Red And White Vaccine Clinical Trials The Indonesian Nation's Big Step In Vaccine Independence

JAKARTA - The clinical trial license granted to the Red and White Vaccine by the Food and Drug Supervisory Agency (BPOM), is a big step for Indonesia in dealing with the COVID-19 pandemic. This was confirmed by Griffith University Epidemiologist, Australia Dicky Budiman.

“This Red and White Vaccine is important. Not only in the short term in terms of responding to the COVID-19 pandemic, but also for the long term," he said in a voice message received by Antara in Jakarta, Saturday, February 12.

He stated that although Indonesia already has PT. Bio Farma to produce vaccines, research on vaccine testing that really starts from the beginning is a big foundation for a country to enter the ranks of countries that can conduct vaccine research. Including assisting the state in producing the availability or stock of vaccines for the community independently.

“It is clear that the production capability is there, but vaccine research from 'research and development' is a distinct advantage which is not easy. It requires investment and takes a long time. With research like this alone, it's actually a very far step forward for us,” said Dicky.

According to him, when it comes to researching a vaccine for infectious diseases, the chances of success are 50 to 50. If the vaccine can pass various series of tests, the country can independently produce a vaccine with unquestionable halalness for distribution to the public.

The state can also change psychosocial as well as community behavior in response to the COVID-19 vaccine. However, if it fails, the Merah Putih vaccine becomes a very valuable experience for further research.

“Even if the others don't work, at least it can be a very valuable experience for the research. Failure is a good foundation to reach the next stage," he said.

Seeing the seriousness of the nation's children, he hopes that the government is really serious in providing assistance in the research that is being carried out. This is because vaccine testing will be clearly visible when the situation will slope down or when the pandemic status is revoked by the government. In addition, the success of the research is also important considering that COVID-19 is not the last pandemic and Omicron is the last variant.

"Once again, this Red and White Vaccine research really needs to be supported and of course with global standards," said Dicky Budiman.

Separately, the Head of the Food and Drug Supervisory Agency (BPOM) Penny K. Lukito said that the implementation of the Red and White Vaccine clinical trials in phases one and two involved 90 volunteers in phase one and 405 people in phase two.

If the clinical trials of phases one and two have obtained interim results and meet the requirements, they can proceed to the phase three clinical trials.

"After obtaining the interim results of the phase three clinical trial, we can proceed to submit it to the POM Agency and get approval for an emergency use permit (EUA) which will be around mid-July 2022," said Penny at a press conference in Jakarta, Monday, February 7.

He emphasized that the quality of the Red and White Vaccine that will be given in this clinical trial has been met and is supported by PT Biotis Pharmaceuticals Indonesia's production facilities that meet the requirements for Good Manufacturing Practices of Medicine (GMP).

According to Penny K. Lukito, PT Biotis as the producer of the Merah Putih vaccine, is in parallel preparing for phase three clinical trials by increasing the scale of vaccine production, including those that will be used on a commercial scale.