BPOM: Red And White Vaccine Clinical Trial Phase 3 Rolling July 2022

JAKARTA - Head of the Indonesian Food and Drug Supervisory Agency (BPOM) Penny K Lukito said the development of the third phase of the Red and White COVID-19 vaccine is targeted to roll out in July 2022.

"Currently, the Red and White Vaccine is in phase two. We hope that April this year will enter phase two and if it goes well in terms of clinical trial data reports, the third phase will be continued in July," said Penny K Lukito at a press conference for the 21st BPOM Anniversary. at the BPOM Jakarta office, quoted by Antara, Wednesday, March 16.

Penny said that the implementation of the first phase of clinical trials on animal subjects was confirmed to be going well. "Currently we are still waiting for the results of the interim (temporary) research data for the second dose of injection in the next two weeks," he said.

The implementation of the Merah Putih vaccine clinical trial involving Airlangga University researchers and PT Biotis is currently entering a two-dose injection clinical trial.

The implementation of the Red and White vaccine clinical trials in phases one and two, said Penny, was followed by human volunteers consisting of 90 phase one subjects and 405 phase two subjects. Research subjects were divided into three groups with different doses.

If the entire series of clinical trials are completed successfully, said Penny, the trials will continue in phase three. "After obtaining the interim results of the phase three clinical trial, we can proceed with the submission to BPOM for approval of an emergency use permit (EUA)," he said.

Penny added that the Red and White Vaccine with an inactivated virus platform was developed in collaboration with Unair researchers and PT Biotis as a producer.

PT Biotis is responsible for the parallel production of the Red and White Vaccine through phase three clinical trials by increasing the scale of vaccine production, including those that will be used on a commercial scale.

"BPOM is helping to assist PT Biotis to prepare production facilities. So this is really a domestic production with production facilities that were also prepared from scratch in Indonesia," he said.