NIMENRIX®

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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


No concerning ingredients yet found



Reported Serious Adverse Events and Awards Given for Injuries from this type of vaccine ( Meningococcal Quadrivalent Conjugate)
(These numbers may include only 1% of actual adverse events, according to the DHS's own study, p 6, line 12, which states, 'Likewise, fewer than 1% of vaccine adverse events are reported.')
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)



Adverse reactions
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



Other Ingredient(s)
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.



Babies and children normal body temperature: 97.9°F to 100.4°F (36.6°C to 38.0°C).

Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Ref
Grade 1 - Mild
Grade 2 - Moderate
Grade 3 - Severe
Grade 4 - Life-threatening
Grade 5 - Death