The FDA said that if any of the vaccines were exported, J & J and Emergent would need to allow authorities to confidentially share information about the manufacture of those batches with regulators in other countries.
Health
Some of the J & J vaccines can be used, but many must be discarded.Government and politics
An FDA statement suggested that the batch did not meet all of the authorities’ manufacturing quality standards. “This review was conducted while Emergent BioSolutions was preparing to resume manufacturing operations with corrective action to ensure compliance with the FDA’s manufacturing requirements,” said the FDA’s Bioforms Assessment. Dr. Peter Marks, director of the research center, said in a statement.
Authorities said the vaccine was “critically needed” given the current public health emergencies and made the decision after reviewing the records and quality inspection results.
However, the FDA stopped before allowing the factory to resume vaccine production. The agency said it is addressing the management issues of J & J and Emergent BioSolutions.
Emergent is one of J & J’s contractors for mass production of one-shot vaccines. The concentrated vaccine is shipped to other factories for final stages, such as diluting it to the appropriate concentration and packaging it in vials.
Approximately 100 million doses of vaccine made from bulk vaccines manufactured at Emergent’s factory were added by FDA staff as factory employees accidentally contaminated previous batches, including those just approved for use. It was reserved for review.
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