Teken MoU, Vaksin Nusantara Tidak untuk Produksi Massal
Indonesia OKs ´Private Research´ of COVID-19 Vaccine After Barring Phase II Trial
Editor : Kemal A Praghotsa
Translator : Novita Cahyadi
INDONESIA telah menyetujui penelitian vaksin Covid-19 Nusantara yang diusung oleh mantan Menteri Kesehatan, namun baru-baru ini uji coba tahap II tidak dapat dilanjutkan lantaran masalah keamanan dan integritas data.
Badan Pengawas Obat dan Makanan [BPOM] Indonesia merilis bahwa persetujuan untuk uji coba tahap II vaksin, yang dikembangkan oleh perusahaan lokal PT Rama Emerald Multi Sukses dan Aivita Biomedical Amerika, tidak akan diberikan ijin karena gagal memenuhi Tahap I, uji klinis.
Padahal, beberapa anggota parlemen bahkan secara sukarela sudah memberikan sampel darah untuk berpartisipasi dalam penelitian ini.
Tetapi, para ilmuwan dan ahli kesehatan masyarakat indonesia khawatir ini menjadi preseden yang salah bagi perusahaan farmasi global yang mencari peluang untuk melacak obat mereka dengan cepat
Kepala BPOM Penny Lukito mengatakan kepada Reuters bahwa sebuah nota kesepahaman [MoU] telah ditandatangani pada hari Senin [19/04] oleh Menteri Kesehatan [Menkes] Budi Gunadi dan Kepala staf Militer Angkatan Darat [KSAD] Andika Perkasa, memungkinkan penelitian swasta terhadap vaksin tersebut dilakukan di Rumah Sakit Angkatan Darat Gatot Subroto, Jakarta.
Dengan ditandatangani Mou ini, maka pengambangan vaksin Nusantara ini hanya demi kepentingan penelitian dan pelayanan, bukan untuk dikomersialkan.
“Uji klinis diubah menjadi layanan berbasis penelitian yang diatur dan diawasi oleh kementerian kesehatan. Sehingga produk tersebut tidak bisa didaftarkan sebagai vaksin massal,” kata Kepala BPOM, Penny Lukito.
Menurutnya, baik badan maupun kementerian kesehatan tidak dapat segera mengklarifikasi ruang lingkup penelitian yang diizinkan, atau apakah itu akan mencakup uji coba manusia yang berkelanjutan.
Uji coba fase I vaksin, yang dilakukan di Jawa pada bulan Desember, menunjukkan bahwa 70% dari 28 partisipan menderita efek samping yang merugikan termasuk beberapa kasus hipernatremia, peningkatan nitrogen urea darah dan peningkatan kolesterol, yang dirilis BPOM.
Ahli Biologi Molekuler, Ines Atmosukarto mengatakan bahwa mengidentifikasi masalah dengan praktik lab dan inkonsistensi data dalam uji coba, yang membuatnya memutuskan untuk tidak menyetujui uji coba Tahap II seperti dikutip Reuters yang dilansir MailOnline.
"Tampaknya tidak ada hukuman bagi pihak yang tidak berperilaku etis, dan tidak mengikuti pedoman penelitian klinis yang diterima secara internasional dengan dana publik," kata ahli biologi molekuler Atmosukarto.
Indonesia has approved private research of COVID-19 vaccine candidate Nusantara that is backed by a former health minister, after recently saying a mid-stage trial for it could not proceed amid safety and data integrity issues.
Just this month, Indonesia´s drug and food agency (BPOM) said approval for a Phase II trial for the vaccine, developed by local firm PT Rama Emerald Multi Sukses and America´s Aivita Biomedical, would not be granted as its sponsors had failed to fulfil Phase I clinical trial requirements.
The nod for private research comes amid mounting political pressure to approve the trial for the vaccine, which is backed by former minister Terawan Agus Putranto who enjoys the support of some in Indonesia´s political and military elite.
Some parliamentarians have even volunteered to provide blood samples and participate in the study in a show of support.
But Indonesian scientists and public health experts are worried this sets a wrong precedent for global pharmaceutical firms looking for opportunities to fast track their drugs.
"Indonesia aspires to be a hub for innovation, including in the biomedical space, but for it to be taken seriously, it needs to establish a conducive ecosystem," said Ines Atmosukarto, a molecular biologist who works on vaccine development.
Terawan, who initially downplayed the seriousness of the COVID-19 pandemic before being replaced in December, was not immediately available for comment. Rama Emerald Multi Sukses and Aivita were also not available to comment.
The Nusantara vaccine uses a dendritic cell method commonly used in research for cancer treatment and is built upon immune cells drawn from patients´ blood.
BPOM chief Penny Lukito told Reuters that a memorandum of understanding (MOU) was signed on Monday by the health minister, the drug regulator and the military chief of staff to allow the private research into the vaccine to be conducted at the Gatot Subroto Army Hospital in Jakarta.
"The clinical trial was converted to a research-based service that is regulated and supervised by the health ministry. So the product cannot be registered as a mass vaccine," the BPOM chief added.
Neither the agency nor the health ministry could immediately clarify the scope of permissible research, or whether it would include continued human trials.
Jonny, a military doctor on the vaccine development team who goes by one name like many Indonesians, said he had not received official notification of the MOU and was unable to comment.
A Phase I trial of the vaccine, which was conducted in Java in December, showed that 70% of its 28 participants suffered adverse side effects including several cases of hypernatremia, increased blood urea nitrogen and increased cholesterol, according to BPOM.
It also identified issues with lab practices and data inconsistencies in the trial, leading it to decide against approving the Phase II trial.
"There seems to be no punishment for parties that do not behave ethically, and don´t follow internationally accepted guidelines for clinical research with public funding," the molecular biologist Atmosukarto noted.
Indonesia is grappling with the worst COVID-19 outbreak in Southeast Asia, having reported over 1.61 million infections and more than 43,000 deaths.