HAVRIX® 1440 Adult
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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
HAVRIX® 1440 Adult's global sales in 2018:£808 million (includes all GSK hepatitis). Reference: 2018 Annual Report p 228
British Columbia Center for Disease Control expense, F/Y 2018/19 for HAVRIX® 1440 Adult$199,479 Reference: BCCDC FOIA request by TMOV, 12-06-19
 
The Product:
Description of Vaccine: Active immunizing agent against infection by hepatitis A virus
 
Type of vaccine: Hepatitis A Adult. Given by Intramuscular injection
Primary medical reference: Package insert for Canada


Concerning Ingredient(s)
Ingredient (follow link to independent info) Quantity Units Reference
aluminum as aluminum hydroxide 0.5 mg Highlights of Prescribing (FDA)
MRC-5 cellular proteins < 5.0 mcg Havrix® Prescribing Information
Single stranded human fetal DNA 35.74 ng/vial Spontaneous Integration of Human DNA Fragments into Host Genome
Double stranded human fetal DNA 276 ng/vial Spontaneous Integration of Human DNA Fragments into Host Genome




Reported Serious Adverse Events and Awards Given for Injuries from this type of vaccine ( Hepatitis A Adult)
(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 HEPATITIS A
Serious adverse events, USA, during 2018 (Definition of serious: Note 1, Source: Note 2)141 (Includes Adult and Junior)
Number of injury awards paid by VICP (USA) for this vaccine type from 1988 until September 1, 2019 (Note 3)57 (Includes Adult and Junior)
Serious adverse events following immunization, Canada, during 2018, for the group [Chol-Ecol-O, HA, HA-Typh-I, HAHB, Typh-I, Typh-O, YF, JE] which includes this type of vaccine. (Note 4)N/A



Adverse reactions
Age of patient Intensity Adverse reaction Frequency Reference
n/a n/a irritability Very common: >= 10% Canadian monograph, p 6
n/a n/a headache Very common: >= 10% Canadian Monograph, p 6
n/a n/a pain and redness at the injection site, fatigue Very common: >= 10% Canadian Monograph, p 6
n/a n/a appetite loss Common: >= 1% and < 10% Canadian Monograph, p 6
n/a n/a drowsiness Common: >= 1% and < 10% Canadian Monograph, p 6
n/a n/a gastrointestinal symptoms (such as nausea, vomiting, diarrhea) Common: >= 1% and < 10% Canadian Monograph, p 6
n/a n/a malaise, injection site reaction (such as swelling or induration), fever (>= 37.5°C) Common: >= 1% and < 10% Canadian Monograph, p 6
n/a n/a upper respiratory tract infection, rhinitis Uncommon: >= 0.1% and < 1% Canadian Monograph, p 6
n/a n/a dizziness Uncommon: >= 0.1% and < 1% Canadian Monograph, p 6
n/a n/a rash Uncommon: >= 0.1% and < 1% Canadian Monograph, p 6
n/a n/a myalgia, musculoskeletal stiffness Uncommon: >= 0.1% and < 1% Canadian Monograph, p 6
n/a n/a influenza-like illness Uncommon: >= 0.1% and < 1% Canadian Monograph, p 6
n/a n/a hypoaesthesia, paraesthesia Rare: >= 0.01% and < 0.1% Canadian Monograph, p 6
n/a n/a pruritis Rare: >= 0.01% and < 0.1% Canadian Monograph, p 6
n/a n/a chills Rare: >= 0.01% and < 0.1% Canadian Monograph, p 6
n/a n/a anaphylaxis n/a Canadian Monograph, p 6
n/a n/a allergic reactions including anaphylactoid reactions and mimicking serum sickness n/a Canadian Monograph, p 6
n/a n/a convulsions n/a Canadian Monograph, p 6
n/a n/a vasculitis n/a Canadian Monograph, p 6
n/a n/a angioneurotic oedema n/a Canadian Monograph, p 6
n/a n/a arthralgia n/a Canadian Monograph, p 6
n/a n/a urticaria n/a Canadian Monograph, p 6
n/a n/a erythema multiforme n/a Canadian Monograph, p 6



Other Ingredient(s)
Ingredient Quantity Units Notes
formaldehyde OR formalin <= 0.1 OR <= 0.1 mg
inactivated HM175 hepatitis A virus strain 1440 ELISA units
amino acid supplement 0.3% w/v
disodium phosphate not shown
monopotassium phosphate not shown
neomycin sulphate < 20 ng
phosphate-buffered saline solution and polysorbate 20 .05 mg
potassium chloride not shown
water not shown
sodium chloride 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