| Rotateq® |
| Image may differ from actual product |
| 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 |
| Rotateq®'s global sales in 2018: | $728 million. Reference: 2018 Annual Report p 124 |
| British Columbia Center for Disease Control expense, F/Y 2018/19 for Rotateq® | $954,386 (incl Rotarix & Rotateq) Reference: BCCDC FOIA request by TMOV, 12-06-19 |
| The Product: | |
| Description of Vaccine: | Live, Pentavalent Vaccine Against Rotavirus Gastroenteritis |
| Type of vaccine: | Rotavirus. Given by Oral |
| Primary medical reference: | Package insert for Canada |
| CDC Vaccine Type | ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT |
| Serious adverse events, USA, during 2018 (Definition of serious: Note 1, Source: Note 2) | 266 |
| Number of injury awards paid by VICP (USA) for this vaccine type from 1988 until September 1, 2019 (Note 3) | 61 |
| Serious adverse events following immunization, Canada, during 2018, for the group [Rot-1, Rot-5, Rota] which includes this type of vaccine. (Note 4) | 46 |
| Age of patient | Intensity | Adverse reaction | Frequency | Reference |
| No concerning adverse reactions. | Canadian Product Monograph |
| Ingredient | Quantity | Units | Notes |
| Human-bovine rotavirus reassortant G1 | 2.2 x 106 | infectious units | |
| Human-bovine rotavirus reassortant G2 | 2.8 x 106 | infectious units | |
| Human-bovine rotavirus reassortant G3 | 2.2 x 106 | infectious units | |
| Human-bovine rotavirus reassortant G4 | 2.0 x 106 | infectious units | |
| Human-bovine rotavirus reassortant P1A[8] | 2.3 x 106 | infectious units | |
| sucrose | 1080 | mg | |
| sodium citrate dihydrate | 127 | mg | |
| sodium phosphate monobasic monohydrate | 29.8 | mg | |
| sodium hydroxide | 2.75 | mg | |
| polysorbate 80 | 0.17-0.86 | mg | |
| diluent and cell culture media | 15% | (v/v) | |
| Vero cells | residue | ||
| Vero cell DNA | < 100 | mcg | <100 mcg per dose is the World Health Organization (WHO) recommended upper limit for orally administered vaccines. |
| fetal bovine serum | trace amounts | ||
| DNA fragments from porcine circoviruses (PCV) 1 and 2 | residue |
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.