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WHO provides an HPV vaccine for single-dose use

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October 4, 2024

WHO introduced {that a} fourth WHO-prequalified human papillomavirus (HPV) vaccine product, Cecolin® has been confirmed to be used in a single-dose schedule. The choice is made primarily based on new information on the product that fulfilled the factors set out within the WHO’s 2022 recommendations for alternative, off-label use of HPV vaccines in single-dose schedules. This necessary milestone will contribute to bettering sustainable provide of HPV vaccines—permitting extra ladies to be reached with the vaccines that stop cervical most cancers.

“In contrast to most different cancers, now we have the flexibility to remove cervical most cancers, together with its painful inequities,” stated Dr Tedros Adhanom Ghebreyesus, WHO Director-Common. “By including another choice for a one-dose HPV vaccination schedule, now we have taken one other step nearer to consigning cervical most cancers to historical past.”

Greater than 95% of the 660 000 cervical most cancers instances occurring globally annually are brought on by HPV. Each two minutes, a girl dies from this preventable illness globally, and 90% of those deaths happen in low- and middle-income nations. Of the 20 hardest hit nations by cervical most cancers 19 are in Africa.

HPV vaccine introductions have been hampered by international provide shortages since 2018 and manufacturing challenges encountered by one of many producers earlier this yr led to additional shortfalls, doubtlessly impacting hundreds of thousands of ladies in want of HPV vaccines in Africa and Asia.

“Having 90% of ladies absolutely vaccinated with the HPV vaccine by 15 years of age is the goal for the primary pillar of the WHO global strategy for cervical cancer elimination,” stated Dr Kate O’Brien, Director of the Division of Immunization, Vaccines and Biologicals at WHO. “Given the persevering with provide challenges, this addition of single-dose vaccine product means nations can have larger alternative of vaccines to succeed in extra ladies.”

A rising variety of vaccine merchandise initially prequalified to be used in a 2-dose schedule can now be utilized in a single-dose schedule. The only-dose use indication for this extra vaccine, Cecolin®, is included into the second version of WHO’s technical document on considerations for HPV vaccine product choice (mirrored in Desk 4 of this doc). Like for different medicines and vaccines, when there may be information to help modified use, guided by a transparent public well being profit, public well being advisory our bodies can recommend “off-label” use, till a producer provides this modified use to their label.

International information launched on 15 July 2024 signifies that the one dose HPV vaccine protection amongst ladies aged 9-14 years increased from 20% in 2022 to 27% in 2023. In 2023, 37 nations have been implementing the single-dose schedule. As of 10 September 2024, 57 nations are implementing the single-dose schedule.  WHO estimates that the single-dose schedule adoption has resulted in no less than 6 million further ladies being reached with HPV vaccines in 2023.

Earlier this yr, nations and companions committed nearly US$ 600 million in new funding towards elimination of cervical cancer. Funding contains US$ 180 million from the Invoice & Melinda Gates Basis, US$ 10 million from UNICEF, and US$ 400 million from the World Financial institution. Along with the robust persevering with dedication by Gavi, these investments will assist to speed up introductions and increase protection of HPV vaccine amongst ladies by 2030.

WHO prequalified a fifth HPV vaccine

An extra piece of excellent information is the WHO prequalification on 2 August 2024, of an additional HPV vaccine, Walrinvax®, making it the fifth product accessible on the worldwide market. This can contribute to a extra sustainable provide of HPV vaccines, enabling extra ladies to obtain the vaccine. Walrinvax® is prequalified with a two-dose schedule. Additional information shall be wanted to evaluate if this vaccine may be really useful for single-dose schedule sooner or later.

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