Jakarta,-Badan Pengawas Obat dan Makanan (BPOM) RI menyatakan, vaksin Covid-19 AstraZeneca sudah tidak digunakan lagi dalam program vaksinasi/imunisasi. Berdasarkan penelusuran BPOM, saat ini vaksin COVID-19 AstraZeneca sudah tidak beredar di Indonesia.
Sebelumnya, vaksin AstraZeneca sempat menjadi perhatian publik lantaran adanya kejadian trombosis with thrombocytopenia syndrome (TTS) atau pembekuan darah. Berita itu ramai di jagat maya setelah diberitakan media Inggris dan beberapa media nasional.
“Hingga April 2024, tidak terdapat laporan kejadian terkait keamanan termasuk kejadian TTS di Indonesia yang berhubungan dengan vaksin COVID-19 AstraZeneca. Telah dimonitor oleh BPOM dalam pemantauan Post Authorization Safety Study (PASS),” tulisnya dalam keterangan BPOM, Senin (6/5/2024).
Diketahui, Emergency Use Authorization (EUA) vaksin Covid-19 AstraZeneca disetujui BPOM pada 22 Februari 2021. Sebelumnya, lebih dari 73 juta dosis telah digunakan untuk program vaksinasi di Indonesia.
“Pemantauan keamanan vaksin di Indonesia juga dilakukan oleh Kementerian Kesehatan bersama dengan Komite Nasional Pengkajian dan Penanggulangan Kejadian Ikutan Paska Imunisasi (KOMNAS PP KIPI). Pemantauan ini termasuk pelaksanaan surveilans aktif terhadap Kejadian Ikutan dengan Perhatian Khusus (KIPK) pada program vaksinasi COVID-19,” ucapnya.
Hasil kajian BPOM, Kementerian Kesehatan, dan KOMNAS PP KIPI terhadap surveilan aktif dan rutin terkait keamanan vaksin COVID-19 Astra Zeneca menunjukkan hasil:
- Manfaat pemberian vaksin COVID-19 AstraZeneca lebih besar daripada risiko. efek samping yang ditimbulkan.
- Hingga April 2024, tidak terdapat laporan kejadian terkait keamanan termasuk kejadian TTS di Indonesia yang berhubungan dengan vaksin COVID-19 AstraZeneca.
- Hasil kajian WHO menunjukkan bahwa kejadian TTS yang berhubungan dengan vaksin COVID-19 AstraZeneca dikategorikan sebagai sangat jarang/very rare (kurang dari 1 kasus dalam 10.000 kejadian).
- Kejadian TTS yang sangat jarang tersebut terjadi pada periode 4 sampai dengan 42 hari setelah pemberian dosis vaksin COVID-19 AstraZeneca. Apabila terjadi di luar periode tersebut, maka kejadian TTS tidak terkait dengan penggunaan vaksin COVID-19 AstraZeneca.
- Pemantauan terhadap keamanan vaksin COVID-19 AstraZeneca masih terus dilaksanakan dalam bentuk surveilans rutin selama penggunaan vaksin ini dalam program imunisasi.
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