This Is The Fault Of Clinical Trial Phase 1 Vaccine Nusantara Artificial Terawan That Cause BPOM Has Not Allowed Further Phase 2

JAKARTA - The Food and Drug Administration (BPOM) released the results of clinical trials of phase 1 of the Nusantara vaccine by former Minister of Health Terawan Agus Putranto.

The phase 1 clinical trial was conducted at Dr. Kariadi Hospital, Semarang, Central Java since December 22, 2020. The study subjects were 28 people.

Then, on January 15, January 29, February 9, and February 18, Nusantara vaccine researchers delivered the results of a phase 1 clinical trial in the form of 14-day safety observations and immunogenicity 1 month after the vaccine test.

However, Head of BPOM Penny K. Lukito called the data of phase 1 clinical trial results fickle. Therefore, bpom team conducted an inspection to the clinical test site, DR. Kariadi Hospital. As it turns out, Penny considers the clinical test results not yet feasible.

"Based on the results of Phase 1 clinical trials, Nusantara vaccine is considered to have not met many rules of clinical trial stages, including good manufacturing practice (GMP) and good clinical practice (GCP)," Penny said in a statement received by VOI on Thursday, April 15.

BPOM found five errors in the fulfillment aspect of good manufacturing practice (GMP) clinical trial phase 1 vaccine nusantara. First, dendritic vaccine products are not made under sterile conditions.

Penny said the research team claimed the vaccine was made closely, with blood removed from the human body until it was re-inserted there was never a process of opening blood tubes. But in reality everything is done manually and open system.

"Products should be sterile, not contaminated, but the data don't show that," Penny said.

Second, sars cov-2 antigen used as the main product of dendritic vaccine manufacture is not guaranteed cleanliness.

"It was stated by the manufacturer (Lake Pharma-USA) that it is not guaranteed sterility. The antigen is used only for research in the laboratory, not to be given to humans," said Penny.

Third, the results of dendritic cell processing products that become vaccines are not carried out sterility testing correctly before being given to humans.

"This has the potential to include products that are not sterile and cause a risk of bacterial infection in vaccine recipients," he said.

Fourth, the final product of the dendritic vaccine is not conducted dendritic cell quality testing. Penny says researchers only count the number of cells.

However, it is also inconsistent because there are 9 out of 28 preparations that are not measured, and of the 19 measured there are 3 preparations that are outside the standard, but still included.

Fifth, Penny claimed that BPOM had conducted inspections before. Unfortunately, the results of the first inspection were not followed up by completing Corrective Action and Preventive Action (CAPA).

In this case, CAPA is an improvement and preventive measure in a study, so that the quality, safety and quality of health products can be guaranteed.

"Unfortunately, the nusantara vaccine research team did not make corrections with the submission of CAPA. On the contrary, it is repeatedly neglected at the request of BPOM," explained Penny.

Therefore, Penny asked the research team to make improvements and convey to BPOM. "Please correct the proof of concept, then the data needed to prove the validity of the stage I clinical trial, then if it is all fulfilled then we decide whether it is possible to step into the next phase," he concluded.