Phase 2 clinical trial results of the Medigen Vaccine Biologics Corp’s COVID-19 vaccine on Wednesday were published on the Web site of The Lancet: Respiratory Medicine, in an early preview before publication.
The study paves the way for other nations to issue emergency use authorizations or produce the Medigen vaccine, given The Lancet’s credibility as a highly respected medical journal with a rigorous peer-review process, Medigen’s international affairs director Lien Chia-en (連加恩) said.
Lien said that the study is important as it proposes methods for converting international units for efficacy comparisons.
Photo courtesy of the Food and Drug Administration
The methods have been used for correlating the efficacy of hepatitis B and HPV vaccines, but could become a first for COVID-19, he said.
The extrapolations from phase 2 data show that the Medigen vaccine has a predicted 80 to 90 percent efficacy, he said.
The leading vaccines for the pandemic have predominantly made use of mRNA technology, while the Medigen vaccine uses protein subunit technology, he said.
The phase 2 trials were double-blind, randomized and placebo-controlled, while the enrollment of more than 3,000 study participants offered an unusually large sample size, he said.
All of the participants were Asian, except for one Caucasian, he said.
National Health Research Institutes Chairman Lin Tzou-yien (林奏延), who is the principal investigator of phase 2 trials, said the EU has already approved using correlates of immunity for approving vaccines, making it more likely that the eurozone would authorize Medigen vaccines.
Yin Yi-ling (林宜玲), a research fellow at Academia Sinica’s Institute of Biomedical Research, said the institute’s biosafety level 3 lab has been fully mobilized to test samples for both Medigen’s and United Biomedical’s COVID-19 vaccines.
The task was completed within two months with the help of automation and lab partnerships whenever possible, she said.
On July 19, the Medigen vaccine became the only locally developed vaccine to receive emergency use authorization from the Food and Drug Administration after an expert panel voted in favor of the move.
The decision was criticized by some, as Medigen has yet to complete phase 3 trials, which are normally required for determining the efficacy of a vaccine.
The administration said at the time said that it granted authorization because the neutralizing antibodies generated in Medigen recipients compared well to those inoculated with AstraZeneca’s COVID-19 vaccine, a concept known as immunobridging.
Taiwan began its rollout of the Medigen vaccine on Aug. 23.
Additional reporting by Rachel Lin, Wu Liang-yi and CNA
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