US drug giant Johnson & Johnson was given full control over the Emergent Bayview Facility manufacturing the company’s covid vaccine in Baltimore after a major goof-up led to over 15 million doses of the vaccine being contaminated. It was reported that “human error” led to cross-contamination of the AstraZeneca vaccine material that was also being manufactured at the same plant.
The owner company Emergent BioSolutions might be allowed to retain some of its employees as long as it completely relinquishes the plant’s control. None of the doses left the manufacturing site as the error was caught in a routine on-site check. The incident happened before the Food and Drug Administration had verified the plant.
A senior official said that health officials held more than a week of discussions leading to the plant’s handover negotiation. This also means that the manufacturing of the AstraZeneca vaccine would be moved out of the unit. It is also to be noted that the AstraZeneca vaccine hasn’t yet been officially authorized for use in the United States.
In a press release, the company said, “Johnson & Johnson is providing additional experts in manufacturing, technical operations, and quality to be on-site at Emergent to supervise, direct and support all manufacturing of the Johnson & Johnson COVID-19 vaccine.”
Johnson & Johnson has also assured that they will still be able to furnish the agreed-upon 20 million doses by 7th April and an additional 24 million doses by the end of April.
“There are rigorous quality checks throughout our vaccine manufacturing processes, and through these checks, a single batch of drug substance was identified that did not meet specifications and our rigorous quality standards. We isolated this batch and it will be disposed of properly. Importantly, the quality control systems worked as designed to detect and isolate this single batch,” said Emergent Biosolutions, a long-time government contractor.
With 66% efficacy proven in clinical trials, the J&J vaccine has been approved for use in the United States and multiple European countries. It is a one-shot vaccine instead of the Pfizer and Moderna vaccines, and that it can be stored at temperatures much lower than the alternative vaccines make it a desirable option. Furthermore, the vaccine was able to prevent severe cases and hospitalizations to a very high degree.
On the other hand, the AstraZeneca vaccine has been shown to have an efficacy of 76%. It has been approved by the United Kingdom, India and several European countries. It is being manufactured by the Serum Institute of India in Pune under the name Covishield. Some safety concerns have been raised over this vaccine after reports of rare blood clots in some recipients. This led to multiple countries suspending the vaccine’s use before stating that the vaccine is ultimately safe. The UK recently said that it would give an alternative to people under 30 years of age over blood clot concerns as the “benefits outweigh the risks”.