Tesis

Kejadian ikutan pasca imunisasi COVID-19 pada pegawai dan peserta didik di RSCM dan faktor-faktor yang berhubungan = Adverse events following COVID-19 immunization COVID-19 in employees and students at RSCM and their associated factors.

Latar Belakang: Pandemi Coronavirus disease 2019 (COVID-19) menyebabkan dampak luas termasuk di bidang kesehatan dan perekonomian global. Vaksinasi COVID- 19 adalah salah satu upaya penting memutus rantai penularan selama pandemi. Vaksin COVID-19 adalah produk baru yang dibuat dalam waktu sangat cepat dan saat program vaksinasi dimulai data keamanannya belum cukup banyak. Oleh karena itu, pengamatan KIPI (kejadian ikutan pasca imunisasi) penting sebab belum ada data tersebut di Indonesia. Faktor-faktor yang berhubungan dengan munculnya KIPI juga belum diketahui Tujuan: mengetahui gambaran profil KIPI COVID-19 pada pegawai dan peserta didik di RSCM dan faktor-faktor yang berhubungan Metode: penelitian ini menggunakan desain kohort retrospekatif di Rumah Sakit Umum Pusat dr. Cipto Mangunkusumo (RSCM). Inklusi penelitian adalah seluruh pegawai dan peserta didik penerima vaksinasi COVID-19 pada Januari 2021 -November 2022 yang mengisi laporan KIPI. Hasil: Sebanyak 4.250 responden mengisi total 7.625 laporan. Mayoritas responden perempuan (66,6%) dengan median usia 34 tahun, berprofesi sebagai dokter (46,2%) dan perawat (30,6%). Vaksin terbanyak adalah CoronaVac (68,3%) diikuti mRNA-1273 (24%). KIPI dilaporkan pada 1.962 kasus, 72,8% di antaranya pada vaksin mRNA-1273, paling banyak dilaporkan pada vaksinasi ketiga (53,7%). KIPI yang dilaporkan umumnya reaksi lokal dan reaksi sistemik ringan seperti meriang, demam, nyeri sendi, nyeri kepala, mual, dan rasa mengantuk. Terdapat dua belas laporan KIPI serius, salah satunya adalah kejadian Sindrom Guillain-Barre. Variabel yang berhubungan dengan KIPI adalah hipertensi (p < 0,001, aOR 1,79, IK95% 1,46-2,24), diabetes melitus (p 0,002, aOR 1,9, IK95% 1,26-2,86), riwayat sakit jantung (p = 0,001, aOR 3,71, IK95% 1,7-7,8), dan riwayat sakit paru (p < 0,001, aOR 9,28, IK95% 5,86-14,71). Kesimpulan: Vaksin COVID-19 memiliki profil keamanan yang baik. Terdapat asosiasi hipertensi, diabetes melitus, riwayat sakit jantung, dan riwayat sakit paru terhadap KIPI. KIPI serius jarang ditemukan.
Kata kunci: COVID-19, kejadian ikutan pasca imunisasi, CoronaVac, mRNA-1273


Background: Coronavirus disease 2019 (COVID-19) pandemic was reported to have a wide range ofimpacts on global health and the economy. To address this problem, several vaccination efforts were carried out to break the chain of transmission. However, due to the urgency demanded by the situation, COVID-19 vaccines were produced rapidly without sufficient safety data, including in Indonesia, therefore adverse event surveillance is essential. Factors associated with adverse events following immunization (AEFI) are currently unknown. Objective: This study aimed to determine the profile of adverse events following immunization (AEFI) of COVID-19 vaccines in employees and students at dr. Cipto Mangunkusumo General Hospital, Jakarta (RSCM), and the associated factors. Metods: A retrospective cohort design was used, and the study was conducted at RSCM. All employees and students who received COVID-19 vaccination in January 2021 - November 2022 and filled out AEFI reports were included as respondents. Results: The results showed that a total of 4,250 respondents filled out about 7,625 reports. The majority were female (66.6%) with a median age of 34 years, doctors (46.2%) and nurses (30.6%). The most common vaccine used was CoronaVac (68.3%) followed by mRNA-1273 (24%). Furthermore, AEFI was reported in 1,962 cases, 72.8% of which were in the mRNA-1273 vaccine, most reported in the third dose vaccination (53.7%). Common AEFI reported were local reactions and mild systemic reactions such as chills, fever, joint pain, headache, nausea, and drowsiness. There were 12 reports of serious AEFI, one of which was a case of Guillain-Barre Syndrome. Determinants associated with AEFI were hypertension (p < 0.001, aOR 1.79, 95%CI 1.46-2.24), diabetes mellitus (p 0.002, aOR 1.9, 95%CI 1.26-2.86), history of cardiac disease (p = 0,001, aOR 3,71, 95%CI 1,7-7,8), and history of lung disease (p < 0.001, aOR 9.28, 95%CI 5.86-14.71). Conclusion: COVID-19 vaccines have a good safety profile. There is an association between hypertension, diabetes mellitus, history of cardiac disease, and history of lung disease with AEFI.
Keywords: COVID-19, adverse events following immunization, CoronaVac, mRNA- 1273