. The Washington Post reported that workers at the facility in late February mixed up the ingredients for the AstraZeneca and Johnson & Johnson vaccines both being produced there, throwing the entire batch into question. The FDA had previously flagged quality control concerns at Emergent’s Baltimore plant related to its testing of a potential treatment for anthrax, according to the records obtained by the Associated Press.
All vaccine manufacturing plants – domestic and international – require authorization from the FDA before they can supply vaccines to the U.S. population. The Johnson & Johnson vaccines currently used in the U.S. were manufactured in Johnson & Johnson’s own facility in the Netherlands.
The U.S. government’s Operation Warp Speed has also been involved in quality control. At one point, it deployed 16 Department of Defense personnel to two manufacturing sites to fill gaps in the quality control workforce so production could continue.
After vaccines have been distributed, the Centers for Disease Control and Prevention continues to monitor for any problems in patients.
How much time goes into quality checks?
Flu vaccine-maker Sanofi says it now spends about 70% of its production time on quality checks, and its vaccines are checked again by health officials once they’re shipped from the facility.
The new mRNA technology used by COVID-19 vaccine-makers Moderna and Pfizer is somewhat less challenging because it doesn’t involve live virus, as traditional flu vaccines do. Pfizer says it spends more than half of its production time on assuring the quality of each batch.
Manufacturing improvements are also crucial
Manufacturing process improvement is just as important as thorough quality testing, because errors do happen.
In 2020, AstraZeneca revealed that a manufacturing error led to one-and-a-half – instead of two – doses of its vaccine being given to nearly 3,000 study patients. That error clouded its study results and delayed the U.S. approval process by months.
The Biden administration has asked Johnson & Johnson to step up its supervision of Emergent’s production process.
The incident shows that the industry has work to do to minimize manufacturing errors. Yet, I would argue that the public has every reason to remain confident in the rigorous quality control process that prevents bad vaccines from circulating and ensures vaccine safety.
This article was originally posted on Why Johnson & Johnson throwing out 15 million COVID-19 vaccine doses shouldn’t scare you