FDA licensed two tests in 1990 to detect Hepatitis C. Previously, researchers from CDC and industry constructed a non-A, non-B viral protein from a single stranded ribonucleic acid isolated from an animal model infected with non-A, non-B hepatitis. Recombinant DNA manipulation of this protein produced enough quantity to enable development of a commercial assay to detect antibodies to this viral protein. Clinical trials assessed the ability of this assay to detect antibodies formed against this viral protein, now designated c100-3, in donor blood. The trials showed that eliminating units that tested positive for antibodies to the c100-3 protein could eliminate non-A, non-B hepatitis, and that there was one major non-A, non-B virus, subsequently designated Hepatitis C. The first anti-HCV antibody test was licensed in May, and the second two months later.

In July 1986, OBRR licensed the first recombinant viral vaccine, for Hepatitis B. The same manufacturer, Merck, Sharp & Dohme, had received a license for a Hepatitis B vaccine some years earlier.

In July 1992, the Center for Biologics Evaluation and Research (CBER), which is what biologics regulation is still called at the FDA today, issued the first license for a treatment of chronic Hepatitis B for recombinant interferon alfa-2b. FDA had previously approved this for other indications, including hairy cell leukemia. CDC estimated at that time 750,000 to 1 million Americans had the Hepatitis B virus, and one-quarter would develop chronic, active hepatitis.

Image Modified