Date shown reflects the date that the evidence was documented
2022-01-17
Poliovirus-Vaccine-Package-Insert-IPOL
"The cells are grown in Eagle MEM modified medium,7
supplemented with newborn calf bovine serum..."
"Each dose (0.5 mL) of trivalent vaccine is formulated to contain 40 D antigen units of Type 1, 8 D
antigen units of Type 2, and 32 D antigen units of Type 3 poliovirus. For each lot of IPOL
vaccine, D-antigen content is determined in vitro using the D-antigen ELISA assay. IPOL vaccine
is produced from vaccine concentrates diluted with M-199 medium. Also present are 0.5% of 2-
phenoxyethanol and a maximum of 0.02% of formaldehyde per dose as preservatives. Neomycin,
streptomycin, and polymyxin B are used in vaccine production; and, although purification
procedures eliminate measurable amounts, less than 5 ng neomycin, 200 ng streptomycin, and 25
ng polymyxin B per dose may still be present. The residual calf bovine serum albumin is less than
50 ng/dose in the final vaccine."
https://www.fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Package-Insert---IPOL.pdf
Poliovirus-Vaccine-Package-Insert-IPOL
"The cells are grown in Eagle MEM modified medium,7
supplemented with newborn calf bovine serum..."
"Each dose (0.5 mL) of trivalent vaccine is formulated to contain 40 D antigen units of Type 1, 8 D
antigen units of Type 2, and 32 D antigen units of Type 3 poliovirus. For each lot of IPOL
vaccine, D-antigen content is determined in vitro using the D-antigen ELISA assay. IPOL vaccine
is produced from vaccine concentrates diluted with M-199 medium. Also present are 0.5% of 2-
phenoxyethanol and a maximum of 0.02% of formaldehyde per dose as preservatives. Neomycin,
streptomycin, and polymyxin B are used in vaccine production; and, although purification
procedures eliminate measurable amounts, less than 5 ng neomycin, 200 ng streptomycin, and 25
ng polymyxin B per dose may still be present. The residual calf bovine serum albumin is less than
50 ng/dose in the final vaccine."
https://www.fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Package-Insert---IPOL.pdf