FDA approves some J&J Covid-19 vaccine batches from Baltimore site previously responsible for contamination
The regulator announced on Friday that two lots of doses of the vaccine made at the Emergent BioSolutions facility are “suitable for use”, despite recent concerns that conditions at the plant could compromise the safety of vaccines.
In April, FDA inspectors flagged a series of health and safety concerns at the plant, where the previous month’s production of the Janssen jab had been stopped after 15 million doses were ruined in an inadvertent contamination.
The reported issues included the personal hygiene of staff, inadequate training and a failure to keep surfaces clean.
The FDA said in a statement on Friday it had made its decision to use some doses from the site following a review and in light of the “current Covid-19 public health emergency.”Also on rt.com Scathing FDA report finds J&J Covid vaccine plant where 15mn doses were ruined is unsanitary, staff training inadequate
It did, however, add that it was still “not yet ready to include the Emergent BioSolutions plant in the Janssen EUA [Emergency Use Authorization] as an authorized manufacturing facility.”
The regulator also confirmed it had determined that “several other batches are not suitable for use,” while others remain under review.
On Friday the New York Times, citing anonymous sources, said the FDA had ordered J&J to discard 60 million doses of the Janssen jab produced at the Baltimore site, due to their “possible contamination.”
Reuters reported it had confirmed via sources close to the matter that J&J has already thrown away around 10 million doses.
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