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Mon, 02/07/2022 - 14:10
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Indonesia's Merah Putih vaccine clinical trials to involve 495 volunteers

Jakarta, February 7 (ANTARA) - At least 495 volunteers will take part in the first two phases of the clinical trials for the Merah Putih (Red and White) vaccine, the National Agency of Drug and Food Control (BPOM) has informed. "The phase one and two clinical trials will involve 90 participants for phase one and 405 participants for phase two. The participants are, of course, humans. The participants will be divided into three groups (who will be administered) with different doses (of the vaccine)," BPOM head Penny K. Lukito said at an online press conference here on Monday. She expressed the hope that the Merah Putih vaccine would be added to the list of COVID-19 vaccines currently being administered in Indonesia and would prove effective in protecting the community from COVID-19 infection. "We are working together to become an independent nation in terms of vaccine, both in its development and production," she said. If the interim results for phase one and two clinical trials meet the requirements, the trials will proceed to phase three, Lukito said. Then, after the interim results of phase three clinical trials are obtained, an application will be made to BPOM for granting emergency-use authorization (EUA) for the vaccine, she added. This is expected to happen by mid-July 2022, she informed. She emphasized that the Merah Putih vaccine is of good quality as it is being produced in a production facility owned by PT Biotis Pharmaceuticals Indonesia that meets the applicable standards. She further said that PT Biotis Pharmaceuticals, as the producer of the Merah Putih vaccine, is currently preparing for phase three 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," Lukito remarked.