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What you need to know about Indonesia's vaccine development
As Indonesia struggles to contain the COVID-19 epidemic, the country, like many others, is pinning its hopes on vaccine development.
Indonesia is looking to secure access to candidate vaccines, with its diplomats and local companies seeking cooperation with producers such as Sinovac Biotech of China and Genexine Inc. of South Korea, as well as the Bill Gates-backed Coalition for Epidemic Preparedness Innovations (CEPI).
Meanwhile, for a longer-term, self-sufficient strategy, a national consortium under the Research and Technology Ministry is working on developing its own vaccine, helmed by the Eijkman Institute for Molecular Biology. The vaccine will be named after Indonesia's flag colors, Merah Putih, or red and white.
All of these attempts are progressing at different paces, while also offering various timelines, production targets and types of vaccines. But they are expected to complement each other, given the broad need to cover Indonesia's large population of some 270 million people.
How is the progress so far?
State-owned pharmaceutical company PT Bio Farma has partnered with Sinovac, with the former soon to be launching phase III clinical trials in humans of a Sinovac vaccine alongside Padjadjaran University (Unpad) in Bandung, West Java.
It is one of 26 candidate vaccines that are in clinical evaluation according to a compilation made by the World Health Organization (WHO) on July 31. There are 139 candidate vaccines in preclinical evaluation.
Indonesia is launching the phase III trials -- the last stage of clinical testing in humans during which the vaccine is given to thousands of people to confirm and expand results on safety and efficacy from phase I and II trials -- along with several countries like Brazil and Bangladesh.
Bio Farma and Unpad are now recruiting 1,620 volunteers -- all of whom must be healthy adults between the age of 18 and 59 years old with no history of having contracted COVID-19 -- to participate in the clinical trials.
The clinical trial research team leader, Unpad professor Kusnandi Rusmil, told The Jakarta Post that about 500 people had applied for the trials, which involve at least 30 doctors and 20 specialist doctors.
Bio Farma is also deliberating a contract with the Bill Gates-backed CEPI, with no decision yet made on the number of vaccines that it would “fill and finish” during the manufacturing process, Bio Farma's R&D project integration manager Neni Nurainy told the Post.
Read also: Indonesia teams up with global manufacturers in vaccine hunt
Meanwhile, homegrown health giant Kalbe Farma is cooperating with Genexine for the trials of Genexine’s DNA vaccine GX-19. Indonesia is expected to run phase II clinical trials for the potential vaccine in September or October, continuing from the phase I trials underway in South Korea until August.
As for the Merah Putih vaccine, Eijkman director Amin Soebandrio said his team was now entering the "critical" process that would "determine the success of the vaccine in the future".
He was referring to the process of producing recombinant proteins by isolating genes of the spike protein and nucleocapsid protein and inserting them into mammalian cells.
The team, comprising around 10 young researchers, is now waiting for the cells to reproduce the recombinant proteins, which might take two months, before isolating, purifying and testing the proteins on animals.
The team is making a vaccine specifically for the virus strain spread in Indonesia, which, according to Amin, has similarities to the strain circulating around Asia.
What are the timelines and production targets?
The Sinovac phase III clinical trials in Bandung are to run for six months.
Should the applicants pass the administrative and other preliminary procedures, the team will administer them with the first dose of the experimental vaccine or a placebo, and then a second dose of the vaccine 14 days later.
Kusnandi said the vaccine would be gradually given to all the subjects, estimating 25 subjects per day for five days a week at each of the six trial centers.
Read also: Indonesian COVID-19 vaccines to undergo strict human, animal testing
Bio Farma said it was expecting the preliminary results of the clinical trials to be submitted for emergency use authorization by the Indonesian Food and Drug Monitoring Agency (BPOM) by the first quarter of 2021.
The company said it would produce 40 million doses for the first batch of vaccine, but the number would increase gradually as the company aims to see its production capacity reach 250 million doses per year by the end of this year.
This vaccine must be injected twice to develop immunity.
The government, meanwhile, has given Eijkman 12 months starting from April to develop vaccine prototypes that have been tested on animals, to be given to Bio Farma for clinical trials. Bio Farma aims to mass-produce the vaccine by 2022 after earning approval from the BPOM.
The Merah Putih vaccine, Amin said, was expected to cover at least 50 percent of Indonesia's vaccine needs, given the country's large population.
What vaccine types will be offered?
The vaccines under development mentioned fall into different types.
The Sinovac vaccine is an inactivated virus vaccine, a traditional category of vaccines which consists of entire pathogens that have been killed with chemicals, heat or radiation. Hence, this type cannot cause diseases but still has antigens to elicit an immune response, experts said.
Kusnandi said the previous first two stages of trials showed a few minor side effects, such as swelling and pain in the injection area as well as fever. All volunteers in the phase III trials, therefore, would be insured so that they could receive free treatment if they were to develop complaints, he said.
The Genexine vaccine is a DNA vaccine which will also be administered twice. According to the WHO, this type of vaccine is a rather new invention that offers "potential advantages over traditional approaches", such as improved vaccine stability and the absence of any infectious agents.
The Merah Putih vaccine, meanwhile, is a recombinant vaccine. It is a type that "includes only the components, or antigens, that best stimulate the immune system" that can make vaccines safer and minimize side effects, according to the United States' National Institute of Allergy and Infectious Diseases.
https://www.thejakartapost.com/news...now-about-indonesias-vaccine-development.html
- Ardila Syakriah
The Jakarta Post
As Indonesia struggles to contain the COVID-19 epidemic, the country, like many others, is pinning its hopes on vaccine development.
