Merck gets FDA approval for pneumococcal vaccine competing with Pfizer's

the U.S. Food and Drug Administration (FDA) granted approval for a new vaccine developed by Merck & Co. The vaccine, named Capvaxive, protects against 21 types of pneumococcal bacteria, which can cause severe infections in the lungs, blood, and spinal cord, the latter when known as meningitis. This vaccine is intended for adults aged 18 and older. Merck plans to release Capvaxive by late July, contingent on recommendations from the Centers for Disease Control and Prevention (CDC) advisors, who are convening later this month.

Pneumococcal disease poses a significant risk, particularly for adults over 65 and those with weakened immune systems. The FDA approval of Capvaxive marks an important addition to the vaccines available for combating this disease. Merck already markets two other pneumococcal vaccines: Pneumovax 23, which is intended for adults over 50 and children older than two who are at high risk, and Vaxneuvance, suitable for individuals from six weeks old and up.

Until now, Pfizer's Prevnar vaccines have dominated the market. Approved in 2021, Pfizer’s Prevnar 20 is available for adults 18 and older and has been cleared for infants and teenagers. While Prevnar 20 covers 20 serotypes of the pneumococcal bacteria, Merck's Vaxneuvance includes 15 serotypes. In comparison, Capvaxive targets 21 serotypes, offering a broader range of protection, including eight serotypes that are not covered by other vaccines.

Paula Annunziato, Merck's vice president of vaccine clinical development, emphasized that Capvaxive is the first pneumococcal conjugate vaccine specifically designed to protect against the serotypes causing the majority of invasive pneumococcal disease in adults. She noted that Capvaxive covers serotypes responsible for approximately 84% of invasive pneumococcal disease cases in adults 50 years and older. In contrast, Pfizer's Prevnar 20 covers serotypes responsible for around 52% of these cases.

Merck also highlighted that the eight unique serotypes covered solely by Capvaxive account for more than a quarter of invasive pneumococcal disease cases in adults aged 50 and older. Louise Chen, an analyst from Cantor Fitzgerald, mentioned that a favorable recommendation from the Advisory Committee on Immunization Practices (ACIP) could significantly boost Capvaxive's sales. The ACIP is scheduled to meet on June 27 to discuss this matter.

Merck has priced Capvaxive at $287 per single dose. The company assured that most people in the United States would have access to the vaccine at no out-of-pocket cost if the CDC panel recommends it for routine use. This pricing strategy aims to make the vaccine widely accessible and encourage its adoption, thereby enhancing public health outcomes.

In summary, the FDA's approval of Merck’s Capvaxive introduces a promising new option in the fight against pneumococcal disease, particularly for vulnerable adult populations. With its broader coverage of bacterial serotypes, Capvaxive stands out among existing vaccines and may soon become an important tool in preventing severe pneumococcal infections. The upcoming CDC advisory panel meeting will be crucial in determining the vaccine’s integration into immunization practices and its availability to the public.

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