Jakarta – BRIN Public Relations. The pandemic due to the Covid-19 virus outbreak that has hit most countries in the world since 2 years ago has not yet ended. The government continues to provide vaccines which are claimed to be an effort to prevent entry of the Covid-19 virus into the body. Meanwhile, the vaccine development process in Indonesia is still facing various obstacles, although it has shown quite encouraging progress.

Head of the National Research and Innovation Agency (BRIN), Laksana Tri Handoko, highlighted the various obstacles faced in the development of the Merah Putih Vaccine. Indonesia can be considered as a large-scale vaccine producing country, but ironically it does not yet have a vaccine that it develops from scratch.

“Some facts that obstruct the development of merah putih vaccines include lack of infrastructure to support vaccine development, such as certified BSL-3 laboratory infrastructure for phase 2 preclinical trial for primates,” said Handoko in a Webinar on Development of National Health Resilience under the theme Merah Putih Vaccine Development, Wednesday (16/03).

Another obstacle in the development of the Merah Putih Vaccine, said Handoko, is unavailability of sufficient facilities for administering limited testing with Good Manufacturing Practices (GMP) standards for vaccines from various platforms developed by researchers.

“As an effort to overcome these obstacles, BRIN is currently trying to build 2 facilities, namely a GMP standard- limited test facility and BSL 3 animal test facility for macaques with a capacity of 80,” he added.

Stages and Status of Merah Putih Vaccine Development

Deputy for Drug, Narcotics, Psychotropics, Precursor, and Additive Substances Control – Food and Drug Supervisory Agency (BPOM), Maya Agustina Andarini said developing vaccines is not an easy job, there are many stages and requirements that must be met. Based on its duties and functions, BPOM supervises and provides assistance to drug production activities, including vaccines.

In order for the vaccine development process to run smoothly and meet the specified requirements, researchers should coordinate intensely with BPOM. “For researchers who will conduct research related to medicinal products or vaccines that will be commercialized, they should consult with BPOM from the start so that at the time the product is registered to get distribution permit, it complies with applicable standards and regulations,” said Maya.

In detail, Maya explained the stages of vaccine development that must be passed in accordance with applicable standards and regulations. The stages begin with initial development followed by pre-clinical trials, clinical trials phase 1 to 3, vaccine registration, BPOM approval, and post-marketing.

“The initial development phase and pre-clinical trials are included in the laboratory scale that must be adjusted to the Good Laboratory Practices (GLP),” added Maya.

Then, continued Maya, phase 1 clinical trial and phase 2 clinical trials are included in the pilot scale, while phase 3 clinical trials and vaccine registration are included in the production scale. For pilot scale and production scale, the standard of Good Manufacturing Practice (GMP) must be observed.

High safety standards are applied to vaccine development with the aim of ensuring the safety of users (pur)