Merck Wins Key FDA Approval for Pediatric Pneumococcal Vaccine

FDA Approves Merck’s Pneumocal Disease Vaccine for Infants and Children

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Merck scored another big win Wednesday with a U.S. Food and Drug Administration approval for an expanded indication of Vaxneuvance, its pneumococcal 15-valent conjugate vaccine. The new indication includes children 6 weeks through 17 years of age.

This news is the latest in a series of approvals for the vaccine.

Streptococcus pneumoniae, or pneumococcus, is a bacteria that causes pneumococcal disease. Per the U.S. Centers for Disease Control and Prevention, some of the most common parts of the body that can be affected by invasive pneumococcal disease (IPD) are the lungs (pneumonia), ears, sinuses, brain, spinal cord (meningitis) and blood.

While there are approximately 100 different types of S. pneumoniae, called serotypes, certain serotypes are usually responsible for IPD in children. Merck’s vaccine now offers a layer of protection for children against those serotypes, including 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F. Vaxneuvance consists of purified capsular polysaccharides, individually conjugated to the CRM197 carrier protein. 

"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," Eliav Barr, M.D., senior vice president, head of global clinical development and chief medical officer at Merck Research Laboratories, said in a statement. "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.”

This FDA nod is the latest in a series of wins for Vaxneuvance. The vaccine received FDA approval for IPD in adults 18 years and older for 15 different serotypes in July 2021. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) gave the vaccine a positive opinion in October 2021. Then, in December 2021, the vaccine received approval from the European Commission, allowing the marketing of Vaxneuvance in all 27 European Union Member States plus Iceland, Norway and Lichtenstein.

When Merck began expanding its work on Vaxneuvance for pediatric uses, the company received a Breakthrough Therapy Designation from the FDA for the vaccine in children. Merck filed for a supplemental Biologics License Application (sBLA) for Vaxneuvance for the prevention of invasive pneumococcal disease in children 6 weeks through 17 years of age, and the FDA accepted the application with Priority Review in December 2021.

In April, Merck hit a snag when the FDA extended its review, asking for additional data analyses from the pediatric studies Merck submitted. 

The FDA granted the pediatric approval based on data from seven randomized, double-blind clinical studies assessing the safety, tolerability and immunogenicity of Vaxneuvance in infants, children and adolescents. The data showed that it was effective and supported the use of Vaxneuvance in special populations, such as preterm infants and children living with HIV or sickle cell disease.

"With the robust clinical data supporting Vaxneuvance and this FDA approval, Vaxneuvance will be an important new option to help advance protection for children," Dr. Steven Shapiro, chairman, department of pediatrics, Jefferson Abington Hospital, and investigator for the Vaxneuvance PNEU-PED trial, said in a statement. 

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