The influenza virus has been particularly nasty in the last few years: in 2017, the U.S. death toll was the highest it had been in four decades. With such a high risk, the need for influenza vaccines worldwide has skyrocketed. While many inoculations have gone off without a hitch, Taiwan is facing an unsettling prospect.
After discovering that two batches of influenza vaccines had been found to contain impurities, they were returned to the manufacturer. According to Wang Po-yu, a senior specialist at the Taiwan Food and Drug Administration (TFDA), the vials contained “suspicious white and black suspended matter”; the normal color should be colorless and transparent.
Bad batches arise from a number of beginnings: a mistake or missed step in the manufacturing process, contamination with bacteria (or other viruses), and failure to maintain temperature controls. That last one is the hardest to manage due to the extensive travel involved in vaccine transportation. Since vaccines need to be stored at an ideal temperature, and some of them are traveling from the U.S. to Asia, it can be increasingly difficult to guarantee that they’re kept precisely at that temperature through the long journey, and as such they may not be functional anymore upon arrival.
Breakdowns can occur within laboratories as well if the three proper temperature guidelines are not followed: store the vaccine at the right temperature, record that temperature daily when the workday begins, and check it every time the refrigerator or freezer door is opened.
The nervousness surrounding the impure batches forced TFDA to put two more batches on hold pending investigation into the problem. They had been imported, along with 6 million other flu vaccines, from French vaccine manufacturer Sanofi and Taiwan-based vaccine maker Adimmune Corporation during 2018.
Fortunately, the Taiwan Centers for Disease Control (CDC) Deputy Director-General Chuang Jen-Hsiang confirmed ‘that none of the vaccines from the two batches have been distributed to local health centers.’ However, it is extremely likely that those in desperate need of their vaccines were forced to wait longer than is ideal.