WHO officials announced that Cecolin has now been prequalified; it is the fourth vaccine that can be delivered as a single dose. The allowance is based on the new information taken to “meet all the requirements set for the alternative, off-label use of HPV vaccines” as stated in WHO’s 2022 guidelines. This news may be expected to more surely help with a sustainable supply of HPV vaccines and most importantly provide fuller protection against cervical cancer to even more girls.
“We can eradicate cervical cancer and its associated inequalities because, in principle, it is fundamentally different from other cancers,” stated WHO Director-General Dr. Tedros Adhanom Ghebreyesus.
Every year, over 660,000 women are diagnosed with cervical cancer globally, and the infection leading to this disease is caused by HPV in more than 95 percent. A woman dies from this preventable disease every two minutes, and 90 percent of these deaths occur in low- and middle-income countries, especially in Africa, which has 19 out of the 20 worst affected countries by cervical cancer. Since 2018, supply shortages have restricted the rollout of HPV vaccines in some areas.
Production problems for one of the manufacturers have aggravated this recently. “One of the global strategy targets to eliminate cervical cancer is reaching 90% coverage for girls by age 15,” said WHO’s Director in the Department of Immunization, Vaccines and Biologicals, Dr Kate O’Brien. With persistent supply problems, the single dose of vaccine becomes an alternate way for countries to immunize girls efficiently, he added.
More and more prequalified vaccines, which were initially developed for two-dose regimens as part of primary immunization, are now entering the single-dose market.
The use of Cecolin single dose falls within the scope of the second edition of WHO’s technical document for selection of HPV vaccine product. Advisory bodies may require evidence for off-label use and a significant number of public health considerations for a recommendation to be made. As of the end of September 2024, 57 countries had switched from 37 in 2023 to the one-shot schedule. WHO projects this could mean that at least 6 million more girls are vaccinated against HPV in 2023.
The WHO prequalified a fifth HPV vaccine, Walrinvax on August 2, 2024. This will add another available vaccine to the mix, with a two-dose schedule, which will expand choices but still require data to consider future use in the context of single-dose application.
