The Chinese Nationalist Party (KMT)-affiliated National Policy Foundation yesterday questioned the safety and effectiveness of COVID-19 vaccine candidates from Medigen Vaccine Biologics Corp, citing a lack of phase 3 trials.
Foundation deputy director Huang Hsin-hua (黃心華) made the remarks in an online news conference a day after Medigen unblinded data from its phase 2 trials.
Although Medigen increased the sample pool of subjects in its phase 2 clinical tests in a bid to secure emergency use authorization, an expanded phase 2 is no substitute for phase 3 trials, Huang said.
Photo provided by the Military News Agency
The lack of phase 3 studies sets the Taiwan-made vaccines apart from those that have obtained international certifications, he said, adding that the nation should use its vaccines only as a backup to imported ones.
United Biomedical Inc, the other local firm developing a COVID-19 vaccine, has said it expects to complete the unblinding process this month.
The government has ordered 5 million doses each from Medigen and United Biological.
As indigenous vaccines are not fully tested, Taiwan should use them as a backup for when better-proven vaccines are not available, Huang said.
Vaccine evaluation, procurement and distribution are processes that should be regulated by professionalism, which government officials have failed to display, he said.
The government should show more transparency, use accredited evaluators and keep full records when evaluating domestically developed vaccines for emergency use, Huang added.
“It was curious that Medigen’s principal investigator was not at the conference to unblind the trials,” said former KMT legislator Arthur Chen (陳宜民), who was formerly vice president of Kaohsiung Medical University.
Chen asked why the government ordered vaccines before trials were unblinded and why the emergency use authorization criteria were announced by the Food and Drug Administration only a few hours before Medigen published its data.
Medigen’s and United Biomedical’s vaccines are designed around strains of the virus found in Wuhan, China, and the US, but the UK variant is predominant in Taiwan, Chen said.
“The entire world is watching a democratic state giving emergency authorization to vaccines still in phase 2 trials that conducted tests on fewer than 4,000 people, and jabbing 5 million to 10 million people with them,” he said.
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