WHO: Therapeutic HPV Vaccine is Crucial for Cancer Prevention and Treatment
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WHO: Therapeutic HPV Vaccine is Crucial for Cancer Prevention and Treatment
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WHO: Therapeutic HPV Vaccine is Crucial for Cancer Prevention and Treatment.
On July 3, 2024, the World Health Organization (WHO) released the Preferred Product Characteristics (PPCs) document for therapeutic HPV vaccines. This document highlights the significant public health demand for these vaccines, particularly in low- and middle-income countries (LMICs), where cervical cancer prevention and control needs are unmet. The strategic public health goal of therapeutic HPV vaccines is to save more lives on the path to eliminating cervical cancer by eradicating high-risk HPV infections and treating advanced precancerous lesions. The document was developed by WHO’s Department of Immunization, Vaccines, and Biologicals (IVB) in consultation with global experts over nearly four years.
PPCs guide the development of new vaccines for key global diseases, specifying indications, target populations, usage scenarios, and immunization strategies. They also outline preliminary data collection considerations for safety, efficacy, and policy evaluation. The WHO Vaccine Product Development Advisory Committee (PDVAC) determines the focus areas based on three criteria: significant disease burden in LMICs, ongoing product development with feasible market pathways, and the potential for WHO involvement to accelerate licensing and accessibility in LMICs.
The document outlines two critical scenarios for the application of therapeutic vaccines:
1. In regions where cervical cancer screening and existing treatments are difficult to expand, therapeutic vaccines can reduce the incidence of new or existing cervical precancerous lesions among women who cannot receive preventive vaccines in time.
2. In regions where screening and treatment are feasible, therapeutic vaccines can serve as a simpler alternative therapy, reducing patient loss during follow-up and increasing the overall treatment rate for HPV-positive women.
An ideal therapeutic HPV vaccine should effectively eliminate high-risk HPV infections to prevent precancerous lesions and treat existing lesions. The effectiveness of these vaccines may vary for these two outcomes due to different mechanisms of action.
The document details two types of therapeutic HPV vaccines:
1. Vaccines that eliminate high-risk HPV infections, suitable for population-based vaccination without prior testing for adult women (e.g., 25-49 years old) or for HPV-positive women if feasible.
2. Vaccines that promote the regression of high-grade precancerous lesions, particularly those related to HPV-16/18. These vaccines could be used as an alternative or adjunct therapy for women with or at risk of cervical precancerous lesions, based on positive screening results.
Both vaccine types could fill gaps in current cervical cancer prevention strategies. The choice of target populations, including the optimal age range and specific vaccination strategies (e.g., widespread population vaccination or targeted vaccination based on HPV test results), depends on factors such as the vaccine’s effectiveness, the prevalence of high-risk HPV infections and precancerous lesions, cost-effectiveness, and healthcare system factors.
Cervical cancer is almost entirely caused by sexually transmitted infections with high-risk HPV types (primarily HPV-16 and HPV-18), posing a significant global public health issue. In 2022, an estimated 662,000 women worldwide were diagnosed with cervical cancer (an incidence rate of 14.1 per 100,000 women), and about 349,000 women died from the disease (a mortality rate of 7.1 per 100,000 women), meaning a woman dies from cervical cancer every 90 seconds. In China, approximately 110,000 new cases and 60,000 deaths from cervical cancer were reported in 2020, making it the third most common cancer among Chinese women. Over 90% of cervical cancer deaths occur in LMICs due to the lack of effective prevention and management measures. Besides cervical cancer, persistent high-risk HPV infections can cause anal, penile, vaginal, vulvar, and oropharyngeal cancers.
In November 2020, WHO launched the “Global Strategy to Accelerate the Elimination of Cervical Cancer as a Public Health Problem,” with the goal of reducing the incidence of cervical cancer to less than 4 per 100,000 women-years by the next century. Achieving this goal requires meeting the 90-70-90 targets by 2030: 90% of girls fully vaccinated with the HPV vaccine by age 15, 70% of women screened with a high-quality test at ages 35 and 45, and 90% of women with cervical disease treated, including 90% of precancerous lesions and 90% of cervical cancers managed. If these targets are met, it is estimated that over 300,000, 1.4 million, and 6.2 million cervical cancer deaths could be avoided by 2030, 2070, and 2120, respectively.
However, the global implementation of this strategy is lagging significantly behind the 2030 targets. The cost and complexity of current cervical cancer screening and treatment methods (e.g., requiring multiple visits for women testing positive for high-risk HPV) and the accessibility of preventive HPV vaccination are major obstacles, especially in LMICs. In China, less than 1% of girls aged 9-14 have completed the HPV vaccination series, about 43.3% of women aged 35-44 have undergone cervical cancer screening, and there are no statistics on the treatment rates of precancerous lesions and cervical cancer. Significant disparities in healthcare resources across regions lead to serious issues of underdiagnosis, misdiagnosis, undertreatment, and overtreatment of precancerous lesions.
Currently, no therapeutic HPV vaccines have been approved for marketing worldwide. Therapeutic HPV vaccines in clinical development include peptide, recombinant protein, viral vector, bacterial vector, and DNA vaccines, most of which are in the early stages of clinical research. Only a few DNA vaccines have entered phase III clinical trials. A recent systematic review and meta-analysis of 12 high-quality clinical trials found that patients with cervical intraepithelial neoplasia grade 2/3 (CIN2/3) who received therapeutic HPV vaccines showed a significantly higher rate of lesion regression and viral clearance than those who received a placebo. Among the evaluated vaccines, VGX-3100, a DNA vaccine co-developed by Orangelight and Inovio, was the most effective in clearing the virus.
WHO: Therapeutic HPV Vaccine is a Crucial Supplement to Current HPV-Related Cancer Prevention and Treatment
References:
1.WHO preferred product characteristics for therapeutic HPV vaccines. Geneva: World Health Organization;2024. Licence: CC BY-NC-SA 3.0 IGO.
2.Global strategy to accelerate the elimination ofcervical cancer as a public health problem. Geneva:World Health Organization; 2020
(https://www.who.int/publications/i/item/9789240014107, accessed2 January 2024).
3.Ibrahim Khalil A, Zhang L, Muwonge R, Sauvaget C,Basu P. Efficacy and safety of therapeutic HPV vaccines to treat CIN 2/CIN 3 lesions: a systematicreview and meta-analysis of phase II/III clinical trials.BMJ Open. 2023;13(10):e069616.
4.Skolnik JM, Morrow MP. Vaccines for HPV-associated diseases. Mol Aspects Med. 2023 Dec;94:101224. doi: 10.1016/j.mam.2023.101224. Epub 2023 Nov 4. PMID: 37931422.
(source:internet, reference only)
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