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Taiwan's United Biomedical reapplies for vaccine authorization

UB-612 previously rejected because it did not 'match up to AstraZeneca vaccine'

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UBI offices. (Google Maps photo)

UBI offices. (Google Maps photo)

TAIPEI (Taiwan News) — Taiwan's United Biomedical Inc (UBI Asia) announced Friday (Aug. 27) it would resubmit an application for emergency use authorization (EUA) of its COVID-19 vaccine UB-612, per CNA.

UBI released its phase 2 trial results on June 27 and filed an EUA for its coronavirus vaccine candidate. The application was rejected by the Taiwan Food and Drug Administration (TFDA) in August, saying the antibodies triggered by the candidate didn’t “match up to those of the AstraZeneca vaccine.”

On Friday, the company said in a statement its UB-612 vaccine is the first "multitope" protein/synthetic peptide vaccine developed to fight COVID-19. It said the vaccine had proven effective in stimulating T-cell and cell immunity in clinical trials.

Although the phase 2 clinical trial results fell slightly short of EUA standards, the UB-612 vaccine is expected to be effective against the rapidly expanding delta strain of the virus, according to UBI Pharma. UBI said data will be sent to Taiwan's Center for Drug Evaluation and the TFDA for re-examination.


Updated : 2021-09-20 22:21 GMT+08:00