NIMENRIX® |
Image may differ from actual product | |
The Business: | |
Manufacturer: | GlaxoSmithKline |
GlaxoSmithKline's total sales 2018: | £30.8 billion. Reference: GSK Key Facts |
GlaxoSmithKline's vaccine sales 2018: | £5.9 billion. Reference: 2018 Annual Report |
NIMENRIX®'s global sales in 2018: | £232 million (Menveo). Reference: 2018 Annual Report p 228 |
British Columbia Center for Disease Control expense, F/Y 2018/19 for NIMENRIX® | $1,070,006 (incl Menactra, Menveo $ Nimenrix) Reference: BCCDC FOIA request by TMOV, 12-06-19 |
The Product: | |
Description of Vaccine: | Meningococcal polysaccharide groups A, C, W-135 and Y conjugate vaccine. aka Menveo® |
Active Immunizing Agent | |
Type of vaccine: | Meningococcal Quadrivalent Conjugate. Given by Intramuscular injection |
Primary medical reference: | Package insert for Canada |
CDC Vaccine Type | MENINGOCOCCAL VACCINE (MENACTRA) |
Serious adverse events, USA, during 2018 (Definition of serious: Note 1, Source: Note 2) | 110 |
Number of injury awards paid by VICP (USA) for this vaccine type from 1988 until September 1, 2019 (Note 3) | 45 (Includes Meningococcal C Conjugate and Meningococcal Quadrivalent Conjugate) |
Serious adverse events following immunization, Canada, during 2018, for the group [Men-C, Men-C-ACYW-135, Men-C-C, Men-B] which includes this type of vaccine. (Note 4) | 78 (Includes Meningococcal C Conjugate and Meningococcal Quadrivalent Conjugate) |
Age of patient | Intensity | Adverse reaction | Frequency | Reference |
6 weeks to 12 months | All | Pain | 39.8% | Monograph, p 7 |
6 weeks to 12 months | All | Drowsiness | 52.8% | Monograph, p 7 |
6 weeks to 12 months | All | Irritability | 62.9% | Monograph, p 7 |
6 weeks to 12 months | All | Loss of Appetite | 38.4% | Monograph, p 7 |
6 weeks to 12 months | >=38℃ | Fever | 30.6% | Monograph, p 7 |
12 to 23 months | All | Pain | 29.2% | Monograph, p 8 |
12 to 23 months | All | Drowsiness | 28.1% | Monograph, p8 |
12 to 23 months | All | Irritability | 40.9% | Monograph |
6 to 10 years | All | Pain | 43.9% | Monograph, p 11 |
6 to 10 years | All | Fatigue | 22.3% | Monograph, p11 |
10 to 25 years | All | Pain | 51.4% | Monograph, p 11 |
10 to 25 years | All | Fatigue | 29.2% | Monograph, p 11 |
10 to 25 years | All | Headache | 26.1% | Monograph, p 11 |
All except infants | All | Injection site hematoma | Common (>= 1% to < 10%) | Monograph, p 11 |
All | All | Diarrhea | Common (>= 1% to < 10%) | Monograph, p 11 |
All | All | Vomiting | Common (>= 1% to < 10%) | Monograph, p 11 |
All except infants | All | Nausea | Common (>= 1% to < 10%) | Monograph, p 11 |
Ingredient | Quantity | Units | Notes |
Neisseria meningitidis serogroup A polysaccharide | 5 | mcg | conjugated to tetanus toxoid carrier protein |
Neisseria meningitidis serogroup C polysaccharide | 5 | mcg | conjugated to tetanus toxoid carrier protein |
Neisseria meningitidis serogroup W-135 polysaccharide | 5 | mcg | conjugated to tetanus toxoid carrier protein |
Neisseria meningitidis serogroup Y polysaccharide | 5 | mcg | conjugated to tetanus toxoid carrier protein |
tetanus toxoid carrier protein | 44 | mcg | |
Trometamol | 97 | mcg | |
sucrose | 28 | mg | |
sodium chloride | 4.5 | mg | |
water for injection | q.s. to 0.5 | ml |
Notes:
Note 1- USA - Definition of serious adverse events: According to the CDC's Vaccine Adverse Events Reporting System (VAERS), events are classified as serious when any of the following outcomes are associated with the event: Death, Permanent Disability, Life Threatening, Hospitalized, Existing Hospitalization Prolonged, Congenital Anomaly or Birth Defect.
Note 2- United States Department of Health and Human Services (DHHS), Public Health Service (PHS), Centers for Disease Control (CDC) / Food and Drug Administration (FDA), Vaccine Adverse Event Reporting System (VAERS) 1990 - last month, CDC WONDER On-line Database. Accessed at http://wonder.cdc.gov/vaers.html on Sep 28, 2019 1:51:20 AM. A most user-friendly interface for you to access the VAERS database is here. It is presented by the National Vaccine Information Center and is called MedAlerts.
Note 3- VICP is the National Vaccine Injury Compensation Program, Monthly Statistics Report
Note 4- Canada - Definition of serious Adverse Events Following Immunization are those which are life-threatening, result in hospitalization or a prolongation of hospitalization, result in persistent or significant disability, or where the outcome is a birth defect or death, as defined by the World Health Organization. Source: Adverse Events Following Immunization (AEFI) Bi-annual Report from July 1 to December 31, 2018. and Adverse Events Following Immunization (AEFI) Bi-annual Report from January 1 to June 30, 2018.