Baltimore Factory Forced to Toss Millions of COVID Vaccines to Resume Production

Emergent BioSolutions a Baltimore factory that helped Johnson & Johnson make its COVID-19 vaccine, was forced to toss out millions of doses of the vaccine in order to resume production due to a contamination issue, the Associated Press reported.

Emergent was shut down in mid-April by the Food and Drug Administration (FDA) due to a contamination problem with the vaccines produced there. Emergent tossed out tens of millions of doses of the vaccine which were contaminated with an ingredient for AstraZeneca's COVID-19 vaccine, which was made in the same factory.

The company did not say when exactly production would resume.

For more reporting from the Associated Press, see below.

Since April, FDA inspectors have combed the factory and reviewed security camera footage to identify lapses in handling material inside the factory and worked with Gaithersburg, Maryland-based Emergent to resolve a host of problems, including unsanitary conditions and poorly trained workers.

The agency also has been reviewing data on months' worth of vaccine substance made in the factory and has allowed several large batches of vaccine doses made from it to be released for distribution.

Emergent is one of several J&J contractors that produce 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.

The lapses at the Bayview factory 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. It's also cheaper than some other vaccines.

The productions problems have forced J&J to import millions of doses from its factory in the Netherlands to the U.S. and to miss supply commitments.

Emergent Chief Executive Robert Kramer said the company had fallen short of the public's expectations.

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.

The Biden administration has been working to find a different American manufacturing partner for British drugmaker AstraZeneca, whose COVID-19 vaccine isn't authorized for distribution in the U.S.