| M-M-R® II |
| 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 |
| M-M-R® II's global sales in 2018: | $1,798 million (Includes ProQuad/M-M-R II/Varivax). Reference: 2018 Annual Report p 1 |
| British Columbia Center for Disease Control expense, F/Y 2018/19 for M-M-R® II | Reference: BCCDC FOIA request by TMOV, 12-06-19 |
| The Product: | |
| Description of Vaccine: | Measles, mumps and rubella virus vaccine, live, attenuated, Merck Std. |
| Active Immunizing Agent Against Measles, Mumps and Rubella (German measles) | |
| Type of vaccine: | MMR. Given by Intramuscular injection |
| Primary medical reference: | Package insert for Canada |
| Ingredient (follow link to independent info) | Quantity | Units | Reference |
| Rubella virus, Wistar RA 27/3 strain (live, attenuated) propogated in human diploid lung fibroblasts | not less than 1,000 | CCID50 | Package Insert |
| Double stranded human fetal DNA (in the Rubella vaccine Meruvax® II) | 142.05 | ng/vial | Spontaneous Integration of Human DNA Fragments into Host Genome |
| Single stranded human fetal DNA (in the Rubella vaccine Meruvax® II) | 35.00 | ng/vial | Spontaneous Integration of Human DNA Fragments into Host Genome |
| CDC Vaccine Type | MEASLES, MUMPS AND RUBELLA VIRUS VACCINE, LIVE |
| Serious adverse events, USA, during 2018 (Definition of serious: Note 1, Source: Note 2) | 327 |
| Number of injury awards paid by VICP (USA) for this vaccine type from 1988 until September 1, 2019 (Note 3) | 405 |
| Serious adverse events following immunization, Canada, during 2018, for the group [MMR, MMRV, Var] which includes this type of vaccine. (Note 4) | 94 (Includes MMR, MMRV, Var) |
| Age of patient | Intensity | Adverse reaction | Frequency | Reference |
| n/a | n/a | All gastrointestinal disorders, VR (VR = vaccine related. Entries with 'VR' refer to the % of subjects with systemic adverse experiences that were determined by the investigator to be possibly, probably, or definitely related to the vaccine.) |
01.3% | Monograph, p 8-13 |
| n/a | n/a | All general disorders and administration site conditions, VR | 09.6% | Monograph, p 8-13 |
| n/a | n/a | All infections and infestations, VR | 02.4% | Monograph, p 8-13 |
| n/a | n/a | All nervous system disorders, VR | 00.2% | Monograph, p 8-13 |
| n/a | n/a | All psychiatric disorders, VR | 04.3% | Monograph, p 8-13 |
| n/a | n/a | All respiratory, thoracic and mediastinal disorders, VR | 00.6% | Monograph, p 8-13 |
| n/a | n/a | All skin and subcutaneous tissue disorders, VR | 07.9% | Monograph, p 8-13 |
| n/a | n/a | ear pain | 01.1% | Monograph, p 8-13 |
| n/a | n/a | conjunctivitis | 03.5% | Monograph, p 8-13 |
| n/a | n/a | constipation | 00.5% | Monograph, p 8-13 |
| n/a | n/a | diarrhea NOS (NOS = not otherwise specified) | 07.1% | Monograph, p 8-13 |
| n/a | n/a | loose stools | 01.3% | Monograph, p 8-13 |
| n/a | n/a | teething | 01.7% | Monograph, p 8-13 |
| n/a | n/a | vomiting NOS | 05.5% | Monograph, p 8-13 |
| n/a | n/a | pain NOS | 01.6% | Monograph, p 8-13 |
| n/a | n/a | pyrexia | 22.7% | Monograph, p 8-13 |
| n/a | n/a | hypersensitivity NOS | 00.3% | Monograph, p 8-13 |
| n/a | n/a | croup infectious | 01.3% | Monograph, p 8-13 |
| n/a | n/a | ear infection NOS | 03.6% | Monograph, p 8-13 |
| n/a | n/a | gastroenteritis NOS | 01.7% | Monograph, p 8-13 |
| n/a | n/a | nasopharyngitis | 12.6% | Monograph, p 8-13 |
| n/a | n/a | otitis media NOS | 12.5% | Monograph, p 8-13 |
| n/a | n/a | sinusitis NOS | 00.8% | Monograph, p 8-13 |
| n/a | n/a | upper respiratory tract infection NOS | 15.5% | Monograph, p 8-13 |
| n/a | n/a | upper respiratory tract infection viral NOS | 01.3% | Monograph, p 8-13 |
| n/a | n/a | viral infection viral NOS | 03.9% | Monograph, p 8-13 |
| n/a | n/a | viral rash NOS | 02.2% | Monograph, p 8-13 |
| n/a | n/a | arthropod bite | 02.4% | Monograph, p 8-13 |
| n/a | n/a | insomnia | 01.1% | Monograph, p 8-13 |
| n/a | n/a | irritability | 07.7% | Monograph, p 8-13 |
