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The US Food and Drug Administration (FDA) has granted approval to Capvaxive (Pneumococcal 21-valent Conjugate Vaccine), a groundbreaking new vaccine designed to prevent invasive pneumococcal disease and pneumococcal pneumonia in adults. This injectable vaccine, developed by Merck, targets 21 serotypes responsible for the majority of such diseases in adults, providing robust protection.
According to Merck’s announcement, these 21 serotypes account for approximately 84% of invasive pneumococcal disease cases in adults aged 50 years and older, and 85% in adults aged 65 years and older. Annually, about 150,000 adults in the United States are hospitalized due to pneumococcal pneumonia, highlighting the urgent need for improved preventative measures.
“Many cases of adult disease are caused by serotypes not included in other approved pneumococcal conjugate vaccines,” noted Dr. Walter Orenstein, a professor emeritus at Emory University and a member of Merck’s Scientific Advisory Committee. “CAPVAXIVE is designed to include the serotypes that cause the majority of invasive pneumococcal disease in adults, helping to protect adults against invasive pneumococcal disease and pneumococcal pneumonia.”
The vaccine’s efficacy and safety were demonstrated in clinical trials, with participants reporting common side effects such as injection site pain, fatigue, headaches, and muscle aches. Capvaxive specifically covers serotypes 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B, which are not addressed by other existing pneumococcal vaccines.
A meeting of the US Centers for Disease Control and Prevention (CDC) advisory panel is scheduled for June 27 to discuss Capvaxive. If the panel votes in favor, the CDC director will decide on its nationwide availability.
In terms of cost, Merck announced that Capvaxive would have a wholesale acquisition price of $287 per dose. However, most individuals are expected to access the vaccine at no charge if it receives routine CDC recommendation, thanks to insurance coverage and public health programs. The main competitor for Capvaxive is Pfizer’s Prevnar 20, which was approved in 2021 for adults aged 18 and older.
As the CDC deliberates on Capvaxive, the medical community remains hopeful that this new vaccine will significantly reduce the incidence of invasive pneumococcal disease and pneumonia, offering enhanced protection for the adult population.
