WHO is pleased to announce that a fourth WHO-prequalified human papillomavirus vaccine product, Cecolin®, has been confirmed for use in a single-dose schedule. This decision was reached based on new data about the product and is in line with the WHO 2022 recommendations on alternative, off-label use of HPV vaccines in single-dose schedules. This critical milestone will contribute to improving the sustainable supply of HPV vaccines, allowing more girls to be reached with the vaccines that prevent cervical cancer.
“Unlike most other cancers, we can 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 that occur globally each year are caused by HPV. Every two minutes, a woman dies from this preventable disease tragedy that occurs 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.
Global supply shortages since 2018 constrained the introduction of the HPV vaccine while manufacturing challenges this year experienced by one of the manufacturers resulted in further shortfalls that may have hit at the hope of vaccinating several millions of girls in Africa and Asia who need HPV vaccines.
Ninety percent of girls fully vaccinated with the HPV vaccine by age 15 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 a greater choice of vaccines to reach more girls.
A single-dose schedule indication has also been recommended from the increasing number of vaccine products, which initially had been prequalified for use according to a 2-dose schedule. WHO’s technical document on considerations for HPV vaccine product choice, second edition, includes a single-dose use indication for this additional vaccine, Cecolin®. As with other medicines and vaccines, when data supports modified use guided by a clear public health benefit, public health advisory bodies may recommend “off-label” use until a manufacturer adds this modified use to their label.
Global data as of 15 July 2024, show that 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 are implementing the single-dose schedule. WHO estimates that at least 6 million additional girls were reached with HPV vaccines in 2023 following the adoption of the single-dose schedule.
Earlier this year, countries and partners pledged close to US$ 600 million in new funding towards the 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. Along with the continuing strong commitment by Gavi, these investments will help accelerate introductions and boost coverage of the HPV vaccine among girls by 2030.
WHO prequalified a fifth HPV Vaccine
Another good news came with the prequalification, by WHO, of another HPV vaccine Walrinvax®, on 2 August 2024 – it becomes the fifth product available on the global market. This will further contribute to a more sustainable supply of vaccines, allowing more girls to be vaccinated against HPV. Walrinvax® is prequalified with a two-dose schedule. Further data will be required to assess if this vaccine can be recommended for a single-dose schedule.
