WHO announced that Cecolin®, the fourth WHO prequalified human papillomavirus (HPV) vaccine product, has been confirmed for use in a single-dose schedule. This decision will be based on new data on products that meet the criteria set out in the WHO’s 2022 Recommendation on Alternative Off-Label Use of HPV Vaccines in Single-Dose Schedules. This important milestone will contribute to improving the sustainable supply of HPV vaccines and will enable more girls to receive vaccines to prevent cervical cancer.
WHO Director-General Dr Tedros Adhanom Ghebreyesus said: “Unlike most other cancers, we have the capacity to end cervical cancer and its painful inequalities.” “By adding another option to the one-dose HPV vaccination schedule, we are one step closer to relegating cervical cancer to history.”
Of the 660,000 cases of cervical cancer that occur around the world each year, over 95% are caused by HPV. One woman dies every two minutes around the world from this preventable disease, and 90% of these deaths occur in low- and middle-income countries. Of the 20 countries most affected by cervical cancer, 19 are in Africa.
The rollout of HPV vaccines has been hampered by global supply shortages since 2018, and one manufacturer faced production challenges earlier this year, leading to further shortages and increasing demand for HPV vaccines in Africa and Asia. It could impact millions of girls in need.
“Having 90% of girls fully vaccinated against HPV by the age of 15 is the goal of the first pillar of the WHO Global Strategy to Eliminate Cervical Cancer,” said Kate, Director of Immunization and Vaccines. Dr. O’Brien said. and a WHO biologist. “Given ongoing supply challenges, this addition of single-dose vaccine products means countries will have more vaccine options to reach more girls.”
A growing number of vaccine products that were originally prequalified for use in a two-dose schedule are now available for use in a single-dose schedule. The single-dose indication for this additional vaccine, Cecolin®, has been incorporated into the second edition of the WHO technical document on considerations for the selection of HPV vaccine products (reflected in Table 4 of this document). As with other medicines and vaccines, if there is data to support a modified use based on clear public health benefits, public health advisory bodies will require manufacturers to add this modified use to their labels. may be recommended for “off-label” use.
According to global data released on July 15, 2024, single-dose HPV vaccination coverage among girls aged 9 to 14 increased from 20% in 2022 to 27% in 2023. In 2023, 37 countries had implemented a single-dose vaccination schedule. As of September 10, 2024, 57 countries have implemented single-dose schedules. WHO estimates that at least 6 million additional girls will be vaccinated against HPV in 2023 with the adoption of a single-dose schedule.
Earlier this year, countries and partners committed nearly $600 million in new funding to end 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. Together with Gavi’s continued strong efforts, these investments will help accelerate HPV vaccine adoption and uptake for girls by 2030.
WHO prequalifies fifth HPV vaccine
Even better news is that on August 2, 2024, an additional HPV vaccine, Walrinvax®, was prequalified by the WHO, making it the fifth product available on the global market. This will contribute to a more sustainable supply of HPV vaccines, allowing more girls to receive the vaccine. Walrinvax® is prequalified on a two-dose schedule. Further data are needed to assess whether this vaccine can be recommended as a single-dose schedule in the future.
