New HPV vaccine from Innovax receives WHO prequalification

Cecolin®, a vaccine against human papillomavirus (HPV), has received prequalification by the World Health Organization (WHO). Cecolin is manufactured by Xiamen Innovax Biotech CO., LTD. (Innovax), a wholly owned subsidiary of Beijing Wantai Biological Pharmaceutical Co., LTD. (Wantai), and 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 expanding their HPV vaccine program to the full cohort due to price or supply constraints will now have another option for affordable, sustainable access.

“The approval of WHO prequalification is of great significance, marking that Wantai’s vaccine development, manufacturing process, and product quality meets strict international standard, and paving a broader way for Wantai towards global market,” says Mr. Li Shicheng, the chairman of Innovax.

HPV is extremely common worldwide; of the more than 100 types of HPV, at least 14 are cancer causing—including types 16 and 18, which cause about 70 percent of cervical cancers. 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 fully vaccinate 90 percent of girls with HPV vaccine by age 15 by the year 2030. Currently, 28 low- and lower-middle-income countries deliver HPV vaccine as part of their national immunization program.

WHO recommends two doses of HPV vaccine for 9- to 14-year-old girls. Girls aged 15 years and older and girls who are immune compromised, including those living with HIV, should receive three doses of vaccine.

However, the existing supply of HPV vaccines provided to Gavi, the Vaccine Alliance is insufficient to meet current demand through 2023. Some Gavi-eligible countries have postponed vaccination in multiple age groups to allow approved countries to start vaccinations in a single age group initially. For example, in Senegal, only girls aged 9 are receiving the vaccine, instead of starting with girls 9 to 14 years of age and continuing routine immunization at 9 years of age.

WHO prequalification—which ensures a vaccine meets strict international quality, safety, and efficacy standards—allows Cecolin to be procured by United Nations agencies and Gavi. Cecolin is licensed for use in China, but prequalification allows it to enter the global public vaccine market—a critical step in expanding vaccine access.

Prior to Cecolin’s licensure in China, PATH provided Innovax with technical assistance for the WHO prequalification process. Activities included improving the quality management system, establishing a post-marketing pharmacovigilance system, and collecting information on regulatory requirements for registration of vaccines in Gavi countries.

“HPV vaccines so far have been mainly available on the private market. But with Cecolin, China— and the world—is on its way to more equitable HPV vaccination in girls. We really appreciate Innovax’s willingness to supply this highly efficacious vaccine to low- and-middle-income countries at an affordable price,” says Yuan Yuan, PATH China country representative.

Only three other HPV vaccines are currently prequalified by WHO. Merck manufactures two: GARDASIL®, a quadrivalent vaccine that covers four HPV types (6, 11, 16, and 18), first licensed in the United States in 2006, and GARDASIL 9, a nonvalent vaccine that covers nine viral types (6, 11, 16, 18, 31, 33, 45, 52, and 58), first licensed in the United States in 2014. And GlaxoSmithKline manufactures a bivalent HPV vaccine (Cervarix®) that protects against two HPV types (16 and 18), first licensed in Europe in 2007. GARDASIL 9 is not currently available for Gavi-eligible countries.

Cecolin is currently being evaluated in a Phase 3 clinical study at the icddr,b in Matlab, Bangladesh, and at the Malaria Research Center in Agogo, Ghana. This PATH-sponsored clinical study will generate data regarding the safety and immunogenicity of alternative dosing regimens of Cecolin. These data will help determine flexibility in administration schedules and thus help countries tailor use more specifically to their needs, further expanding confidence in and access to lifesaving vaccines. Research began in 2021, and results are expected in 2024.

About Xiamen Innovax Biotech CO., LTD.

Innovax is a wholly owned subsidiary of Beijing Wantai Biological Pharmaceutical Co., Ltd., under the YangShengTang Group. Established in 2005, Innovax is dedicated to providing innovative, reliable, and affordable vaccines to combat infectious diseases. Innovax established a core platform using recombinant technology to express protein in Escherichia coli for vaccine production. Based on this platform, the world’s first hepatitis E vaccine, Hecolin®, was launched in China in October 2012. Cecolin was licensed in China in December 2019. In addition, Innovax initiated a Phase 3 clinical trial with its 9-valent HPV candidate vaccine.

About PATH

PATH is a global organization that works to accelerate health equity by bringing together public institutions, businesses, social enterprises, and investors to solve the world’s most pressing health challenges. With expertise in science, health, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales solutions—including vaccines, drugs, devices, diagnostics, and innovative approaches to strengthening health systems worldwide. www.path.org.