CDC’S ACIP Recommends Merck’s CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for Pneumococcal Vaccination in Adults 50 Years of Age and Older
Merck's CAPVAXIVE receives CDC's ACIP recommendation for pneumococcal vaccination in adults aged 50 and older, lowering the previous age-based recommendation from 65. Based on CDC surveillance data, CAPVAXIVE covers serotypes responsible for approximately 84% of invasive pneumococcal disease cases, compared to 52% covered by PCV20. The vaccine is indicated for active immunization against invasive disease and pneumonia caused by 21 Streptococcus pneumoniae serotypes in adults 18 years and older. The recommendation includes a single dose for adults 50+ and those 19-49 with certain medical conditions who haven't received previous pneumococcal conjugate vaccines.
CAPVAXIVE di Merck riceve la raccomandazione dell'ACIP del CDC per la vaccinazione pneumococcica negli adulti di età pari o superiore a 50 anni, abbassando la precedente raccomandazione di età da 65. Basato sui dati di sorveglianza del CDC, CAPVAXIVE copre i sierotipi responsabili di circa l'84% dei casi di malattia pneumococcica invasiva, rispetto al 52% coperto da PCV20. Il vaccino è indicato per l'immunizzazione attiva contro la malattia invasiva e la polmonite causata da 21 sierotipi di Streptococcus pneumoniae negli adulti di età pari o superiore a 18 anni. La raccomandazione include una singola dose per gli adulti di età superiore ai 50 anni e per quelli di età compresa tra 19 e 49 anni con determinate patologie mediche che non hanno ricevuto precedenti vaccini coniugati pneumococcici.
CAPVAXIVE de Merck recibe la recomendación del ACIP de los CDC para la vacunación contra el neumococo en adultos de 50 años o más, reduciendo la recomendación de edad anterior de 65. Basado en los datos de vigilancia de los CDC, CAPVAXIVE cubre los serotipos responsables de aproximadamente el 84% de los casos de enfermedad neumocócica invasiva, en comparación con el 52% cubierto por PCV20. La vacuna está indicada para la inmunización activa contra la enfermedad invasiva y la neumonía causada por 21 serotipos de Streptococcus pneumoniae en adultos de 18 años o más. La recomendación incluye una dosis única para adultos mayores de 50 años y aquellos de 19 a 49 años con ciertas condiciones médicas que no han recibido vacunas conjugadas contra el neumococo previamente.
머크의 CAPVAXIVE가 50세 이상 성인을 위한 폐렴구균 예방접종에 대한 CDC의 ACIP 권고를 받았습니다. 이는 이전에 65세 이상이라는 연령 기준을 낮춘 것입니다. CDC의 감시 데이터에 따르면, CAPVAXIVE는 약 84%의 침습성 폐렴구균 질환 사례와 관련된 혈청형을 포함하고 있으며, 이는 PCV20이 커버하는 52%와 비교됩니다. 이 백신은 18세 이상의 성인에서 21가지 폐렴구균 혈청형에 의해 발생하는 침습성 질병 및 폐렴에 대해 능동 면역화를 목적으로 합니다. 권고 사항에는 50세 이상의 성인과 특정 의학적 상태가 있는 19-49세 성인을 위한 단일 투여가 포함되어 있으며, 이들은 이전에 폐렴구균 결합 백신을 접종받지 않았습니다.
CAPVAXIVE de Merck reçoit la recommandation de l'ACIP des CDC pour la vaccination pneumococcique chez les adultes de 50 ans et plus, abaissant la recommandation d'âge précédente de 65 ans. Basé sur les données de surveillance des CDC, CAPVAXIVE couvre des sérotypes responsables d'environ 84% des cas de maladie pneumococcique invasive, contre 52% pour PCV20. Le vaccin est indiqué pour l'immunisation active contre les maladies invasives et la pneumonie causées par 21 sérotypes de Streptococcus pneumoniae chez les adultes de 18 ans et plus. La recommandation inclut une dose unique pour les adultes de 50 ans et plus et ceux de 19 à 49 ans avec certaines conditions médicales qui n'ont pas reçu de vaccins conjugués pneumococciques auparavant.
