Saturday, July 13, 2024

Pneumonia Prevention Enhanced with FDA Approval of Merck’s Capvaxive for Adults

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Pneumonia prevention has advanced with the Food and Drug Administration’s (FDA) approval of Merck’s Capvaxive, a 21-valent pneumococcal conjugate vaccine, to prevent invasive pneumococcal disease (IPD) and pneumococcal pneumonia in adults aged 18 and older. According to Merck, Capvaxive offers superior protection compared to other vaccines, such as PCV20, by targeting eight specific serotypes responsible for a significant number of IPD cases in adults. This approval was based on positive outcomes from the Phase III STRIDE-3, STRIDE-5, and STRIDE-6 trials, which compared Capvaxive to PCV20 in both vaccine-naïve and vaccine-experienced patients.

“Complications from invasive pneumococcal pneumonia 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,” stated Walter Orenstein, MD, 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 pneumonia disease in adults, helping to protect adults against both invasive pneumococcal disease and pneumococcal pneumonia.”

The double-blind STRIDE-3 trial compared Capvaxive to PCV20 in adults who had not previously received a pneumococcal pneumonia conjugate vaccine. Patients were divided into two cohorts: those over 50 years of age and those aged 49 years and younger. All patients were randomly assigned to receive either Capvaxive or PCV20. In the cohort of adults aged 50 and older, Capvaxive was found to be equal to PCV20 for all 10 shared serotype polysaccharides and superior for 10 of the 11 unique serotype polysaccharides included in Capvaxive.

Pneumonia Vaccine Capvaxive Demonstrates Promising Immune Response in Clinical Trials

The immune response for serotype 15C showed promise but requires further investigation. Additionally, Capvaxive had a comparable safety profile to PCV20. In the younger cohort, the vaccine demonstrated non-inferior immune responses compared to the older cohort.

The randomized, double-blind STRIDE-5 trial evaluated Capvaxive when administered either concomitantly or sequentially with the quadrivalent influenza vaccine (QIV) in adults over 50 years old. The results indicated that Capvaxive could be safely given at the same time as QIV or one month apart, as the immune responses for both vaccines remained robust regardless of the administration method. Adverse events (AEs) were similar whether QIV was taken with Capvaxive or Capvaxive was taken alone.

The randomized descriptive STRIDE-6 trial focused on adults over 50 years who had previously received a pneumococcal pneumonia vaccine at least one year before the start of the trial. Patients were divided into three cohorts: those who had been vaccinated with PPSV23, those who had taken PCV13, and those who had received PPSV23 followed by or preceded by PCV13, PPSV23 preceded by PCV15, or PCV15 alone. Cohort one was randomly assigned to receive either Capvaxive or PCV15; cohort two received either Capvaxive or PPSV23; and all of cohort three received Capvaxive.


Capvaxive Approved as Effective Booster for Pneumonia Prevention, Offers Broad Protection

In patients previously vaccinated with either PPSV23 or PCV13, Capvaxive acted as a strong booster. For cohort one, Capvaxive was comparable to PCV15 for the six common serotypes and higher for the 15 unique serotypes, including serotype 15B. In cohort two, Capvaxive was comparable to PPSV23 for the 12 common serotypes and serotype 15B, with a higher immune response for the nine unique serotypes. Additionally, Capvaxive had a safety profile consistent with both PCV15 and PPSV23.

“Today’s approval is a testament to our population-specific strategy behind Capvaxive, which demonstrated robust immunogenicity across a range of adult populations and is driven by a deep understanding of pneumococcal pneumonia disease,” said Dean Y. Li, MD, PhD, president of Merck Research Laboratories. “We are proud to provide Capvaxive as a new option specifically designed to help protect against the majority of invasive pneumococcal disease-causing serotypes in adults.”

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This new approval marks a significant milestone in the fight against pneumococcal pneumonia disease. Capvaxive’s ability to target a broader range of serotypes offers enhanced protection for adults, addressing a critical gap in current vaccine options. With its strong safety profile and proven efficacy, Capvaxive stands out as a pivotal tool in preventing serious complications arising from pneumococcal infections, ultimately contributing to better public health outcomes.


Resource: Merck, June 18, 2024

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