Taiwan approves Medigen’s COVID-19 vaccine candidate

 People receive a vaccine against the coronavirus disease (COVID-19) during a vaccination session for elderly people over 85 years old, at a sports stadium in New Taipei City, Taiwan June 15, 2021. REUTERS FILE PHOTO

TAIPEI — Taiwan’s government on Monday approved the emergency use and production of Medigen Vaccine Biologics Corp’s COVID-19 vaccine candidate, a major step in the island’s plans to develop its own vaccines to protect against the coronavirus.

The vaccine candidate has yet to finish clinical trials and no efficacy data is available, but Taiwan’s health ministry said studies so far have shown that antibodies created by the shot have been “no worse than” those created by AstraZeneca’s vaccine.

Taiwan-based Medigen said last month it was seeking a speedy emergency use authorization, or EUA, from the government for its 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 and the COVAX global sharing scheme.

The health ministry said there were no major safety concerns during clinical trials in Taiwan of Medigen’s vaccine candidate.

It added that Medigen had to present a monthly report on safety for the vaccine candidate, MVC-COV1901, which is designed for people aged over 20, who will get two shots 28 days apart.

Health Minister Chen Shih-chung told reporters that with the EUA approved, it would now take some time for the company to ramp up its production.

“There should be a small amount of supply available in August,” he added.

Chen said the government “encourages” manufacturers to submit efficacy reports from further clinic trials within one year, referring to trials akin to Phase III trials.

Medigen’s shares closed down 1.35% on Monday before the announcement, compared to a 0.6% fall in the broader market.

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

Taiwan’s government in May signed deals with Medigen, and another firm developing a domestic vaccine, UBI Pharma, for five million doses each, and has agreements for another five million each, for a total of 20 million shots.

The EUA for UBI’s vaccine candidate is still pending.

Taiwan has massively ramped up its vaccination program in the last month following the donation of almost 6 million vaccine doses from Japan and the United States and the gradual arrival of vaccines directly ordered from manufacturers.

Around 20% of Taiwan’s 23.5 million people have received at least one of the two-shot vaccine regimen.

Taiwan now has the coronavirus under control after domestic cases spiked in May.

Chen said it was “possible” Taiwan would lower its COVID-19 alert level next week, under which personal gatherings are currently restricted and entertainment venues closed.