National Taiwan University Hospital’s (NTUH) Ethical Review Committee on Tuesday approved the hospital’s application to conduct human trials of mixed Moderna and Medigen COVID-19 vaccines.
The hospital yesterday said that 220 volunteers aged 20 to 70 who have received one dose of a Moderna vaccine eight to 12 weeks ago are to be enrolled in the program.
The volunteers are to be separated into two groups — a treatment group and a control group — and a double-blind study would be conducted, assigning Medigen or Moderna vaccines to the groups on a random basis, it said.
Photo courtesy of the Changhua County Government
The trial is expected to start next week at the earliest, with the data to be unblinded about one month later to inform participants which vaccine they had, it added.
Clinical trial head Hsieh Szu-min (謝思民) said the study is being conducted as vaccine availability remains in flux and several countries have started administering a mixture of COVID-19 jabs to address the shortage.
The study has elected to mix Moderna with Medigen as they share the same protein make-up, Hsieh said, adding that if the tests prove that the mix is viable, using the locally produced Medigen vaccine, which is more readily available and has lesser side effects compared with Moderna, would be a boon for the public.
Ministry of Health and Welfare Advisory Committee on Immunization Practices convener Lee Ping-ing (李秉穎) has said that a second dose of the Moderna vaccine has been observed to produce stronger side effects, while Medigen’s side effects are less pronounced.
Blood samples are to be drawn on the 14th day and 28th day of the first month, as well as on the third month and sixth month for testing, Lee said.
At least two to three months would be needed to collect enough data to judge whether there are “good” immunoreactions that can be used as reference material for formulating vaccine policies, he said.
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