Human errors at a manufacturing plant forced Johnson & Johnson to throw away 15 million doses of its COVID-19 vaccine – enough to immunize 7% of America’s adult population.
The New York Times, which first reported the loss on March 31, 2021, called it a “major inconvenience” for the vaccine maker and its subcontractor, Emergent BioSolutions.
But while errors with an impact of this magnitude seem shocking, they are also a reminder that the vaccine manufacturing process in the United States has strict quality control measures designed to detect these problems before they reach the public. .
The manufacture of vaccines is complex, with many potential points of error. As an expert in healthcare operations and COVID-19 vaccine deployment, I follow the vaccine manufacturing and approval processes closely. The multiple levels of quality controls by the producer and external inspectors throughout the process are essential to protect public health.
Check vaccines and check them again
A big part of the vaccine development process is ensuring vaccine safety.
After authorizing a vaccine, the United States Food and Drug Administration must approve and regularly inspect each vaccine manufacturing facility. Before each batch of vaccine 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 vaccine 48 hours before distribution. This rigorous quality control process has led to what the FDA describes as the safest vaccine supply in US history.
The quality control process is also how Johnson & Johnson discovered flaws in the 15 million dose batch at the Emergent BioSolutions plant.
The Baltimore plant was one of many factories hired by the federal government in 2020 to help vaccine manufacturers ramp up production. The facility was still awaiting FDA clearance to deliver the vaccines destined for the United States when the issues were discovered. As standard practice, Johnson & Johnson said there were specialists on site to verify safety and quality. The Washington Post reported that workers at the facility in late February mixed ingredients for AstraZeneca and Johnson & Johnson vaccines, both produced there, calling the whole batch into question. The FDA had previously reported quality control issues at the Emergent Baltimore plant related to its testing of a potential treatment for anthrax, according to records obtained by The Associated Press.
All vaccine manufacturing plants – domestic and international – must obtain clearance from the FDA before they can supply vaccines to the American population. The Johnson & Johnson vaccines currently in use in the United States were manufactured at Johnson & Johnson’s own facilities in the Netherlands.
The US government’s Operation Warp Speed was also involved in quality control. At one point, it deployed 16 Defense Department staff to two manufacturing sites to fill gaps in the quality control workforce so that production could continue.
After the vaccines are distributed, the Centers for Disease Control and Prevention will continue to monitor patients for any problems.
[Get the best of The Conversation, every weekend. Sign up for our weekly newsletter.]
How long does it take for quality checks?
The United States learned years ago how critical quality controls and independent verification are to vaccine safety. In 1955, the deployment of the polio vaccine led to 40,000 vaccine-induced polio infections.
Flu vaccine maker Sanofi says it spends around 70% of its production time on quality checks and that its vaccines are re-checked by health officials once they are shipped from the world. establishment.
The new mRNA technology used by COVID-19 vaccine makers Moderna and Pfizer is a little less difficult because it does not involve a live virus like traditional influenza vaccines do. Pfizer says it spends more than half of its production time ensuring the quality of each batch.
Manufacturing improvements are also crucial
Improving the manufacturing process is just as important as thorough quality testing because mistakes do happen.
In 2020, AstraZeneca revealed that a manufacturing error led to a dose and a half – instead of two – of its vaccine being administered to nearly 3,000 patients in the study. This error clouded the results of his study and delayed the US approval process by several months.
The Biden administration has asked Johnson & Johnson to strengthen its oversight of Emerging’s production process. The incident shows that the industry has work to do to minimize manufacturing errors. Yet I would say that the public has every reason to remain confident in the rigorous quality control process that prevents the circulation of bad vaccines and ensures vaccine safety.