"Currently, the Merah Putih vaccine is going to enter its Phase 2 (clinical trials). We hope that April this year, it will enter Phase 2 and if it goes well in terms of clinical trial data reports, the third phase will be continued in July," she informed at a press conference on the 21st anniversary of the agency at the BPOM office here on Wednesday.
Penny assured that the Phase 1 pre-clinical trials that were conducted on animals went well. "Currently, we are still waiting for the interim data on research for the second dose injection in the next two weeks," she informed.
The Merah Putih vaccine developed by Airlangga University (Unair) researchers and PT Biotis is currently entering clinical trials for the second dose.
The Phase 1 involved 90 human volunteers and the Phase 2 will involve 405 human volunteers. The research participants have been divided into three groups, who will get different doses of the vaccine.
According to her, if the Phase 1 and 2 run well, the process will continue to the Phase 3.
"After obtaining the interim results of the Phase 3 clinical trials, we can proceed with the application to BPOM for approval of an emergency-use permit (EUA)," she informed.
The BPOM head added that the Merah Putih Vaccine, which is based on an inactivated virus platform, was developed in collaboration with Unair researchers and PT Biotis as the producer.
PT Biotis will be responsible for the parallel production of the Merah Putih Vaccine during Phase 3 clinical trials by increasing the scale of production, including for commercialized vaccines.
"The BPOM helps to assist PT Biotis to prepare production facilities. Therefore, this is really a domestic production with production facilities that were also prepared from scratch in Indonesia," she remarked.
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Translator: Andi Firdaus, Raka Adji
Editor: Suharto
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