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Taiwan’s Medigen set to begin Phase 3 trials for its COVID vaccine in Europe

Study to compare vaccine efficacy with other jabs already approved by European Medicines Agency

Medigen COVID-19 vaccine. 

Medigen COVID-19 vaccine.  (CNA photo)

TAIPEI (Taiwan News) — Taiwan-based Medigen Vaccine Biologics Corp. (MVC) announced Wednesday (Sept. 22) that it has received a "positive response" from the European drug and food regulator to run third-phase human trials in Europe for its COVID-19 vaccine.

The European Medicines Agency (EMA) allowed the study to be carried out via immunobridging, meaning comparing the antibody levels in trial participants to that of people inoculated with vaccines already approved by the EMA. Vaccines authorized for use in the EU include Pfizer-BioNTech, Moderna, AstraZeneca and Johnson & Johnson.

The company is still finalizing details of the plan to apply for its Phase 3 clinical trials per the advice of the EMA, reported CNA.

The experiments would be conducted in multiple countries starting in October or November, involving no more than 4,000 participants. Results could be expected in the first quarter of 2022 as Medigen seeks EU certification for its jab, according to the company's board.

Separately, a third-stage trial for Medigen’s COVID jab is underway in Paraguay, also via immune-bridging. The study will pave the way for the indigenous Taiwanese vaccine to enter the Latin American market.

Last week, Medigen announced it had been permitted to conduct COVID trials in Colombia in a WHO-sponsored program for high-risk groups along with U.S.-based Inovio Pharmaceuticals.