Indonesia green lights China’s Sinovac COVID-19 vaccine

By Jane Byrne

- Last updated on GMT

© GettyImages/Isparmo
© GettyImages/Isparmo

Related tags COVID-19 Vaccine Sinovac mRNA vaccine

Indonesia's food and drug agency, BPOM, today granted emergency use authorization to Sinovac’s vaccine against COVID-19.

In doing so, it became the first country outside China to greenlight the vaccine, according to a report on Reuters​.

Sinovac is carrying out COVID-19 vaccine Phase 3 trials in Turkey, Indonesia and Brazil. Interim data from a phase 3 trial in Indonesia showed the shot, called CoronaVac, was 65.3% effective, said Penny K Lukito, who heads up BPOM.

Phase 3 findings 

Having shown a substantial immune response and minimal safety concerns (mostly mild pain at the injection site) in phase 1 and 2 clinical trials, CoronaVac was then tested in phase 3 clinical trials carried out in Brazil, Indonesia and Turkey.

Last week, Indonesia health ministry’s Covid-19 vaccination spokesperson, Dr Siti Nadia Tarmizi, said that clinical trials of the Sinovac vaccine in Turkey and Brazil delivered what she described as “quite good”​ results.

Interim data from a late-stage trial in Turkey showed that the Covid-19 vaccine developed by Sinovac is 91.2%, said Turkish health minister, Fahrettin Koca, and professor Serhat Unal, a member of the Turkish government's COVID-19 advisory board in late December.

And, at a press conference last week, Brazilian researchers reported the vaccine made by Sinovac was safe and had 78% efficacy in preventing mild cases of COVID-19 in a study of more than 12,000 health care workers. It also completely prevented moderate and severe illness caused by SARS-CoV-2 infections, the team said. “The result we are seeing today is fantastic,”​ Rosana Richtmann, a physician from the Emilio Ribas Institute of Infectious Disease, as per a report in Science​.

Dimas Tadeu Covas, head of the Butantan Institute—a state-owned vaccine maker that is co-sponsoring the trial—expects Brazil’s regulatory agency to authorize the vaccine, called CoronaVac, for emergency use in the coming days, according to that report.

There were complaints, however, that the announcement included very little actual trial data.

Both Sinovac and Sinopharm have imposed limits on what their trial partners can reveal about their vaccines, noted the piece in Science​.

Vaccination program

Indonesian state vaccine producer, Bio Farma, received 1.2 million doses of the Sinovac vaccine on December 6 and 1.8 million doses at the end of that month. It began distributing CoronaVac to health facilities across the country’s 34-provinces on January 3, with the Indonesia government there aiming to inoculate 181.5 million people aged over 18 or around 67% of its nearly 270 million people, within 15 months, noted The Straits Times​.

The vaccination program needed the regulatory go ahead from BPOM.

Indonesia has declared 836,718 COVID-19 infections and 24,343 deaths as of today, January 11. The country has, so far, secured nearly 330 million COVID-19 vaccines doses from five different suppliers as well as 53 million doses under the COVAX/GAVI program – a world body working to ensure developing countries have access to the coronavirus vaccines.

How it works  

Sinovac has been approved for emergency use in high-risk groups in China since July. The vaccine is an inactivated, two dose vaccine: with doses administered 14 days apart.

The biotech was among the first group of companies to initiate development of a vaccine against COVID-19. Work on the inactivated vaccine prospect began in late January 2020, and clinical development got underway in mid-April.

The Sinovac vaccine works by using killed viral particles to expose the body's immune system to the virus without risking a serious disease response as opposed to the candidates from Moderna and Pfizer-BioNTech, which are mRNA vaccines.

"CoronaVac is a more traditional method [of vaccine] that is successfully used in many well-known vaccines like rabies,"​ Luo Dahai, associate professor, Nanyang Technological University, Singapore, told the BBC.

Like the AstraZeneca vaccine, CoronaVac has advantages in terms of logistics as it can be stored in a standard refrigerator at 2-8 degrees Celsius.

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