| CERVARIX |
| 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 |
| CERVARIX's global sales in 2018: | £138 million. Reference: 2018 Annual Report p 228 |
| British Columbia Center for Disease Control expense, F/Y 2018/19 for CERVARIX | Reference: BCCDC FOIA request by TMOV, 12-06-19 |
| The Product: | |
| Description of Vaccine: | Human Papillomavirus vaccine Types 16 and 18 (Recombinant, AS04 adjuvanted) |
| Active Immunizing Agent | |
| Type of vaccine: | HPV. Given by Intramuscular injection |
| Primary medical reference: | Package insert for Canada |
| Ingredient (follow link to independent info) | Quantity | Units | Reference |
| aluminum as aluminum hydroxide | 0.5 | mg | Package Insert |
| 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 |
| Ingredient | Quantity | Units | Notes |
| Human Papillomavirus type 16 L1 protein | 20 | mcg | |
| Human Papillomavirus type 18 L1 protein | 20 | mcg | |
| 3 -0-desacyl-4'-monophosphoryl lipid A (MPL) | 50 | mcg | |
| sodium chloride | 4.4 | mg | |
| sodium dihydrogen phosphate dihydrate | 0.624 | 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.