Collaborative Study for the Establishment of Three Product Specific European Pharmacopoeia Biological Reference Preparations for Inactivated Adsorbed Hepatitis a Vaccines
نویسندگان
چکیده
Hepatitis A vaccines prepared by formalin inactivation of purified cell-culture grown hepatitis A virus are licensed in several European countries. The potencies of these vaccines are expressed in units unique to each manufacturer. Standardisation of potency statements requires establishment of an international reference material. At its 1999 meeting, the ECBS(2) established a preparation coded 95/500 as the 1st IS for hepatitis A vaccine, inactivated.
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