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The Emergent BioSolutions plant in Baltimore in April 2021. Photo: Saul Loeb/AFP via Getty Images

Emergent BioSolutions announced Thursday that the Food and Drug Administration is allowing its Baltimore plant to resume manufacturing materials for vaccines after it was shutdown in April due to contamination problems.

Why it matters: The plant, which had been producing vaccine materials for Johnson & Johnson and AstraZeneca, conflated ingredients between the two different types of vaccines last year and destroyed 15 million doses of J&J's vaccine.

  • The FDA launched an inspection of the plant and found unsanitary conditions near sensitive manufacturing areas, including peeling paint, waste that was not decontaminated and workers mishandling medical waste.

What they're saying: Emergent said Thursday that it addressed the contamination issues revealed through the inspection in coordination with J&J and FDA.

  • “The American people should have high expectations of the partners its government chooses to help prepare them for disaster, and we have even higher expectations of ourselves,” Emergent CEO Robert Kramer said in a statement.
  • “We have fallen short of those lofty ambitions over the past few months but resumption of manufacturing is a key milestone, and we are grateful for the opportunity to help bring this global pandemic to an end," he added.

The big picture: The error and the unsanitary conditions halted the potential production and shipment of tens of millions of J&J doses and prevented the company from distributing its vaccine in multiple countries.

  • The European Union, Canada and South Africa withheld J&J vaccines produced at the plant for several days this year to conduct safety testing.

Go deeper

Bryan Walsh, author of Future
Nov 5, 2021 - Health

New COVID pill shows the need for widescale testing

Illustration: Eniola Odetunde/Axios

Pfizer's new COVID-19 antiviral is highly effective when given early in the course of an infection — underscoring the importance of cheap, easily accessible COVID-19 tests, including at-home rapid versions.

Driving the news: Pfizer's oral antiviral drug reduced the risk of hospitalization or death from COVID-19 by 89%, according to interim results from a mid-to-late-stage study announced by the company on Friday, my colleague Rebecca Falconer writes.

Updated 4 hours ago - Politics & Policy

Omicron dashboard

Illustration: Brendan Lynch/Axios

  1. Health: Pfizer and Moderna boosters overwhelmingly prevent Omicron hospitalizations, CDC finds — Omicron pushes COVID deaths toward 2,000 per day — The pandemic-proof health care giant.
  2. Vaccines: The case for Operation Warp Speed 2.0 — Starbucks drops worker vaccine or test requirement after SCOTUS ruling — Kids' COVID vaccination rates are particularly low in rural America.
  3. Politics: Biden concedes U.S. should have done more testing — Arizona says it "will not be intimidated" by Biden on anti-mask school policies — Federal judge blocks Biden's vaccine mandate for federal workers.
  4. World: American Airlines flight to London forced to turn around over mask dispute — WHO: COVID health emergency could end this year — Greece imposes vaccine mandate for people 60 and older — Austria approves COVID vaccine mandate for adults.
  5. Variant tracker

Arizona governor sues Biden administration over COVID funds tied to mandates

A teacher prepares a hallway barrier to help students maintain social distancing at John B. Wright Elementary School in Tucson, Arizona, on Aug. 14, 2020. Photo: Cheney Orr/Bloomberg via Getty Images

Arizona Gov. Doug Ducey (R) filed a lawsuit Friday against the Biden administration for ordering the state to stop allocating federal COVID relief funds to schools that don't comply with public health recommendations such as masking, the Arizona Republic reports.

Why it matters: The Treasury Department said last week that the state would have to pay back the money if Ducey does not redesignate the $173 million programs to ensure they don't "undermine efforts to stop the spread of COVID-19."