Indonesia is looking to secure access to candidate vaccines, with its diplomats and local companies seeking cooperation with producers such as Sinovac Biotech of China and Genexine Inc. of South Korea, as well as the Bill Gates-backed Coalition for Epidemic Preparedness Innovations (CEPI).
Meanwhile, for a longer-term, self-sufficient strategy, a national consortium under the Research and Technology Ministry is working on developing its own vaccine, helmed by the Eijkman Institute for Molecular Biology. The vaccine will be named after Indonesia's flag colors, Merah Putih, or red and white.
All of these attempts are progressing at different paces, while also offering various timelines, production targets and types of vaccines. But they are expected to complement each other, given the broad need to cover Indonesia's large population of some 270 million people.
How is the progress so far?
State-owned pharmaceutical company PT Bio Farma has partnered with Sinovac, with the former soon to be launching phase III clinical trials in humans of a Sinovac vaccine alongside Padjadjaran University (Unpad) in Bandung, West Java.
It is one of 26 candidate vaccines that are in clinical evaluation according to a compilation made by the World Health Organization (WHO) on July 31. There are 139 candidate vaccines in preclinical evaluation.
Indonesia is launching the phase III trials -- the last stage of clinical testing in humans during which the vaccine is given to thousands of people to confirm and expand results on safety and efficacy from phase I and II trials -- along with several countries like Brazil and Bangladesh.
Bio Farma and Unpad are now recruiting 1,620 volunteers -- all of whom must be healthy adults between the age of 18 and 59 years old with no history of having contracted COVID-19 -- to participate in the clinical trials.
The clinical trial research team leader, Unpad professor Kusnandi Rusmil, told The Jakarta Post that about 500 people had applied for the trials, which involve at least 30 doctors and 20 specialist doctors.
Bio Farma is also deliberating a contract with the Bill Gates-backed CEPI, with no decision yet made on the number of vaccines that it would “fill and finish” during the manufacturing process, Bio Farma's R&D project integration manager Neni Nurainy told the Post.
Read also: Indonesia teams up with global manufacturers in vaccine hunt
Meanwhile, homegrown health giant Kalbe Farma is cooperating with Genexine for the trials of Genexine’s DNA vaccine GX-19. Indonesia is expected to run phase II clinical trials for the potential vaccine in September or October, continuing from the phase I trials underway in South Korea until August.
As for the Merah Putih vaccine, Eijkman director Amin Soebandrio said his team was now entering the "critical" process that would "determine the success of the vaccine in the future".
He was referring to the process of producing recombinant proteins by isolating genes of the spike protein and nucleocapsid protein and inserting them into mammalian cells.
The team, comprising around 10 young researchers, is now waiting for the cells to reproduce the recombinant proteins, which might take two months, before isolating, purifying and testing the proteins on animals.
The team is making a vaccine specifically for the virus strain spread in Indonesia, which, according to Amin, has similarities to the strain circulating around Asia.
What are the timelines and production targets?
The Sinovac phase III clinical trials in Bandung are to run for six months.
Should the applicants pass the administrative and other preliminary procedures, the team will administer them with the first dose of the experimental vaccine or a placebo, and then a second dose of the vaccine 14 days later.
Kusnandi said the vaccine would be gradually given to all the subjects, estimating 25 subjects per day for five days a week at each of the six trial centers.
Read also: Indonesian COVID-19 vaccines to undergo strict human, animal testing
Bio Farma said it was expecting the preliminary results of the clinical trials to be submitted for emergency use authorization by the Indonesian Food and Drug Monitoring Agency (BPOM) by the first quarter of 2021.
The company said it would produce 40 million doses for the first batch of vaccine, but the number would increase gradually as the company aims to see its production capacity reach 250 million doses per year by the end of this year.
This vaccine must be injected twice to develop immunity.
The government, meanwhile, has given Eijkman 12 months starting from April to develop vaccine prototypes that have been tested on animals, to be given to Bio Farma for clinical trials. Bio Farma aims to mass-produce the vaccine by 2022 after earning approval from the BPOM.
The Merah Putih vaccine, Amin said, was expected to cover at least 50 percent of Indonesia's vaccine needs, given the country's large population.
What vaccine types will be offered?
The vaccines under development mentioned fall into different types.
The Sinovac vaccine is an inactivated virus vaccine, a traditional category of vaccines which consists of entire pathogens that have been killed with chemicals, heat or radiation. Hence, this type cannot cause diseases but still has antigens to elicit an immune response, experts said.
Kusnandi said the previous first two stages of trials showed a few minor side effects, such as swelling and pain in the injection area as well as fever. All volunteers in the phase III trials, therefore, would be insured so that they could receive free treatment if they were to develop complaints, he said.
The Genexine vaccine is a DNA vaccine which will also be administered twice. According to the WHO, this type of vaccine is a rather new invention that offers "potential advantages over traditional approaches", such as improved vaccine stability and the absence of any infectious agents.
The Merah Putih vaccine, meanwhile, is a recombinant vaccine. It is a type that "includes only the components, or antigens, that best stimulate the immune system" that can make vaccines safer and minimize side effects, according to the United States' National Institute of Allergy and Infectious Diseases.
https://www.thejakartapost.com/news...now-about-indonesias-vaccine-development.html
