JAKARTA - A vaccine development company from China, Sinovac Biotech, together with PT Bio Farma (Persero) and Padjajaran University will conduct a third phase clinical trial of the COVID-19 vaccine in Indonesia. Apart from Indonesia, Sinovac is also conducting clinical trials in Brazil and Bangladesh. So what is the profile of Sinovac and the company's ability to develop vaccines?
Quoting the official website of Sinovac, a company based in Beijing, China, focuses on research, development, manufacture and sale of vaccines. Some of the products they have made include vaccines for hepatitis A and B, seasonal influenza, pandemic influenza H5N1 (bird flu), influenza H1N1 (swine flu), mumps and rabies.
In 2009, Sinovac was the first company in the world to receive approval for its H1N1 influenza vaccine. The company is also the only supplier of the H5N1 influenza pandemic vaccine for the Chinese government's vaccine stockpiling program.
Trial stageAs we know, there are many stages in vaccine testing. The United States disease control authority, the CDC, says there are at least six stages. First the exploration stage, followed by the pre-clinical stage, then clinical trials, processing regulatory approval, manufacturing preparations, and finally quality control.
At the preclinical stage, testing is started on animals. This stage may be continued to the clinical trial stage, namely testing on humans, if the body of the animal being tested is in a stable condition. While this clinical trial stage is further divided into three phases.
The first phase was tested on 100 adults. If it is declared safe, the trial will enter the second phase, which is testing for at least 400 people. If successful, enter the third phase, with the number of volunteers reaching thousands of people.
Where did Sinovac go?Citing CNN, Sinovac has conducted clinical trials in the first and second stages in mid-June. At that time they immediately combined the first and second phase clinical trials.
In that experiment, they attracted 700 volunteers to be tested. "The results of phase II clinical trials show that the vaccine induces neutralizing antibodies 14 days after vaccination," the company said in a written statement.
As many as 90 percent of the 600 volunteers experienced this reaction. However, this has not clearly demonstrated whether the antibodies that appear can protect people against COVID-19 infection.
Therefore, they have to pass the third stage of clinical trials until the vaccine can be used by many people. Apart from Indonesia, Sinovac is also holding clinical trials in Brazil and Bangladesh.
How in Brazil?In Brazil, Sinovac in collaboration with the Butantan Institute will conduct clinical trials of the vaccine to 9,000 people. The population is divided in the states of Sao Paulo, Rio Grande do Sul, Minas Gerais, and Paraná.
Brazil's Department of Health Anvisa gave Sinovac the green light to conduct clinical trials after they analyzed data from previous product developments. "Nonclinical studies on animals were carried out, and the results show that the vaccine provides an acceptable safety," according to Anvisa's statement quoted by Bio World.
The testing process itself just started last July 20. Those who are not allowed to take part in clinical trials include people with COVID-19, pregnant women, and those with a history of diseases that attack the immune system.
As is known, the duration of clinical trials in Brazil is estimated to be up to three to six months. This process has been accelerated from usual, which can take five or even ten years to complete a vaccine for a new disease.
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