| n/a | n/a | cough | 06.5% | Monograph, p 8-13 |
| n/a | n/a | nasal congestion | 03.5% | Monograph, p 8-13 |
| n/a | n/a | rhinitis NOS | 00.9% | Monograph, p 8-13 |
| n/a | n/a | rhinorrhoea | 06.5% | Monograph, p 8-13 |
| n/a | n/a | wheezing | 02.4% | Monograph, p 8-13 |
| n/a | n/a | dermatitis diaper | 04.9% | Monograph, p 8-13 |
| n/a | n/a | eczema | 01.6% | Monograph, p 8-13 |
| n/a | n/a | heat rash | 03.9% | Monograph, p 8-13 |
| n/a | n/a | rash morbilliform | 03.2% | Monograph, p 8-13 |
| n/a | n/a | rash NOS | 08.4% | Monograph, p 8-13 |
| n/a | n/a | urticaria NOS | 01.3% | Monograph, p 8-13 |
| n/a | n/a | All ear and labyrinth disorders | 01.7% | Monograph, p 8-13 |
| n/a | n/a | All eye disorders | 04.3% | Monograph, p 8-13 |
| n/a | n/a | All gastrointestinal disorders | 15.6% | Monograph, p 8-13 |
| n/a | n/a | All general disorders and administration site conditions | 24.9% | Monograph, p 8-13 |
| n/a | n/a | All immune system disorders | 00.9% | Monograph, p 8-13 |
| n/a | n/a | All infections and infestations | 44.0% | Monograph, p 8-13 |
| n/a | n/a | All injury, poisoning and procedural complications | 05.2% | Monograph, p 8-13 |
| n/a | n/a | All metabolism and nutrition disorders | 01.1% | Monograph, p 8-13 |
| n/a | n/a | All nervous system disorders | 01.1% | Monograph, p 8-13 |
| n/a | n/a | All psychiatric disorders | 08.4% | Monograph, p 8-13 |
| n/a | n/a | All respiratory, thoracic and mediastinal disorders | 17.2% | Monograph, p 8-13 |
| n/a | n/a | All skin and subcutaneous tissue disorders | 25.6% | Monograph, p 8-13 |
| n/a | n/a | diarrhea NOS, VR | 00.6% | Monograph, p 8-13 |
| n/a | n/a | loose stools, VR | 00.2% | Monograph, p 8-13 |
| n/a | n/a | vomiting NOS, VR | 00.5% | Monograph, p 8-13 |
| n/a | n/a | pain NOS, VR | 00.6% | Monograph, p 8-13 |
| n/a | n/a | pyrexia, VR | 08.8% | Monograph, p 8-13 |
| n/a | n/a | ear infection NOS, VR | 00.2% | Monograph, p 8-13 |
| n/a | n/a | gastroenteritis NOS, VR | 00.2% | Monograph, p 8-13 |
| n/a | n/a | nasopharyngitis, VR | 00.6% | Monograph, p 8-13 |
| n/a | n/a | otitis media NOS, VR | 00.2% | Monograph, p 8-13 |
| n/a | n/a | upper respiratory infection NOS, VR | 00.5% | Monograph, p 8-13 |
| n/a | n/a | viral infection NOS, VR | 00.3% | Monograph, p 8-13 |
| n/a | n/a | viral rash NOS, VR | 00.5% | Monograph, p 8-13 |
| n/a | n/a | insomnia, VR | 00.2% | Monograph, p 8-13 |
| n/a | n/a | irritability, VR | 04.3% | Monograph, p 8-13 |
| n/a | n/a | cough, VR | 00.2% | Monograph, p 8-13 |
| n/a | n/a | rhinorrhoea, VR | 00.5% | Monograph, p 8-13 |
| n/a | n/a | wheezing, VR | 00.2% | Monograph, p 8-13 |
| n/a | n/a | dermatitis diaper, VR | 00.2% | Monograph, p 8-13 |
| n/a | n/a | heat rash, VR | 00.6% | Monograph, p 8-13 |
| n/a | n/a | rash morbilliform, VR | 03.2% | Monograph, p 8-13 |
| n/a | n/a | rash NOS, VR | 03.2% | Monograph, p 8-13 |
| n/a | n/a | urticaria NOS, VR | 00.5% | Monograph, p 8-13 |
| Ingredient | Quantity | Units | Notes |
| Measles virus, Enders' Edmonston strain (live, attenuated) | not less than 1,000 | CCID50 | CCID50 = 50% cell culture infectious dose |
| Mumps virus, Jeryl Lynn® (B level) strain (live, attenuated) | not less than 5,000 | CCID50 | CCID50 = 50% cell culture infectious dose |
| sorbitol | <=14.5 | mg | |
| Hydrolyzed gelatin | <=14.5 | mg | |
| Medium 199 with Hank's salts | <=3.3 | mg | |
| sodium phosphate monobasic | <=3.1 | mg | |
| sodium phosphate dibasic (anhydrous) | <=2.2 | mg | |
| sucrose | <=1.9 | mg | |
| sodium bicarbonate | <=0.5 | mg | |
| Minimum Essential Medium, Eagle | <=0.1 | mg | |
| Potassium phosphate dibasic (anhydrous) | <=30 | mcg | |
| Neomycin | <=25 | mcg | |
| Monosodium L-glutamate monohydrate | <=20 | mcg | |
| potassium phosphate monobasic | <=20 | mcg | |
| Phenol red | <=3.4 | mcg | |
| water | to volume | ||
| Recombinant human albumin | <=0.3 | mg | |
| fetal bovine serum | <1 | ppm |
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.