JERUSALEM - The Israeli Health Ministry approved Bio-Hep-B, the genetically engineered hepatitis B vaccine from Bio-Technology General Corp.
BTG, of Iselin, N.J., originated in Israel some 15 years ago and is widely considered the country's biotech progenitor company. It still has its primary R&D branch in Rehovot. Israel has waited for 10 years of research and testing for this approval, which was delayed while BTG worked out patents and licensing.
Israel is one of the first 10 countries in the world to institute universal vaccination against hepatitis B, and the first against hepatitis A.
"This is a story of the effects of immigration on national health policy, and Israel is a model system in microcosm for the massive problems facing most of Europe and the United States, said Daniel Shouval, head of the Liver Center at the Hadassah University Medical Center in Jerusalem, who looked back at the 10 years of research, development and testing of this "unique recombinant vaccine containing pre S antigens" and of the clinical trials mounted in such far off places as Vietnam, Singapore and Thailand. Bio-Hep-B has been tested in a clinical research program involving several thousand people.
Bio-Hep-B vaccine was proven significantly more effective and thus needed in lower doses than other recombinant hepatitis B vaccines.
In all the studies, Bio-Hep-B elicited a quicker response and higher levels of circulating antibodies to the hepatitis B virus than other recombinant hepatitis B vaccines, the company said.