BPOM: Dengue mRNA Vaccine Proof that RI is Capable of Strengthening Pharmaceutical Independence

JAKARTA - The Food and Drug Supervisory Agency (BPOM) said the launch of the mRNA-based dengue vaccine prototype is proof that Indonesia is capable of innovating to meet the challenges of infectious diseases, while strengthening national independence in the fields of pharmaceuticals and biotechnology.

Head of BPOM Taruna Ikrar said the prototype was the result of collaboration between the University of Indonesia (UI), Tsinghua University, and PT Etana, with funding support from the Education Fund Management Institution (LPDP), the Ministry of Health (Kemenkes), the Ministry of Science and Technology of China, the National Research and Innovation Agency (BRIN), and regulatory assistance from BPOM.

"Dengue is still a serious health threat, both globally and nationally. This condition requires the presence of faster, adaptive, and science-based innovations, including through the development of mRNA-based dengue vaccines," said Taruna Ikrar in a statement in Jakarta, Antara, Thursday, July 9.

Therefore, he said, the launch of this vaccine prototype is an important milestone in strengthening the national health research and innovation ecosystem, as well as the implementation of strategic cooperation between Indonesia and China in the fields of vaccines, genomics, and health biotechnology.

He emphasized that the success of the downstreaming of health research results not only depends on the ability of researchers and industries, but also requires the involvement of regulators from the earliest stages of product development.

According to him, the paradigm that BPOM only plays a role at the end stage through the issuance of distribution permits must be changed.

"The industrialization of everything related to vaccines and medicines. Don't think that BPOM is just a stamper. BPOM must be involved from the beginning because we understand the standards, methods, and characteristics of products that must be met," he said.

He said that many products that had previously been processed could not be continued because BPOM was only involved in the final stage. In fact, his party has standards that refer to global regulations, so it can help accompany and improve product quality.

The cadet appreciated the research team and all partners who from the beginning involved BPOM in the process of developing the prototype of the mRNA-based dengue vaccine. This approach is considered to accelerate the product development process without reducing the aspects of safety, efficacy, and quality.

"In the development of this vaccine, BPOM is determined to support it to the maximum because we are trying to create history, namely developing the world's first mRNA vaccine for dengue fever," said Taruna.

As a regulator, BPOM conducts comprehensive supervision ranging from research, development, clinical trials, production, to post-marketing supervision, as mandated in Law Number 17 of 2023 concerning Health.

"This approach is also realized through a mechanism to support the development of new drugs so that regulators are present as strategic partners for researchers and industries," he said.

This commitment is strengthened by the international recognition that BPOM has achieved as a WHO-Listed Authority (WLA) and a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). This recognition is a symbol that the credibility of Indonesia's regulatory system is international standard and at the same time increases the world's confidence in the results of BPOM evaluations.

In recent years, his party has also continued to transform regulatory services.

The percentage of completion of approval of drug distribution permits according to the target time increased from 70.6 percent in 2024 to 76 percent in 2025 and reached 87.5 percent in the first quarter of 2026.