Merck receives FDA approval for expanded CAPVAXIVE indication

• Merck (NYSE:MRK) announced that the U.S. FDA has approved an expanded indication for CAPVAXIVE® to include children and adolescents aged 2 through 17 who are at increased risk for pneumococcal disease.
• Following the news, Merck shares were trading at $115.49 on June 18, 2026, reflecting a modest daily gain of 0.28%.
• This approval allows CAPVAXIVE to be used as a follow-on vaccine for at-risk youth who have already completed a primary pediatric pneumococcal vaccination series.

Merck (NYSE:MRK) announced today that the U.S. Food and Drug Administration (FDA) has expanded the indication for CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) to include children and adolescents aged 2 through 17 years who are at increased risk for pneumococcal disease.

The approval applies specifically to patients in this age group who have already completed their primary pediatric pneumococcal vaccination series, offering additional protection through serotypes not contained in standard primary series.

"This approval recognizes the potential of CAPVAXIVE to deliver additional protection by including serotypes not contained in approved primary pediatric PCV series," said Dr. Rotem Lapidot, investigator for the STRIDE-13 trial.

The expansion is supported by data from the Phase 3 STRIDE-13 trial, which compared the vaccine against PPSV23 in children and adolescents with chronic medical conditions such as chronic heart disease, lung disease, or diabetes.

Dr. Paula Annunziato, senior vice president of infectious diseases and vaccines at Merck Research Laboratories, noted that while the vaccine was originally designed for adults, it addresses a specific unmet need for young patients with high-risk health conditions.

Following the announcement, the Merck share price was $115.49, representing a change of 0.28% during the trading session on June 18, 2026.

Merck continues to emphasize its commitment to public health, noting that for the studied risk group, CAPVAXIVE covers serotypes responsible for approximately 79% of invasive pneumococcal disease cases.

The company remains a prominent leader in the pharmaceutical sector, maintaining a market capitalization of approximately $285 billion.