About 15 million doses of Johnson & Johnson’s coronavirus vaccine were mistakenly damaged at a factory in the United States, the New York Times reported.
When contacted by AFP, the pharmaceutical company said it identified a batch of doses in a Baltimore plant of the Emergent BioSolutions company “that did not meet quality standards.”
The company also said the batch “never advanced to the final stages of the manufacturing process.”
“Quality and safety remain our top priorities,” he said.
The plant is run by Emergent BioSolutions, a manufacturing partner of Johnson & Johnson and AstraZeneca, the British-Swedish company whose vaccine has not yet been licensed for use in the United States. Federal officials attributed the error to human error.
The confusion has delayed future shipments of Johnson & Johnson doses in the United States while the Food and Drug Administration investigates.
Johnson & Johnson has moved to strengthen its control over the work of Emergent BioSolutions to avoid additional quality failures.
“There are rigorous quality controls in all of our vaccine manufacturing processes and through these controls, a single batch of drug substance was identified that did not meet specifications and our rigorous quality standards. We isolate this batch and we will dispose of it properly,” said the company.
“Importantly, the quality control systems worked as designed to detect and isolate this single batch,” they said.
The company noted that batch discarding occurs occasionally during vaccine manufacture. It said it remains confident that it can meet its commitments to Johnson & Johnson and AstraZeneca, as well as to the federal government, which spent $ 628 million to reserve capacity and make improvements to the Emergent plant.
Disposal of a bulk batch of drug substance, while disappointing, occasionally occurs during vaccine manufacture, which is a complex, multi-step biological process.
Johnson & Johnson said it was dispatching more experts to the site to “oversee, direct and support all production of the Covid-19 vaccine,” of which it expects to deliver an additional 24 million doses “during April.”
The Emergent BioSolutions plant has not been licensed by regulators to produce a “drug substance” for the J&J vaccine, the company said, but US media reported that it is expected to produce millions of doses in the near future.
The J&J vaccine has been praised for being single-dose and because it does not require as low temperatures for storage as Moderna and Pfizer, which simplifies its distribution.