Safety Evaluation Research Institute "When Will the COVID-19 Treatment Candidates Arrive?"

Exterior view of the Safety Evaluation Research Institute

[Asia Economy Reporter Hwang Junho] The Safety Evaluation Research Institute, responsible for toxicity evaluation of treatments and vaccines for the novel coronavirus infection (COVID-19), stated on the 16th that it is currently "just waiting for candidate substances to arrive." Although various research institutions have presented clinical plans for developing COVID-19 treatments and vaccines, no toxicity evaluations have been conducted yet.

This institute is the only government-funded research institution in South Korea specializing in toxicity research. The fact that no evaluation cases related to COVID-19 have been submitted here indicates that research on COVID-19 treatments or vaccines has not yet matured enough to proceed to animal testing. Toxicity evaluations on animals must be completed before clinical trials on humans can begin.

The institute emphasized, "We are prepared to support safety evaluations for treatments and vaccines." It added, "toxicity evaluations of COVID-19 treatments must be conducted at accredited toxicity research facilities. In particular, depending on the type of treatment or vaccine, it may be necessary to use monkeys for toxicity testing." It explained, "Our institute is the only one in the country that holds internationally recognized Good Laboratory Practice (GLP) certification for monkey toxicity testing. We have received qualified certifications not only from domestic agencies such as the Ministry of Food and Drug Safety, the Rural Development Administration, and the Ministry of Environment, but also from international bodies like the OECD and the U.S. FDA, and we have extensive experience responding to various regulatory requirements."

Director Song Chang-woo said, "For biopharmaceuticals such as antibody treatments or vaccines, specific immune responses can cause serious side effects. Therefore, it is necessary to confirm safety using monkeys whose immune systems are similar to humans to minimize accidents during subsequent clinical trials on humans." He added, "Given the national disaster situation, the institute intends to focus all its capabilities on developing treatments and vaccines for COVID-19. Whether from companies or research institutes, as soon as candidate substances are brought in, we will set everything else aside and concentrate on toxicity testing."

This content was produced with the assistance of AI translation services.