TrialSite Staff Posted on Aug. 14, 2022, 10:30 a.m.
A drug and vaccine drug production facility in Baltimore plagued with problems was shut down by the U.S. Food and Drug Administration (FDA) in early 2021. Apparently suspended due to contaminants, the FDA allowed the production facility to go back online just months later in August of 2021. Now about 135 million doses of the Johnson & Johnson vaccine will need to be destroyed due to yet more quality mishaps at the same facility. Other production problems at an Emergent BioSolutions production facility reported by this media led to the destruction of 400 million vaccine doses last year. According to a statement by Johnson & Johnson has ended its relationship with Emergent BioSolutions. The New York Times covered this latest quality debacle late last month.
Emergent BioSolutions benefited from multiple federal contracts during the pandemic yet couldn’t keep the quality together to avoid the wastage of hundreds of millions of vaccine doses.
Emergent BioSolutions was a costly partner for AstraZeneca as well as Johnson & Johnson. A manufacturing partner in America they were apparently the cause of vaccine safety issues at the now notorious Baltimore plant run by Emergent BioSolutions. The most recent quality debacle was more widely reported in places such as India.
While Emergent BioSolutions has been plagued with production errors, they still benefit from ongoing federal government grants—meaning ultimately taxpayer-funded research.
Why aren’t the feds more concerned? TrialSite reported just a few months ago that the National Institutes of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) granted Emergent BioSolutions funds for yet another vaccine development effort. This time the funds went to Emergent BioSolutions to conduct a Phase 1 study evaluating an early-stage vaccine for Eastern Equine Encephalitis virus (EEV), Western Equine Encephalitis virus (WEEV) and Venezuelan Equine Encephalitis virus (VEEV).
Perhaps the quality issues plaguing the Emergent BioSolutions Baltimore production facility won’t be an issue for the development of investigational products for this novel vaccine?