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.
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FDA announced in 1990 the first screening test for Hepatitis C (from the Hartford Courant, Friday, May 4, 1990).
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FDA History Office
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.
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FDA announced in 1990 the first screening test for Hepatitis C (from the Hartford Courant, Friday, May 4, 1990).
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FDA History Office
Vaccines
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Development of the present killed hepatitis A vaccine depended on a series of breakthrough discoveries made during the last half of the 20th century. These were marmoset propagation (1967), definition of virus attributes (1974-1975), development of diagnostic tests and seroepidemiology (1974-1975), and the preparation and proof of efficacy of a prototype killed hepatitis A vaccine (1976). Successful cultivation of hepatitis A virus in cell culture in 1979 quickly led to development of both live and killed hepatitis A vaccines for tests in humans (1980-1990). The year 1991 marks the initiation of protective efficacy trials of two different killed virus vaccines in human beings. The safety and protective efficacy of the first hepatitis A vaccine (manufactured by Merck) was reported on in an article by Maurice Hilleman in 1993.
Also, the National Institute of Allergy and Infectious Diseases (NIAID) Drs. Robert H. Purcell, Suzanne U. Emerson, and Jeffrey I. Cohen, and the FDA’s Drs. Stephen Feinstone and Richard Daemer of the Center for Biologics Evaluation and Research (CBER), developed and patented a hepatitis A virus (HAV) and related technology used to develop the vaccine. The patents cover a strain of human HAV, HM175, an attenuated form of HM175 and the methods developed to isolate and grow the viruses in cultures of kidney cells derived from African green monkeys. In 1985, based on the scientific and commercial potentials of the NIAID inventions, SmithKline Beecham took a nonexclusive license on the patents and, in 1986, established a cooperative research and development agreement to develop HAVRIX, the world’s first commercially available HAV vaccine. HAVRIX uses an inactivated HM175 strain of HAV. In 1994, SmithKline received the European Prix Gallen award for HAVRIX in honor of its overall contribution to medicine in terms of safety, efficacy, and innovation. Currently, HAVRIX is registered in more than 40 countries.
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SmithKline Beecham Biologicals Hepatitis A Vaccine, Harvix, adolescent dose. NIAID’s Drs. Robert H. Purcell, Suzanne U. Emerson, and Jeffrey I. Cohen, and the FDA’s Drs. Stephen Feinstone and Richard Daemer of the Center for Biologics Evaluation and Research, developed and patented a hepatitis A virus (HAV) and related technology used to develop the vaccine.
