China’s Sinovac launches phase 3 trial of COVID-19 vaccine in Indonesia

The vaccine candidate known as CoronaVac is among those few potential vaccines that have entered the phase 3 trial for a large-scale study.

Aug 11, 2020 18:55 IST
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Sinovac Biotech Ltd. of China has launched a phase 3 human trial of COVID-19 vaccine candidate on August 11, 2020, which will involve as many as 1,620 patients in Indonesia. Sinovac has been developing the vaccine with Indonesian state-owned peer Bio-Farma.

Sinovac also released the details on August 10 from phase 2 study in which it mentioned that the COVID-19 vaccine candidate has appeared to be safe and has induced detectable antibody-based immune responses in the patients.

The vaccine candidate, which is known as CoronaVac, is among those few potential vaccines that have entered the phase 3 trial for a large-scale study in order to gather proof for the regulatory approval.

CoronaVac vaccine enters phase 3 trial:

CoronaVac has already been undergoing phase 3 human trial in Brazil and Sinovac has also been expecting to test it in Bangladesh.

Joko Widodo, Indonesian President during a ceremony to launch the trial in West Java mentioned that the Coronavirus will not be subsided until the effective vaccine is given to all the people. Hopefully, in January, the government will be able to produce and vaccinate everyone in the country.

Sinovac has been testing its vaccine abroad as China is no longer a satisfactory site for phase 3 trials as there are a low number of new cases of infection.

In addition to Bio Farma of Indonesia and Sinovac, South Korea’s Genexine and private Indonesian firm Kalbe Farma have also been cooperating for producing a separate set of vaccines.

What do the released details of phase 2 human trial entails?

In Sinovac’s phase 2 human trial, which involved 600 patients from China, the rate of fever in them was found to be relatively lower than other COVID-19 patients.

Mid-Stage trial or phase 2 human trial usually test a candidate’s safety and ability to trigger an immune response in a relatively small number of people before it enters the 3 phase of the trial.

The released study has reportedly noted that the process of making the vaccines used in the Phase 2 trial was more optimized than in the Phase 1 trial, which further produced more immunogens and had triggered better immune responses.

As per the Sinovac Spokesperson, vaccines used in phase 3 of human trials will be made using the optimized process.

The researchers have also observed that the phase 2 results had only included antibody-based immunity and added that the candidate was evaluated for other important components of the immune system.

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