WHO approves Cecolin® for single-dose HPV vaccination

 SWITZERLAND—The World Health Organization (WHO) has announced the prequalification of a fourth human papillomavirus (HPV) vaccine, Cecolin®, for use in a single-dose schedule.

This comes after another prequalification of Euvichol-S, a novel oral cholera vaccine (OCV), for cholera treatment in April.

Euvichol-S, manufactured by EuBiologicals Co., Ltd. in the Republic of Korea, provides a simpler formulation with comparable efficacy to existing vaccines.

This latest decision comes after new data confirmed that the vaccine meets the criteria outlined in WHO’s 2022 recommendations for the off-label use of HPV vaccines, specifically in single-dose schedules.

This marks a significant milestone in the global fight against cervical cancer, as it will help address vaccine shortages and ensure more girls receive life-saving protection.

According to WHO Director-General Dr. Tedros Adhanom Ghebreyesus, cervical cancer stands out as a disease that can be entirely eliminated, unlike many other cancers.

He emphasized that introducing another one-dose HPV vaccine option is a critical step toward consigning cervical cancer to history, as well as addressing the inequities associated with the disease.

 This is particularly urgent as more than 95% of the 660,000 cervical cancer cases reported globally each year are caused by HPV, with the disease taking a woman’s life every two minutes.

Tragically, 90% of these deaths occur in low- and middle-income countries, with 19 of the 20 hardest-hit nations located in Africa.

The announcement comes amid a backdrop of ongoing challenges in the global supply of HPV vaccines.

Since 2018, shortages have hampered vaccine introductions, with production setbacks further exacerbating the situation.

These shortages have put millions of girls in Africa and Asia at risk of not receiving the vaccine.

Dr. Kate O’Brien, Director of WHO’s Department of Immunization, Vaccines, and Biologicals, noted that the organization’s target is to fully vaccinate 90% of girls by the age of 15 as part of its global strategy to eliminate cervical cancer.

She welcomed the approval of Cecolin® for single-dose use, stating that this new option will allow countries to vaccinate more girls, despite ongoing supply challenges.

A growing number of HPV vaccines initially approved for two doses can now be administered as a single dose, providing greater flexibility for countries facing supply constraints.

 WHO has incorporated the single-dose use of Cecolin® into its latest technical guidance document, which advises on HPV vaccine product choices.

 In cases where clinical data supports modified use, public health authorities can recommend off-label use until the manufacturer updates the product label.

Global data released in July 2024 revealed an encouraging increase in HPV vaccine coverage among girls aged 9-14, rising from 20% in 2022 to 27% in 2023.

By 2023, 37 countries had adopted the single-dose schedule, and this number grew to 57 countries as of September 2024.

WHO estimates that the adoption of the single-dose schedule helped vaccinate an additional 6 million girls in 2023.

In parallel with these advancements, international funding efforts to eliminate cervical cancer have gained momentum.

In 2024, nearly US$ 600 million in new funding was committed, with major contributions including US$ 180 million from the Bill & Melinda Gates Foundation, US$ 10 million from UNICEF, and US$ 400 million from the World Bank.

These investments, alongside Gavi’s continued commitment, are expected to accelerate vaccine introductions and increase coverage by 2030.

Adding to this positive news, on August 2, 2024, WHO prequalified a fifth HPV vaccine, Walrinvax®, which was initially approved for a two-dose schedule.

While more data is needed to determine its suitability for single-dose administration, adding this vaccine will help ensure a more sustainable supply and allow more girls to access HPV vaccination globally.

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