Confident of meeting US govt standards, says supplier of Johnson and Johnson Covid-19 vaccine
Apr 02, 2021
Washington [US], April 2 : Johnson and Johnson (J&J) vaccine supplier Emergent BioSolutions said in a statement that it acknowledges it botched a batch of vaccines but is confident of its ability to meet 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 an Emergent Biosolutions' plant in the city of Baltimore, as reported by Sputnik.
"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."
"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," the statement further read.
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 May.
