U.S. FDA Approves CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults
The U.S. FDA has approved Merck's CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for preventing invasive pneumococcal disease and pneumonia in adults 18 and older. CAPVAXIVE covers 84% of invasive pneumococcal disease (IPD) serotypes in adults 50+ and 85% in adults 65+. The approval is backed by robust Phase 3 trials demonstrating strong immune responses in both vaccine-naïve and experienced adults. The CDC's Advisory Committee on Immunization Practices is set to meet and discuss recommendations for CAPVAXIVE's use in adults. This approval, under the FDA's Priority Review, aims to address serotypes not covered by other vaccines. Continued approval may require verification of clinical benefits in a confirmatory trial.
- FDA approval offers a new vaccine option for preventing invasive pneumococcal disease in adults.
- Covers serotypes responsible for approximately 84% of IPD in adults 50+ and 85% in adults 65+.
- Includes eight unique serotypes not covered by other vaccines, addressing 27-30% of IPD in older adults.
- Strong immune responses demonstrated in Phase 3 trials for both vaccine-naïve and experienced adults.
- Approval under FDA's Priority Review highlights the vaccine's potential significance.
- Continued approval contingent upon verification of clinical benefits in a confirmatory trial.
- No direct efficacy comparison with PCV20, raising questions about relative performance.
- Potential risks for individuals with severe allergies to vaccine components or diphtheria toxoid.
Insights
CAPVAXIVE is now approved by the FDA for the prevention of invasive pneumococcal disease and pneumonia in adults, making it a significant addition to the vaccine market, especially given its 21-valent conjugate composition.
From a medical research standpoint, several aspects stand out. The vaccine covers 84% of invasive pneumococcal disease in adults over 50, a substantial improvement over existing vaccines like PCV20, which covers approximately 52%. The inclusion of serotypes responsible for a higher percentage of IPD is critical, especially since these serotypes cause severe complications such as hospitalization and even death.
However, it’s essential to consider that the approval is contingent upon further verification of clinical benefits. This means ongoing trials will need to confirm the expected efficacy and safety profile of CAPVAXIVE. If successful, this could solidify the vaccine's position in the market and potentially influence CDC recommendations.
In the short term, the news is likely to bolster investor confidence in Merck's vaccine portfolio, potentially increasing its stock value. Long term, the vaccine's market performance will hinge on its real-world efficacy and adoption rates, which will become clearer only after additional data and CDC recommendations are available.
The approval of CAPVAXIVE by the FDA is strategically important for Merck. From a financial perspective, it can significantly enhance Merck's competitive positioning in the vaccine market. Given the robust results from Phase 3 trials, the vaccine will likely command a competitive pricing strategy, possibly leading to substantial revenue generation.
The accelerated approval, based on opsonophagocytic activity, reflects a calculated risk, but one that is mitigated by ongoing confirmatory trials. Investors should note this approval underlines the strong R&D capabilities of Merck, which is vital for maintaining long-term growth and innovation in the pharmaceutical landscape.
Moreover, the market dynamics could shift favorably for Merck as CAPVAXIVE addresses a larger segment of the adult population, particularly those aged 50 and older who are at higher risk of invasive pneumococcal diseases. If the CDC’s Advisory Committee endorses the vaccine, it could lead to wider adoption and higher sales volumes, further positively impacting Merck’s financial performance.
CAPVAXIVE's entry into the market is poised to disrupt existing pneumococcal vaccine offerings significantly. The FDA approval, based on comprehensive clinical data, highlights its potential to cover a broader range of serotypes compared to current alternatives like PCV20.
From a market analysis perspective, Merck has cleverly positioned CAPVAXIVE to fill unmet needs within the vaccine landscape. By targeting adult populations, particularly those over 50, who are more susceptible to severe pneumococcal diseases, Merck can capture a substantial market share. Additionally, the unique serotypes included in CAPVAXIVE that are not present in PCV20 offer a compelling value proposition for healthcare providers and patients alike.
However, it is worth noting that the market's reaction will partly depend on CDC's forthcoming recommendations. A favorable recommendation could accelerate market penetration and boost sales, while any reservations could slow adoption.
Overall, the approval strengthens Merck’s vaccine portfolio and could provide a significant competitive edge, especially if follow-up studies corroborate the vaccine’s efficacy and safety.
