| PEDIACEL® |
| Image may differ from actual product |
| The Business: | |
| Manufacturer: | Sanofi |
| Sanofi's total sales 2018: | €34.4 billion. Reference: Sanofi At a Glance |
| Sanofi's vaccine sales 2018: | €5.1 billion. Reference: Sanofi At a Glance |
| PEDIACEL®'s global sales in 2018: | €1,749 million (Polio, Pertussis, Hib) €470 million (Adult Booster Vaccines)(See Imovax and TdAdsorbed). Reference: 2018 Sales Report (Excel file) |
| British Columbia Center for Disease Control expense, F/Y 2018/19 for PEDIACEL® | $705,246 Reference: BCCDC FOIA request by TMOV, 12-06-19 |
| The Product: | |
| Description of Vaccine: | Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine and Haemophilus b Conjugate Vaccine (Tetanus Protein - Conjugate) |
| Type of vaccine: | DTaP-IPV-Hib. Given by Intramuscular injection |
| Primary medical reference: | Package insert for Canada |
| Ingredient (follow link to independent info) | Quantity | Units | Reference |
| aluminum phosphate | 1.5 | mg | Package Insert |
| CDC Vaccine Type | DIPHTHERIA AND TETANUS TOXOIDS ACELLULAR PERTUSSIS VACCINE + INACTIVATED POLIOVIRUS VACCINE + HAEMOPHILUS B CONJUGATE VACCINE |
| Serious adverse events, USA, during 2018 (Definition of serious: Note 1, Source: Note 2) | 124 |
| Number of injury awards paid by VICP (USA) for this vaccine type from 1988 until September 1, 2019 (Note 3) | 14 |
| Serious adverse events following immunization, Canada, during 2018, for the group [DTaP, DTaP-IPV, DTaP-IPV-Hib, DTaP-HB-IPV-Hib, DTaP-Hib, DTaP-HB-IPV] which includes this type of vaccine. (Note 4) | 89 |
| Ingredient | Quantity | Units | Notes |
| diphtheria toxoid | 15 | Lf | |
| tetanus toxoid | 5 | Lf | |
| pertussis toxoid | 20 | mcg | |
| filamentous haemagglutinin | 20 | mcg | |
| pertactin | 3 | mcg | |
| fimbriae Types 2 and 3 | 5 | mcg | |
| Inactivated Poliomyelitis Vaccine-Type 1 (Mahoney) | 40 | D-antigen units | |
| Inactivated Poliomyelitis Vaccine-Type 2 (MEF1) | 8 | D-antigen units | |
| Inactivated Poliomyelitis Vaccine-Type 3 (Saukett) | 32 | D-antigen units | |
| Purified Polyribosylribitol Phosphate Capsular Polysaccharide (PRP) of Haemophilus influenzae-Type b covalently bound to 18-30 mcg of Tetanus Protein | 10 | mcg | |
| 2-phenoxyethanol | 0.6 | %v/v | |
| polysorbate 80 | <=0.1 | %w/v (by calculation) | |
| bovine serum albumin | trace | ||
| Neomycin | trace | ||
| polymyxin B | trace | ||
| streptomycin | trace | ||
| formaldehyde | trace | ||
| glutaraldehyde | trace |
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.