WHO Approves Single-Dose HPV Vaccine to Fight Cervical Cancer

This move is expected to significantly improve the sustainable supply of HPV vaccines, allowing more girls to be vaccinated against cervical cancer.

The World Health Organization (WHO) has announced that a fourth human papillomavirus (HPV) vaccine, Cecolin, has been prequalified for use in a single-dose schedule.

This decision marks a major milestone in the global fight against cervical cancer, which is caused by HPV in more than 95% of cases.

The WHO's decision to approve Cecolin for a single-dose schedule is based on new data meeting the criteria established in the organization's 2022 recommendations for off-label use of HPV vaccines.

This move is expected to significantly improve the sustainable supply of HPV vaccines, allowing more girls to be vaccinated against cervical cancer.

"Unlike most other cancers, we have the ability to eliminate cervical cancer, along with its painful inequities,” said WHO Director-General Dr. Tedros Adhanom Ghebreyesus.

“By adding another option for a one-dose HPV vaccination schedule, we have taken another step closer to consigning cervical cancer to history.”

Cervical cancer is a preventable disease, yet every two minutes, a woman dies from it globally.

Over 660,000 cervical cancer cases are reported each year, with 90% of deaths occurring in low- and middle-income countries, particularly in Africa.

Global Supply Shortages Impacting Vaccine Access

Since 2018, the introduction of HPV vaccines has been hampered by global supply shortages, with production challenges worsening earlier this year.

These shortages have particularly affected millions of girls in Africa and Asia, where the need for HPV vaccines is most critical. The new single-dose approval for Cecolin, along with previous vaccine options, aims to address this supply issue.

According to Dr Kate O’Brien, Director of WHO’s Department of Immunization, Vaccines, and Biologicals, "Having 90 percent 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."

The addition of Cecolin as a single-dose option provides countries with more flexibility in choosing vaccines to reach a greater number of girls.

Increasing HPV Vaccination Rates

A growing number of HPV vaccine products that were initially approved for use in two-dose schedules are now available for single-dose administration.

This includes Cecolin, which has been incorporated into WHO’s updated technical guidelines on HPV vaccine product selection.

These off-label recommendations allow vaccines to be used in ways that maximize public health benefits until manufacturers update their product labels to reflect the modified usage.

Global data released in July 2024 shows that coverage for one-dose HPV vaccines among girls aged 9-14 increased from 20% in 2022 to 27% in 2023.

By September 2024, 57 countries had adopted the single-dose schedule, up from 37 countries in 2023. WHO estimates that the adoption of the single-dose schedule led to at least six million additional girls being vaccinated in 2023.

Commitment to Cervical Cancer Elimination

Earlier in 2024, countries and global health partners committed nearly US$ 600 million to accelerate the elimination of cervical cancer. This includes $180 million from the Bill & Melinda Gates Foundation, $10 million from UNICEF, and $400 million from the World Bank.

These investments, coupled with ongoing support from Gavi, the Vaccine Alliance, will help speed up the introduction and coverage of HPV vaccines, particularly among girls in low- and middle-income countries.

In addition to Cecolin, WHO also prequalified a new HPV vaccine, Walrinvax, in August 2024. This brings the total number of HPV vaccines on the global market to five. Walrinvax is currently prequalified for use in a two-dose schedule.

WHO stated that further data is needed before Walrinvax can be considered for use in a single-dose schedule.

These new vaccine options and increased funding demonstrate a renewed commitment to ending cervical cancer.

With a combination of advanced technologies, sustained funding, and global cooperation, the WHO hopes to reach its target of vaccinating 90% of girls against HPV by 2030, bringing the world closer to eliminating cervical cancer as a public health threat.

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