- The Maryland-based contractor tapped to make Johnson & Johnson's coronavirus vaccine failed to appropriately investigate the cross-contamination that ruined millions of doses last month, according to inspectors sent by the Food and Drug Administration to review the factory's operations.
- Agency officials documented numerous breaches of manufacturing and sanitary standards at the Emergent Biosolutions facility, a report made public Wednesday showed, including mishandled waste, peeling paint in hallways and rooms, and piled-up equipment. Employees were not properly trained, the inspectors concluded, and frequently moved between areas producing separate vaccines without following procedures meant to prevent contamination.
- The federal government contracted Emergent to produce the "drug substance" material for both J&J's vaccine and a similar shot developed by AstraZeneca at its site in Baltimore. But the manufacturing mix-up in March reportedly ruined material for some 15 million J&J doses and led the the FDA to shut down production there.
The FDA's report gives the clearest picture yet of some of the manufacturing failings that led to the costly error at Emergent's plant last month, a setback that could imperil the steady supply of J&J's vaccine in the U.S.
Inspectors from the agency descended on the Baltimore facility, known as Bayview, on April 12, nearly two weeks after initial reports of the contamination and its immediate consequences. Over nine days at the site, and after reviewing security camera footage and building access logs, the officials made nine specific "observations," or findings of concern.
Topmost was their conclusion that Emergent failed to "conduct thorough investigations into unexplained discrepancies." While the document is partially redacted, the inspectors' account appears to describe a case of cross-contamination between drug substance batches of two viral vector vaccines, almost certainly J&J's and AstraZeneca's.
"There is no assurance," the FDA inspectors wrote, "that other batches have not been subject to cross-contamination," raising the possibility that more supply may have been ruined than initially reported.
They documented other concerns, too, including the sanitary condition of the plant itself and cramped spaces through which materials were moved. Security camera footage showed workers tossing unsealed bags of medical waste into a service elevator and dragging them across the warehouse floor.
Employees appeared to repeatedly enter and re-enter areas used to manufacture the two separate vaccines. But shower logbooks and camera footage, the inspectors wrote, don't appear to show the employees appropriately de-gowned, showered and re-gowned in between.
In a statement, Emergent said the observations are "correctable" and committed to taking "swift action to remedy them."
The Baltimore plant, however, is now being overseen directly by J&J, which took over responsibility after the initial incident and has final sign-off on manufacturing that takes place at the site. As a result, production of AstraZeneca's vaccine was stopped, and the federal government is currently looking for other contractors to help produce the British drugmaker's shot.
No vaccines made by Emergent at the Bayview site were ever distributed in the U.S., as the FDA hadn't yet approved the site before the mix-up occurred. Supplies came instead from J&J's own plant in the Netherlands.
Vaccinations with J&J's shot are currently on pause in the U.S. after regulators identified an unusual combination of blood clots alongside low platelet levels that occurred in six women who received the vaccine. All were hospitalized and one died. The apparent side effect is extremely rare, but regulators acted forcefully, partially due to concern about instructing physicians how to appropriately treat the condition.
A committee of advisers to the Centers for Disease Control and Prevention meets Friday to discuss resumption of use and any potential restrictions that might be needed to ensure patient safety.
Even if the panel gives a green light to resume vaccinations — as European regulators did this week — J&J's shot isn't likely to play a major role for some time due to the supply problems unfolding at the Emergent plant.
On a conference call Tuesday, J&J executives reiterated their commitment to delivering 100 million doses to the U.S., which had been expected to come by the end of June.
"At this time, as we continue in discussions with the FDA, it is premature to speculate on any potential impact that this may have on our timing of our vaccine deliveries," said J&J CEO Alex Gorsky on the Tuesday call.
At the FDA's request, production at the plant is now paused while the observations in the report are addressed.
Already manufactured vaccine substance will undergo additional testing, the FDA said. "We will not allow the release of any product until we feel confident that it meets our expectations for quality," the agency added.
Nearly 135 million Americans have received at least one vaccine dose through April 21, according to CDC data. Of those, only about 8 million received a J&J shot.