WHO Approves Fourth HPV Vaccine for Single-Dose Use

The World Health Organization (WHO) has announced a major breakthrough in the fight against cervical cancer with the approval of a fourth human papillomavirus (HPV) vaccine, Cecolin, for single-dose use.

This milestone decision is based on new data that meets the WHO’s 2022 recommendations for alternative, off-label use of HPV vaccines in single-dose schedules.

According to Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, “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.”

Cervical cancer claims the lives of over 660,000 women globally each year, with 95% of cases caused by HPV. Every two minutes, a woman dies from this preventable disease, and 90% of these deaths occur in low- and middle-income countries. Africa is disproportionately affected, with 19 of the 20 hardest-hit countries located on the continent.

The approval of Cecolin comes at a critical time, as global supply shortages and production challenges have hindered HPV vaccine introductions since 2018. Dr. Kate O’Brien, Director of the Department of Immunization, Vaccines and Biologicals at WHO, notes that “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.

Statistics shows that 37 countries implemented the single-dose schedule in 2023 while 57 countries are now implementing the single-dose schedule as of September 2024.

According to the WHO estimates  the single-dose schedule adoption has resulted in at least 6 million additional girls being reached with HPV vaccines in 2023. At the same time, nearly $600 million in new funding has been committed towards eliminating cervical cancer, including $180 million from the Bill & Melinda Gates Foundation.

In related news, the WHO has prequalified a fifth HPV vaccine, Walrinvax, with a two-dose schedule. This development will contribute to a more sustainable supply of HPV vaccines, enabling more girls to receive the vaccine. Further data will be needed to assess if Walrinvax can be recommended for single-dose use in the future.

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