Medigen Vaccine Biologics Corp (高端疫苗) on Tuesday said it has begun manufacturing its experimental COVID-19 vaccine, which it hopes to offer once it obtains an emergency use authorization (EUA).
The company has started producing antigens for its vaccine and filling them at a plant in Hsinchu, company spokesperson Leo Lee (李思賢) said by telephone.
“We hope to be able to offer our COVID-19 vaccine immediately after the Food and Drug Administration [FDA] greenlights it,” Lee said, declining to reveal how many doses the company has manufactured.
Photo: Huang Mei-chu, Taipei Times
President Tsai Ing-wen (蔡英文) has said that locally developed COVID-19 vaccines are expected to be available in July.
Medigen is running a phase 2 clinical trial of its experimental vaccine with 3,752 participants, who had been given the second shot by the end of last month, Lee said, adding that it plans to evaluate the drug’s efficacy at the end of this month.
The firm in the middle of next month would submit to health authorities its interim analysis report and hopes to gain the EUA soon, he said.
Asked if it is wise to start production when the FDA might change the vaccine formula, Lee said that the chances of that are slim, as the regulator reviewed the formula after the phase 1 trials.
“We expect two potential conclusions from the regulator’s review next month: pass or fail,” Lee said.
Medigen tested three doses of its vaccine — low, medium and high — in the phase 1 trials, with the medium dose showing the best potential, so the phase 2 trials only use the medium dose, he said.
“Even if the FDA concludes that the medium dose is not strong enough, the formula does not need to be changed, as the issue could be solved by giving people a third shot,” Lee said.
Medigen has not found serious adverse reactions or vaccine-associated enhanced diseases among participants in the phase 2 trials, it said.
An independent data monitoring committee said that its candidate is safe at a meeting on May 8, Medigen said.
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