Taiwan's FDA Approves Second Local Vaccine for Human Trials, Expediting COVID-19 Research Efforts

Strategic Insights -

Taiwan's Food and Drug Administration (FDA) has conditionally approved United Biomedical, Inc., Asia (UBI Asia) to start clinical trials for its coronavirus vaccine, marking the second Taiwanese-made vaccine to enter the human testing phase. This move follows Adimmune Corporation's approval to begin Phase I clinical trials for its vaccine candidate, AdimrSC-2f (COVID-19 S-protein), last week. UBI Asia's UB-612 vaccine is expected to begin human trials after receiving official notice from the FDA, with the company having promised to supplement additional technical documents before administering vaccines.

Key Takeaways:

  • Taiwan's FDA has conditionally approved UBI Asia for clinical trials of its coronavirus vaccine, UB-612, making it the second Taiwanese-made vaccine to enter human testing.
  • UBI Asia's human trials will begin after receiving official notice from the FDA, which is expected to arrive in the next few days.
  • The company has promised to supplement additional technical documents before administering vaccines, as approved by local health experts.
  • Adimmune Corporation, a Taiwanese vaccine maker, was previously approved for Phase I clinical trials of its vaccine candidate, AdimrSC-2f (COVID-19 S-protein).
  • Medigen Vaccine Biologics Corp. is expected to receive approval for human trials soon, bringing the total number of Taiwanese vaccine developers in clinical trial stages to three.
  • The National Health Research Institutes (NHRI) and Enimmune Corp. have not filed applications for the approval of human trials for their vaccines.

Statistics:

  • 2 Taiwanese-made vaccines have entered the human testing phase, with UBI Asia's UB-612 and Adimmune Corporation's AdimrSC-2f (COVID-19 S-protein) being the two approved candidates.
  • 3 Taiwanese vaccine companies are expected to start clinical trials: UBI Asia, Medigen Vaccine Biologics Corp., and Adimmune Corporation.
  • The number of local health experts involved in the approval process for UBI Asia's vaccine trials is not specified.
  • UBI Asia has not specified the number of subjects expected to participate in the upcoming human trials.

Sources:

  • Taiwan's FDA (Aug. 28)
  • CNA (Aug. 28)