Covid-19 Vaccine Clinical Trial Starting Early August


Jakarta, – The Indonesian government, through PT Biofarma, is collaborating with a number of agencies currently developing vaccines for Covid-19 production from within the country. It is targeted that in August 2020 the clinical trial of the Covid-19 vaccine will be carried out, and all the processes are going well, it is targeted that by early 2021 it can be produced. Production capacity is allocated as many as 250 million doses of vaccine each year.

Director of PT Bio Farma (Persero) Honesti Basyir, said, for the development of the Covid-19 vaccine, his party was accelerating the availability of the Covid-19 vaccine. For the short term, it will collaborate with two institutions, namely Sinovac Biotech Ltd China and The Coalition for Epidemic Preparedness Innovations (CEPI). PT Biofarma will be one of the vaccine manufacturers appointed by CEPI to make the vaccine Covid-19 immediately. For collaboration with Sinovac Biotech itself, it has received permission from the Ministry of Health and the POM Agency to assemble its clinical trial protocol.

“The clinical trial protocol has been issued, and in early August the Bandung clinical trial was immediately conducted. If all clinical trials are carried out well, we will immediately produce the Biofarma production facility in Bandung in Q1 2021, “Honesti said in a working meeting with the House of Representatives Commission IX, Tuesday (07/14/2020).

According to Honesti, vaccine production facilities Covid-19 continue to be developed. One more production capacity will be installed soon and the equipment will start operating in December 2020, so that by early 2021, it can accelerate the production of Covid-19 vaccine.

For the long term, according to Honesti, a national Covid-19 vaccine consortium has been formed, chaired by the Eijkman Institute where Biofarma plays an active role in production after vaccine seeds have been found and accepted by Biofarma.

It is hoped that in mid-2021, Biofarma will be able to produce Covid-19 vaccine according to the strain of the Indonesian virus. But to speed up the process, according to Honesti, it still needs cooperation with Sinovac Biotech and CEPI.

The budget requirement for the production of the Covid-19 vaccine is estimated to be around Rp 103 billion. Consisting of Rp. 63.2 billion for the development of national vaccines, and Rp. 40.5 billion for collaborative vaccines with Sinovac and CEPI, especially for pre clinical. Meanwhile there is also a budget requirement for developing vaccines in general outside of vaccines Covid-19 in the amount of Rp. 68.7 billion. For this general vaccine according Honesti will be sought from cash flow Biofarma.

Honesti said that the funding for developing this vaccine would be the fastest using the government budget. A number of mechanisms have been proposed by Biofarma to the government, especially related to the research budget. One of them is a budget at the Ministry of Research and Technology to finance starting from the development stage, pre-clinical trials, to clinical trials.

“It is also possible that for production we can use funds from sponsors both from within and outside the country. But specifically Covid-19 from talks with the Ministry of Research and Technology seems like we will have full funds in the Ministry of Research and Technology, “he said.

Minister of Research and Technology / Head of Research Agency Bambang Brodjonegoro said, the national vaccine development team led by the Ministry of Research, Technology, Ministry of Health, and the Ministry of SOEs continues to coordinate to look for vaccines that might be quickly declared as Covid-19 vaccines. So far, from monitors conducted by the World Health Organization (WHO), there are three developers whose positions are the fastest developing vaccines. Phase three clinical trials have been entered. First is Sinovac Biotech in collaboration with Biofarma, AstraZeneca-Oxford and Moderna.

“Of course we are trying to make Biofarma’s collaboration with Sinovac, it is planned that the third phase of clinical trials in Indonesia will be soon. So the most important thing is that Indonesia is one of the countries that received a place as a clinical trial, “said Bambang.

According to Bambang, if the vaccine seed has been clinically tested in Indonesia, the process and the results can be seen directly by the POM, so that it can be declared as a vaccine Covid-19 for use in Indonesia.

Bambang said it took three months to carry out the clinical trial starting in August 2020. After the results of the clinical trial, a distribution permit from the POM was needed.

“We hope that in January 2021 Biofarma will have begun producing vaccine-19, the development of which will be carried out by Sinovac,” Bambang said.

To note, the vaccine which will soon be produced by Biofarma is developed by Sinovac seeds. The vaccine seed will be clinically tested in Indonesia, after which it is submitted to Biofarma for production. After it is produced, it is distributed or used by the Ministry of Health for mass vaccinations.

In addition to the vaccine developed by Sinovac, the government is also working on developing its own vaccine, especially from the SARS Cov-2 virus which is transmitting in Indonesia.

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