GARDASIL® 9

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The Business:
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
 
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 reactions
Age 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