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The World Health Organization (WHO) has recently confirmed the prequalification of a fourth human papillomavirus (HPV) vaccine, Cecolin®, for administration in a single-dose regimen. This decision is based on new evidence that aligns with the WHO’s 2022 guidelines regarding alternative, off-label HPV vaccination schedules. This significant development aims to enhance the sustainable availability of HPV vaccines, thereby increasing access for more girls to receive these vital cervical cancer prevention shots.
“Unlike many other forms of cancer, we possess the means to eradicate cervical cancer and its associated disparities,” stated Dr. Tedros Adhanom Ghebreyesus, Director-General of WHO. “By introducing another option for a one-dose HPV vaccination schedule, we are making strides toward eliminating cervical cancer from our world.”
Globally, over 95% of the approximately 660,000 annual cases of cervical cancer are attributed to HPV infection. Alarmingly, every two minutes a woman succumbs to this preventable illness worldwide; with 90% of these fatalities occurring in low- and middle-income nations. Among the countries most severely affected by cervical cancer, 19 out of 20 are located in Africa.
Since 2018, global supply shortages have hindered the rollout of HPV vaccines. Additionally, production issues faced by one manufacturer earlier this year exacerbated these shortages and could potentially affect millions of girls needing vaccinations across Africa and Asia.
“The goal is to ensure that by age 15 at least 90% of girls are fully vaccinated against HPV,” remarked Dr. Kate O’Brien from WHO’s Department for Immunization, Vaccines and Biologicals. “Given ongoing supply challenges, having an additional single-dose vaccine option will provide countries with more flexibility in their vaccination strategies.”
A growing number of vaccines initially approved for two-dose regimens can now also be administered as single doses. The inclusion of Cecolin® as an option for single-dose use has been documented in the second edition of WHO’s technical guidance on selecting HPV vaccine products, specifically noted in Table 4 within this document. Similar to other medical products when supported by data demonstrating public health benefits clearly outlined by advisory bodies can recommend “off-label” usage until manufacturers officially update their labels.
As per global statistics released on July 15th, 2024; coverage rates for one-dose HPV vaccinations among girls aged between nine and fourteen years rose from 20% in 2022 to an impressive 27% in just one year. By September 10th ,2024 ,57 countries had adopted this single-dose schedule compared to only thirty-seven earlier that same year . The WHO estimates that implementing this approach has allowed at least six million additional girls access essential vaccinations throughout 2023.
This past year saw nations and partners pledge nearly US$600 million towards initiatives aimed at eradicating cervical cancer.Funding sources include US$180 million from Bill & Melinda Gates Foundation ,US$10 million contributed through UNICEF ,and US$400 million allocated via World Bank .These investments combined with Gavi’s ongoing commitment will significantly enhance both introduction efforts as well as overall coverage rates among young females before reaching 2030.
New Developments: Fifth Prequalified HPV Vaccine
In further positive news regarding public health advancements,the WHO announced on August 2nd ,2024 the prequalification status granted towards another new product named Walrinvax®. This marks it as fifth available option globally within market space contributing towards improved sustainability concerning supplies available enabling greater numbers receiving necessary immunizations.Walrinvax® currently holds approval under two dose regimen but further research will determine if it may also qualify under future recommendations allowing its use within single dose framework too .
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