Xiamen Innovax Biotech
Hepatitis E Vaccine (HEV 239)
In October 2012, Xiamen Innovax Biotech created the HEV 239 vaccine to treat Hepatitis E. The vaccine was approved by the Chinese Ministry of Science and Technology after it was tested during a controlled trial of 100,000+ people from the Jiangsu Province over a 12-month period. Of the 100,000 people treated, none were infected as compared to 15 that were infected from the controlled placebo group. Xiamen Innovax Biotech used DNA recombinant technology to express the protein in E. coli which was then used as the base for the vaccine production.
Xiamen Innovax Biotech is responsible for creating a cervical cancer vaccine that is currently under a phase III clinical trial, a Genital Warts Vaccine that is under a phase II clinical trial, as well as a 9-valent HPV vaccine which is currently in the process of receiving clinical approval.
WHO Position on HEV 239
The World Health Organization (WHO) stated that the Phase I, II, and III clinical trials were effective and safe in healthy subjects, however the WHO does not make a recommendation regarding the HEV 239 Vaccine because of a lack of evidence in people 16 years of age or younger, and 65 years of age and older. China is currently the only country to approve the HEV 239 vaccine since Hepatitis E is rare in developed countries. There are further clinical trials planned to make the drug available to susceptible populations. National authorities may however, decide to use the vaccine based on the local epidemiology.
- "First hepatitis E vaccine hits market in China". China Daily. Retrieved August 8, 2017.
- "China Approves World's First Hepatitis E Vaccine". Asian Scientist. Retrieved August 8, 2017.
- "Health in the Future: Hepatitis E to Z". Independent UK. Retrieved August 8, 2017.
- Park, S. B. (November 2012). "Hepatitis E vaccine debuts". Nature. 491 (7422): 21–22. Bibcode:2012Natur.491...21P. doi:10.1038/491021a. PMID 23128204.
- Labrique, Alain B.; Sikder, Shegufta S.; Krain, Lisa J.; West, Keith P.; Christian, Parul; Rashid, Mahbubur; Nelson, Kenrad E. (2012-09-01). "Hepatitis E, a Vaccine-Preventable Cause of Maternal Deaths". Emerging Infectious Diseases. 18 (9): 1401–1404. doi:10.3201/eid1809.120241. ISSN 1080-6040. PMC 3437697. PMID 22931753.
- Hu, Yuemei (October 2013). "Safety of an Escherichia coli-expressed bivalent human papillomavirus (types 16 and 18) L1 virus-like particle vaccine". Human Vaccines & Immunotherapeutics. 52 (3): 218–23. doi:10.4161/hv.26846. PMC 4185883. PMID 24161937.
- "Human papillomavirus 6/11 vaccine recombinant bivalent". Adis Insight.
- "Meeting on Appropriate Clinical Endpoints for Second Generation HPV Vaccine Trials" (PDF). WHO Immunization Research: 1–2. 19 November 2013.
- "Hepatitis E vaccine: WHO position paper, May 2015" (PDF). Releve epidemiologique hebdomadaire. 90 (18): 185–200. 1 May 2015. PMID 25935931.