U.S. HHS Orchestrates COVID-19 Vaccine Production Plant Take-Over
The NYT reported at the direction of the US Department of Health and Human Services, Johnson & Johnson (J&J) will take charge of Emergent BioSolution's Baltimore product plant that ruined 15 million doses of its Janssen COVID-19 vaccine, senior federal health officials confirmed on April 3, 2021.
New Jersey-based J&J confirmed this news to the Washington Post.
News reports indicate workers at the Emergent plant mixed up ingredients of two experimental COVID-19 vaccines, J&J's Janssen and AstraZeneca. The production error was detected, and none of the contaminated vaccine doses were distributed.
On March 31, 2021, J&J released the following statement:
'Since January of 2020, Johnson & Johnson has been working directly with governments, health authorities, and other companies to help end the global pandemic. We continue to expect to deliver our COVID-19 vaccine at a rate of more than one billion doses by the end of 2021.
We are pleased we have met our commitment to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the United States. This is part of our plan to deliver 100 million single-shot vaccines to the U.S. during the first half of 2021, aiming to deliver those doses by the end of May.
As with the manufacturing of any complex biologic medication or vaccine, the start-up for a new process includes test runs and quality checks to ensure manufacturing is validated and the end product meets our high-quality standards. This approach includes having dedicated specialists on the ground at the companies that are part of our global manufacturing network to support safety and quality.
This quality control process identified one batch of drug substances that did not meet quality standards at Emergent Biosolutions, a site not yet authorized to manufacture drug substances for our COVID-19 vaccine. This batch was never advanced to the filling and finishing stages of our manufacturing process.
This is an example of the rigorous quality control applied to each batch of a drug substance. The issue was identified and addressed with Emergent and shared with the United States Food & Drug Administration.'
And on April 1, 2021, Gaithersburg, MD-based Emergent released the following statement:
'Our Bayview facility has been designed and validated to meet all current Good Manufacturing Practices. In addition, 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.
Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process.
We continue to manufacture in support of our customers and the U.S. government, and we remain confident in our ability to meet the FDA requirements. We are very proud of the role the Emergent team is playing in support of the response to COVID-19 and look forward to continuing to do our part to help stem this pandemic.'