FDA Clears 10M Johnson & Johnson COVID Vaccine Doses From Baltimore's Emergent BioSolutions
BALTIMORE (AP/WJZ) -- U.S. regulators are allowing for the release of 10 million doses of Johnson & Johnson's COVID-19 vaccine from a troubled Baltimore factory, WJZ has confirmed. But material to make many more must be thrown out because of possible contamination, according to the Associated Press.
The Food and Drug Administration announced that it had determined that two batches from the plant could be released. But it said several other batches are not suitable for use and additional batches are still under review.
The batches include about 10 million doses of the vaccines. These batches were fully inspected.
The doses originated at an Emergent BioSolutions factory, known as Bayview, that is making the vaccine for J&J. Those doses would be the first from the factory approved for use. J&J doses that had been administered came from other plants.
Emergent is one of several contractors for J&J that produces its one-shot vaccine in bulk. The concentrated vaccine then is shipped to other factories for final steps, including diluting them to the correct strength, putting them in vials and packaging them up.
Roughly 100 million doses made from bulk vaccine produced at Emergent's factory had been set aside for additional testing by FDA staff after factory employees accidentally contaminated a batch.
Back in April, a human error caused 15 million potential doses of the Johnson & Johnson vaccines to be "ruined."
That contamination led the FDA to shut down the factory in mid-April and send in a team of inspectors. They spent a week going through the factory and reviewing security camera footage that showed employees carelessly handling vaccine materials. The inspectors reported unsanitary conditions, poorly trained employees and other problems.
The lapses have hampered J&J's efforts to be a major player in vaccinating people, particularly in remote areas and poor countries, given that it's the only drugmaker with an authorized vaccine that only requires one dose and standard refrigeration.
The problems forced J&J to import millions of doses from its factory in the Netherlands and to miss supply commitments.
Emergent's factory had a history of FDA citations for problems including mold, dirty walls and floors, poorly trained employees and an inadequate strategy to prevent contamination, yet it was given a huge role in COVID-19 vaccine production by the Trump administration. Emergent was handed a lucrative contract to make many millions of COVID-19 vaccines for both J&J and AstraZeneca at the Bayview factory.
Emergent's chief executive has blamed the contamination and other problems on the complexity of scaling up the factory in just months to make two different vaccines.
Emergent BioSolutions' executives were grilled in a Capitol Hill hearing last month. Lawmakers wanted answers on what went wrong at the Baltimore facility when products that would have been used for 15 million doses of the Johnson & Johnson COVID-19 vaccine became contaminated.
The Biden administration is working to find a different American manufacturing partner for the British drugmaker, which has yet to request authorization to distribute it in the U.S.
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