 | Image may differ from actual product |
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The Business:
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| 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® 720 Junior'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® 720 Junior | $205,114 Reference: BCCDC FOIA request by TMOV, 12-06-19 |
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| The Product: | |
| Description of Vaccine: | Active immunizing agent
against infection by hepatitis A virus |
| | |
| Type of vaccine: |
Hepatitis A Junior. Given by Intramuscular injection |
| Primary medical reference: |
Package insert for Canada |
Reported Serious Adverse Events and Awards Given for Injuries from this type of vaccine ( Hepatitis A Junior)
(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 |
pruritus |
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 |
<= 0.05 OR <=0.05 |
mg |
|
| inactivated HM175 hepatitis A virus strain |
720 |
ELISA units |
|
| amino acid supplement |
0.3% |
w/v |
|
| disodium phosphate |
not shown |
|
|
| monopotassium phosphate |
not shown |
|
|
| neomycin sulphate |
< 10 |
ng |
An aminoglycoside antibiotic included in the cell growth media |
| phosphate-buffered saline solution and polysorbate 20 |
0.025 |
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