Mercks CAPVAXIVE erhält die Empfehlung des ACIP des CDC für die pneumokokkale Impfung bei Erwachsenen ab 50 Jahren, wodurch die vorherige Altersempfehlung von 65 auf 50 Jahre gesenkt wird. Basierend auf den Überwachungsdaten der CDC deckt CAPVAXIVE Serotypen ab, die für etwa 84% der Fälle invasiver pneumokokkal Erkrankungen verantwortlich sind, im Vergleich zu 52%, die durch PCV20 abgedeckt werden. Der Impfstoff wird zur aktiven Immunisierung gegen invasive Krankheiten und Pneumonien verursacht durch 21 Serotypen von Streptococcus pneumoniae bei Erwachsenen ab 18 Jahren angezeigt. Die Empfehlung umfasst eine Einzeldosis für Erwachsene ab 50 Jahren und für 19- bis 49-Jährige mit bestimmten medizinischen Bedingungen, die zuvor keine pneumokokkalen Konjugatimpfstoffe erhalten haben.
- CDC recommendation expands target market by lowering vaccination age from 65 to 50
- CAPVAXIVE shows superior coverage (84%) of invasive pneumococcal disease cases compared to competitor PCV20 (52%)
- Broad protection against 21 serotypes of Streptococcus pneumoniae
- Approval for pneumonia prevention is under accelerated approval, requiring confirmatory trials
- effectiveness in certain at-risk populations where serotype 4 is prevalent
- Potential reduced immune response in immunocompromised individuals
Insights
The CDC's ACIP recommendation for Merck's CAPVAXIVE represents a significant market opportunity expansion. Lowering the age recommendation from 65 to 50 years substantially increases the eligible patient population. The vaccine's superior coverage of
The accelerated approval pathway and broader serotype coverage provide Merck with a competitive advantage in the adult pneumococcal vaccine space. This could translate into significant revenue potential, considering the expanded age group and the vaccine's demonstrated superiority in pathogen coverage. The shared clinical decision-making recommendation for those 65+ who completed previous vaccine series creates additional market opportunities.
This development strengthens Merck's position in the vaccine market against key competitor Pfizer's PCV20. The expanded age recommendation creates a new addressable market of adults aged 50-64, representing millions of potential patients. The superior serotype coverage provides a compelling differentiator for healthcare providers and payers.
The recommendation's timing aligns with increasing focus on preventive healthcare, particularly for aging populations. Implementation could drive significant revenue growth in Merck's vaccine segment, though market penetration will depend on factors including insurance coverage, healthcare provider adoption and patient education efforts.
Age-based recommendations for adult pneumococcal vaccination lowered from 65 to 50 years of age and older
National-level CDC surveillance data shows CAPVAXIVE covers the serotypes responsible for approximately
The updated ACIP guidelines recommend a single dose of CAPVAXIVE for:
- Adults 50 years of age and older who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown;
- Adults 19-49 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.
Shared clinical decision-making is also 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.
CAPVAXIVE should not be administered 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.
“The CDC’s decision to lower the age-based vaccination recommendations to begin at age 50 has the potential to be a practice-changing milestone,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “This recommendation is a significant step forward in efforts to enhance equitable access and may improve vaccination rates. We’re pleased about this progress and thank the CDC for their commitment to addressing invasive pneumococcal disease and pneumococcal pneumonia in adults.”
Based on national-level CDC data from 2018-2022, the serotypes covered by CAPVAXIVE are responsible for more cases of invasive pneumococcal disease (IPD) in adults compared to PCV20 (pneumococcal 20-valent conjugate vaccine). In adults 50 years of age and older, CAPVAXIVE covers the serotypes responsible for approximately
These provisional recommendations will be published on the CDC website following the meeting and will be official once reviewed and finalized by the director of the CDC and the Department of Health and Human Services.
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 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.
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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FAQ
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