Capvaxive

Capvaxive is approved for both the prevention of invasive pneumococcal disease and pneumococcal pneumonia. Credit: Sonia Bonet via Shutterstock. Merck & Co (MSD) has won US Food and Drug Administration (FDA) approval for its 21-valent pneumococcal vaccine, Capvaxive, for the prevention of invasive pneumococcal disease and pneumococcal pneumonia. According to MSD, the strains covered by Capvaxive were responsible for 84% of invasive pneumococcal disease in patients 50 years and older between 2018 and 2021. Though the approval is for ages 18 and above, the pharma giant has adapted the vaccine specifically for adults aged 50 and older. This includes the eight unique serotypes, 15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B compared to other pneumococcal vaccines. MSD’s 21-valent pneumococcal vaccine introduces a new rival to Pfizer ’s 20-valent product Prevnar 20 (20-valent Pneumococcal Conjugate Vaccine), which was approved in 2021 for both children and adults. Prevnar 20 currently dominates the pneumococcal vaccine market for adults, however, MSD stated that the strains covered by the Prevnar 20 vaccine are responsible for only 52% of invasive pneumococcal disease in the same population, as per US Centers for Disease Control and Prevention (CDC) data from 2018-2021. According to a GlobalData’s Pharma Intelligence Center, Capvaxive is forecast to generate $1.16bn in 2030. GlobalData is the parent company of Pharmaceutical Technology. See Also: SGNB-7H4V by Pfizer for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer): Likelihood of Approval SGNB-7H4V by Pfizer for Epithelial Ovarian Cancer: Likelihood of Approval Among the clinical data supporting the approval are results from the Phase III STRIDE-3 trial (NCT05425732), which compared Capvaxive to Prevnar 20 in adults aged 18 and older who had not previously received a pneumococcal vaccine. When comparing immune responses, the study showed Capvaxive was non-inferior in the 10 serotypes common to both vaccines and superior in 10 of its 11 unique serotypes. Pneumococcal disease, caused by the bacteria Streptococcus pneumoniae, encompasses illnesses such as pneumonia, meningitis, and bloodstream infections. There are about 100 different types (referred to as serotypes) of pneumococcal bacteria, which can affect adults differently than children. The CDC Advisory Committee on Immunization Practices is expected to meet later this month on 27 June, to discuss and make recommendations for the use of Capvaxive in adults. Walter Orenstein, a member of MSD’s scientific advisory committee said: “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.”

Dive Brief:The Food and Drug Administration on Monday approved a new vaccine from Merck & Co. that protects against 21 types of the bacteria that causes pneumococcal disease.The vaccine, cleared for use in adults 18 and older, will be sold by Merck as Capvaxive. Pneumococcal disease can lead to severe infection in the lungs or sometimes in the blood and spinal cord, when it is known as meningitis. Adults older than 65 or who have compromised immune systems are at particular risk for the disease.Merck expects to make the vaccine available as soon as late July, depending on the recommendations provided by advisers to the Centers for Disease Control and Prevention, who are scheduled to meet later this month.Dive Insight:Merck currently sells two pneumococcal vaccines. One, dubbed Pneumovax 23, is for adults at least 50 years of age and children older than two who are increased risk of infection. The other,Vaxneuvance, is for those aged six weeks and older.But its Pfizers Prevnar shots that have dominanted the market. The companys Prevnar 20 gained approval in 2021 for adults 18 years or older and is now also cleared for infants and teenagers. The vaccine protects against 20 serotypes, while Mercks Vaxneuvance covers 15.Capvaxive could have an edge there, as it targets 21 serotypes, including eight not covered by other shots.[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, wrote Paula Annunziato, vice president of vaccine clinical development at Merck, in an email to BioPharma Dive. It covers the serotypes responsible for ~84% of cases of [invasive pneumococcal disease] in adults 50 years and older.The comparator number for Prevnar 20 is 52%, per Merck. And according to the company, the eight unique serotypes covered by Capvaxive alone account for more than one-quarter of invasive pneumococcal disease cases in adults 50 years and older.In a note to clients, Cantor Fitzgerald analyst Louise Chen said a preferential recommendation from the Advisory Committee on Immunization Practices, or ACIP, would help boost sales of Mercks vaccine. The advisory committee is set to meet on June 27.Merck set the price of Capvaxive at $287 per the single dose used for immunization. In a statement, Merck said most people in the U.S. would have access at no out-of-pocket cost if the CDC panel gives a routine recommendation to Capvaxive. '