CAPVAXIVE (V116) is specifically designed for adults and covers serotypes responsible for approximately
Across four Phase 3 studies, CAPVAXIVE demonstrated robust immune responses in both vaccine-naïve and vaccine-experienced adult populations
- 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 in individuals 18 years of age and older;
- 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 in individuals 18 years of age and older.
CAPVAXIVE is specifically designed to help protect adults against the serotypes that cause the majority of invasive pneumococcal disease (IPD) cases. The approval follows the FDA’s Priority Review of Merck’s application. Do not administer CAPVAXIVE to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid; see additional Select Safety Information below.
This indication 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 is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
The
“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 Dr. Walter Orenstein, professor emeritus of medicine, epidemiology, global health and pediatrics at Emory University and 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 to protect adults against invasive pneumococcal disease and pneumococcal pneumonia.”
Based on CDC data from 2018-2021, the serotypes covered by CAPVAXIVE are responsible for more cases of IPD in adults compared to PCV20 (pneumococcal 20-valent conjugate vaccine).
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In adults 50 years of age and older, CAPVAXIVE covers the serotypes responsible for approximately
84% of IPD cases, compared to approximately52% covered by PCV20. -
In adults 65 years of age and older, CAPVAXIVE covers the serotypes responsible for approximately
85% of IPD cases, compared to approximately51% covered by PCV20.
These values are based on CDC epidemiologic data and do not reflect the efficacy of the respective vaccines. There are currently no studies comparing the efficacy of CAPVAXIVE and PCV20.
CAPVAXIVE includes eight unique serotypes not covered by other currently approved pneumococcal vaccines; those serotypes were responsible for approximately
“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 Dr. Dean Y. Li, president, 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.”
Among the clinical data supporting the approval are results from the pivotal Phase 3 STRIDE-3 trial (NCT05425732), which evaluated CAPVAXIVE compared to PCV20 in adults 18 years of age and older who had not previously received a pneumococcal vaccine. The approval is also supported by results from the Phase 3 STRIDE-5 (NCT05526716) and STRIDE-6 (NCT05420961) trials evaluating CAPVAXIVE in vaccine-naïve and vaccine-experienced adults (see “Clinical Data Supporting FDA Approval,” below, for additional details).
About CAPVAXIVE
CAPVAXIVE is Merck’s approved 21-valent pneumococcal conjugate vaccine indicated for active immunization for the prevention of invasive disease and pneumonia in adults 18 years of age and older. CAPVAXIVE is specifically designed to help address Streptococcus pneumoniae serotypes predominantly responsible for adult invasive pneumococcal disease (IPD), including eight unique serotypes, 15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B compared to other pneumococcal vaccines. CAPVAXIVE is administered as a single dose.
Select Safety Information for CAPVAXIVE
Do not administer CAPVAXIVE to individuals with a history of a severe allergic reaction (eg, anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid.
Individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to CAPVAXIVE.
The most commonly reported (>
The most commonly reported (>
Vaccination with CAPVAXIVE may not protect all vaccine recipients.
Clinical Data Supporting FDA Approval
CAPVAXIVE was approved based on data that included Phase 3 clinical studies designed to evaluate its safety and immunogenicity in a variety of adult populations. These included studies of:
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Vaccine-naïve adults: STRIDE-3 (NCT05425732) is a double-blind, Phase 3 study which evaluated CAPVAXIVE compared to PCV20 in individuals 18 years of age and older who had not previously received a pneumococcal conjugate vaccine. Participants 50 years of age and older were enrolled in cohort 1 (n=2,362), and participants 18 through 49 years of age were enrolled in cohort 2 (n=300). Participants were randomized to receive a single dose of either CAPVAXIVE or PCV20. Results from the study include:
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In adults 50 years of age and older (cohort 1), CAPVAXIVE was non-inferior to PCV20 for the 10 serotype polysaccharides shared with both vaccines (3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, 33F), as assessed by serotype-specific OPA geometric mean titers (GMTs) at 1 month postvaccination;
- CAPVAXIVE was superior to PCV20 for 10 of 11 serotype polysaccharides included in CAPVAXIVE but not in PCV20 (9N, 15A, 16F, 17F, 20A, 23A, 23B, 24F, 31, 35B), as assessed by serotype-specific OPA GMTs 1 month postvaccination and the proportions of patients with a greater than or equal to four-fold increase in OPA from prevaccination to 1 month postvaccination;
- Immune responses were observed for serotype 15C in participants receiving CAPVAXIVE but did not meet criteria for statistical significance.
