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WHO adds single-use HPV vaccine
The World Health Organization (WHO) has announced that the fourth pre-qualified WHO human papillomavirus (HPV) vaccine, Cecolin®, has been approved for use in a single-dose schedule. The decision is made on the basis of new data on the product that met the criteria specified in 2022 WHO recommendations for alternative, off-label use of HPV vaccines in a single-dose schedule. This important milestone will help improve the sustainable supply of HPV vaccines—allowing more girls to be covered by vaccines that prevent cervical cancer.
“Unlike most other cancers, we have the ability to eliminate cervical cancer, along with its painful disparities,” said Dr. Tedros Adhanom Ghebreyesus, WHO Director-General. “By adding another option to the single-dose HPV vaccination schedule, we've taken another step closer to consigning cervical cancer to history.”
More than 95% of the 660,000 cases of cervical cancer that occur annually worldwide are caused by HPV. Every two minutes, a woman dies of this preventable disease worldwide, 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.
HPV vaccine rollout has been hampered by global supply shortages since 2018, and production challenges experienced by one manufacturer earlier this year have led to further shortages, potentially affecting millions of girls in need of HPV vaccines in Africa and to Asia.
“The goal of the first pillar of the WHO is to have 90% of girls fully vaccinated against the HPV vaccine by the age of 15. global strategy to eliminate cervical cancer“, said Dr Kate O'Brien, Director of WHO's Department of Immunisation, Vaccines and Biologicals. “Given ongoing supply challenges, this addition of a single-dose vaccine means countries will have a greater choice of vaccines to reach more girls.”
An increasing number of vaccine products originally prequalified for use in a 2-dose schedule can now be used in a 1-dose schedule. The indication for the administration of one dose of this additional vaccine, Cecolin®, is included in the second edition WHO technical document on considerations for HPV vaccine product selection (reflected in table 4 of this document). As with other drugs and vaccines, when data exist to support a modified use, driven by a clear public health benefit, public health advisory bodies may recommend “off-label” use.until the manufacturer adds this modified use to its label.
Global data released on July 15, 2024 shows that HPV single-dose vaccine coverage among girls aged 9-14 years increased from 20% in 2022 to 27% in 2023. In 2023, 37 countries implemented a single dose schedule. As of September 10, 2024, 57 countries are implementing a single dose schedule. WHO estimates that adoption of the single-dose schedule would result in at least 6 million additional girls being covered by HPV vaccines in 2023.
Earlier this year, countries and partners allocated nearly US$600 million in new funding to eliminate 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 strong ongoing commitment, these investments will help accelerate the rollout and increase HPV vaccine coverage among girls by 2030.
WHO has prequalified the fifth HPV vaccine
Another good news is WHO prequalification August 2, 2024. additional vaccine against HPV, Walrinvax®making it the fifth product available in the global market. This will contribute to a more sustainable supply of HPV vaccines, allowing more girls to receive the vaccine. Walrinvax® is prequalified with a two-dose schedule. Additional data will be needed to assess whether this vaccine can be recommended for the single-dose schedule in the future.
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