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Why Johnson & Johnson throwing out 15 million COVID-19 vaccine doses shouldn’t scare you

Why Johnson & Johnson throwing out 15 million COVID-19 vaccine doses shouldn’t scare you

Human errors at a manufacturing plant forced Johnson & Johnson to throw out 15 million doses of its COVID-19 vaccine – enough to vaccinate 7% of the U.S. adult population.

The New York Times, which first reported the loss on March 31, 2021, called it “a major embarrassment” for the vaccine-maker and its subcontractor, Emergent BioSolutions.

But while errors with an impact of that magnitude sound shocking, they’re also a reminder that the U.S. vaccine manufacturing process has strict quality control measures designed to catch these problems before they reach the public.

Vaccine manufacturing is complex, with many potential points for errors. As an expert in health care operations and the COVID-19 vaccine rollout, I closely follow vaccine manufacturing and approval processes. The multiple layers of quality checks by the producer and external inspectors throughout the process are essential to protect public health.

Checking the vaccines, and checking them again

After authorizing a vaccine, the U.S. Food and Drug Administration must approve and regularly inspect each vaccine manufacturing facility.

Before each batch of vaccines is released by the FDA, it undergoes rigorous and extensive testing to ensure vaccine safety. In the case of COVID-19 vaccines, manufacturers are required to submit the results of each quality control test for each batch of vaccines 48 hours prior to its distribution. This stringent quality control process has led to what the FDA describes as the safest vaccine supply in U.S. history.

The quality control process is also how Johnson & Johnson discovered defects within the batch of 15 million doses at the Emergent BioSolutions facility.

The Baltimore plant was one of several contracted by the federal government in 2020 to help vaccine-makers ramp up production. The facility was still awaiting authorization from the FDA to deliver the vaccines for U.S. use when the problems were discovered. As standard practice, Johnson & Johnson said it had specialists at the facility to check safety and quality. 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.

April 1, 2021 

https://theconversation.com/

April 2, 2021 / Pharma News
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