BioWorld International Correspondent

BRUSSELS, Belgium - The European Medicines Agency has given a clean bill of health to two recombinant hepatitis B vaccines from Sanofi-Pasteur MSD, after a three-month review. The agency has concluded that effective protection is offered by HBVaxpro (recombinant hepatitis B virus small surface antigen [HbsAg]) and Procomvax (haemophilus influenzae b conjugate and hepatitis B [recombinant] vaccine).

The review of the vaccines' benefits was requested last year by the European Commission, after it suspended the same company's Hexavac from the market. They share the same recombinant hepatitis B component as Hexavac, which remains suspended due to concerns about its capacity to provide long-term protection against hepatitis B, based on suspicions about variability in the production process.

The agency commenced its review of those two vaccines last February, and now has concluded that there is no evidence of decreased effectiveness. In consequence, "there is no need to revaccinate individuals who have received the appropriate dosing in the past," the agency added. But some changes are to be made to the prescribing information, unrelated to the safety profile of the vaccines, and intended to ensure the optimal use of the two vaccines, including reinforced recommendations on blood tests. The company is to run additional studies in different age and risk groups, to provide further assurance about long-term efficacy.

HBVaxpro is marketed in Austria, Belgium, Germany, Spain, Finland, France, the United Kingdom, Greece, Hungary, Ireland, Italy, Luxembourg, the Netherlands, Poland and Sweden, and Procomvax in Greece, Italy and Poland.