Merck given FDA approval for new Vaxneuvance indication

Merck has received the Food and Drug Administration’s nod for an expanded indication for Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) to include children aged 6 weeks old to 17 years old.

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 aged 6 weeks old and older.

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

“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, chairman of the department of pediatrics at 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.”

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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, which 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 also can result in long-term neurological complications. Children under the age of 2 years old are particularly vulnerable to IPD.

“Our goal with Vaxneuvance is to expand coverage of key invasive disease-causing serotypes and provide a strong immune response to serotypes that pose substantial risk to infants and children,” said Eliav Barr, senior vice president, head of global clinical development and chief medical officer at Merck Research Laboratories. “With this approval, we bring forward our first pediatric pneumococcal conjugate vaccine — and the first pediatric pneumococcal conjugate vaccine to be approved in almost a decade — building on our commitment to preventing invasive pneumococcal disease and on our legacy in pediatric vaccine development. We thank the investigators and the families of our clinical trial participants for participating in the research studies and the role they played in this milestone.”

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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 aged 6 weeks old 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 and previously granted Vaxneuvance breakthrough therapy designation and priority review for the pediatric indication.