MFDS: "Decision on Pfizer Vaccine Introduction in Korea After Phase 3 Clinical Trial Completion"

[Image source=Yonhap News]

[Asia Economy Reporter Cho Hyun-ui] Interest is focusing on whether to introduce the COVID-19 vaccine being developed by the U.S. pharmaceutical company Pfizer and the German company BioNTech, as interim results show an efficacy rate of over 90%. The Ministry of Food and Drug Safety (MFDS) stated, "We will make a comprehensive judgment after reviewing the final results once the Phase 3 clinical trial is completed."

Seo Kyung-won, head of the Pharmaceutical Evaluation Department at MFDS, said at a regular briefing in the afternoon, "(The fact that the preventive effect is over 90%) is positive, but these are interim results." Pfizer's vaccine is currently undergoing Phase 3 clinical trials in six countries, including the U.S. and Brazil.

Seo added, "Once Phase 3 is completed, we will be able to comprehensively assess safety, duration of immunity, and effectiveness in the elderly," and "The government plans to discuss the introduction of the vaccine at the national level going forward."

Meanwhile, according to MFDS, a total of 28 clinical trials for COVID-19 treatments and vaccines have been approved domestically. Among these, 7 treatment clinical trials have been completed, leaving 21 ongoing trials: 19 for treatments and 2 for vaccines.

The newly approved clinical trials for treatments include two cases: Korea MSD's 'MK-4482' Phase 2/3 trial and NewGen Therapeutics' 'NewGen Nafamostat Tablets' Phase 1 trial. MK-4482 is a drug repurposing effort to develop a new drug originally for influenza treatment into a COVID-19 treatment. Nafamostat Tablets are developed as oral tablets from nafamostat mesylate injections, which are used as anticoagulants.

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