United Biomedical Inc Asia (UBI, 聯亞生技) has reapplied for emergency use authorization (EUA) for its COVID-19 vaccine candidate after an attempt last year to get one fell through.
An EUA request for the company’s UB-612 product was delivered to the Food and Drug Administration (FDA) on Monday, the company said in a statement yesterday.
The company said that it is analyzing data from its second clinical trial and planning for a phase 3 clinical trial is ongoing.
Photo: Screen grab from the Web site of United Biomedical Inc Asia
The original EUA request was rejected on Aug. 16 last year after the ability of the UB-612 candidate to neutralize SARS-CoV-2 failed in one aspect to meet the FDA’s standards.
For a vaccine candidate to be granted an EUA, it has to have geometric mean titers (GMTs) — an indicator of neutralizing antibodies across a test group — of at least two-thirds the level in people given the AstraZeneca vaccine.
UBI’s candidate fell short of the 125 GMTs necessary to meet the threshold, and its EUA application was therefore rejected, the FDA said at the time.
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