“As of the week of May 13, 2024, 44 countries have announced the implementation of single-dose immunization schedules for HPV vaccines,” said Paul Bloem, Senior Technical Officer, Department of Immunization, Vaccines, and Biologics (IVB), World Health Organization Geneva, and HPV Vaccine Impact Lead, at an online workshop hosted by the Innovation Lab for Vaccine Delivery Research (Vaxlab) on May 15, 2023. The HPV and PCV Vaccine Dose Reduction workshop shared the global and national experience in the vaccination schedule change.
In April 2022, following an evaluation of recent, the World Health Organization’s Strategic Advisory Group on Immunization (SAGE) concluded that a single-dose HPV vaccine schedule could provide comparable efficacy to the two or three-dose regimens, which indicated a significant value in improving vaccine access and cost-effectiveness. The WHO position paper on HPV vaccines was thus updated in December 2022, recommending that women aged 9 to 20 (9-14 years being the highest priority group) be given one dose of HPV vaccine.
Early this year, the National Medical Products Administration (NMPA) approved a two-dose schedule for the 9-valent HPV vaccine for girls aged 9-14 in January 2024. The two domestic-manufactured 2-valent HPV vaccines currently apply a two-dose schedule in China. On March 13, Merck announced plans to conduct clinical trials to evaluate the efficacy and safety of a single-dose regimen for Gardasil®9 compared to the approved three-dose regimen.
“In recent years, the incidence and mortality rates of cervical cancer in China have been on the rise among women over the age of 20. The standardized mean age at diagnosis of cervical cancer has declined by about 2 years from 2000 to 2014, which means the incidence is increasing among younger age groups. The decline trend was more obvious in rural China (Significantly declined by 5.18 years). Expanding vaccination coverage and promoting cervical cancer screening is critical to fulfilling the targets of the World Health Organization’s Cervical Cancer Elimination Initiative in China. The clock is ticking,” Dr. Youlin Qiao, Distinguished Professor of the Chinese Academy of Medical Sciences/Beijing Union Medical College and Deputy Secretary General of the China Cancer Foundation, introduced in the workshop.
A multicenter real-world study evaluating the effectiveness of single-dose HPV vaccination has been initiated in China. “More local evidence is needed to support whether to adopt a single-dose HPV vaccination strategy for the Chinese female population, especially girls aged 9-14 years. This is vital to improve HPV vaccine coverage, especially in central and western China.”
The UK was the first country to announce the advice of a routine HPV schedule change, with several European countries following suit. Countries in Africa and Latin America have also begun to adopt the one-dose plan gradually. “Of course, countries are also deciding to continue with the current two-dose regimen, which has been well-implemented,” Paul shared.
“The single dose schedule is not exclusive to resource-limited low- and middle-income countries. It is cost-effective and could scale up the HPV vaccine coverage, which further prioritizes the HPV vaccination in public health policy agenda,” said Dr. Anna Du, Senior Program Officer of Health, Innovation, and Partnerships at the Bill & Melinda Gates Foundation China Country Office.
Newly published research data shows that implementing a single-dose HPV vaccine program in the United Kingdom is cost-effective. The model assessed that over a 70-year period, the health system could save more than £1.073 billion by changing the two-dose regimen to the single-dose schedule.
The introduction of the single-dose schedule poses new requirements for Chinese-manufactured HPV vaccines. Currently, only one domestic-made product is undergoing an immunobinding study. Additional clinical data on single-dose schedule efficacy is crucial and would significantly aid China-made HPV vaccines in aligning with the global vision of eliminating cervical cancer.
