Monday, August 10, 2020

INDIGENOUS VACCINE IN THE MAKING by Fardah

Jakarta, Aug 11, 2020 - The world is racing against time for developing a vaccine against the novel coronavirus disease (COVID-19), which has plagued more than 200 countries since it first emerged in Wuhan, China in late 2019.

 

At least 28 COVID-19 vaccine candidates are being tested in human clinical trials in 13 countries, while 131 other potential vaccines have not made it to the stage of human trials yet.


Indonesia has also entered the fray by developing its own vaccine called Red and White, which refers to the colors of its national flag.


The Red and White vaccine is being entirely developed by Indonesia. The Eijkman Institute for Molecular Biology, the Agency for the Assessment and Application of Technology (BPPT), the Indonesian Institute of Sciences (LIPI), the Food and Drug Supervisory Agency (BPOM), the Ministry of Research and Technology, and several universities are working on the vaccine.


“For the past three months, we have been developing our own vaccine, specifically from the COVID-19 virus strain that has been spreading in Indonesia,” President Joko Widodo (Jokowi) said in Bandung on August 11, 2020.


The animal trials for the Red and White vaccine are expected to be completed in 2020. If it is effective, the seed vaccine will be submitted to Bio Farma for preclinical and clinical trials.


The Red and White vaccine is projected to be fully ready in mid-2021.


The local vaccine candidate was earlier mentioned during the commemoration of the 25th National Technology Awakening Day (Hakteknas) 2020 on August 10, 2020.


The Harketnas offered the right momentum for Indonesian scientists to develop the COVID-19 vaccine, Indonesian Vice President Ma'ruf Amin said at the function.


On the occasion, Minister of Research and Technology/Head of the Research and Innovation Agency (Menristek/Head of BRIN), Bambang Brodjonegoro, confirmed that several studies and innovations were under way in the country for tackling the COVID-19 pandemic.


Research and innovations to handle the COVID-19 crisis cover the production of ventilators, rapid diagnostic tests, polymerase chain reaction (PCR) test kits, mobile lab Biosafety level 2 (BSL-2), and the Red and White vaccine.


"We, through the Eijkman Institute, continue to develop the Red and White vaccine against all strains of the COVID-19 virus. Efforts have been undertaken to produce recombinant protein to manufacture vaccines," Brodjonegoro remarked.


President Jokowi also touched upon the development of the Red and White vaccine while visiting the Padjajaran University (Unpad) Teaching Hospital, Bandung, West Java, on August 11, 2020 to witness the third stage clinical trial of a COVID-19 vaccine developed by China-based Sinovac Biotech Ltd.


The Unpad's Faculty of Medicines is carrying out the six-month-long clinical trial of the Sinovac vaccine, which will be mass produced by Indonesian government-owned pharmaceutical company Bio Farma in January, 2021. 


A total of 1,620 samples are planned for the phase III clinical trial.


"As we know it (Bio Farma) could produce approximately 100 million doses of (Sinovac) vaccine in August, and by the end of the year, in December, production will increase to 250 million. This means these vaccines will be utilized for vaccination in Indonesia," Jokowi said.


In its vaccine, Sinovac is using a single virus that is multiplied in the laboratory. The virus is isolated to develop an inactivated vaccine that can be safely administered to humans.

Hence, it is a whole virus vaccine.


In the meantime, the Red and White vaccine is being developed using a recombinant method, wherein, instead of the whole virus, only certain parts of it that are deemed important will be multiplied and used as antigens.


PT Bio Farma president director Honesti Basyir has assured that Indonesians will be prioritized during the distribution of the COVID-19 vaccine after it passes the clinical trial stage and secures permission for production.


As per calculations, 160 million Indonesians will be prioritized to receive the vaccine originating from China's Sinovac. Each individual will have to be administered two doses of the vaccine.

 

"Next year, the target is set to vaccinate 160 million members of the population, with each individual receiving two doses, thereby translating to the fact that we will require to prepare 320 million doses," he stated.

 

Basyir noted that once the vaccination requirements for Indonesians are met, Bio Farma will then consider exporting the vaccine to other countries.

 

Currently, the company is awaiting the conclusion of the clinical trial as well as the licensing phase from the Food and Drug Supervisory Agency (BPOM) that is targeted for completion in January, 2021.

 

Earlier, spokesperson for the COVID-19 Handling Task Force, Wiku Adisasmito, had echoed the government's commitment to prioritize the triad of safety, precision, and speed in the domestic production of the COVID-19 vaccine.

 

"We need to explain what safety means, which is that the vaccine must be able to provide protection to the people of Indonesia, and there are no side effects. Secondly, it must be precise. The vaccine must truly be able to trigger specific immunity against the viruses (strains) circulating in Indonesia," Adisasmito noted.

 

The third aspect is speed in wake of the wide-ranging impact of the COVID-19 pandemic worldwide, including in Indonesia. Hence, the government must act quickly to protect the people of Indonesia, he said.

 

"Thus, clinical trials too should be conducted quickly, but also correctly. Additionally, they (vaccine doses) must be produced properly and in sufficient quantities to truly offer vaccines to all Indonesians in need of protection," Adisasmito emphasized.

 

While awaiting the results of the Sinovac clinical trial, Erick Thohir, executive chairman of the Policy Committee for COVID-19 Handling and National Economic Recovery, has urged public adherence to health protocols, such as wearing masks, maintaining physical distancing, washing hands, and applying other guidelines outlined in the protocols.

 

The country would need to spend US$4.5 billion, or roughly Rp65.9 trillion, to purchase 320-380 million doses of the COVID-19 vaccine for Indonesia’s 290 million people, according to Thohir.

 

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