FDA Licenses Merck’s Capvaxive Pneumococcal Vaccine

On June 17, 2024, the U.S. Food and Drug Administration (FDA) licensed Merck & Company, Inc.’s new pneumococcal conjugate vaccine Capvaxive (formerly V116) for adults 18 years of age and older. The vaccine is designed to protect against 21 types of the bacteria causing pneumococcal disease, which can lead to severe infection in the lungs (pneumococcal pneumonia) or in the blood and spinal cord (pneumococcal meningitis).^{1 2 3 4 5 6 7 8} According to Paula Annunziato, MD, Vice President and Therapeutic Area Head for Vaccine Clinical Development at Merck:

[Capvaxive] will be the first approved pneumococcal conjugate vaccine specifically designed to help protect against the serotypes that cause the majority of invasive pneumococcal disease in adults. It covers the serotypes responsible for 84% of cases of [invasive pneumococcal disease] in adults 50 years and older.¹

It is estimated that some 150,000 adults in the United States are hospitalized for pneumococcal pneumonia annually and about one in 20 who develop the disease die from it. About 3,000 older adults in the U.S. are estimated to die from pneumococcal meningitis infections each year, with one in six infected persons dying.^{2 4 6}

“Complications from invasive pneumococcal disease can lead to hospitalization, organ damage and even death. Many cases of adult disease are caused by serotypes not included in other approved pneumococcal conjugate vaccines,” said Walter Orenstein, MD, professor emeritus of medicine, epidemiology, global health and pediatrics at Emory University and a member of Merck’s Scientific Advisory Committee, as well as the former Director of the CDC’s Immunization Program and Deputy Director of Immunization Programs for the Bill & Melinda Gates Foundation.^{3 6 7 8}

Dr. Orenstein added:

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.³ 

Merck May Begin Selling Capvaxive in July

Depending on recommendations by U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) on June 27, 2024, Merck expects to make Capvaxive commercially available to the public as early as next month. The company plans to sell the vaccine for $287 per dose.^{1 2 4 6}

Analyst Louise Chen of financial services firm Cantor Fitzgerald, LP of New York wrote:

Whether or not [Merck] receives a preferential recommendation from the Advisory Committee on Immunization Practices (ACIP) will help determine what sales for Capvaxive could look like, and how the competitive landscape for adult PCVs will shape up going forward.⁹

The FDA licensed Capvaxive based on the results of immunogenicity tests, in which the immune responses of individuals who received the shot were compared to the immune responses of those who were given a competing vaccine such as Pfizer, Inc’s Prevnar 20. Additionally, other trials were performed on people who had previously received pneumococcal vaccine and those who had not. Merck stated it plans to conduct a clinical trial to determine “real-world effectiveness” of Capvaxive.²

Over $10 Billion Market Projected for Pneumococcal Vaccines

Cantor Fitzgerald estimates the current market for pneumococcal conjugate vaccines is worth approximately $7 billion and projects it could grow to more than $10 billion over the next few years. Pfizer’s Prevnar 20 and Prevnar 13, which dominate the market, accounted for $6.4 billion in sales last year.^{4 5 9}

Capvaxive adds to Merck’s current product line of pneumococcal vaccines, which includes Pneumovax 23 for adults 50 years of age and older and children older than two years and Vaxneuvance for babies six weeks and older.¹

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