In a significant advancement towards the global elimination of cervical cancer, 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 approval is based on recent data meeting the criteria outlined in the WHO’s 2022 recommendations for alternative, off-label use of HPV vaccines in single-dose schedules.

This milestone aims to address the longstanding issue of HPV vaccine shortages and expand vaccination coverage, particularly in low- and middle-income countries where cervical cancer rates are disproportionately high. WHO Director-General Dr. Tedros Adhanom Ghebreyesus highlighted the impact of the decision, stating, “Unlike most other cancers, we have the ability to 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.”

A Step Closer to Cervical Cancer Elimination

Cervical cancer is one of the most preventable cancers, yet it remains a major health threat for women globally. More than 95% of the 660,000 new cases each year are caused by HPV, and a woman dies from the disease every two minutes worldwide. Alarmingly, 90% of these deaths occur in low- and middle-income countries, with 19 out of the 20 hardest-hit countries located in Africa.

Global HPV vaccine supply shortages have hindered the progress of vaccination programs since 2018, with production challenges faced by manufacturers further exacerbating the situation earlier this year. The availability of a new single-dose vaccine option, Cecolin®, could now alleviate these supply constraints and allow more countries to expand their immunization campaigns.

“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 a single-dose vaccine product means countries will have greater choice of vaccines to reach more girls.”

Expanding Access: From Two-Dose to Single-Dose Schedules

Initially prequalified for use in a two-dose schedule, a growing number of HPV vaccine products are now eligible for single-dose administration based on recent evidence. The single-dose use indication for Cecolin® has been incorporated into WHO’s updated technical guidelines for HPV vaccine product choices, enabling public health bodies to recommend its “off-label” use until manufacturers update their product labels.

Global data released on July 15, 2024, reveals that one-dose HPV vaccine coverage among girls aged 9-14 years increased from 20% in 2022 to 27% in 2023. By September 2024, 57 countries had implemented the single-dose schedule, an increase from 37 countries in 2023. WHO estimates that this transition has resulted in at least 6 million additional girls receiving HPV vaccines in 2023 alone.

Increased Funding and Commitments for Cervical Cancer Elimination

The drive to eliminate cervical cancer has gained momentum with nearly USD 600 million in new funding announced earlier this year. The Bill & Melinda Gates Foundation has committed USD 180 million, while UNICEF and the World Bank have pledged USD 10 million and USD 400 million, respectively. These investments, along with strong support from Gavi, will accelerate HPV vaccine introductions and boost coverage among girls by 2030.

Adding to this positive momentum, the WHO prequalified a fifth HPV vaccine, Walrinvax, on August 2, 2024. While Walrinvax is currently prequalified for use in a two-dose schedule, further data may allow it to be used in single-dose schedules in the future, thereby contributing to a more sustainable supply of HPV vaccines globally.

A Brighter Future for Cervical Cancer Prevention

With the new prequalification of Cecolin and the introduction of Walrinvax, global health authorities are now better positioned to tackle cervical cancer with a more robust and diversified vaccine supply. These developments bring hope for millions of girls, particularly in regions with limited access to healthcare, and represent a crucial step towards achieving WHO’s goal of eliminating cervical cancer as a public health problem by 2030.