ROTARIX is a liquid suspension of the live attenuated RIX4414 strain of human rotavirus of the G1P type for use in the prevention of rotavirus gastro-enteritis. The virus strain derived from the 89-12 strain is obtained by propagation on a well-characterised Vero cell line.
ROTARIX is presented as a clear, colourless liquid, free of visible particles, for ORAL administration only.
Each 1.5 mL dose of the vaccine contains not less than 106.0 CCID50 (cell culture infectious dose 50%) of the RIX 4414 strain of human rotavirus. The vaccine also contains sucrose, di-sodium adipate, Dulbecco’s Modified Eagle Medium and sterile water.
(VAN’s note: Vero cell line is monkey kidney tissue).
The manufacture of this product includes exposure to bovine derived materials at the very early steps of the production process. No bovine materials are used in routine production. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.
(VAN’s note: Cases of vCJD have occured in clusters in people who have had the same batch of another type of vaccine and scientists agree that the most likely form of transmission is via injection or IV – see this http://www.youtube.com/watch?v=2GpD0wt3LXM).
Unintended Pig Virus in the Rotavirus Vaccine
Porcine Circovirus type 1 (PCV-1) material has been detected in ROTARIX vaccine. PCV-1 is not known to cause disease in animals and is not known to infect or cause disease in humans. There is no evidence that the presence of PCV-1 poses a safety risk.
Rotavirus is likely to affect all children up to the age of five years of age. The peak incidence of rotavirus gastro-enteritis is between 6-24 months of age. Dehydration from rotavirus gastro-enteritis can lead to hospitalisation, which is most common in children under 2 years of age.