Medigen Vaccine Biologics Corp (高端疫苗) yesterday announced that it has recruited 3,752 participants for the phase 2 clinical trial of its experimental vaccine against COVID-19, surpassing its target of 3,700 participants announced in January, and the Ministry of Health and Welfare’s requirement of 3,500 participants.
The participants have received the first dose of the experimental vaccine, MVC-COV1901, the company told a news conference in Taipei.
A total of 4,129 volunteers showed up for the trial, but some could not participate, as they were found to be ineligible due to autoimmune disorders, said National Taiwan University Hospital associate professor Hsieh Szu-min (謝思民), the principal investigator of the trials.
Photo: CNA
“We are still grateful to them. They knew they were not that strong, but they were willing to take the risk and support our clinical trials,” Hsieh said.
Some dropped out due to personal reasons.
For example, Minister of Health and Welfare Chen Shih-chung (陳時中) participated in the trial, but left as he opted for the AstraZeneca vaccine to demonstrate its safety to the public, Medigen said.
The company is collaborating with 11 local hospitals to conduct the trials to accelerate the process, it said.
While it was a challenge to recruit volunteers aged above 65, the company enrolled 746 senior citizens, above the ministry’s requirement of 700 people, Hsieh said.
Participants need to wait for 28 days before receiving a second dose, after which they would wait for another 28 days before the vaccine’s efficacy can be evaluated, he said.
As Medigen aims to apply for an emergency use authorization (EUA) for the experimental vaccine in early June, it needs to conduct an interim analysis in late May at the latest, which means the participants must receive a second dose by the end of next month, Medigen spokesman Leo Lee (李思賢) said.
The company is racing against time, Lee said, adding that it plans to conduct a phase 3 trial after obtaining an EUA.
The phase 3 trial would be crucial for Medigen to obtain formal marketing approval, which would help it sell the vaccine in overseas markets, Lee said.
The company is discussing with regulators the protocols for phase 3 human trials, he said.
“The phase 3 trial would need to be conducted overseas, as the outbreak of coronavirus has slowed down in Taiwan. However, it would be unethical to give placebos to participants in the test when COVID-19 vaccines are already available,” Lee said.
Placebos are used in double-blind human trials and Medigen uses them in its phase 2 trials.
The ministry is soon expected to announce its standards for neutralizing antibodies for COVID-19 vaccines, Lee said, adding that Medigen would find out if its vaccine meets the standard in the interim analysis.
Medigen reported a net loss of NT$29.37 million (US$1.03 million) for the first two months of this year, compared with a net loss of NT$79 million a year earlier.
It share price rose 4.04 percent to close at NT$296 in Taipei trading yesterday.
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