WHO Approves Cecolin® for Single-Dose HPV Vaccination in Fight Against Cervical Cancer

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The World Health Organization (WHO) has recently prequalified Cecolin®, a Human Papillomavirus (HPV) vaccine, for use in a single-dose regimen to help prevent cervical cancer.

This marks a significant step forward in the global fight against the disease, which continues to affect hundreds of thousands of women each year, particularly in low- and middle-income countries.

In a statement released on Friday, WHO announced that Cecolin® has successfully met the criteria outlined in its 2022 recommendations for the alternative, off-label use of HPV vaccines in single-dose schedules.

The approval is expected to contribute to a more sustainable and accessible supply of HPV vaccines worldwide, potentially allowing many more girls to be vaccinated and protected from the devastating effects of cervical cancer.

“This important milestone will contribute to improving the sustainable supply of HPV vaccines, allowing more girls to be reached with the vaccines that prevent cervical cancer,” the WHO stated.

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Dr. Tedros Ghebreyesus, Director-General of WHO, emphasized the significance of this development, underscoring how it brings the world closer to eliminating cervical cancer.

“Cervical cancer, unlike most other cancers, is preventable with the right interventions. By adding another option for a one-dose HPV vaccination schedule, we have taken a step closer to consigning cervical cancer to history,” Dr. Ghebreyesus said.

Cervical cancer remains one of the most preventable yet deadly forms of cancer, with more than 660,000 new cases reported annually.

Over 95% of these cases are caused by HPV, a sexually transmitted virus. Tragically, 90% of cervical cancer deaths occur in low- and middle-income countries, where access to preventive measures such as vaccines is limited.

In addition to Cecolin®, WHO prequalified another HPV vaccine, Walrinvax®, on August 2, 2024. Although Walrinvax® is currently approved for a two-dose schedule, research is ongoing to evaluate the potential for its use in a single-dose format.

The addition of Walrinvax® to the global market provides yet another critical tool in the fight against cervical cancer, reinforcing efforts to increase access to life-saving vaccines.

With these recent advancements, the WHO continues to push toward its goal of significantly reducing cervical cancer cases worldwide, particularly in regions where the burden of disease is most severe.

By enabling broader access to single-dose vaccines like Cecolin®, more girls and women stand a better chance of receiving timely protection, contributing to the long-term goal of eliminating cervical cancer globally.

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Dr. Kate O’Brien, Director of WHO’s Department of Immunization, highlighted that supply shortages have delayed the introduction of HPV vaccines since 2018, with recent production issues affecting millions of girls in Africa and Asia. She noted that WHO’s target is to vaccinate 90% of girls by age 15, and the approval of single-dose vaccines like Cecolin® offers countries more options to reach this goal.

By September 2024, 57 countries had adopted the single-dose HPV schedule, up from 37 in 2023, enabling 6 million more girls to be vaccinated. Global efforts, including nearly $600 million in new funding, aim to eliminate cervical cancer by 2030.

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