- In individuals 18 through 49 years of age (cohort 2), CAPVAXIVE elicited non-inferior immune responses (immunobridged) compared to individuals 50 through 64 years of age, as assessed by serotype-specific OPA GMTs 1 month postvaccination;
- Across both cohorts, CAPVAXIVE had a safety profile comparable to PCV20.
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In adults 50 years of age and older (cohort 1), CAPVAXIVE was non-inferior to PCV20 for the 10 serotype polysaccharides shared with both vaccines (3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, 33F), as assessed by serotype-specific OPA geometric mean titers (GMTs) at 1 month postvaccination;
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Co-administration of CAPVAXIVE with quadrivalent influenza vaccine (QIV): STRIDE-5 (NCT05526716) is a randomized, double-blind, Phase 3 study which evaluated CAPVAXIVE when administered concomitantly or sequentially (30 days later) with QIV in adults 50 years of age and older (n=1,080). Results from the study include:
- For the primary immunogenicity endpoints, CAPVAXIVE administered concomitantly with QIV was non-inferior to CAPVAXIVE administered sequentially with QIV for 20 of 21 serotypes in CAPVAXIVE (as assessed by OPA GMTs at 1 month postvaccination), as well as for three of four influenza strains in QIV (as assessed by hemagglutination inhibition (HAI) GMTs at 1 month postvaccination);
- The rates and severity of solicited systemic adverse reactions and solicited local adverse reactions at the CAPVAXIVE injection site were similar when CAPVAXIVE was administered with or without inactivated QIV.
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Vaccine-experienced adults: STRIDE-6 (NCT05420961) is a randomized descriptive Phase 3 study which evaluated CAPVAXIVE in individuals 50 years of age and older who had previously received a pneumococcal vaccine at least one year before enrollment. Participants were enrolled into one of three cohorts based on their previous pneumococcal vaccination history (cohort 1: PPSV23 [pneumococcal 23-valent polysaccharide vaccine], cohort 2: PCV13 [pneumococcal 13-valent conjugate vaccine], or cohort 3: PPSV23 followed by or preceded by PCV13, PPSV23 preceded by PCV15 [pneumococcal 15-valent conjugate vaccine], or PCV15 alone). Participants in cohort 1 were randomized to receive CAPVAXIVE (n=231) or PCV15 (n=119), participants in cohort 2 were randomized to receive CAPVAXIVE (n=176) or PPSV23 (n=85), and participants in cohort 3 were allocated to receive CAPVAXIVE (n=106). In each of the 3 cohorts, serotype-specific OPA GMTs and the proportion of individuals with ≥4-fold rise in OPA responses from baseline to 1-month postvaccination were assessed. Results from the study include:
- In cohort 1, CAPVAXIVE elicited OPA responses that were comparable to PCV15 for the 6 common serotypes, and higher for the 15 unique serotypes and serotype 15B;
- In cohort 2, CAPVAXIVE elicited OPA responses comparable to PPSV23 for the 12 common serotypes and serotype 15B, and higher for the 9 unique serotypes;
- OPA responses to CAPVAXIVE were similar across the 3 cohorts of participants who previously received one or more pneumococcal vaccines;
- CAPVAXIVE had a safety profile comparable to both PCV15 and PPSV23.
About Pneumococcal Disease
Pneumococcal disease is an infection caused by a bacteria called Streptococcus pneumoniae. There are about 100 different types (referred to as serotypes) of pneumococcal bacteria, which can affect adults differently than children. Pneumococcal disease can be invasive or non-invasive. Non-invasive pneumococcal illnesses include pneumonia (when pneumococcal disease is confined to the lungs), whereas invasive pneumococcal illnesses include pneumococcal bacteremia (infection in the bloodstream), bacteremic pneumococcal pneumonia (pneumonia with bacteremia) and pneumococcal meningitis (infection of the coverings of the brain and spinal cord). Pneumococcal pneumonia is a type of bacterial pneumonia, which is the most common clinical presentation of pneumococcal disease in adults. It’s estimated that over 150,000 adults are hospitalized from pneumococcal pneumonia each year in the
About Merck
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Please see Prescribing Information for CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) at https://www.merck.com/product/usa/pi_circulars/c/capvaxive/capvaxive_pi.pdf and Patient Information/Medication Guide for CAPVAXIVE at https://www.merck.com/product/usa/pi_circulars/c/capvaxive/capvaxive_ppi.pdf.
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