Loss of the Month
Risk category: Product
Too complex to handle: Control of the COVID 19 vaccines
The Fierce Pharma article of April 2 gives some very interesting background information regarding the loss of 15 million doses of the Johnson & Johnson's COVID-19 vacciness at the Emergent BioSolutions’ plant at Baltimore Bayview.
This Emergent plant produces both J&J and the Vaxzevria AstraZeneca vaccines.
A Emergent spokesperson informed Fierce Pharma after the loss of the batch:
“Emergent BioSolutions performs "rigorous" quality checks throughout the vaccine manufacturing process and through these checks, a single batch of drug substance was identified that did not meet specifications and the rigorous quality standards. This batch will be isolated and it will be disposed of properly. This shows that Emergent's quality control systems are working. Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process."
One could argue that this a just a single batch, and distribution was halted. But what would have happened if this single control had not identified that the batch was not according to specs and would this have had serious health impact on the injected persons?
What is really worrying is that Medicine Agencies as FDA, MHRA and EMA perform all their own in-depth approval processes. The focus of their approval processes is primary the review of documents and papers provided by the Pharmaceutical companies. The control of the complete production chain from sourcing, production, distribution and sampling is far less covered and highly dependent on companies as Emergent BioSolutions and quality control systems managed by 3rd parties.
The single failure of mixing up, or contamination at the Emergent production sets back the delivery of millions of vaccines of both J&J and AstraZeneca.
This single batch was more than enough to vaccinate the complete population of The Netherlands and to give these people back their lives, let alone the huge financial impact.
This case illustrates that J&J; AstraZeneca; the authorities and the subcontractors loss sight of the impact of an incident and that approval processes are too much based on tick boxes and procedures and not on a risk based analysis taking the impact for the beneficiaries into consideration.
April 4, 2021
Risk category: Product- Recall