Date shown reflects the date that the evidence was documented
2022-01-19
MMR-Vaccine-Package-Insert-Measles-Mumps-and-Rubella-Virus-Vaccine-Live
"M-M-R II vaccine is a sterile lyophilized preparation of (1) Measles Virus Vaccine Live, an attenuated
line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in chick embryo
cell culture; (2) Mumps Virus Vaccine Live, the Jeryl Lynn™ (B level) strain of mumps virus propagated in
chick embryo cell culture; and (3) Rubella Virus Vaccine Live, the Wistar RA 27/3 strain of live attenuated
rubella virus propagated in WI-38 human diploid lung fibroblasts. {20,21} The cells, virus pools,
recombinant human serum albumin and fetal bovine serum used in manufacturing are tested and
determined to be free of adventitious agents.
After reconstitution, each 0.5 mL dose contains not less than 3.0 log10 TCID50 (tissue culture infectious
doses) of measles virus; 4.1 log10 TCID50 of mumps virus; and 3.0 log10 TCID50 of rubella virus.
Each dose is calculated to contain sorbitol (14.5 mg), sucrose (1.9 mg), hydrolyzed gelatin (14.5 mg),
recombinant human albumin (≤0.3 mg), fetal bovine serum (<1 ppm), approximately 25 mcg of neomycin
and other buffer and media ingredients. The product contains no preservative."
https://www.fda.gov/media/75191/download
MMR-Vaccine-Package-Insert-Measles-Mumps-and-Rubella-Virus-Vaccine-Live
"M-M-R II vaccine is a sterile lyophilized preparation of (1) Measles Virus Vaccine Live, an attenuated
line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in chick embryo
cell culture; (2) Mumps Virus Vaccine Live, the Jeryl Lynn™ (B level) strain of mumps virus propagated in
chick embryo cell culture; and (3) Rubella Virus Vaccine Live, the Wistar RA 27/3 strain of live attenuated
rubella virus propagated in WI-38 human diploid lung fibroblasts. {20,21} The cells, virus pools,
recombinant human serum albumin and fetal bovine serum used in manufacturing are tested and
determined to be free of adventitious agents.
After reconstitution, each 0.5 mL dose contains not less than 3.0 log10 TCID50 (tissue culture infectious
doses) of measles virus; 4.1 log10 TCID50 of mumps virus; and 3.0 log10 TCID50 of rubella virus.
Each dose is calculated to contain sorbitol (14.5 mg), sucrose (1.9 mg), hydrolyzed gelatin (14.5 mg),
recombinant human albumin (≤0.3 mg), fetal bovine serum (<1 ppm), approximately 25 mcg of neomycin
and other buffer and media ingredients. The product contains no preservative."
https://www.fda.gov/media/75191/download