Medigen vaccines are far from receiving international certification: TPP legislator

TAIPEI (The China Post) — Taiwan People’s Party (台灣民眾黨) legislator Kao Hung-an (高虹安) announced on Thursday that Medigen vaccines (高端疫苗) are still far from receiving international certification.

She explained that it became especially so since the United States Food and Drug Administration (FDA) plans on canceling the Emergency Use Authorization (EUA).

After the unblinding process, Medigen decided to replace phase three trials for the vaccine with the process of immune-bridging.

However, this decision was rejected by the FDA as it is not scientifically certified.

According to Health Minister Chen Shih-chung (陳時中), without reaching the standards for EUA, Medigen vaccines cannot be proven to have any protective effect against the coronavirus.

Kao also cited Chen’s statement last week at the Legislative Yuan that no other country has received EUA by replacing phase three trials with immune-bridging.

According to Kao, the FDA’s response had been that immune-bridging is not an option.

As for whether requirements might change in the future, Kao said that since the FDA plans on canceling EUA, this can make it hard for Taiwan-produced vaccines to receive international certification.