications. Children under the age of 2 are particularly vulnerable to IPD.

The FDA's approval was based on data from seven randomized, double-blind clinical studies assessing safety, tolerability and immunogenicity of Vaxneuvance in infants, children and adolescents (see "Clinical Data Supporting FDA Approval" below for additional details).

Clinical data from the pivotal study showed that immune responses elicited by Vaxneuvance following a four-dose pediatric series were non-inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 shared serotypes based on serotype-specific immunoglobulin G geometric mean concentrations.

In a secondary analysis, immune responses for Vaxneuvance following a four-dose pediatric series were superior to PCV13 for shared serotype 3 and the two serotypes unique to Vaxneuvance, 22F and 33F.

Randomized controlled trials assessing the clinical efficacy of Vaxneuvance compared to PCV13 have not been conducted.

Data from the clinical program also support the use of Vaxneuvance concomitantly with other commonly administered routine pediatric vaccines, and in a variety of clinical settings, such as interchangeable use following initiation of an infant vaccination schedule with PCV13 or in a catch-up setting for older children who are either pneumococcal vaccine-naïve or who previously received an incomplete series of another PCV.

Additionally, data support the use of Vaxneuvance in special populations, such as in preterm infants and children living with HIV infection or sickle cell disease.

Vaxneuvance, Merck's 15-valent pneumococcal conjugate vaccine, consists of purified capsular polysaccharides from S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F individually conjugated to CRM197 carrier protein.

Vaxneuvance is indicated for active immunization of individuals 6 weeks of age and older for the prevention of invasive disease caused by the S. pneumoniae serotypes contained in the vaccine.

The FDA initially approved Vaxneuvance in July 2021. The FDA previously granted Vaxneuvance Breakthrough Therapy designation and Priority Review for the pediatric indication.