WASHINGTON — The FDA on Tuesday issued a use authorization for an additional batch of Johnson & Johnson vaccines, that were manufactured at the troubled Emergent BioSolutions facility in Baltimore.
This comes days after regulators signed off on about 10 million doses to be distributed, but directed that 60 million be tossed due to possible contamination and conflation with the AstraZeneca vaccine, which is also being manufactured at the facility.
It was the first time any of the doses at that plant were approved for use.
Still, the FDA recommended the authorized doses come with a disclosure that states the batches were not made in total compliance with requirements.
The discarding of millions of vaccines is the latest setback for Emergent.
Several red flags were raised back in April, following an 8-day inspection that uncovered dirty conditions, potential cross contamination and ill trained employees.
That prompted congress to open up their own investigation into how the company ended up with the J&J vaccine contract in the first place.
It also coincided with a nationwide pause of the Johnson & Johnson vaccine after concerns arose of blood clotting, that were not in any way related to the Baltimore facility.
As of June 17, Emergent BioSolutions has yet to receive FDA authorization as a manufacturing facility for the Johnson & Johnson vaccine.