Walrinvax™, a bivalent human papillomavirus (HPV) vaccine, has been prequalified by the World Health Organization (WHO). Walrinvax is manufactured by Yuxi Zerun Biotechnology Co., Ltd. in Yuxi City, Yunnan Province, China, a fully owned subsidiary of Shanghai Zerun Biotechnology under Walvax Biotechnology Co., Ltd. Walrinvax is designed to protect against HPV types 16 and 18, the most common virus types that lead to cervical cancer. Countries facing barriers to national introduction or struggling to expand their HPV vaccine program due to price or supply constraints will now have another option for affordable, sustainable access.

“There is currently a significant gap in the existing HPV vaccine supply worldwide,” says Mr. Yunchun Li, Board Chairman of Walvax. “With the achievement of WHO prequalification, and our commitment to supplying more than half our HPV production capacity to the global market, Walrinvax can be a great help in the global effort to fill that supply gap.”

HPV is extremely common worldwide. Of the more than 100 types of the virus, at least 14 are cancer causing—including types 16 and 18, which cause about 70 percent of cervical cancers globally. Cervical cancer is a leading cause of cancer death among women in countries with low- and middle-income economies.

HPV vaccines are highly effective. Since their introduction, they have significantly reduced vaccine-type HPV infections and precancerous cervical lesions. WHO’s global strategy to accelerate the elimination of cervical cancer calls on countries to, by the year 2030, fully vaccinate 90 percent of girls against HPV by age 15. WHO recommends one or two doses of HPV vaccine in girls and women between 9 and 20 years of age.

WHO prequalification—which ensures a vaccine meets strict international quality, safety, and efficacy standards—allows Walrinvax to be procured by United Nations agencies and Gavi, the Vaccine Alliance. Walrinvax was licensed for use in China on March 22, 2022, and has been widely administered to girls and women locally, but prequalification allows it to enter the global public vaccine market—a critical step in expanding vaccine access.

PATH has been providing technical assistance to Zerun Bio to support the product development and prequalification process since 2017. Activities included improving the quality management and pharmacovigilance systems and providing chemistry, manufacturing, and controls; quality; and clinical advice for the prequalification dossier.

“The prequalification of Walrinvax will help move the world closer to its HPV vaccination goals, and we are encouraged by Zerun and Walvax’s commitment to serving the global market,” says Yuan Yuan, PATH China country representative. “The addition of another HPV vaccine to the global toolkit will help ensure equitable vaccination for girls in low- and middle-income countries.”

Only four other HPV vaccines are currently prequalified by WHO. Merck International manufactures GARDASIL®, a quadrivalent vaccine that covers HPV types 6, 11, 16, and 18, first licensed in the United States in 2006; and GARDASIL 9, a nonavalent vaccine that covers HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, first licensed in the United States in 2014. GlaxoSmithKline manufactures a bivalent HPV vaccine, Cervarix®, that protects against HPV types 16 and 18, first licensed in Europe in 2007. Xiamen Innovax Biotech Co., Ltd. manufactures Cecolin®, a bivalent vaccine that covers HPV types 16 and 18, first licensed in China in 2019, and to which PATH also provided technical assistance prior to prequalification. GARDASIL 9 is not currently available for Gavi-eligible markets.

About Zerun Bio

Zerun Bio is an innovative biopharmaceutical company focusing on the research, development, and manufacturing of new recombinant human vaccines. The company was founded in 2003 with its R&D facility located in Zhanjiang Hi-Tech Park, Pudong New District, Shanghai, China and its manufacturing operations, which is called Yuxi Zerun Biotechnology Co., Ltd., in Yuxi City, Yunnan Province, China. Zerun Bio is a majority owned subsidiary of Walvax, a company listed on Shenzhen Stock Exchange of China. For more information, please visit https://www.zerunbio.com and https://www.walvax.com.

About PATH

PATH is a global nonprofit dedicated to achieving health equity. With more than 40 years of experience forging multisector partnerships, and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world’s most pressing health challenges. For more information, visit https://www.path.org.