The Johnson & Johnson vaccine

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April 20, 2021 Johnson & Johnson said in late March that it had identified a batch of doses in a Baltimore facility run by Emergent Biosolutions "that did not meet quality standards". The

New York Times then revealed the huge amount of about 15 million doses

.



Emergent Biosolutions itself said in a note to the Securities and Exchange Commission that the FDA asked on April 16 to stop production at the Baltimore plant pending an inspection. "On April 16, 2021, at the request of the FDA, Emergent agreed not to start production of any new material at its Bayview facility and to quarantine existing material pending completion of the inspection and repair of any anomalies. ", explains the document.



Johnson & Johnson itself announced an internal investigation. At the time, the Emergent Biosolutions facility was not licensed by US regulators to produce a "drug substance" for the J&J vaccine, while tens of millions of doses are currently expected to be produced.