TAIPEI, July 19 (Reuters) – The government of Taiwan on Monday approved the emergency use and production of Medigen Vaccine Biologics Corp’s (6547.TWO) COVID-19 vaccine candidate, a major milestone in the plans of the island to develop its own vaccines to protect against the coronavirus.
The vaccine candidate has not yet completed clinical trials and no efficacy data is available, but Taiwan’s health ministry said studies so far have shown that the antibodies created by the vaccine were “not worse than” those created by the AstraZeneca vaccine (AZN.L).
Taiwanese company Medigen said last month it was asking the government for a Rapid Emergency Use Clearance, or EUA, for its vaccine candidate after safely completing Phase II trials.
Developing its own vaccine has been a major goal of the Taiwanese government, although it has also ordered some 20 million vaccines from Moderna Inc (MRNA.O), AstraZeneca and the global sharing program COVAX.
The health ministry said there were no major safety concerns during clinical trials in Taiwan of Medigen’s vaccine candidate.
He added that Medigen was due to submit a monthly safety report on the vaccine candidate, MVC-COV1901, which is designed for people over 20, who will receive two injections 28 days apart.
Health Minister Chen Shih-chung told reporters that with EUA approval, the company would now need some time to ramp up production.
“There should be a small amount of supply available in August,” he added.
Chen said the government “encourages” manufacturers to submit efficacy reports of other clinical trials within a year, referring to trials similar to phase III trials.
Medigen shares closed 1.35% lower on Monday before the announcement, compared to a 0.6% decline in the broad market (.TWII).
The recombinant protein vaccine was developed in collaboration with the United States National Institutes of Health.
The government of Taiwan in May signed agreements with Medigen and another company developing a national vaccine, UBI Pharma (6562.TWO), for five million doses each, and has agreements for another five million each, for a total of 20 million hits. Read more
The EUA for UBI’s vaccine candidate is still pending.
Taiwan massively stepped up its vaccination program last month following the donation of nearly 6 million doses of vaccine from Japan and the United States and the gradual arrival of vaccines ordered directly from manufacturers.
About 20% of Taiwan’s 23.5 million people have received at least one of the two-shot vaccine regimens.
Taiwan now has the coronavirus under control after domestic cases increased in May.
Chen said it was “possible” for Taiwan to lower its COVID-19 alert level next week, under which personal gatherings are currently restricted and entertainment venues closed.
Reporting by Ben Blanchard and Yimou Lee; Editing by Kirsten Donovan Christopher Cushing and Michael Perry
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