VARILRIX
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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
VARILRIX's global sales in 2018:£305 million (Priorix, Priorix Tetra, Varilrix). Reference: 2018 Annual Report p 228
British Columbia Center for Disease Control expense, F/Y 2018/19 for VARILRIX$2,454,974 Reference: BCCDC FOIA request by TMOV, 12-06-19
 
The Product:
Description of Vaccine: Varicella virus vaccine, live, attenuated (Oka-strain). Active immunizing agent against infection by varicella-zoster virus
 
Type of vaccine: Varicella. Given by Intramuscular injection
Primary medical reference: Package insert for Canada


Concerning Ingredient(s)
Ingredient (follow link to independent info) Quantity Units Reference
varicella virus vaccine, live, attenuated (Oka-strain) 103.3 plaque-forming units (PFU)




Reported Serious Adverse Events and Awards Given for Injuries from this type of vaccine ( Varicella)
(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 VARIVAX-VARICELLA VIRUS LIVE
Serious adverse events, USA, during 2018 (Definition of serious: Note 1, Source: Note 2)136
Number of injury awards paid by VICP (USA) for this vaccine type from 1988 until September 1, 2019 (Note 3)66
Serious adverse events following immunization, Canada, during 2018, for the group [MMR, MMRV, Var] which includes this type of vaccine. (Note 4)94 (Includes MMR, MMRV, Var)



Adverse reactions
Age of patient Intensity Adverse reaction Frequency Reference
children, adolescents and adults pain Very Common >= 10% Monograph, p 7
children, adolescents and adults redness Very common: >= 10% Monograph, p 7
children, adolescents and adults swelling at the injection site Common >= 1% and < 10% Monograph, p 7
children, adolescents and adults fever (oral/axillary temperature >= 37.5°C or rectal temperature >= 38.0°C) Common >= 1% and < 10% Monograph, p 7
children, adolescents and adults upper respiratory tract infection Uncommon >= 0.1% and < 1% Monograph, p 7
children, adolescents and adults pharyngitis Uncommon >= 0.1% and < 1% Monograph, p 7
children, adolescents and adults lymphadenopathy Uncommon >= 0.1% and < 1% Monograph, p 7
children, adolescents and adults irritability Uncommon >= 0.1% and < 1% Monograph, p 8
children, adolescents and adults headache Uncommon >= 0.1% and < 1% Monograph, p 8
children, adolescents and adults somnolence Uncommon >= 0.1% and < 1% Monograph, p 8
children, adolescents and adults cough Uncommon >= 0.1% and < 1% Monograph, p 8
children, adolescents and adults rhinitis Uncommon >= 0.1% and < 1% Monograph, p 8
children, adolescents and adults nausea Uncommon >= 0.1% and < 1% Monograph, p 8
children, adolescents and adults vomiting Uncommon >= 0.1% and < 1% Monograph, p 8
children, adolescents and adults varicella-like rash Uncommon >= 0.1% and < 1% Monograph, p 8
children, adolescents and adults pruritus Uncommon >= 0.1% and < 1% Monograph, p 8
children, adolescents and adults arthralgia Uncommon >= 0.1% and < 1% Monograph, p 8
children, adolescents and adults myalgia Uncommon >= 0.1% and < 1% Monograph, p 8
children, adolescents and adults fever (oral/axillary temperature > 39.0°C
or rectal temperature > 39.5°C)		 Uncommon >= 0.1% and < 1% Monograph, p 8
children, adolescents and adults fatigue Uncommon >= 0.1% and < 1% Monograph, p 8
children, adolescents and adults malaise Uncommon >= 0.1% and < 1% Monograph, p 8
children, adolescents and adults conjunctivitis Rare >= 0.01% and < 0.1% Monograph, p 8
children, adolescents and adults abdominal pain Rare >= 0.01% and < 0.1% Monograph, p 8
children, adolescents and adults diarrhea Rare >= 0.01% and < 0.1% Monograph, p 8
children, adolescents and adults urticaria Rare >= 0.01% and < 0.1% Monograph, p 8
children, adolescents and adults herpes zoster rarely reported Monograph, p 9
children, adolescents and adults thrombocytopenia rarely reported Monograph, p 9
children, adolescents and adults hypersensitivity rarely reported Monograph, p 9
children, adolescents and adults anaphylactic reactions rarely reported Monograph, p 9
children, adolescents and adults encephalitis rarely reported Monograph, p 9
children, adolescents and adults cerebrovascular accident rarely reported Monograph, p 9
children, adolescents and adults cerebellitis rarely reported Monograph, p 9
children, adolescents and adults cerebellitis like symptoms (including
transient gait disturbance and transient ataxia)		 rarely reported Monograph, p 9
children, adolescents and adults convulsions rarely reported Monograph, p 9
children, adolescents and adults vasculitis (including Henoch Schonlein
purpura and Kawasaki syndrome)		 rarely reported Monograph, p 9
children, adolescents and adults erythema multiforme rarely reported Monograph, p 9



Other Ingredient(s)
Ingredient Quantity Units Notes
amino acids not shown
lactose not shown
mannitol not shown
sorbitol not shown
water for injection not shown
neomycin sulphate not shown


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