China's homegrown 9-valent HPV vaccine expected to boost immunization coverage

A nurse shows human papillomavirus (HPV) vaccines developed by Chinese researchers at the provincial Maternity and Child Healthcare Hospital in Wuhan, central China's Hubei province, May 18, 2020. [Photo/Xinhua]

China's drug regulator has approved the country's first domestically developed 9-valent human papillomavirus (HPV) vaccine, ending over a decade of foreign dominance in the market.

The vaccine, Cecolin 9, has been included on a list of approved medical products that was made public by the National Medical Products Administration on Wednesday.

"The approval of Cecolin 9 not only offers more vaccination options for eligible women in China, but is also expected to improve vaccine accessibility and coverage, reducing the risk of cervical cancer further," said Zhang Jun, dean of the School of Public Health at Xiamen University and a leading member of the vaccine development team.

HPV vaccines are commonly used to prevent cervical cancer in women, as well as genital cancers and warts in both men and women.

Cecolin 9, which targets nine HPV strains, was developed by Xiamen University, the Xiang An Biomedicine Laboratory and Xiamen Innovax Biotech Co., Ltd., marking a breakthrough in China's ability to produce high-valency HPV vaccines independently.

China is now the second country -- after the United States -- capable of supplying 9-valent HPV vaccines.

Compared to bivalent HPV vaccines, which are effective against two high-risk genotypes (HPV 16 and 18), 9-valent HPV vaccines protect against an additional five high-risk genotypes (HPV 31, 33, 45, 52 and 58) and two low-risk genotypes (HPV 6 and 11), and provide better protection against cervical cancer.

Over 18 years of research, scientists overcame major technical challenges in producing virus-like particles (VLPs) from multiple HPV types using an E. coli platform, and completed crucial clinical trial validation processes.

Five related clinical trials have been conducted across China since 2019, and the vaccine has demonstrated a favorable safety profile and a strong immune response, comparable to those of similar international products.

Statistics show that globally, approximately 700,000 cancer cases each year are associated with HPV, including an estimated 530,000 cases of cervical cancer. Vaccination is up to 94 percent effective in preventing HPV infection.

In 2020, the World Health Organization (WHO) launched a global strategy to accelerate the elimination of cervical cancer, aiming for 90 percent of girls to be fully vaccinated against HPV by the age of 15 by 2030.

In alignment with the WHO strategy, China's National Health Commission launched a cervical cancer elimination action plan for the 2022-2030 period, urging the expansion of HPV vaccination coverage nationwide.