First batches of Medigen vaccines pass Taiwan FDA examination

TAIPEI (The China Post) — The Food and Drug Administration (FDA, 食藥署) of the Ministry of Health and Welfare (MOHW, 衛福部) announced on Monday that it had completed the examination and inspection of 265,528 doses of the first four batches of the Medigen Vaccines, and have issued a certificate.

According to the FDA, the vaccines produced by Medigen Vaccine Biologics Corporation (高端疫苗生物製劑股份有限公司), were submitted to them for batch-by-batch inspection and sealing recently.

The FDA then sent personnel to the low-temperature storage site to check the vaccine batch number, count the quantity and check the cold chain.

Around 600 doses of vaccine samples were taken from each batch for foreign body examination, the FDA added.

After the vaccine was sealed, the samples were taken back to the National Laboratory of Food and Drug Administration for tests, including on its appearance, identification, pH value, aluminum content, total protein content, antigen content, bacterial endotoxin, sterility, abnormal toxicity, and more.

After the first four batches of vaccines were reviewed by the FDA and passed the inspection, the seal certificate was issued on the evening of July 30, and the inspection and sealing operation is being carried out in the warehouse.

The sealed vaccine can now be handed over to the Taiwan Centers for Disease Control (CDC, 疾管署) for follow-up vaccination processes.