Ingredient (follow link to independent info) | Quantity | Units | Reference |
DNA from MRC-5 cells | 2 | mcg | https://soundchoice.s3.amazonaws.com/soundchoice/wp-content/uploads/2013/08/Appendix-F-Varivax-Summary-for-Basis-of-Approval.pdf |
Ingredient | Quantity | Units | Notes |
Oka/Merck strain of live, attenuated varicella virus | 1350 | plaque-forming units (PFU) | Human embryonic lung cell cultures, embryonic guinea pig cell cultures, human diploid cell cultures (WI-38) and human diploid cell cultures (MRC-5) were all used in production |
sucrose | 18 | mg | |
hydrolyzed gelatin | 8.9 | mg | |
urea | 3.6 | mg | |
sodium chloride | 2.3 | mg | |
monosodium L-glutamate | 0.36 | mg | |
sodium phosphate dibasic | 0.33 | mg | |
potassium phosphate monobasic | 57 | mcg | |
potassium chloride | 57 | mcg | |
protein from MRC-5 cells | residue | ||
neomycin from MRC-5 culture media | trace | ||
bovine calf serum from MRC-5 culture media | 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.