Company:Xiamen Innovax Biotech
Xiamen Innovax Biotech CO., LTD. (Innovax) is a Chinese company that manufactures, markets, and develops vaccines. It is headquartered in Xiamen, Fujian, China.[1][2]
Hepatitis E Vaccine (HEV 239)
In October 2012, Xiamen 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.[3][4][5]
Other vaccines
The firm also has created a cervical cancer vaccine that is currently under a phase III clinical trial,[6] a genital warts vaccine that is under a phase II clinical trial,[7] and a 9-valent HPV vaccine currently in the process of receiving clinical approval.[8]
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 has not made 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 vaccine since Hepatitis E is rare in developed countries. There are further clinical trials planned before making the drug more generally available. to susceptible populations.[9] The position of the WHO is that, however, national authorities may decide to use the vaccine based on the local epidemiology.[9]
References
- ↑ "First hepatitis E vaccine hits market in China". http://usa.chinadaily.com.cn/china/2012-10/27/content_15851542.htm.
- ↑ "China Approves World's First Hepatitis E Vaccine". 23 January 2012. https://www.asianscientist.com/2012/01/pharma/china-approves-hepatitis-e-vaccine-hecolin-hev-239/.
- ↑ 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. PMID 22931753.
- ↑ "Health in the Future: Hepatitis E to Z". 18 September 2011. https://www.independent.co.uk/life-style/health-and-families/health-in-the-future-hepatitis-e-to-z-2061287.html.
- ↑ Park, S. B. (November 2012). "Hepatitis E vaccine debuts". Nature 491 (7422): 21–22. doi:10.1038/491021a. PMID 23128204. Bibcode: 2012Natur.491...21P.
- ↑ 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. PMID 24161937.
- ↑ "Human papillomavirus 6/11 vaccine recombinant bivalent". http://adisinsight.springer.com/drugs/800042287.
- ↑ "Meeting on Appropriate Clinical Endpoints for Second Generation HPV Vaccine Trials". WHO Immunization Research: 1–2. 19 November 2013. http://who.int/immunization/research/meetings_workshops/HPV_endpoint_nov2013_report.pdf.
- ↑ 9.0 9.1 "Hepatitis E vaccine: WHO position paper, May 2015.". Relevé Épidémiologique Hebdomadaire 90 (18): 185–200. 1 May 2015. PMID 25935931. https://www.who.int/wer/2015/wer9018.pdf?ua=1.
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