On Friday, the World Health Organization (WHO) announced a significant advancement in the fight against cervical cancer: the confirmation of Cecolin, a fourth WHO-prequalified human papillomavirus (HPV) vaccine, for use in a single-dose schedule. This decision is based on new data demonstrating that the vaccine meets the criteria set forth in the WHO’s 2022 recommendations for alternative, off-label use of HPV vaccines. This milestone is expected to improve the sustainable supply of HPV vaccines, ultimately allowing more girls to receive vaccinations that prevent cervical cancer.
The approval of Cecolin as a single-dose vaccine is crucial in the global effort to eliminate cervical cancer, a disease that predominantly affects women. WHO Director-General Dr. Tedros Adhanom Ghebreyesus emphasized the urgency of this issue, stating, “Unlike most other cancers, we have the ability to eliminate cervical cancer, along with its painful inequities.” By expanding the options available for HPV vaccination, the WHO is making strides toward consigning cervical cancer to history.
Cervical cancer remains a major public health concern, with more than 95 percent of the 660,000 cases occurring globally each year caused by HPV. Alarmingly, a woman dies from this preventable disease every two minutes, with 90 percent of these fatalities occurring in low- and middle-income countries. Of the 20 countries most affected by cervical cancer, 19 are located in Africa. The WHO’s initiative to introduce a single-dose vaccine aims to address these disparities and ensure that more girls have access to life-saving vaccinations.
The introduction of HPV vaccines has faced significant hurdles due to global supply shortages that have persisted since 2018. Compounding this issue, production challenges encountered by one of the manufacturers earlier this year further impacted vaccine availability, potentially jeopardizing the health of millions of girls in regions like Africa and Asia.
Dr. Kate O’Brien, Director of the Department of Immunization, Vaccines and Biologicals at WHO, noted, “Having 90 percent of girls fully vaccinated with the HPV vaccine by 15 years of age is the target for the first pillar of the WHO global strategy for cervical cancer elimination.” With ongoing supply challenges, the introduction of a single-dose vaccine offers countries greater flexibility in vaccine choice, thereby facilitating access for more girls.
A growing number of HPV vaccine products initially prequalified for use in a two-dose schedule can now be utilized in a single-dose format. The new single-dose indication for Cecolin has been incorporated into the second edition of WHO’s technical document on considerations for HPV vaccine product choice, reflecting its significance in public health strategy. As with other medications and vaccines, public health advisory bodies can recommend “off-label” use when sufficient data supports the modified use, guided by a clear public health benefit.
Recent global data released on July 15, 2024, indicates that one-dose HPV vaccine coverage among girls aged 9-14 years rose from 20% in 2022 to 27% in 2023. By September 10, 2024, 57 countries had adopted the single-dose schedule, reflecting a substantial increase from 37 countries the previous year. WHO estimates that this adoption has resulted in at least 6 million additional girls being vaccinated against HPV in 2023 alone.
Earlier this year, various countries and partners pledged nearly US$ 600 million in new funding aimed at the elimination of cervical cancer. This funding includes contributions from significant organizations, such as US$ 180 million from the Bill & Melinda Gates Foundation, US$ 10 million from UNICEF, and US$ 400 million from the World Bank. Alongside the strong commitment from Gavi, these investments are expected to accelerate the introduction of HPV vaccines and enhance coverage among girls by 2030.
In August 2024, WHO prequalified an additional HPV vaccine, Walrinvax, making it the fifth product available in the global market. Walrinvax is currently prequalified for use with a two-dose schedule, and further data will be necessary to assess whether it can be recommended for single-dose use in the future. The addition of this vaccine is anticipated to contribute to a more sustainable supply of HPV vaccines, thereby enabling more girls to receive the vaccine they need to prevent cervical cancer.
Conclusion
The WHO's recent approval of Cecolin for single-dose use is a significant step forward in the fight against cervical cancer. By improving access to HPV vaccines and addressing the challenges of supply shortages, the organization is working to ensure that girls around the world can receive the protection they need against this preventable disease. With continued commitment and collaboration, the global community can make strides toward the elimination of cervical cancer, saving countless lives in the process.