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WHO Approves HPV Vaccine for Single-dose Use

According to a press statement released on Friday, the decision was 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.
The World Health Organisation (WHO)  has announced that a fourth WHO-prequalified human papillomavirus (HPV) vaccine known as Cecolin has been confirmed for use in a single-dose schedule.

According to a press statement released on Friday, the decision was 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. 

They say this milestone will contribute to improving sustainable supply of HPV vaccines allowing more girls to be reached with the vaccines that prevent cervical cancer.

“Unlike most other cancers, we have the ability to eliminate cervical cancer, along with its painful inequities,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General.  “By adding another option for a one-dose HPV vaccination schedule, we have taken another step closer to consigning cervical cancer to history.”

More than 95% of the 660 000 cervical cancer cases occurring globally each year are caused by HPV.  Every two minutes, a woman dies from this preventable disease globally, and 90% of these deaths occur in low- and middle-income countries.  Of the 20 hardest hit countries by cervical cancer, 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 HPV vaccines in Africa and Asia.

"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,” said Dr Kate O'Brien, Director of the Department of Immunization, Vaccines and Biologicals at WHO.  “Given the continuing supply challenges, this addition of single-dose vaccine product means countries will have greater choice of vaccines to reach more girls.”

A growing number of vaccine products initially pre-qualified for use in a 2-dose schedule can now be used in a single-dose schedule, according to WHO.

Global data released on 15 July 2024 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 10 September 2024, 57 countries were implementing the single-dose schedule.  WHO estimates that the single-dose schedule adoption has resulted in at least 6 million additional girls being reached with HPV vaccines in 2023.

Earlier  this year, countries committed nearly US$ 600 million in new funding towards elimination of cervical cancer.  Funding includes US$ 180 million from the Bill & Melinda Gates Foundation, US$ 10 million from UNICEF, and US$ 400 million from the World Bank.

The organization says this funding will help to accelerate introductions and boost coverage of HPV vaccine among girls by 2030.

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