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Tag: Universitas Airlangga

Health Minister supports Merah Putih vaccines from UNAIR and PT. Biotis Pharmaceuticals Indonesia

Posted on by Universitas Airlangga News

Minister of Health of the Republic of Indonesia (Menkes RI), Ir. Budi Gunadi Sadikin, CHFC., CLU., expressed his support for the development of the Merah Putih vaccine by Universitas Airlangga (UNAIR). It was stated directly during the Open Assembly of the 67th UNAIR Anniversary on Tuesday, November 9, 2021.

According to Ir. Budi, UNAIR’s vaccine preclinical test on animals, shows good results and has high efficiency. Thus, for the next stage, the clinical trials on humans, it is submitted to PT. Biotis Pharmaceuticals Indonesia.

Furthermore, Ir. Budi explained that the first phase of clinical trials examines the safety aspects of the vaccine, and it requires 100 people as volunteers. Then, the second phase of clinical trials will involve about 400 people to see aspects related to its immunogenicity. Furthermore, the third phase of clinical trials will involve about 3,000 people to see the vaccine’s efficacy.

“I pray that it will go smoothly so that in the second half of next year, the Merah Putih vaccine can be produced. It also relies heavily on assistance from the East Java Governor, because the plan will be carried out in Surabaya,” he explained.

Regarding the third phase of the clinical trial, continued Ir. Budi, it is still in the drafting stage. So, besides being used for the regular vaccination process given twice, a scenario related to the use of vaccines as a booster and for children should be developed.

“So, the first scenario is used for two injections, then for the second scenario, the vaccine will be injected as a booster so that it can strengthen the previous vaccine. And the third scenario, the vaccine will be injected twice, targeting children under 12 years old,” Ir. Budi explained.

On the same occasion, Ir. Budi also witnessed the handover of vaccine seed from the Rector of UNAIR to PT. Biotis Pharmaceuticals Indonesia. Ir. Budi revealed that what UNAIR and PT. Biotis Pharmaceuticals Indonesia did was an extraordinary thing because it can complete the research process to preclinical trials in less than one year.

Since the beginning of the development, added Ir. Budi, the Food and Drug Supervisory Agency (BPOM), has been involved. So all parties support the acceleration of the first national vaccine development.

“Once again, I’d like to express a very high sense of pride towards my colleagues at UNAIR for being the first to create a domestic vaccine production. I’d also express my deepest gratitude to PT. Biotis Pharmaceuticals Indonesia. I’d pray that UNAIR to be better than before and will be better in the future than the current condition,” he concluded. (*)

Phase 1 pre-clinical trial of UNAIR-led Merah Putih Vaccine shows promising result

Posted on by Universitas Airlangga News

The Coordinating Ministry for Economic Affairs and the Cabinet Secretary of the Republic of Indonesia supports the realization of the Merah Putih Vaccine led by Universitas Airlangga, which has undergone phase 1 of the pre-clinical trial.

The tremendous support is shown from a meeting discussing the development of Merah Putih Vaccine particularly undertaken with the platform used by UNAIR.

The meeting was held online and offline at the Balairua Room Management Office Campus C UNAIR, Friday afternoon, May 28, 2021. Several officials attended the meeting, including Prof. Dr. Ni Nyoman Tri Puspaningsih, M.Si., UNAIR Covid-19 Research Coordinator as well as UNAIR Vice-Rector for Research, Innovation and Community Development; Dida Gardera, ST., M.Sc, Assistant Deputy for Agro, Pharmacy, and Tourism of the Coordinating Ministry for Economic Affairs; and Sudirman, Director of PT Biotis Prima Agrisindo.

Several related officials from the Cabinet Secretary of the Republic of Indonesia, the Ministry of State-Owned Enterprises, the Ministry of Health, Drug and Food Monitoring Agency were also present.

In the meeting, the Head of the UNAIR Merah Putih Vaccine research team Prof. Dr. Fedik Abdul Rantam drh, revealed the development of the UNAIR Merah Putih vaccine has entered phase 1 of the preclinical trial and has shown good results.

“Regarding the antibody titer, the trend is very good, PA is also good, and the examination is still ongoing including immunotyping, kidney, haematology, toxicity, and total blood tests. The examination results will be used as the basis for conducting the phase 2 preclinical trial, “said Prof. Fedik.

For this reason, his team is currently preparing a phase 2 preclinical trial.

Previously, Universitas Airlangga (UNAIR) have conducted vaccine research on several platforms, such as the inactivated virus platform, the viral vector with adenovirus platform, and the peptide platform.

The three platforms are still ongoing and construction of the inactivated virus platform has been completed early to advance to preclinical trials and clinical trials.

“We hope in December it will be complete, however, it may be February or March before it included in the industrial scheme, ” he explained.

Furthermore, Prof. Fedik hoped that this research is in line with the expectations of the government and the Indonesian people, the independent development of vaccines so that the government can deal with the Covid-19 virus independently as well.

“For academics, we are optimistic that we can develop the technology to make our own vaccines. Of course, this is a start, “he said.

UNAIR Pharmacy lecturer develops injection-based bone substitute

Posted on by Universitas Airlangga News

Bhagalen, an injectable bone substitute is developed by Dr Aniek Setiya Budiatin, Apt., M.Si., lecturer and researcher at the Faculty of Pharmacy, Universitas Airlangg UNAIR. Bhagalen is an innovation in the form of injectable bone fillers for bone fractures and osteoporosis that oral drugs cannot handle.

This innovative product has received funding from the Ministry of Research and Technology / National Agency for Research and Innovation, Indonesia.

Aniek revealed that the product is in the form of a powder and a solvent. This powder is mixed and then injected into the cavities, both fractures and osteoporotic bones.

Bhagalen consists of bovine hydroxyapatite, gelatin, and alendronate. Bovin hydroxyapatite is a powder obtained from cow bones. The cow bones are produced in-house in UNAIR’s Teaching Industry to reduce imports of materials.

Aniek explained that the composition of Bhagalen consists of 80 percent hydroxyapatite which is part of the components of bone so that it is easily recognized by the bones and can fuse well.

Aniek also explained that bone has two components besides cells and water, organic and inorganic. The organic component used in Bhagalen is gelatin, and the inorganic is hydroxyapatite.

Interestingly, with this Bhagalen, all the damage to the bones can be treated. Bones that are damaged due to fractures or holes continued Aniek; to recover quickly, injections can be made to form new bones to prevent deformities.

“It should be faster with the injection due to the wider surface shape so that it will take about a month,” she explained.

She also said that this injection model is still rare in Indonesia because of its high price. For this reason, Aniek hoped that Bhagalen would be used widely at a more affordable price.

Aniek hoped that her innovation could be widely recognized and used so people in need can be helped and avoid bone defects.