In a rush to produce and distribute millions of COVID vaccines, Johnson & Johnson’s manufacturing facilities have fallen under intense scrutiny for their significant FDA violations. After having to dispose of 15 million vaccines that had been contaminated due to human error, attention is being brought to the prior infractions of the production companies being used.
One of these companies, Emergent BioSolutions, has been working with J&J to produce and distribute over 100 million coronavirus vaccinations. However, FDA reports show that they have a history of repeated violations since 2017, recently receiving FDA criticism for having improperly trained employees working in vaccine production.
Marcellinus Dordunoo, the lead investigator for the FDA, has expressed concerns regarding the data integrity of the biopharmaceutical company as well as the testing and lab procedures which don’t seem to be up to expected standards. Another FDA inspector reported inadequate systems for disposing of rejected vaccines, allowing for possible mix-ups and/or contamination of viruses in circulation.
Emergent is not the only one of J&J’s manufacturers to be accused of insufficient conditions. A factory owned and operated by Merck & Co., another pharmaceutical company that is working with J&J to produce vaccines, has been reported to have many health and safety issues as revealed by a former FDA safety officer.
The whistleblower disclosed that previous inspectors of the Merck factory had significantly minimized major violations they witnessed in 2017, including an account of employees soiling their uniforms instead of taking bathroom breaks because of the lengthy process of taking off their equipment and going to the off-site bathrooms. The former FDA officer also reported that the company knowingly destroyed evidence of these violations.
It seems that quality is being sacrificed for quantity in these cases, but J&J continues to set lofty goals for vaccine production with no sign of slowing down. It seems that in the haste of trying to race to distribute vaccines, the quality of production facilities may have been overlooked. Hopefully there will be more focus on quality control and health/safety standards moving forward so as not to contaminate further batches of vaccinations.