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Johnson & Johnson vaccine supplier says ‘confident’ will meet FDA requirements

Washington: Johnson & Johnson (J&J) vaccine supplier Emergent BioSolutions said in a statement that it acknowledges it botched a batch of vaccines but it remains confident in its ability to meet the US government safety requirements and standards.

The statement comes a day after Johnson & Johnson reported on Wednesday that it found 15 million doses of vaccines to be unusable due to a human error in a Emergent Biosolutions’ plant in the city of Baltimore.

“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,” the statement said on Thursday. “Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process.”

Emergent BioSolutions said in the statement it remains confident the requirements it will meet the safety requirements and standards of the Food and Drug Administration (FDA).

The Johnson & Johnson vaccine was approved for emergency use in the United States at the end of February, becoming the third vaccine to be authorized by the FDA in addition to the ones produced by Pfizer/BioNTech and Moderna.

On Wednesday, Johnson & Johnson said in a statement that it was still planning to supply 100 million doses by the end of June and was aiming to deliver those doses by the end of May.

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