Merck's CAPVAXIVE Gets USFDA Nod for Children, Adolescents at Increased Pneumococcal Disease Risk

With the latest approval, CAPVAXIVE can now be administered to children and adolescents who have completed a primary pediatric pneumococcal vaccination series and have one or more chronic medical conditions that increase their susceptibility to pneumococcal disease. According to the company, CAPVAXIVE is the only pneumococcal conjugate vaccine (PCV) specifically studied and indicated in the United States for this patient population.

Pneumococcal disease, caused by Streptococcus pneumoniae, can lead to serious infections such as pneumonia, meningitis, and bloodstream infections, particularly among individuals with underlying health conditions.

Commenting on the approval, Dr. Rotem Lapidot, Chief of Pediatric Infectious Diseases at Rambam Health Care Campus and an investigator in the STRIDE-13 trial, said, "Children and adolescents with certain chronic conditions are at an increased risk for pneumococcal disease, including pneumonia, meningitis, and bloodstream infections. This approval recognizes the potential of CAPVAXIVE to deliver additional protection by including serotypes not contained in approved primary pediatric PCV series, and represents a new approach to helping protect children and adolescents at increased risk for pneumococcal disease."

The FDA approval was supported by data from the Phase 3 STRIDE-13 trial, a randomized, double-blind, active comparator-controlled study involving 874 participants aged 2 through 17 years with chronic medical conditions such as diabetes, chronic heart disease, chronic kidney disease, chronic liver disease, and chronic lung disease. All participants had previously completed a primary pneumococcal vaccination regimen.

In the study, participants were randomized to receive either a single dose of CAPVAXIVE (n=527) or PPSV23 (n=347). The results showed that CAPVAXIVE was non-inferior to PPSV23 for the 12 shared serotypes and generated significantly higher immune responses for the nine serotypes unique to CAPVAXIVE. The vaccine also demonstrated immune responses to serotype 15B, which is cross-reactive to serotype 15C.

Regarding safety, Merck reported that the safety profile of CAPVAXIVE was generally comparable to PPSV23. Serious adverse events within six months of vaccination were reported in 5.5% of participants receiving CAPVAXIVE and 7.2% of those receiving PPSV23. One serious adverse event considered related to vaccination was reported in the CAPVAXIVE group, involving syncope requiring hospitalization shortly after vaccination.

Dr. Paula Annunziato, Senior Vice President, Infectious Diseases and Vaccines, Global Clinical Development, Merck Research Laboratories, stated, "While CAPVAXIVE was specifically designed for adults, it may also offer additional disease protection for this specific population of children and adolescents, when given after the primary pediatric pneumococcal vaccination series. The approval of CAPVAXIVE for children and adolescents at increased risk for pneumococcal disease demonstrates our commitment to addressing this disease in people of all ages."

According to Merck, CAPVAXIVE includes coverage against 21 pneumococcal serotypes, including eight serotypes not covered by several other approved pneumococcal vaccines. The company cited epidemiological data indicating that among children with risk conditions, the vaccine's serotype coverage corresponds to approximately 79% of invasive pneumococcal disease (IPD) cases, with 11 unique serotypes accounting for around 40% of cases.

Following the approval, CAPVAXIVE is now indicated in the United States for the prevention of invasive pneumococcal disease in adults aged 18 years and older and in children and adolescents aged 2 through 17 years who are at increased risk of pneumococcal disease. The vaccine is also approved for the prevention of pneumococcal pneumonia in adults, under the FDA's accelerated approval pathway based on immune response data.