Both vaccines have passed phase two of the clinical trial with good resultsJakarta (ANTARA) - The Indonesian Food and Drug Supervisory Agency (BPOM) Head Penny Lukito confirmed that President Joko Widodo (Jokowi) has named two domestically made COVID-19 vaccine products that are entering the final phase of clinical trials.
"The first vaccine is called Indovac for the state-owned enterprises (SOEs) vaccine, and the second one is the red and white vaccine, with an inactivated virus platform called Inavec. The president has agreed to both of them," she noted during the Domestic Drug Development Workshop here, Friday.
The agency head remarked that the Indovac vaccine, with a sub-unit recombinant protein platform, was developed by the Eijkman Institute for Molecular Biology along with the state-owned pharmaceutical company, PT Bio Farma, and Baylor College of Medicine.
Meanwhile, the Inavec vaccine, with an inactivated virus platform, is developed by the Research Team from Airlangga University (Unair) in collaboration with production facility provider PT Biotis Pharmaceutical Indonesia, she revealed.
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Lukito targets the Indovac and Inavec vaccines to obtain an emergency use authorization (EUA) from BPOM in September 2022.
"Both vaccines have passed phase two of the clinical trial with good results. They are able to improve the immune system, and the results are not inferior to vaccines that have received EUA with the same technology," she remarked.
Currently, the BPOM is still conducting a review of research reports on thousands of subjects that received a second injection in each trial laboratory.
"Hopefully, in September 2022, the EUA will be completed, and the result will come out according to international standards," she stated.
The third phase of clinical trials of the two domestic vaccines is also accompanied by the granting of permits for clinical trial activities for booster vaccines or booster doses.
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"The booster clinical trial has been approved to be conducted by the end of this year. Thus, the booster vaccination program using these domestic vaccines can be completed before the end of 2022," she remarked.
On the same occasion, President Director of PT Biotis Pharmaceutical Indonesia, FX Sudirman, expressed pride over the domestic vaccines having reached the final phase of clinical trials.
"This is 100 percent the work of domestic human resources. The virus is developed by researchers from Unair, and we are ready to commercialize it," Sudirman noted.
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The downstream production capacity of PT Biotis reaches up to 20 million doses per month, and especially in the early stages, it will be increased to five million doses per month similar to Indovac.
Until now, PT Biotis awaits the results of phase three clinical trials and booster clinical trials.
"We hope that the use of Inavec will provide benefits to the people this year," Sudirman remarked.
He also coordinated with Minister of Health Budi Gunadi Sadikin to implement the administration of the Inavec booster vaccine in October, November, and December 2022.
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Translator: Andi Firdaus, Resinta S
Editor: Fardah Assegaf
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