New Delhi: The World Health Organisation (WHO) has confirmed the fourth-generation prequalified human papillomavirus (HPV) vaccine product, Cecolin, for use in a single-dose schedule.
The decision is based on new data on the product that fulfilled the criteria set out in the WHO’s 2022 recommendations for alternative, off-label use of HPV vaccines in single-dose schedules. This important milestone will contribute to improving the sustainable supply of HPV vaccines by bringing more women under its coverage to prevent cervical cancer.
"Unlike most other cancers, we can 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,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus.
More than 95 per cent of the 6.6 lakh global cervical cancer cases each year are caused by HPV. Every two minutes, a woman dies from this preventable disease and 90 per cent of the deaths occur in low-and-middle-income countries. Of the 20 countries hit hardest by the malaise, 19 are in Africa.
HPV vaccine introductions have been hampered by global supply shortages since 2018 and production challenges encountered by one of the manufacturers earlier this year led to further shortfalls, potentially impacting millions of girls in need of inoculation in Africa and Asia.
“Having 90 per cent of under-15 girls fully vaccinated is the target for the first pillar of the WHO global strategy for cervical cancer elimination,” said Dr Kate O'Brien, Director of the Department of Immunization, Vaccines and Biologicals at WHO.
Given the continuing supply constraints, this addition of single-dose vaccine products means countries will have a greater choice of vaccines to reach more girls, he said.
A growing number of vaccine products initially prequalified for use in a two-dose schedule can now be used in a single-dose schedule. The single-dose use indication for this additional vaccine, Cecolin, is incorporated into the second edition of WHO’s technical document on considerations for HPV vaccine product choice.
Like for other medications and vaccines, when there is data to support modified use, guided by a clear public health benefit, public health advisory bodies can recommend "off-label” use until a manufacturer adds this modified use to their label.
The global data, released on July 15, indicates that the one-dose HPV vaccine coverage among girls aged 9-14 years increased from 20% in 2022 to 27% in 2023. In 2023, 37 countries were implementing the single-dose schedule. As of September 10, 2024, 57 countries are implementing the single-dose schedule. WHO estimates that the single-dose schedule adoption has resulted in at least 6 million additional girls being covered with HPV vaccines in 2023.
Earlier this year, countries and partners committed nearly $600 million in new funding towards the elimination of cervical cancer. The funding includes $180 million from the Bill & Melinda Gates Foundation, $10 million from UNICEF, and $400 million from the World Bank.
Together with the strong commitment by the global vaccine network, Gavi, these investments will help to accelerate introductions and boost coverage of the HPV vaccine among girls by 2030.
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