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Stages of COVID-19 vaccine development: Where do we stand?

In Indonesia, a potential vaccine developed by Chinese biopharmaceutical company Sinovac Biotech entered the phase III clinical trials in August. 

News Desk (The Jakarta Post)
Jakarta
Mon, October 26, 2020

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Stages of COVID-19 vaccine development: Where do we stand? A doctor holds a box of China's Sinovac vaccine for the coronavirus disease (COVID-19) at the Sao Lucas Hospital of the Pontifical Catholic University of Rio Grande do Sul (PUCRS), in Porto Alegre, Brazil, August 8. (REUTERS/Diego Vara)

Pharmaceutical companies from across the globe are racing to develop COVID-19 vaccines.

Reuters reported that, as of August, there were more than 200 vaccine candidates in development globally, including more than 20 in human trials.

In Indonesia, a potential vaccine developed by China-based biopharmaceutical company Sinovac Biotech entered the phase three clinical trials in August. 

Bambang Heriyanto, corporate secretary of state-owned pharmaceutical holding company PT Bio Farma, said on Monday that, as of Oct. 16, 1,620 volunteers had received the first injection of the potential COVID-19 vaccine, 1,074 volunteers had received the second injection and 671 volunteers had undergone blood tests after receiving the second injection.

Vaccine development in Indonesia
Vaccine development in Indonesia (JP/Swi Handono)

With all eyes on COVID-19 vaccine, the National COVID-19 task force experts team coordinator and spokesperson Wiku Adisasmito tried to explain the stages of vaccine development. 

Wiku said on Thursday that vaccine development started with basic research, also known as the exploratory phase.

The stage features basic lab research that focuses on examining the virus and the cells associated with it. 

According to Vaccination Research Group (VRG), this phase usually lasts two to four years and aims to identify the natural or synthetic antigens, which alert the body to harmful pathogens.

Wiku explained that some potential vaccines were also being made at the exploratory phase and that would be followed by the pre-clinical stage. 

The pre-clinical stage featured animal testing to ensure that the vaccine was safe for human trials, Wiku said.

There are three phases of human trials, or clinical trials.

Read also: Bio Farma to produce more than 16 million doses of COVID-19 vaccine per month

The phase 1 clinical trial usually involves 100 people. Wiku explained that this phase was aimed at assessing the safety of a vaccine for humans. 

The phase II clinical trial will involve between 100 and 500 people, and it seeks to assess the proposed doses, immunization schedule, method of administering the vaccine and possible short-term side effects.

It will be followed by the phase III clinical trial. At this phase, scientists will conduct research on 1,000 to 5,000 people to ensure the safety and efficacy in large groups.

Once all the development stages are completed with satisfactory results, then the vaccine will wait for the Indonesia's Food and Drug Monitoring Agency’s (BPOM) approval, before being produced in large quantities. 

Earlier this week, Wiku explained that COVID-19 vaccine would be available once all the clinical trials showed that it was safe and effective. 

However, Wiku said COVID-19 vaccines were not the only reassurance for the country to end the pandemic, explaining that vaccines only served as a form of medical intervention to boost people’s immunity during the pandemic. Wiku urged the public to comply with the “3M” health protocol of mask-wearing, handwashing and physical distancing, while waiting for the COVID-19 vaccine. (jes)

 

Editor’s note: This article is part of a public campaign by the COVID-19 task force to raise people’s awareness about the pandemic.

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