There must be caution in the distribution of COVID-19 vaccines developed by Medigen Vaccine Biologics Corp and United Biomedical Inc before their phase 3 trials are conducted, former Centers for Disease Control director Su Ih-jen (蘇益仁) said on Monday.
Su’s comment came a day after Chinese-language media reported that Academia Sinica research fellow Chen Pei-jer (陳培哲) quit a Food and Drug Administration advisory committee to protest the government’s vaccine authorization plans.
Chen said he resigned late last month because he felt that the committee would have trouble remaining neutral when reviewing domestic vaccine candidates, with the major challenge to neutrality posed by President Tsai Ing-wen (蔡英文) herself after expressed hope that a locally developed COVID-19 vaccine would be available late next month.
Su, a former convener of the Cabinet’s vaccine technology development committee, said that “products that are not certain to be authorized for use or still far from it should certainly not be used in mass inoculation programs.”
Medigen and United Biomedical vaccines, of which the government has ordered 5 million doses each, are not expected to be subjected to phase 3 trials before obtaining emergency authorization, he said.
The Taiwanese firms are using additional test subjects and antibody counts in phase 2 trials in place of efficacy studies that typically are part of phase 3 trials, he said.
The measures are not enough to guarantee that the domestic vaccines will be fully effective, so they should not comprise the main part of Taiwan’s inoculation program, he said.
Although Pfizer, Moderna, AstraZeneca and Johnson & Johnson vaccines were granted emergency use authorizations, the manufacturers had carried out phase 3 trials, demonstrating their readiness for use, he said.
No more than 1 million people should receive domestic vaccines and only as a supplement to the more proven vaccines that the government must obtain from foreign sources, he said.
Should phase 2 trials produce promising results for the Taiwan-made vaccines, they could be deployed as a strategic reserve to plug supply gaps or to counter infection surges, he said.
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