Cecolin® HPV Vaccine Description
The Cecolin® HPV Vaccine protects people 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 Escherichia coli-produced bivalent Cecolin HPV vaccine was jointly developed by Innovax, a biotechnology company based in Xiamen, Fujian province, China, in cooperation with Xiamen University.
Cecolin 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 HPV vaccine against cervical cancer in China. The World Health Organization (WHO) found it safe and prequalified in 2021. On March 12, 2023, The Lancet Regional Health Western Pacific published results from a phase 1 study that concluded that the candidate E. coli-produced 9vHPV vaccine had been preliminarily proven well tolerated and immunogenic.
Cecolin has been licensed in Bangladesh, Morocco, Nepal, Thailand, the Democratic Republic of the Congo, and Cambodia by March 2023.
Xiamen Innovax Biotech Co., Ltd. is a leading company in developing, manufacturing, and marketing innovative vaccines, with its headquarters and manufacturing based in Xiamen, China.
Cecolin 9 Vaccine
The Lancet Infectious Disease published results from a clinical study in July 2023 that compare the immunogenicity of the E coli-produced HPV 9-valent vaccine Cecolin 9 with Gardasil 9. Study Interpretation: Cecolin 9 induced non-inferior HPV type-specific immune responses compared with Gardasil 9. Data on the first-in-human phase 1 clinical trial of Cecolin 9 have been published, which preliminarily reveal its safety and immunogenicity in healthy adults, and the results from its phase 2 clinical trial are in preparation. A multicenter, randomized, double-blind, controlled (with Cecolin) phase 3 clinical trial to evaluate the efficacy, immunogenicity, and safety of Cecolin 9 in women aged 18–45 years is ongoing in China.
According to The Lancet Global Health in 2020, the vaccine Cecolin is priced at ¥329 ($47.7) per dose.
Cecolin is a vaccine indicated for women 9 through 45 years of age to prevent the following diseases caused by two HPV types included in the vaccine. Cervical, vulvar, vaginal, and anal cancer are caused by HPV types 16 and 18. According to the Centers for Disease Control (CDC), HPV is linked to more than 90% of anal and cervical cancer cases, nearly 70% of vaginal cancer cases, and more than 60% of penile malignancy cases .
Cecolin vaccination requires three intramuscular injections over six months (0,1 and 6). In the phase 3 study, the dosage contained 40μg HPV 16 virus-like particle antigen and 20μg HPV 18 virus-like particle antigen adsorbed in alum-adjuvant.
May 2023 - Safety and immunogenicity of an Escherichia coli-produced 9-valent human papillomavirus L1 virus-like particle vaccine (types 6/11/16/18/31/33/45/52/58) in healthy adults: an open-label, dose-escalation phase 1 clinical trial. Study Interpretation - The candidate E. coli-produced 9vHPV vaccine has been preliminarily proven well tolerated and immunogenic, encouraging further studies in large cohorts with a broader age range.
August 26, 2022 - The Lancet Infectious Disease published results after 66 months of phase 3 clinical study. Interpretation of results: The E coli-produced HPV 16 and 18 vaccine was well tolerated and highly efficacious against HPV 16 and 18 associated high-grade genital lesions and persistent infection and would supplement the global HPV vaccine availability and accessibility for cervical cancer prevention.
October 14, 2021 - Xiamen Innovax Biotech Co., Ltd. received an official letter from the World Health Organization (WHO) confirming that WHO has accepted its bivalent human papillomavirus vaccine Cecolin® for Prequalification. It is the first China-manufactured HPV vaccine to receive WHO Prequalification. "The approval of WHO Prequalification is of great significance." Mr. Li Shicheng, the chairman of Innovax, said, "Going through the reviewing process of WHO is a remark and ensuring Wantai's vaccine development, manufacturing process, and product quality meets strict international standards. Thus paving a broad way for Wantai towards a global market."
September 12, 2020 - The city 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 - From May 18, human papillomavirus vaccines developed by Chinese researchers are available in the 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, WHO officially accepted the vaccine 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 for Bivalent Human Papillomavirus (Type 6/11) Recombinant Vaccine (No.2013L0372) for clinical trials of phases 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 Clinical Trial
Clinical Trial NCT01735006: Efficacy and Immunogenicity Study of Recombinant Human Papillomavirus Bivalent（Type 16/18) Vaccine. The efficacy, safety, and immunogenicity results from the pivotal phase 3 clinical trial were conducted on 7,372 healthy women in 5 provinces in China. In preventing precancerous lesions and 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%. Regarding vaccine safety and preventive effect indicators, domestic vaccines' effectiveness is comparable to imported vaccines at an internationally advanced level.