2nd Taiwan COVID vaccine maker to apply for EUA on Phase 2 data

06/27/2021 08:58 PM
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Taipei, June 27 (CNA) Taiwanese vaccine maker United Biomedical Inc. (UBI) Asia announced Sunday that it will seek emergency use authorization (EUA) in Taiwan for its COVID-19 vaccine candidate before the end of June after unveiling the interim results of its Phase 2 clinical trials.

At a press conference, the company said trial results for its UB-612 vaccine had shown no major safety concerns, as no participants in the study experienced severe adverse reactions. The trial also produced good immunogenicity results, the company said.

Based on the results, UBI Asia said it would submit an EUA application to the Taiwan Food and Drug Administration (TFDA) before the end of this month.

UBI is the second Taiwanese drug maker to present Phase 2 clinical trial data.

Medigen Vaccine Biologics Corp. presented data in early June after completing its Phase 2 trial, and it has already filed for an EUA to the Taiwan FDA.

The guidelines announced by the Taiwan FDA for granting an EUA have been controversial because they do not require large-scale Phase 3 trials, which are typically the standard for determining efficacy.

Instead, the FDA will allow Phase 2 results to be analyzed via immunobridging, an approach which uses the immune responses measured in clinical trial participants to infer the vaccine's overall level of protection.

Though the approach has been debated in international forums, no consensus has yet been reached on its validity.

According to the guidelines announced by the Taiwan FDA, domestic COVID-19 vaccines must have a neutralizing antibody potency level equal to or higher than that of the AstraZeneca COVID-19 vaccine in order to be considered for an EUA.

The analysis must be based on samples of serum neutralizing antibodies taken 28 days after participants in a Phase 2 clinical trial of over 3,000 people received their second vaccine dose.

The company said that requirement was fulfilled on June 16.

At its Sunday press conference, UBI Asia said the vaccine's Phase 2 clinical trial was conducted in 12 Taiwan hospitals and enrolled over 4,000 volunteers.

A total of 3,850 final participants remained after screening in three age brackets; 12-18, 19-64, and 65 and above.

Participants in the 19-64 age bracket had a seroconversion rate of 95.65 percent, meaning 95.65 percent of them produced neutralizing antibodies.

Among participants aged above 65, the seroconversion rate fell to 88.57 percent, the company said.

It did not provide much antibody data beyond that, and, like Medigen did not produce any data on the vaccine's actual protective effect against COVID-19 because that was outside the scope of the trial.

UBI Asia said, however, that based on tests done on Phase 1 trial participants, the neutralizing antibodies generated by UB-612 were equally effective against the highly infectious Delta variant of the virus as against other variants.

The company said it will soon begin a Phase 2/3 efficacy trial in India that will feature 11,000 people.

According to the company, the UB-612 vaccine is the first multitope protein/synthetic peptide vaccine being developed to fight the SARS-CoV-2 virus, and elicits responses to several different viral proteins to protect against COVID-19.

The vaccine candidate is designed to mimic a natural infection to activate both antibody (B-cell) and cellular (T-cell) arms of the immune system to generate both protective neutralizing antibodies and T-cells against SARS-CoV-2.

The company said its vaccine is stable at temperature 2 to 8 degree Celsius, allowing for successful cold chain management with existing infrastructure.

UBI Asia announced last week that its U.S. affiliate, Vaxxinity, has signed a contract with Paraguay to provide 1 million doses of its COVID-19 vaccine once it gets emergency EUA from the Taiwan FDA.

Taiwan's government has signed contracts to purchase 5 million doses of the Medigen vaccine and another 5 million doses from UBI Asia.

(By Han Ting-ting and Joseph Yeh)

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