This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryThe combination hepatitis A/B vaccine is approved May 11 as a three-dose regimen for the "active immunization of persons 18 years of age or older against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus." Twinrix will be available in June. As a postmarketing commitment, the firm will do a comparative safety study of Twinrix against its individual components, GSK's Havrix (hepatitis A vaccine) and Engerix-B (recombinant hepatitis B vaccine). Glaxo is planning accelerated dosing studies in the U.S. to evaluate the vaccine for a two-dose regimen, with a BLA filing slated for 2002
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