CDC’S ACIP Unanimously Recommends Merck’s CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for Pneumococcal Vaccination in Appropriate Adults
The CDC's Advisory Committee on Immunization Practices (ACIP) has unanimously recommended Merck's CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for adults 65 years and older, as well as adults 19-64 with certain risk conditions.
This recommendation targets individuals who have not previously received a pneumococcal conjugate vaccine or whose vaccination status is unknown. Additionally, those over 65 who have completed their vaccine series with PCV13 and PPSV23 are advised to consider a supplemental dose of CAPVAXIVE.
CAPVAXIVE covers 24 Streptococcus pneumoniae serotypes, addressing invasive disease and pneumonia. It has accelerated approval based on immune response metrics, though continued approval is contingent on further clinical trial results. Final recommendations are pending review by the CDC and the Department of Health and Human Services.
CAPVAXIVE should not be administered to individuals with severe allergic reactions to its components or diphtheria toxoid. Side effects include injection-site pain, fatigue, and headache.
- ACIP's unanimous recommendation of CAPVAXIVE for adults 65 and older and adults 19-64 with risk conditions.
- CAPVAXIVE targets 24 Streptococcus pneumoniae serotypes, offering broad protection.
- Accelerated approval based on immune response, with potential for continued approval pending further trials.
- CAPVAXIVE should not be administered to individuals with severe allergic reactions to its components or diphtheria toxoid.
- Potential side effects include injection-site pain (73.1% in 18-49 age group) and fatigue (36.0% in 18-49 age group).
Insights
The unanimous recommendation by the CDC's Advisory Committee on Immunization Practices (ACIP) for Merck's CAPVAXIVE™ is a significant milestone. The expansion of the pneumococcal vaccine to cover 21 serotypes is noteworthy because it addresses a broader range of bacterial strains compared to existing vaccines like PCV13 and PPSV23. It's essential to understand that this vaccine is designed to prevent invasive diseases caused by Streptococcus pneumoniae, which can lead to severe illnesses such as pneumonia, meningitis and bacteremia, particularly in older adults and those with underlying conditions.
The clinical implications are substantial. By including a more comprehensive set of serotypes, CAPVAXIVE has the potential to offer better protection and reduce the incidence of these serious infections. However, it is important to keep in mind that the vaccine's approval was based on immunogenicity data rather than direct clinical outcomes. This means that while the vaccine showed strong immune responses in trials, its real-world effectiveness will need to be confirmed through further studies.
For retail investors, the long-term success of CAPVAXIVE will hinge on its uptake and the eventual verification of its clinical benefits. If these outcomes are favorable, the vaccine could become a standard in pneumococcal prevention, potentially driving significant revenue for Merck.
From a financial perspective, this recommendation is poised to positively impact Merck's revenue streams. Pneumococcal vaccines are a significant market, particularly given the aging population and the heightened focus on preventive healthcare. The expanded age and risk-group recommendations mean that a larger portion of the adult population will be eligible for CAPVAXIVE, potentially leading to increased sales.
Market dynamics also play a role here. Being able to offer a vaccine that covers more serotypes than competitors can provide Merck with a competitive edge, attracting both healthcare providers and patients. However, it's important to note that the provisional recommendations will only become official after review by the CDC and the Department of Health and Human Services. Investors should watch for this final approval as a catalyst for market adoption.
In the short term, we could see a positive impact on Merck's stock price as the market reacts to this news. In the long term, sustained revenue growth will depend on the vaccine's real-world efficacy and acceptance in the healthcare community.
The unanimous ACIP recommendation for CAPVAXIVE is likely to influence the market dynamics significantly. Pneumococcal vaccines are a competitive segment and having a product that covers a broader range of serotypes can differentiate Merck in a crowded market. The inclusion of adults aged 65 and older, as well as younger adults with certain health conditions, expands the target demographic, which can drive market share gains.
Consumer acceptance and awareness campaigns will be critical for the vaccine's success. Merck will need to ensure that healthcare providers are well-informed about the benefits of CAPVAXIVE compared to existing vaccines. Additionally, communicating the importance of broader serotype coverage to patients can aid in adoption.
Retail investors should consider the potential market penetration of CAPVAXIVE. If Merck can effectively leverage this expanded recommendation, it could result in a robust revenue stream. Monitoring metrics such as prescription rates and market feedback will be essential to gauge the vaccine's impact on Merck’s overall performance.
CAPVAXIVE (V116) recommended for all adults age 65 and older and for adults 19 to 64 with certain risk conditions, and for those over 65 previously vaccinated with other pneumococcal vaccines
Specifically, the ACIP voted to recommend a single dose of CAPVAXIVE for:
- Adults 65 years of age and older who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown;
- Adults 19-64 years of age with certain underlying medical conditions or other risk factors who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown;
- Adults 19 years of age and older who have started their pneumococcal vaccine series with PCV13 (pneumococcal 13-valent conjugate vaccine) but have not received all recommended PPSV23 (pneumococcal 23-valent polysaccharide vaccine) doses.
Additionally, shared clinical decision-making is recommended regarding use of a supplemental dose of CAPVAXIVE for adults 65 years of age and older who have completed their vaccine series with both PCV13 and PPSV23.
CAPVAXIVE is indicated for:
- Active immunization for the prevention of invasive disease and pneumonia 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 adults 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.
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.
The 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.
These provisional recommendations will be official once reviewed and finalized by the director of the CDC and the Department of Health and Human Services.
“CAPVAXIVE represents an innovative approach to invasive pneumococcal disease prevention in adults, as it is specifically designed to help protect against the strains that cause the majority of severe disease in adults 65 years of age and older,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “The ACIP vote recognizes the clinical profile of CAPVAXIVE for adults in the
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.
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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Source: Merck & Co., Inc.
FAQ
What is CAPVAXIVE recommended for?
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Which Streptococcus pneumoniae serotypes does CAPVAXIVE cover?
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