Cecolin®: New Hope for Global Cervical Cancer Prevention with Single-Dose HPV Vaccine

The World Health Organization (WHO) has announced that Cecolin®, a fourth WHO-prequalified human papillomavirus (HPV) vaccine, has been approved for use in a single-dose schedule. This decision is based on new data that meets the criteria set out in WHO's 2022 recommendations for off-label use of HPV vaccines in a single dose. This approval marks a significant step in enhancing the global supply of HPV vaccines, enabling more girls to be vaccinated and protected from cervical cancer.

WHO Director-General Dr. Tedros Adhanom Ghebreyesus emphasized saying “Unlike most other cancers, we have the ability to eliminate cervical cancer, along with its painful inequities By adding another option for a one-dose HPV vaccination schedule, we have taken another step closer to consigning cervical cancer to history.”

Global HPV vaccine supply has faced shortages since 2018, and recent production issues have further strained access, particularly affecting girls in Africa and Asia. Dr. Kate O'Brien, Director of WHO’s Department of Immunization, Vaccines and Biologicals, said “Having 90% 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,“Given the continuing supply challenges, this addition of single-dose vaccine product means countries will have greater choice of vaccines to reach more girls.”

A growing number of HPV vaccines, originally approved for two doses, can now be administered in a single dose. The approval of Cecolin® for single-dose use has been included in WHO’s updated guidance on HPV vaccine product choices.

Recent global data shows that single-dose HPV vaccine coverage among girls aged 9-14 increased from 20% in 2022 to 27% in 2023, with 57 countries now implementing the single-dose schedule. WHO estimates that this transition has led to 6 million more girls being vaccinated in 2023 alone.

In addition, earlier this year, nearly $600 million in funding was committed to eliminating cervical cancer, including contributions from the Bill & Melinda Gates Foundation, UNICEF, the World Bank, and Gavi. These investments aim to increase HPV vaccine coverage and accelerate global efforts to eliminate cervical cancer by 2030.