Date shown reflects the date that the evidence was documented
2022-01-19
Hepatitis-A-Vaccine-Package-Insert-VAQTA
"VAQTA is a sterile suspension for intramuscular injection. One milliliter of the vaccine contains
approximately 50U of hepatitis A virus antigen, which is purified and formulated without a preservative.
Within the limits of current assay variability, the 50U dose of VAQTA contains less than 0.1 mcg of non-
viral protein, less than 4 x 10 –6 mcg of DNA, less than 10 –4 mcg of bovine albumin, and less than 0.8 mcg
of formaldehyde. Other process chemical residuals are less than 10 parts per billion (ppb), including
neomycin.
Each 0.5-mL pediatric dose contains 25U of hepatitis A virus antigen and adsorbed onto approximately
0.225 mg of aluminum provided as amorphous aluminum hydroxyphosphate sulfate, and 35 mcg of
sodium borate as a pH stabilizer, in 0.9% sodium chloride.
Each 1- mL adult dose contains 50U of hepatitis A virus antigen and adsorbed onto approximately 0.45
mg of aluminum provided as amorphous aluminum hydroxyphosphate sulfate, and 70 mcg of sodium
borate as a pH stabilizer, in 0.9% sodium chloride."
https://www.fda.gov/media/74519/download
https://www.fda.gov/media/79349/download
Hepatitis-A-Vaccine-Package-Insert-VAQTA
"VAQTA is a sterile suspension for intramuscular injection. One milliliter of the vaccine contains
approximately 50U of hepatitis A virus antigen, which is purified and formulated without a preservative.
Within the limits of current assay variability, the 50U dose of VAQTA contains less than 0.1 mcg of non-
viral protein, less than 4 x 10 –6 mcg of DNA, less than 10 –4 mcg of bovine albumin, and less than 0.8 mcg
of formaldehyde. Other process chemical residuals are less than 10 parts per billion (ppb), including
neomycin.
Each 0.5-mL pediatric dose contains 25U of hepatitis A virus antigen and adsorbed onto approximately
0.225 mg of aluminum provided as amorphous aluminum hydroxyphosphate sulfate, and 35 mcg of
sodium borate as a pH stabilizer, in 0.9% sodium chloride.
Each 1- mL adult dose contains 50U of hepatitis A virus antigen and adsorbed onto approximately 0.45
mg of aluminum provided as amorphous aluminum hydroxyphosphate sulfate, and 70 mcg of sodium
borate as a pH stabilizer, in 0.9% sodium chloride."
https://www.fda.gov/media/74519/download
https://www.fda.gov/media/79349/download