Washington, D.C. – The Food and Drug Administration approved Merck’s new vaccine, Capvaxive, designed to protect adults from the pneumococcus bacteria that can cause serious illnesses and pneumonia. Capvaxive specifically targets 21 strains of the bacteria, aiming to prevent severe pneumococcal disease that can lead to pneumonia. This marks the first pneumococcal conjugate vaccine tailored for adults, offering broader protection than currently available shots on the market, as reported by the drugmaker.

Healthy adults can be affected by pneumococcal disease, but older patients and those with chronic or immunocompromising health conditions are at higher risk for the more serious invasive form of the illness. Invasive pneumococcal disease can result in meningitis, inflammation around the brain and spinal cord, and bacteremia, a bloodstream infection.

According to Heather Platt, Merck’s product development team lead, around 150,000 U.S. adults are hospitalized with invasive pneumococcal disease annually. The highest death rates from the severe form of the disease occur in adults 50 and above. Merck’s single-dose vaccine, although FDA-approved, will not be available immediately to patients. An advisory panel for the Centers for Disease Control and Prevention is scheduled to meet on June 27 to discuss eligibility criteria for the vaccine.

Some analysts see Capvaxive as a significant growth driver for Merck, particularly as the company seeks to offset losses from its cancer drug Keytruda. Market projections suggest that the pneumococcal conjugate vaccine market, currently valued at $7 billion, could exceed $10 billion in the coming years. Merck’s new vaccine is expected to bolster its competitiveness in the market, where Pfizer’s Prevnar 20 is currently the recommended product for adults.

Merck’s Capvaxive targets eight bacterial strains not covered by any other approved vaccine, accounting for about 30% of invasive pneumococcal disease cases in patients 65 and older. The vaccine also protects against an additional 13 strains, covering approximately 85% of invasive pneumococcal disease cases in adults 65 and above. These figures surpass Pfizer’s Prevnar, which addresses strains representing roughly 52% of cases. The FDA’s approval was based on the results of Merck’s late-stage trial, STRIDE-3, which compared the efficacy of Capvaxive to Pfizer’s Prevnar 20 in adults aged 18 and older who had not previously received a pneumococcal vaccine.