Indonesia seeks own vaccine, rather than rely on Sinovac

Clinching a deal last month with China’s biopharmaceutical giant Sinovac Biotech, Indonesia is set to produce anti-coronavirus vaccines locally under licence early next year after clinical trials conducted in Indonesia last month. At the same time the Indonesian government has decided to reduce reliance on imports by wholly researching, developing and producing its own COVID-19 vaccine, called Merah-Putih, by mid-2021.

Indonesia’s President Joko Widodo has said the Sinovac vaccine will be in production by January next year but will not meet the country’s demand – Indonesia has a population of almost 270 million – so Indonesia must also produce its own.

Merah-Putih, or red and white in English, is the name of Indonesia’s national flag, to symbolise that the vaccine is developed and produced by Indonesia, separate from China’s Sinovac vaccine known as CoronaVac that will use bulk vaccine antigen imported from China.

CoronaVac has reached stage III human clinical trials involving 1,620 volunteers in Bandung, West Java, to determine efficacy and safety and has so far been showing signs of success. Human trials are also being conducted in Brazil.

“Even if there are side effects but they correspond with our predictions, it will still be a successful trial,” Eddy Fadlyana, a member of the Sinovac vaccine testing team in Indonesia, told University World News, adding: “The predicted effects are a little pain on the injected part of the body, and minor fever.”

So far there have been “no significant complaints”, according to the team, except that 21 volunteers out of 1,629 felt minor pain around the injection spot, which disappeared after a while, the team said.

All the volunteers will be monitored by the clinical test team until the third week of December, with the results of the Sinovac clinical trials expected to be known between December 2020 and January 2021. However, in the case of unpredictable results, “we won’t take the further step into the production stage,” Eddy said.

The World Health Organization has approved CoronaVac production at Bio Farma, which is Indonesia’s state-owned pharmaceutical company based in Bandung. It mainly exports generic drugs. Under its agreement with Sinovac for production for use in Indonesia, “production capacity is 100 million vaccine [doses], which can be increased to 250 million,” Eddy said, referring to a new production facility being built by Bio Farma.

Country must produce its own vaccine

On 16 September, Indonesia reported a total of 228,993 coronavirus cases, including 9,100 deaths.

Addressing the nation on 24 August, President Joko Widodo said the pandemic has weakened Indonesia’s economy, society and education. “We hope once the Merah-Putih vaccine comes into play, the whole situation will soon be back to normal.”

According to Amin Soebandrio, head of the Eijkman Institute for Molecular Biology in Jakarta, the Sinovac vaccine will only meet 20% of the country’s demand. “The remaining 80% will be met by our Merah-Putih vaccine,” he told University World News. “We have the capability and all the resources needed.”

The Merah-Putih project involves Bio Farma, the Eijkman Institute, BPPT (Agency for the Assessment and Application of Technology), LIPI (Indonesian Institute of Sciences), BPOM (National Agency of Drug and Food Control ), the Ministry of Research and Technology, Padjadjaran University in Bandung, University of Indonesia in Jakarta, Airlangga University in Surabaya in East Java, and Gadjah Mada University in Yogyakarta, Central Java.

“China’s Sinovac vaccine uses a single virus, which is bred and multiplied in the laboratory. It is then separated from its elements so that the virus becomes inactive and safe for human use. This inactivated virus is used as material for vaccine,” Amin said, but Merah-Putih uses only the spike protein characteristic of coronavirus and nucleocapsid protein as an antigen.

“If the two elements of COVID-19, the spike protein and nucleocapsid, are put together in a ‘house’ of a mammal cell, they will become a vaccine that enhances human body immunity, particularly immunity against coronavirus,” Amin said, adding: “It is this combination of the two proteins that becomes antigen and will be injected in humans,” Amin explained.

Minister of research and technology and chief of the National Research and Innovation Agency or BRIN, Bambang PS Brodjonegoro, said he wanted the Merah-Putih clinical trials to take place by early 2021. But Amin predicted his institution would be able to deliver material for the Merah-Putih vaccine to the pharmaceutical industry between February and March 2021 and carry out the first clinical trial by mid-2021.

Bambang said work on the Merah-Putih vaccine is 40% complete. When fully completed, the vaccine candidate will first be tested on mammal cells before it goes to clinical trials. And if things go well, it will be ready for mass production.

“If the clinical trials go well, we will be able to mass produce Merah-Putih by early 2022,” he said.

Need for international collaborations

While struggling to produce its own vaccine, Indonesia remains open to international partnerships and joint cooperation for further vaccine development. “We have to build our self-reliance in medicines. With a population of 270 million people, Indonesia cannot depend on imported medicines and drugs,” said Bambang.

Indonesia relies heavily on imported medicines. More than 80% of its drug materials are imported. And more than 60% of them are from China, and a further 30% from India.

This reliance on imported drug materials has become more apparent during the COVID-19 pandemic. In May, supply chain disruptions due to the pandemic caused Indonesia’s pharmaceutical industry to operate at 55% to 66% of capacity, according to the Indonesian Chamber of Commerce and Industry.