Taiwan's Medigen Successfully Unblinds Phase 2 Vaccine Clinical Trials, EUA Review as Early as July
China Times, June 11, 2021
Medigen Vaccine Biologics Corp., a biopharmaceutical company based in Taiwan, unblinded the phase 2 clinical trials of its coronavirus (COVID-19) vaccine. General Manager Charles Chen announced on June 6 that the phase 2 clinical trial was "successful in unblinding" with safety, tolerability, and no adverse reactions, and Medigen would speed up its phase 3 clinical trials. Regarding the vaccine candidate’s demonstration of its efficacy and its international certification, Medigen will hammer them out in a scientific way, and strive to be listed in coming July. Frustrated with President Tsai Ing-wen's "politics before science approach", Academician Chen Pei-jer of Academia Sinica, who resigned from the vaccine review committee of the Food and Drug Administration (FDA), Ministry of Health and Welfare (MOHW), stated that this is a planned script with no surprise.
Medigen Claims Safety, No Adverse Reactions
The phase 2 of the Medigen unblinding was claimed to be a success, when will the inoculation across Taiwan be carried out? Executive Vice President Leo Lee indicated that the data will be submitted to the FDA in the hopes of obtaining the emergency use authorization. If everything goes well, vaccines will be available in July. At the same time, the Medigen will also consult with the European Medicines Agency and others to apply for the Phase 3 clinical trials, with the ultimate goal of obtaining a regular drug certificate for the vaccine and international certification. Deputy Division Chief Wu Ming-mei of the FDA stated that the Medigen will submit the results of the phase 2 clinical trial to the FDA for review. In late June, the said results will be compared with that of AstraZeneca vaccine to measure the efficacy. As early as July, an expert meeting is expected to be held for review. If a green light is given then, the FDA would speed up its administrative tasks, It would take three to five days to sort out.
President Tsai had expressed that she hoped to start administering vaccines island-wide by the end of July. Deputy Minister of Health and Welfare Shih Chung-liang stated during the interpellation at the Legislative Yuan that his ministry will do the best to accommodate President Tsai’s expectation. General Manager Chen pledged that as long as the Medigen is granted the emergency use authorization (EUA), this company could cooperate with the Tsai administration this year to provide 10 million doses of the vaccine.
Comparison with AstraZeneca in June to Determine Efficacy of Neutralizing Antibodies
Although Medigen declared that it set a goal of completion of the Phase 3 clinical trial, Charles Chen admitted that the trial cost is prohibitively high. The Medigen has to spend $10,000 USD on each trial participant. It was expected to enroll 30,000 participants in phase 3 trial, cost of which was estimated to be $300 million USD. In order to achieve this goal, Medigen didn’t rule out the possibility of undertaking the phase 3 clinical trial in some friendly countries or places with high incidence.
The phase 2 clinical trial is to pave the way for the phase 3, while the phase 3 clinical trial is to obtain international certification next year, which not only guarantee the unimpeded travel of nationals abroad, but also further aid the friendly countries by providing them with hundreds of millions of doses, Chen said.
Su Ih-Jen, former Director-General of the Centers for Disease Control, MOHW, indicated that the domestic vaccine candidate has only completed the Phase 2 clinical trial. It should not be rolled out before passing the Phase 3 clinical trial. Therefore, even if the FDA issues an emergency use authorization for the local vaccine manufactured either by Medigen or United BioPharma after successful unblinding, it should only be used as an emergency backup vaccine.
However, Deputy Minister Shih stated that as long as vaccine candidates prove safe and effective through the same standard test, they are good vaccines.
Immuno-Bridging Inference of Efficacy May Generate Regulatory Confusion
As for the FDA’s decision to conduct an immune bridging study to certify locally developed vaccines, Su reminded that BioNTech, Modena, AstraZeneca and other vaccines are all vaccines that have undergone phase 3 clinical trials and have actually been tested in the risk of infection. Even if the FDA uses the bridging approach to infer the efficacy of local vaccines, the positioning of the two is definitely not the same. Administering local as well as AstraZeneca and Modena vaccines to the public may generate confusion in terms of applying current regulations.
From: https://www.chinatimes.com/