| Engerix®-B (Pediatric) |
| 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 |
| Engerix®-B (Pediatric)'s global sales in 2018: | £808 million (all GSK Hepatitis vaccines). Reference: 2018 Annual Report p 228 |
| British Columbia Center for Disease Control expense, F/Y 2018/19 for Engerix®-B (Pediatric) | $531,933 (incl Engerix Pediatric & Recombivax) Reference: BCCDC FOIA request by TMOV, 12-06-19 |
| The Product: | |
| Description of Vaccine: | Hepatitis B vaccine (recombinant) |
| Active immunizing agent against infection caused by all known subtypes of hepatitis B virus | |
| Type of vaccine: | Hepatitis B - Pediatric/Adolescent. Given by Intramuscular injection |
| Primary medical reference: | Package insert for Canada |
| Ingredient (follow link to independent info) | Quantity | Units | Reference |
| Al3+ as aluminium hydroxide | .25 | mg | Package Insert |
| CDC Vaccine Type | HEPATITIS B VACCINE |
| Serious adverse events, USA, during 2018 (Definition of serious: Note 1, Source: Note 2) | 519 (Includes Hepatitis B Adult and Pediatric/Adolescent) |
| Number of injury awards paid by VICP (USA) for this vaccine type from 1988 until September 1, 2019 (Note 3) | (Included in Hepatitis B) |
| Serious adverse events following immunization, Canada, during 2018, for the group [HB, HB-H, HB-dial, HBTmf] which includes this type of vaccine. (Note 4) | (Included in Hepatitis B) |
| Ingredient | Quantity | Units | Notes |
| hepatitis B surface antigen | 10 | mcg | |
| disodium phosphate dihydrate | not shown | ||
| sodium chloride | not shown | ||
| sodium dihydrogen phosphate dihydrate | not shown | ||
| 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.