2004N-0355 - Scientific Considerations Related to Developing Biotechnology Products
FDA Comment Number : EC7
Submitter : Mrs. J LeClair Date & Time: 09/23/2004 04:09:13
Organization : Mrs. J LeClair
Health Professional
Category :
Issue Areas/Comments
GENERAL
GENERAL
Continued for comment 7995
7. Cancer Prevention Vaccines 7. Hepatitis A and Hepatitis B (Liver Cancer (Prevention )Vaccines currently available)
8. Hepatitis C (Liver Cancer~60% possibly higher)
Disease burden. Hepatitis C is comparable to a 'viral time bomb'. WHO estimates that about 200 million people, 3% of the world's population, are infected with hepatitis C virus (HCV) and 3 to 4 million persons are newly infected each year with a global 170 million chronic carriers at risk of developing liver cirrhosis and/or liver cancer (at least 85% of infected persons become chronically infected and about 70% develop chronic hepatitis). Around 844,000 DALYs (WHO, 2002 ) and 46,000 deaths (WHO, 2002 ) have been attributed to HCV in 2001. HCV belongs to the Flaviviridae family, and has been classified in the separate genus hepaciviruses. Research indicates that HCV is responsible for 50-76% of all liver cancer cases, and two thirds of all liver transplants in the developed world. The seroprevalence of HCV in the Nile delta of Egypt increases with age from 19% in 10-19 year olds to about 60% in 30-year-old persons and is thought to be the major cause of high prevalence of liver cirrhosis. In terms of annual mortality, CDC mentions traditionally 10 000 deaths in the US, expected to triple within the next five years.
Mother-to-child HCV transmission has been widely documented. The risk of perinatal infection ranges from 3-15% in different populations. However, correlates of transmission remain to be defined and targeted studies are urgently needed to provide adequate counseling to HCV infected pregnant women and to identify possible preventive measures.
Vaccines. To minimize the health and economic impact of the disease, more efficient, better-tolerated, cost-effective therapies are needed, especially for non-responders to the current treatments. Up to 60% of all HCV-infected patients do not experience significant long-term benefits from the current interferon- and ribavirin-based combination and/or polyclonal HCV antibody therapies. No vaccine is yet available. Several vaccine approaches, essentially therapeutic, are currently in development, mostly in developed countries. In Europe, Innogenetics is a Phase IIa of an E1-based therapeutic vaccine. Berna /Pevion are testing HLA-A2- restricted core epitope peptides formulated with influenza virosomes as carriers for both therapeutic and prophylactic vaccine strategies. Several other projects are EU-funded including HCVACC, Memovax, Protarvac, Theravacc, Euroamp, and in the US, GenPhar, and Epimmune , Merix , and mostly Chiron . Two Chinese teams are also making significant progress in HCV vaccine research: Fudan University , and the National Taiwan University , Taipei .