Indonesia OKs 'private research' of COVID-19 vaccine after barring Phase II trial

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.

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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.