Ethical, Legal, Social, and Health System Implications of 9-valent Human Papillomavirus (9vHPV) Vaccine in the Philippines: A Scoping Review and Qualitative Study

Background. Vaccination for human papillomavirus (HPV) is a key preventive intervention against HPV infections and their associated diseases, including cervical cancer. The bivalent, quadrivalent, and nonavalent HPV vaccines are currently approved for use in the Philippines. The Department of Health (DOH) has included HPV vaccination in its National Immunization Program (NIP) for young girls aged 9 to 14 years old. However, coverage remains limited relative to the target population who should benefit from the program. To achieve equitable and sustained access, there is a critical need to understand how provider and public health decision-maker practices and patient-related factors influence vaccine uptake among Filipino populations.

Objective. The study aimed to understand the factors affecting the ethical, legal, social, and health systems implications of the use of the 9vHPV vaccine, compared to no vaccination, the 2vHPV vaccine, or the 4vHPV vaccine.

Methods. This is a qualitative study design employing a scoping review and semi-structured interviews of ethical, legal, social, and health systems factors influencing the use of the 9vHPV vaccine compared to no vaccination, 2vHPV, or 4vHPV vaccines. Focus group discussions and key informant interviews were conducted with a total of 16 participants. Participants in the focus group discussion were divided into three (3) groups representing the following sectors: government, practitioners and researchers, patient advocates and patient groups. Thematic analysis was conducted using NVivo 14 Qualitative Data Analysis Software.

Results. Evidence suggests high effectiveness of any HPV vaccine type in preventing HPV infection and cervical cancer; however, there are still significant national challenges which contribute to its low utilization rate, primarily due to ethical concerns and cultural or religious misconceptions. The 9vHPV vaccine has yet to be included in the Philippine National Formulary (PNF) and, therefore, cannot be procured for the NIP. Its integration is hindered by health system challenges, particularly its health technology assessment to ensure sustainable financing and strategic investment of the government. Further, the implementation of the government’s vaccination strategy is influenced by the decentralization of procurement and program implementation at the local government level, resulting in variability in program delivery.

Conclusion. The 4vHPV vaccine is preferred for population- wide vaccination due to its perceived cost-effectiveness at the government decision-maker level. Meanwhile, from the perspective of patients, clinicians, and experts, the 9vHPV vaccine is favored for its broader protection. Economic evaluations comparing new vaccines like the 9vHPV to the 4vHPV are essential to determine their added value. Nevertheless, the 9vHPV vaccine should be reviewed for inclusion in the NIP to support the WHO’s 90-70-90 cervical cancer elimination goals, after a careful cost-effectiveness evaluation and budget impact analysis. The one-dose strategy recommended in the Philippine Clinical Practice Guidelines for Cervical Cancer and the Treatment of Premalignant Lesions of the Cervix (2023) as an alternative to the two-dose strategy could further improve vaccine accessibility in resourcelimited settings.