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The Emergent BioSolutions plant in Baltimore, Maryland. Photo: Tasos Katopodis/Getty Images

The European Union, Canada and South Africa are withholding Johnson & Johnson coronavirus vaccines produced at an Emergent BioSolutions plant in Baltimore, Maryland, for safety testing after quality-control problems, according to the New York Times.

Driving the news: Johnson & Johnson said in March that workers at the Emergent facility, which had been producing Johnson & Johnson and AstraZeneca vaccines, had ruined about 15 million doses of its vaccine by contaminating a batch with ingredients used in the AstraZeneca vaccine.

Context: The error halted the potential production and shipment tens of millions of Johnson & Johnson doses while the Food and Drug Administration conducted an investigation.

  • The plant had not been approved by the FDA to produce doses that would be used in the U.S., but it had produced doses that were shipped abroad and are being administered in some countries without issues.
  • But some regulators in various countries are working to ensure that doses produced prior to the accident are uncontaminated.

The big picture...

  • European Union: The European Medicines Agency told the Times that one batch of Johnson & Johnson vaccine manufactured at the Emergent facility is being used but only after "a thorough testing of the batch and a review of the controls in place at the manufacturing site.”
  • Canada: Health Canada told the Times it is performing assessments of vaccine manufactured at the Emergent plant and that the doses “will only be released for distribution once Health Canada is satisfied that they meet the Department’s high standards for quality, safety and efficacy.”
  • South Africa: Its national health ministry told the Times that Johnson & Johnson doses are awaiting “a protracted safety verification process with international regulatory agencies."

The FDA, in a report last month, faulted Emergent for failing to thoroughly review the incident and said the plant suffered from multiple unsanitary conditions, including peeling paint in sensitive manufacturing areas and waste that was not decontaminated.

  • The agency said workers at the plant were also seen on surveillance footage mishandling medical waste.
  • The FDA told the Times that the agency was “in close communication with our foreign regulatory counterparts regarding this ongoing matter to ensure they’re aware of the situation.”
  • "In a statement, Johnson & Johnson said it was working with U.S. and other regulators and emphasized that 'quality and safety' were paramount," the Times reported.

Go deeper

Aug 13, 2021 - Health

Coronavirus case surges force school closures

Students during the first day of school at Roosevelt Elementary School in Anaheim, California, on Aug. 12. Photo: Jeff Gritchen/MediaNews Group/Orange County Register via Getty Images

Several counties across the U.S. have temporarily suspended school because of a surge in coronavirus cases among students and faculty early in the academic year.

Why it matters: Richard Besser, former acting director of the Centers for Disease Control and Prevention, told NBC this week he believes more schools will close due to COVID-19 than last year because the Delta variant spreads with greater ease than other versions of the virus.

Biden administration offers aid to Florida schools defying DeSantis order

Florida Gov. Ron DeSantis (left) and Education Secretary Miguel Cardona. Photos: Joe Raedle and Win McNamee via Getty Images

The Biden administration is stepping in to offer financial assistance to Florida educators defying Gov. Ron DeSantis' law banning local K-12 mask mandates.

Why it matters: The battle over mask mandates in schools has been brewing for weeks. The Republican governor recently threatened to withhold pay from superintendents and school board members who go against his ban.

Oregon governor sending 1,500 National Guard troops to assist hospitals

Photo: Nathan Howard via Getty Images

Oregon Gov. Kate Brown said Friday she is deploying up to 1,500 National Guard troops to support hospitals as Delta continues to reach across the United States.

Why it matters: 733 Oregonians are currently hospitalized with severe cases, including 185 in intensive care, Brown said.