Terawan began his efforts to develop the vaccine, called Nusantara, while he was in office last year. The Health Ministry was touted as a sponsor, alongside American biotechnology firm AIVITA Biomedical and Gresik-based pharmaceutical company Rama Emerald Multi Sukses in East Java.

The candidate vaccine employs a unique mechanism. It is tailored to each recipient through the use of their own antigen-presenting dendritic cells. Such cells have been used in cancer therapies.

“Since 2015, I have been personally developing dendritic cell-based vaccines at the Cell Cure Center of the Gatot Subroto Army Hospital,” Terawan said during a Tuesday meeting with House of Representatives Commission IX overseeing health and manpower.

Terawan, a military doctor known for his unconventional “brain-cleaning” treatment for stroke patients, was a director at Gatot Subroto from 2015 to 2019.

But the BPOM has raised concerns about questionable procedures and claims from the first-stage clinical trials of the candidate vaccine in humans, which were carried out by researchers at the Dr. Kariadi General Hospital in Semarang, Central Java, the training hospital of Diponegoro University.

“The data we received kept changing. This affects the validity aspect and our trust in the process and results [of the trial],” BPOM head Penny K. Lukito said during the Tuesday meeting with lawmakers.

Penny also pointed out that it was unusual for the trial’s ethics committee to be under Gatot Subroto instead of Dr. Kariadi Hospital, where the trials took place.

Lucia Rizka Andalusia, the agency’s director for drug registration, said Nusantara vaccine researchers had initially refused to carry out preclinical trials on animals. But the agency maintained that it was a must, and it only received the preclinical trial report from AIVITA in late February of this year, months after the BPOM allowed it to conduct an initial trial involving three human subjects in December 2020.

But even then, Rizka said, the preclinical trial was reportedly done in January 2020, when the United States had confirmed very few COVID-19 cases.

Researcher Yetty Movieta Nency claimed the team had received new data over time from different laboratories and had also consulted with other experts.

Researchers presented lawmakers with a set of data that they submitted to the BPOM on the same day of the hearing. The document claimed no serious adverse effects and increased immune responses in at least two human subjects out of 28.

Researchers said phase two human trials would be necessary to support the initial results. This depended on a permit from the BPOM, which faced a surge of allegations from lawmakers during the hearing accusing the agency of deliberately slowing down the candidate vaccine’s trials to make room for foreign vaccines.

Lawmakers alleged that the BPOM had not given the Nusantara candidate vaccine the same treatment that foreign vaccines and the Merah Putih candidate vaccine, under development by the Research and Technology Ministry and other institutions, had enjoyed. Lawmakers also questioned the BPOM’s independence and interests.

“Why is [the BPOM] making things harder? We’re defending our country right now. If we’re not proud of our nation [and its products], who will be?” said Saleh Daulay of the National Mandate Party (PAN).

Penny dismissed the allegations, saying the BPOM had let researchers know about the agency’s reviews but that the researchers had not “responded quickly; instead there were many maneuvers” to circumvent them. The BPOM has invited the team to present the trial results to an expert panel on March 16 but has been ignored.

Lawmakers pressured the BPOM to complete the permit for the second phase of trials by March 17, about a week after the hearing, otherwise they would form a mediation team between the agency and the researchers.

Gadjah Mada University has submitted a letter requesting that the Health Ministry remove its researchers from the Nusantara vaccine team. They were included in a ministerial decree but had never been part of the development of the candidate vaccine.

Gadjah Mada University School of Medicine vice dean for research Yodi Mahendradhata said the researchers learned of the vaccine trials on the news. This was a stark difference from their direct involvement in the development of the Merah Putih vaccine, he said.

Yodi said it was natural for the BPOM to be cautious given the country’s limited history of vaccine development.

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