Taiwan’s UBI Pharma Experiences Setback with COVID-19 Vaccine Plans

Taiwan’s FDA has rejected UBI Pharma’s application for emergency use authorization (EUA) of its COVID-19 vaccine candidate (UB-612) on Monday, saying that it did not meet the geometric mean titer (GMT) required for approval.

This apparent setback to the island’s goal of developing home-grown vaccines is offset by Medigen’s planned roll-out of its own vaccine next Monday (Aug 23).

Safe to Use but Not Very Effective 

In order to obtain an EUA from the Taiwan FDA, a vaccine must satisfy two criteria: a seroconversion rate exceeding 50% and a GMT level equal to at least two-thirds of that found in people who received the AZ jab.

Released in late June, interim results of UBI’s Phase 2 clinical trials show that UB-612 recipients aged 19-64 had a seroconversion rate of 95.65%, which meant that 95.65% of them developed neutralizing antibodies, satisfying the first criterion.

However, GMT levels were recorded at 102.3, which fell short of the second requirement.

UBI’s Plans Going Forward 

UBI shares fell by 30% following Monday’s EUA rejection. The company said Monday night that it will file an appeal with the FDA to overturn the EUA rejection.

GMT levels should not be the only deciding factor for efficacy without considering other factors such as the reaction of T cells, said the company. It has also called on the FDA to compare the effectiveness of UB-612 against the Delta variant with that of the AZ vaccine.

The company has confirmed the continuation of its Phase 2 clinical trial in Taiwan. It would also re-evaluate the “benefit assessment” of the Phase 3 clinical trial, which has recently been given the green light by the Ministry of Health and Welfare. Furthermore, UBI will conduct Phase 3 clinical trials in India, with the participation of 11,000 people.

Medigen Acknowledged by President Tsai

The other locally-grown vaccine, developed by Medigen Vaccine Biologics Inc., has had a smoother ride, having secured emergency use approval in Taiwan last month.

Released in early June, interim results of Medigen’s Phase 2 clinical trials revealed that the vaccine had a seroconversion rate of 99.8% across all ages, with a GMT of 662, which satisfied the FDA’s EUA standards.

A roll-out of 614,204 Medigen doses will be made available starting next Monday (Aug 23), while Taiwan’s government has signed a deal to buy 5 million doses. The Presidential Office spokesman has announced that President Tsai Ing-Wen had booked an appointment to receive the Medigen vaccine when distribution begins.

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Joy Lin

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