WHO announced that a fourth WHO-prequalified human
papillomavirus (HPV) vaccine product, Cecolin® has been confirmed for
use in a single-dose schedule. The decision is made based on new data on
the product that fulfilled the criteria set out in the WHO’s 2022 recommendations for alternative, off-label use of HPV vaccines in single-dose schedules.
This important milestone will contribute to improving sustainable
supply of HPV vaccines—allowing more girls to be reached with the
vaccines that prevent cervical cancer.
“Unlike most other
cancers, we have the ability to eliminate cervical cancer, along with
its painful inequities,” said Dr Tedros Adhanom Ghebreyesus, WHO
Director-General. “By adding another option for a one-dose HPV
vaccination schedule, we have taken another step closer to consigning
cervical cancer to history.”
More than 95% of the 660 000 cervical
cancer cases occurring globally each year are caused by HPV. Every two
minutes, a woman dies from this preventable disease globally, and 90% of
these deaths occur in low- and middle-income countries. Of the 20
hardest hit countries by cervical cancer 19 are in Africa.
HPV
vaccine introductions have been hampered by global supply shortages
since 2018 and production challenges encountered by one of the
manufacturers earlier this year led to further shortfalls, potentially
impacting millions of girls in need of HPV vaccines in Africa and Asia.
“Having 90% 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,”
said Dr Kate O'Brien, Director of the Department of Immunization,
Vaccines and Biologicals at WHO. “Given the continuing supply
challenges, this addition of single-dose vaccine product means countries
will have greater choice of vaccines to reach more girls.”
A
growing number of vaccine products initially prequalified for use in a
2-dose schedule can now be used in a single-dose schedule. The
single-dose use indication for this additional vaccine, Cecolin®, is
incorporated into the second edition of WHO’s technical document on considerations for HPV vaccine product choice (reflected
in Table 4 of this document). Like for other medications and vaccines,
when there is data to support modified use, guided by a clear public
health benefit, public health advisory bodies can recommend "off-label” use, until a manufacturer adds this modified use to their label.
Global data released on 15 July 2024 indicates that the one dose HPV vaccine coverage among girls aged 9-14 years increased from 20% in 2022 to 27% in 2023.
In 2023, 37 countries were implementing the single-dose schedule. As of
10 September 2024, 57 countries are implementing the single-dose
schedule. WHO estimates that the single-dose schedule adoption has
resulted in at least 6 million additional girls being reached with HPV
vaccines in 2023.
Earlier this year, countries and partners committed nearly US$ 600 million in new funding towards elimination of 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 the strong continuing commitment by Gavi,
these investments will help to accelerate introductions and boost
coverage of HPV vaccine among girls by 2030.
WHO prequalified a fifth HPV vaccine
A further piece of good news is the WHO prequalification on 2 August 2024, of an additional HPV vaccine, Walrinvax®,
making it the fifth product available on the global market. This will
contribute to a more sustainable supply of HPV vaccines, enabling more
girls to receive the vaccine. Walrinvax® is prequalified with a two-dose
schedule. Further data will be needed to assess if this vaccine can be
recommended for single-dose schedule in the future.
Source: WHO Website