Post Marketing Surveillance Study of 2nd Dose Quadrivalent Human Papilloma Virus Vaccine in Elementary School Children in Jakarta, Indonesia: Safety Result and Implementation of School-Based HPV Immunization Program

Abstract

Objective:Quadrivalent human papillomavirus (QHPV) vaccine has been advised for routine vaccination of pre-adolescent girls globally, and a two-dose QHPV vaccination schedule has been introduced in Indonesia to vaccinate 5th and 6th grade elementary school female students. This post-marketing surveillance study evaluated the possible adverse events following immunization with the two-dose QHPV vaccine in Indonesia.Methods:Girls studying in grade 6 of five designated elementary schools in Jakarta, receiving their 2nd dose of QHPV vaccine and provided informed consent (represented by their parents), were included in the study. Students who had received other immunizations either simultaneously or <1 month ago were excluded. Local and systemic reactions noted at 30 min, and 72 h to 28th day, after the immunization were recorded using a Children Symptom Dairy Card/Kartu Harian Anak Sekolah (KHAS/Student Daily Card).Results:A total of 500 students from 20 schools were included. No serious adverse events were reported during the study period. Fever (systemic reaction) of mild intensity was noted in 1.6 % (n=8) of participants, which subsided after day 6. Local reactions such as pain, redness and swelling were noted in 59.6% (n=295), 23.6% (n=118), and 17.2% (n=86) of participants, respectively. These resolved without any intervention in majority of the cases after day 5.Conclusion:These results along with the safety data from the pre-licensure clinical trials confirm the favorable safety profile of QHPV vaccine in pre-adolescent girls. The school-based two-dose QHPV immunization program in Indonesia is a safe and effective strategy for optimizing HPV vaccine coverage among pre-adolescent girls.

Promosi Kesehatan Terkait Imunisasi Dasar Dalam Rangka Meningkatkan Pemanfaatan Pelayanan Imunisasi Anak Pada Masa Pandemi

“…Selaras dengan usaha kesehatan global, di Indonesia seluruh anak mendapatkan layanan imunisasi rutin, baik melalui fasilitas kesehatan umum atau program imunisasi berbasis sekolah. Vaksin campak, difteri, dan tetanus diberikan kepada siswa kelas satu sekolah dasar, sedangkan vaksin tetanus dan difteri (Td) diberikan kepada siswa kelas dua dan lima sekolah dasar (Satari et al, 2019) . Ketika program imunisasi dihentikan atau terganggu, dapat diamati terjadi peningkatan jumlah kejadian infeksi yang dapat dicegah dengan vaksin (vaccine-preventable infections) dan kematian terkait.…”

Exploring Indonesian Primary Schoolgirls’ Experiences of School-based HPV Vaccination, Knowledge of HPV Risks and Prevention, and Preferences for Cervical Cancer Education

“…While HPV-related studies in Indonesia are emerging, most have been clinically focused [8][9][10][11]. These studies primarily focused on identifying the most prevalent HPV types in Indonesia and investigating HPV vaccine safety for adolescent girls.…”

The potential impact of COVID-19 pandemic on the immunization performance in Indonesia

“…In Indonesia, all children receive routine immunization services in public health facilities, free of charge. Immunization services for school children are centrally funded and conducted through the school-based immunization program, where regional health center staffs deliver vaccines in local schools [2]. As a part of this program, measles, diphtheria, and tetanus vaccines are administered to pupils in the first grade of elementary school, while tetanus and diphtheria (Td) vaccine is administered to those in the second and fifth grades of elementary school.…”