Merck’s Capvaxive Approved by FDA for Additional Indication in Pediatric Pneumococcal Disease

Editor’s Take: Children with certain chronic conditions may be at increased risk for conditions like pneumonia, meningitis, or bloodstream infections.

Merck, MSD outside the United States and Canada, gained a new U.S. FDA approval for Capvaxive (pneumococcal 21-valent conjugate vaccine). The expanded indication covers those aged 2 through 17 who’ve completed a primary pediatric pneumococcal vaccination series. Additionally, they must have one or more chronic medical conditions that increase their risk for pneumococcal disease, to be eligible.

New Pneumococcal Treatment

The approval makes Capvaxive the only pneumococcal conjugate vaccine (PCV) studied and indicated in the U.S. for this specific population.

The FDA expanded its indication based on a Phase III trial (STRIDE-13) evaluating Capvaxive versus PPSV23 (pneumococcal 23-valent polysaccharide vaccine).

Rotem Lapidot, MD, STRIDE-13 investigator and Chief, Pediatric Infectious Diseases, Rambam Health Care Campus, touted this Capvaxive indication’s protection potential.

“Children with certain chronic conditions are at increased risk for pneumococcal disease, including pneumonia, meningitis, and bloodstream infections,” Lapidot said. “This approval recognizes Capvaxive’s potential to deliver additional protection by including serotypes not contained in approved primary pediatric PCV series. [It] represents a new approach to helping protect children and adolescents at increased risk for pneumococcal disease.”

Merck Marks Capvaxive Anniversary

Paula Annunziato, MD, Merck Research Laboratories Senior Vice President, Infectious Diseases and Vaccines, Global Clinical Development, applauded expansion to children.

News of the new indication came two years to the day since the FDA first approved Capvaxive for adults.

“While Capvaxive was specifically designed for adults, it may also offer additional disease protection for this specific population,” Annunziato said.

Those with histories of severe allergic reaction to Capvaxive’s components, or diphtheria toxoid, should not take the vaccine.

Continued approval for the new indication may be contingent on verification, and description of clinical benefit, in confirmatory trials.