Medigen vaccine authorized for manufacturing: FDA

TAIPEI (The China Post) — Taiwan Food and Drug Administration (FDA, 食品藥物管理署) announced on Monday that it had authorized the manufacturing of Medigen vaccine (高端新冠肺炎疫苗) after an expert meeting.

Medigen vaccines confer active immunization against COVID-19, and the vaccine will be applicable to adults aged over twenty with a 28-day interval between two doses, the FDA added.

FDA Director-General Wu Shou-mei (吳秀梅) indicated that the FDA convened with experts in chemical manufacturing control, pharmacology, toxicology, clinical medicine, public health, law and medical ethics on Sunday to examine the manufacturing application for Medigen vaccine.

Considering that Medigen vaccines induce a similar Neutralizing Antibody Level as AstraZeneca (AZ) COVID-19 vaccines, the meeting reached the conclusion that Medigen vaccine satisfies the country’s regulations on manufacturing or importing COVID-19 vaccines without any major safety concerns.

Wu said the meeting was convened to analyze the overall medical benefits and risk out of the Taiwan Centers for Disease Control (CDC, 疾病管制署)’s concerns about the domestic pandemic and emergent public health demand.

She also indicated that except for the moderator, out of the other 20 experts present, 18 agreed, one disagreed, and one requested further inspection.

The meeting also proposed a recommendation that the pharmaceutical corporation should provide monthly safety monitoring reports throughout the entire authorization term and an effectiveness report by other institutions within one year after authorization

The authorization was in accordance with Pharmaceutical Affairs Act Article 48-2.