FDA Approves Pneumococcal 21-Valent Conjugate Vaccine Capvaxive

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The vaccine covers 8 serotypes not currently covered by any FDA-approved pneumococcal vaccines.

The FDA has approved Merck’s Capvaxive (V116), Merck’s pneumococcal 21-valent conjugate vaccine, for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults aged 18 years and older.1

Capvaxive specifically targets the serotypes responsible for a majority of cases of invasive pneumococcal disease. It is approved for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B, as well as for active immunization for the prevention of pneumonia caused by S pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A,15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B.

Bacterial pneumonia | image credit: Dr_Microbe - stock.adobe.com

Bacterial pneumonia | image credit: Dr_Microbe - stock.adobe.com

“Complications from invasive pneumococcal disease can lead to hospitalization, organ damage, and even death,” said Walter Orenstein, MD, a professor emeritus of medicine, epidemiology, global health, and pediatrics 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 protect adults against invasive pneumococcal disease and pneumococcal pneumonia.”

READ MORE: Exploring the Link Between Low Socioeconomic Status and Risk of Invasive Pneumococcal Disease

These 8 additional serotypes that Capvaxive targets—15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B—that are not covered by other FDA-approved pneumococcal vaccines account for approximately 27% and 30% of cases of invasive pneumococcal disease in adults aged 50 and 65 years and older, respectively. CDC data from 2018 to 2021 show that as a whole, the serotypes covered by Capvaxive are responsible for more cases of invasive pneumococcal disease in adults vs the serotypes covered by Pfizer’s Prevnar 20 (pneumococcal 20-valent conjugate vaccine).

“Today’s approval is a testament to our population-specific strategy behind Capvaxive, which demonstrated robust immunogenicity in a range of adult populations and is driven by a deep understanding of pneumococcal disease,” said Dean Y Li, MD, president of Merck Research Laboratories.

FDA approval for Capvaxive was based on clinical data from the pivotal phase 3 STRIDE-3 trial (NCT05425732), which evaluated Capvaxive vs PCV20 in adults aged 18 years sand older who had not received a previous pneumococcal vaccine. Additional data were provided by results from the phase 3 STRIDE-5 and STRIDE-6 clinical trials (NCT05526716, NCT05420961), which evaluated Capvaxive in both vaccine-naïve and vaccine-experienced adults.

The most common adverse events in adults aged 18 to 49 included injection site pain, fatigue, headache, myalgia, injection site erythema, and injection site swelling. In adults aged 50 years and older, the most common adverse events included injection site pain, fatigue, and headache.

Current estimates suggest that more than 150,000 adults are hospitalized due to pneumococcal pneumonia each year. There are approximately 100 strains of pneumococcal bacteria, causing both invasive and non-invasive pneumococcal disease. Invasive pneumococcal illnesses included pneumococcal bacteremia, bacteremia pneumococcal pneumonia, and pneumococcal meningitis.

The CDC Advisory Committee on Immunization Practices is expected to meet later in June to discuss potential recommendations for the use of Capvaxive in adults.

READ MORE: Immunization Resource Center

Reference
1. US FDA approves Capvaxive (pneumococcal 21-valent conjugate vaccine) for prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults. News release. Merck. June 17, 2024. Accessed June 18, 2024. https://www.merck.com/news/u-s-fda-approves-capvaxive-pneumococcal-21-valent-conjugate-vaccine-for-prevention-of-invasive-pneumococcal-disease-and-pneumococcal-pneumonia-in-adults/
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