Introducing a new way to help prevent invasive pneumococcal disease in adults
Prevenar 13® can be administered to adults who are aged 50+, this includes those who have been previously vaccinated with pneumococcal polysaccharide vaccine (PPV) and those with certain co-morbidities.
Vaccinate your adult patients 50+ with Prevenar 13® for the prevention of invasive pneumococcal disease.
Invasive Pneumococcal Disease
Invasive pneumococcal disease remains a serious health problem.
In adults (≥50 years old), the most common manifestations of invasive pneumococcal disease (IPD) are meningitis, bacteraemia without a focus and bacteraemic pneumonia (of which alone accounts for around 80% of IPD in adults).
Increased risk of invasive pneumococcal disease in adults
Invasive pneumococcal disease incidence rate per 100,000 population by age grouping England and Wales, 1996-2005
Mortality
Invasive pneumococcal disease carries a high mortality rate with an average of 20% in adults with bacteraemia, this may be as high as 60% among elderly patients.
The incidence of invasive pneumococcal disease increases with age and comorbidities
Invasive pneumococcal disease continues to be a serious health problem in adults. The approval of Prevenar 13® in adults aged 50 years and older is an important step forward in the prevention of invasive pneumococcal disease, which causes significant morbidity and mortality in this age group.
In addition to age, compromised immune function plays a significant role in the risk of invasive pneumococcal disease.
Our need to rethink strategies for disease prevention becomes more apparent as our patient population is getting older.
Serotypes
Prevenar 13® contains Streptococcus pneumoniae serotypes, the 13 serotypes are as follows:
1 3 4 5 6A 6B 7F 9V 14 18C 19A 19F 23F
Prevenar 13® demonstrated functional antibody response in adults aged 50 to 80+, including those:
*previously vaccinated with pneumococcal polysaccharide vaccine (PPV)
*naive to pneumococcal vaccines
*with certain co-morbidities such as cardiovascular disease, diabetes, and pulmonary disease
Conjugate Technology
Prevenar 13® is the only licensed adult pneumococcal vaccine that benefits from conjugation technology, an advance in vaccine development.
Conjugate vaccines represent an evolution in vaccine development technology, believed to offer long-term protection and superior immune response
Mode of Action
Vaccines trigger an immune response to invading pathogens.
Vaccines simulate an infection by delivering antigens that prime the immune system by appearing to be threatening pathogens.
Conjugation elicits a T cell-dependent immune response
Conjugation of a plain polysaccharide to a carrier protein transforms the immune response to a T cell-dependent response generating:
*Immunological memory
*Responsiveness to a further dose of vaccine
Prevenar 13® uses CRM197: a carrier protein, which transforms the immune response to a T cell dependant response.
Naive pivotal study
Prevenar 13® demonstrated functional antibody response in adults aged 50 to 70+ in pivotal phase 3 studies.
Functional antibody response in pneumococcal vaccine-naive adults.†**
Antibody responses elicited by Prevenar 13® were noninferior to pneumococcal polysaccharide vaccine (PPV) among shared serotypes.
Prevenar 13® induced significantly higher antibody responses compared to PPV in the majority of the common serotypes to both vaccines and serotype 6A (not included in PPV).§
Functional antibody responses in PPV-naive adults aged 60-64 years†
**PPV-naive adults aged 60-64 years were randomly assigned to receive Prevenar 13® (N=359-404) or PPV (N=367-402)
†Functional antibody response was measured using the OPA (opsonophagocytic assay), which quantifies the ability of immune sera to mediate the killing of S. pneumoniae by phagocytic cells. The clinical relevance of this is unknown
§This was a noninferiority study. Noninferiority was defined as the lower limit of the 2-sided 95% CI for GMR greater than 0.5
Statistically significantly higher antibody responses were defined as the lower bound of the 2-sided 95% CI for GMR greater than 1
Serotype 6A is unique to Prevenar 13
Prevaccinated pivotal study
Functional antibody response in adults previously vaccinated with pneumococcal polysaccharide vaccine (PPV)†**
Antibody responses elicited by Prevenar 13® were noninferior to PPV among shared serotypes.
Prevenar 13® induced significantly higher antibody responses compared to PPV in the majority of the common serotypes to both vaccines and serotype 6A (not included in PPV).§
Functional antibody responses in adults 70+ previously vaccinated with PPV ≥5 years prior, after receiving Prevenar 13® or PPV.†
**Adults aged ≥70 years vaccinated with PPV ≥5 years prior were randomly assigned to receive Prevenar 13® (N=400–426) or PPV (N=395–445)
†Functional antibody response was measured using the OPA (opsonophagocytic assay), which quantifies the ability of immune sera to mediate the killing of S. pneumoniae by phagocytic cells. The clinical relevance of this is unknown
§This was a noninferiority study. Noninferiority was defined as the lower limit of the 2-sided 95% CI for GMR greater than 0.5
Statistically significantly higher antibody responses were defined as the lower bound of the 2-sided 95% CI for GMR greater than 1
Serotype 6A is unique to Prevenar 13
Safety profile
Prevenar 13® has an acceptable safety profile and is generally well tolerated.
Prevenar/Prevenar 13®
Over 400 million doses administered in children worldwide.
Prevenar 13® is built on the established scientific foundation of Prevenar (its 7-valent predecessor) and is approved for use in children 6 weeks through 5 years of age, and in adults ≥50 years.
Safety was accessed in 6 clinical studies including 6,198 adults ranging in age from 50 to 95 years.
In clinical trials with more than 6000 adults ≥50, Prevenar 13® has been shown to have an acceptable safety profile and is generally well tolerated.
Most commonly reported local and systemic adverse events:
Redness, swelling, tenderness, hardness, and pain at the injection site, and limitation of arm movement.
Decreased appetite, headache, diarrhoea, chills, fatigue, rash, and worsening of or new joint or muscle pain.
Prevenar 13® in adults can be co-administered with the trivalent influenza vaccine.
Concomitant use with other adult vaccines has not been investigated.
Vaccination procedure
Prevenar 13®: Vaccinate your adult patients 50+ for the prevention of invasive pneumococcal disease.
Prevenar 13® is administered intramuscularly as 1 dose and is packaged in a 0.5 mL, single-dose, prefilled syringe.
Contains 2.2 µg of polysaccharide for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A,19F and 23F, and 4.4µg of polysaccharide for serotype 6B.
Must be refrigerated and stored at +2 to -8°C.
Do not freeze; if frozen, it must be discarded.
The shelf life of Prevenar 13® is 3 years.
The tip and rubber cap of the syringe are latex-free.
Prevenar 13® should be shaken well before usage.
The need for revaccination with a subsequent dose of Prevenar 13® has not been established.
Ordering
To order, contact Movianto on 01234 248631
Pack of 1: single-dose pre-filled syringe (with separate needle) £49.10
Pack of 10: single-dose pre-filled syringes £491.00
Vaccinate your adult patients 50+ with Prevenar 13® for the prevention of invasive pneumococcal disease.