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The Business:
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Manufacturer: | Merck & Co., Inc. |
Merck & Co., Inc.'s total sales 2018: | $42.3 billion. Reference: Facts about Merck |
Merck & Co., Inc.'s vaccine sales 2018: | $6.8 billion. Reference: 2018 Annual Report p 124 |
GARDASIL® 9's global sales in 2018: | $3,151 million. Reference: 2018 Annual Report p 124 |
British Columbia Center for Disease Control expense, F/Y 2018/19 for GARDASIL® 9 | $6,570,894 Reference: BCCDC FOIA request by TMOV, 12-06-19 |
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The Product: | |
Description of Vaccine: | Human Papillomavirus 9-valent Vaccine, Recombinant |
| Active Immunizing Agent |
Type of vaccine: |
HPV. 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 Amorphous Aluminum Hydroxyphosphate Sulfate adjuvant) |
500 |
mcg |
Package Insert |
Reported Serious Adverse Events and Awards Given for Injuries from this type of vaccine ( HPV)
(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 | HUMAN PAPILLOMAVIRUS (TYPES 6, 11,16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE |
Serious adverse events, USA, during 2018 (Definition of serious: Note 1, Source: Note 2) | 227 |
Number of injury awards paid by VICP (USA) for this vaccine type from 1988 until September 1, 2019 (Note 3) | 130 |
Serious adverse events following immunization, Canada, during 2018, for the group [HPV, HPV-2, HPV-4, HPV-9] which includes this type of vaccine. (Note 4) | 16 |
Adverse reactionsAge of patient |
Intensity |
Adverse reaction |
Frequency |
Reference |
9 to 15 years |
All |
Injection site pain |
89.3% |
Monograph, p 7 |
9 to 15 years |
All |
Injection site swelling |
47.8% |
Monograph, p 7 |
9 to 15 years |
All |
Injection site erythema |
34.1% |
Monograph, p 7 |
9 to 15 years |
All |
Headache |
11.4% |
Monograph, p 8 |
9 to 15 years |
All |
Fever |
5.0% |
Monograph, p 8 |
16 to 26 years |
All |
Injection site pain |
89.9% |
Monograph, p 8 |
16 to 26 years |
All |
Injection site swelling |
40.0% |
Monograph, p 8 |
16 to 26 years |
All |
Injection site erythema |
34.0% |
Monograph, p 8 |
16 to 26 years |
All |
Temperature > 37.8℃ |
6.0% |
Monograph, p 9 |
16 to 26 years |
All |
Injection site pain |
63.4% |
Monograph, p 9 |
9 to 15 years |
All |
Injection site pain |
70.2% |
Monograph, p 10 |
9 to 15 years |
All |
Headache |
9.1% |
Monograph, p 10 |
9 to 15 years |
All |
Pyrexia |
8.6% |
Monograph, p 10 |
All |
Serious |
Adverse events, not named |
2.3% (356) |
Monograph, p 10 |
All |
Unknown |
Autoimmune hemolytic anemia |
unknown |
Monograph, p 12 |
All |
Unknown |
Idiopathic thrombocytopenic purpura |
unknown |
Monograph, p 12 |
All |
Unknown |
Lymphadenopathy |
unknown |
Monograph, p 12 |
All |
Unknown |
Pulmonary embolus
|
unknown |
Monograph, p 12 |
All |
Unknown |
Nausea
|
unknown |
Monograph, p 12 |
All |
Unknown |
Pancreatitis
|
unknown |
Monograph, p 12 |
All |
Unknown |
Vomiting |
unknown |
Monograph, p 12 |
All |
Unknown |
Asthenia |
unknown |
Monograph, p 13 |
All |
Unknown |
Chills |
unknown |
Monograph, p 13 |
All |
Unknown |
Death |
unknown |
Monograph, p 13 |
All |
Unknown |
Fatigue |
unknown |
Monograph, p 13 |
All |
Unknown |
Malaise |
unknown |
Monograph, p 13 |
All |
Unknown |
Anaphylactic/anaphylactoid reactions |
unknown |
Monograph, p 13 |
All |
Unknown |
Bronchospasm |
unknown |
Monograph, p 13 |
All |
Unknown |
Urticarial hypersensitivity |
unknown |
Monograph, p 13 |
All |
Unknown |
Arthralgia, myalgia |
unknown |
Monograph, p 13 |
All |
Unknown |
Acute disseminated encephalomyelitis |
unknown |
Monograph, p 13 |
All |
Unknown |
Dizziness |
unknown |
Monograph, p 13 |
All |
Unknown |
Guillain-Barré syndrome |
unknown |
Monograph, p 13 |
All |
Unknown |
Headache |
unknown |
Monograph, p 13 |
All |
Unknown |
Motor neuron disease |
unknown |
Monograph, p 13 |
All |
Unknown |
Paralysis |
unknown |
Monograph, p 13 |
All |
Unknown |
Syncope sometimes accompanied by tonic-clonic movements |
unknown |
Monograph, p 13 |
All |
Unknown |
Transverse myelitis |
unknown |
Monograph, p 13 |
All |
Unknown |
Cellulitis |
unknown |
Monograph, p 13 |
Other Ingredient(s)
Ingredient |
Quantity |
Units |
Notes |
HPV Type 6 L1 protein |
30 |
mcg |
|
HPV Type 11 L1 protein |
40 |
mcg |
|
HPV Type 16 L1 protein |
60 |
mcg |
|
HPV Type 18 L1 protein |
40 |
mcg |
|
HPV Type 31 L1 protein |
20 |
mcg |
|
HPV Type 33 L1 protein |
20 |
mcg |
|
HPV Type 45 L1 protein |
20 |
mcg |
|
HPV Type 52 L1 protein |
20 |
mcg |
|
HPV Type 58 L1 protein |
20 |
mcg |
|
L-histidine |
0.78 |
mg |
|
polysorbate 80 |
50 |
mcg |
|
sodium borate |
35 |
mcg |
|
sodium chloride |
9.56 |
mg |
|
water for injection |
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