Taiwan's Medigen seeks usage approval for COVID-19 vaccine candidate


Posted at Jun 10 2021 07:40 PM

TAIPEI - Taiwan's Medigen Vaccine Biologics Corp said on Thursday that it was seeking a speedy emergency use authorization, or EUA, from the government for its COVID-19 vaccine candidate after safely completing phase II trials.

Developing its own vaccine has been a major goal of Taiwan's government, though it also has ordered some 20 million shots from Moderna Inc, AstraZeneca Plc and the COVAX global sharing scheme for lower income countries.

Only about 3% of Taiwan's 23.5 million people have received at least one shot, with further supplies held up by global production problems, as the island deals with a spike in domestic cases after months of relative safety.

Medigen's chief executive, Charles Chen, told a briefing they were pleased with the phase II results and would be submitting an EUA request to Taiwan's food and drug administration soon.

"Safety is very important, and our vaccine is very safe," he said, adding he was "very optimistic" about getting EUA.

Chen said that ultimately the company was preparing to produce 100 million doses, and export them to the small number of countries with which Chinese-claimed Taiwan has diplomatic relations after the vaccine gets international regulatory approval.

Taiwan's government last month signed deals with Medigen, and another local firm, United Biomedical Inc, for five million doses each, and has agreements for another five million each, for a total of 20 million shots.

Medigen says that more than 4,000 people participated in its second phase clinical trial and received two shots, and that it had seen no serious adverse reactions, with a placebo given to one in every seven participants.

The recombinant protein vaccine has been developed in collaboration with the National Institutes of Health in the United States.

Taiwan's government hopes to start administering the domestically developed vaccines next month.

The government, however, has come under criticism from opposition parties after President Tsai Ing-wen pledged last month to start administering domestically developed vaccines in July before results of the second clinical trial were released.

Tsai later said her government would strictly scrutinize the process under international scientific norms and put safety first.