The World Health Organization (WHO) has prequalified Cecolin®, a Human Papillomavirus (HPV) vaccine, for use in a single-dose regimen to help prevent cervical cancer.
In a statement released on Friday, WHO announced that Cecolin® met the criteria set out in its 2022 recommendations for the alternative, off-label use of HPV vaccines in single-dose schedules.
According to WHO, this approval will contribute to a more sustainable supply of HPV vaccines, potentially enabling more girls to be vaccinated and protected against cervical cancer. “This important milestone will contribute to improving sustainable supply of HPV vaccines, allowing more girls to be reached with the vaccines that prevent cervical cancer,” the WHO statement read.
Dr. Tedros Ghebreyesus, WHO’s Director-General, highlighted the importance of this development in the global fight against cervical cancer. He emphasized that cervical cancer, unlike most other cancers, can be eliminated with the right interventions.
“By adding another option for a one-dose HPV vaccination schedule, we have taken another step closer to consigning cervical cancer to history,” Ghebreyesus stated.
He pointed out that more than 95% of the 660,000 cervical cancer cases reported annually are caused by HPV, with 90% of the deaths occurring in low- and middle-income countries.
In addition to Cecolin®, WHO prequalified a fifth HPV vaccine, Walrinvax®, on August 2, 2024. This vaccine adds to the global market and provides another critical tool in the fight against cervical cancer. While Walrinvax® is currently approved for use as a two-dose schedule, further research may allow its future use in a single-dose schedule.
Dr. Kate O’Brien, Director of WHO’s Department of Immunization, Vaccines, and Biologicals, noted that supply shortages have hindered the introduction of HPV vaccines since 2018. She said production challenges earlier this year worsened the situation, impacting millions of girls in Africa and Asia.
“Having 90% of girls fully vaccinated with the HPV vaccine by 15 years of age was the target for the first pillar of the WHO global strategy for cervical cancer elimination,”
“Given the continuing supply challenges, this addition of a single-dose vaccine product means countries will have greater choice of vaccines to reach more girls.” O’Brien explained.
According to WHO, the number of countries implementing the single-dose HPV vaccination schedule has grown significantly. In 2023, 37 countries had adopted the schedule, but by September 2024, the number had increased to 57. WHO estimates that the adoption of the single-dose schedule has enabled an additional 6 million girls to receive HPV vaccines in 2023 alone.
Global data released in July 2024 also showed that one-dose HPV vaccine coverage among girls aged 9 to 14 years increased from 20% in 2022 to 27% in 2023.
Earlier in 2024, countries and global health partners committed nearly $600 million in new funding to support the elimination of cervical cancer.
This funding includes $180 million from the Bill & Melinda Gates Foundation, $10 million from UNICEF, and $400 million from the World Bank. These investments are expected to accelerate the introduction and coverage of HPV vaccines by 2030.