Cecolin HPV Vaccine Description
Cecolin HPV Vaccine protects women against HPV 16 and 18, two major Human Papillomavirus (HPV) types causing 70 percent of all cervical cancers, the third most common cancer among women.
The new HPV vaccine was jointly developed by Innovax, a biotechnology company based in Xiamen, Fujian province, China, in cooperation with Xiamen University.
It was approved by the National Medical Products Administration of China on December 30, 2019, and officially launched in China (excluding Hong Kong, Macao, and Taiwan) in May 2020. It is the first domestically manufactured vaccine against cervical cancer in China.
Since 2016, Wantai has received support from PATH in areas including quality systems improvement, clinical and regulatory compliance, and pharmacovigilance systems set up. The Bill & Melinda Gates Foundation funded this support.
Xiamen Innovax Biotech Co., Ltd. is a leading company in developing, manufacturing, and marketing innovative vaccines with its headquarters and manufacture based in Xiamen, China. In collaboration with the national institute of Diagnostics and Vaccine Development in Infectious Diseases (NIDVD), Innovax has established a core platform using DNA recombinant technology to express the protein in E. coli for vaccine production. Xiamen is a wholly-owned subsidiary of Beijing Wantai Biological Pharmaceutical Co., LTD., under the YangShengTang Group.
Cecolin HPV Vaccine Indication
Cecolin is a vaccine indicated for girls and women 9 through 45 years of age to prevent the following diseases caused by 2 HPV types included in the vaccine. Cervical, vulvar, vaginal, and anal cancer are caused by HPV types 16 and 18
Cecolin HPV Vaccine Dosage
Cecolin will require two intramuscular injections over six months.
Cecolin HPV Vaccine News
October 14, 2021 - Xiamen Innovax Biotech Co., Ltd. received an official letter from the World Health Organization (WHO), confirming that its bivalent human papillomavirus vaccine Cecolin® has been accepted by WHO for Prequalification. It is the first China-manufactured HPV vaccine receiving WHO Prequalification. "The approval of WHO Prequalification is of great significance." Said Mr. Li Shicheng, the chairman of Innovax, "Going through the reviewing process of WHO is a remark and ensure Wantai's vaccine development, manufacturing process, and product quality meets strict international standard. Thus, paving a broad way for Wantai towards a global market."
September 12, 2020 - The city's of Xiamen, Fujian province, China's health commission announced, 'Free human papillomavirus vaccinations will be provided to girls aged 13 to 14 until the end of 2022 to help prevent cervical cancer. Xiamen's Haicang district is expected to kick off the free HPV vaccination project by the end of September.
June 3, 2020 - Vaccine manufacturers MSD, GSK, Innovax, Serum Institute of India Pvt. Ltd. (SII), and Walvax have pledged to ramp up human papillomavirus (HPV) vaccine supply availability for Gavi-supported countries ahead of tomorrow's Global Vaccine Summit 2020.
May 18, 2020 - Starting from May 18, human papillomavirus vaccines developed by Chinese researchers are available in provincial Maternity and Child Healthcare Hospital in Wuhan. (Xinhua/Xiong Qi).
April 30, 2020 – In a significant step forward in fighting cervical cancer in China, a human papillomavirus (HPV) vaccine developed by Chinese researchers will be widely available for women under 45. Starting in May 2020, the Cecolin HPV vaccine's first batch will be available in community hospitals in provincial-level regions, including Hubei, Jilin, and Xinjiang Uygur Autonomous Region reported Xinhuanet on April 26, 2020.
March 16, 2020 - Submitted on January 20, the Innovax HPV vaccine technical dossier screening has been completed. Therefore, on March 16, 2020, the vaccine was officially accepted by WHO for Prequalification evaluation.
January 2, 2020 – According to a notice from the National Medical Products Administration (NMPA), China has approved its first domestically made cancer prevention vaccine against the human papillomavirus (HPV) for use by females between the ages of 9 to 45.
December 16, 2019 – China announced the goal of launching an innovative national vaccine tracking system before March 31, 2020.
September 9, 2019 – Xiamen Innovax Biotech and GSK Biologicals announced they had entered a partnership to develop and commercialize a next-generation adjuvanted Human Papillomavirus vaccine. This vaccine will combine the innovative antigen detection method developed by Prof. Xia Ningshao's team at Xiamen University with GSK's proprietary adjuvant AS04, which leverages this antigen technology.
November 12, 2013 - Xiamen Innovax Biotech Co., Ltd., got CFDA approvals of Bivalent Human Papillomavirus (Type 6/11) Recombinant Vaccine (No.2013L0372) for clinical trials of phase I, II, III. The vaccine is mainly used for Genital warts prevention.
2009 - China's government launched the National Cervical Cancer Screening Program in rural areas.
Cecolin HPV Vaccine Clinical Trial
Clinical Trial NCT01735006: Efficacy and Immunogenicity Study of Recombinant Human Papillomavirus Bivalent（Type 16/18) Vaccine. The efficacy, safety, and immunogenicity result from the pivotal phase 3 clinical trial:
It was conducted on 7,372 healthy women in 5 provinces in China.
In preventing precancerous lesions and preventing persistent HPV infection, these two key indicators of effectiveness are that the corresponding protection rate for high-grade precancerous lesions is 100%. The protection rate for persistent HPV infection is 97.8%.
In terms of vaccine safety and preventive effect indicators, domestic vaccines' effectiveness is comparable to imported vaccines at an internationally advanced level.