Emergent: FDA letting troubled COVID vaccine factory restart

FILE - In this April 8, 2021 file photo, the Johnson & Johnson COVID-19 vaccine is seen at a pop up vaccination site in the Staten Island borough of New York. The U.S. Food and Drug Administration is allowing the problem-plagued factory of contract manufacturer Emergent BioSolutions to resume production of COVID-19 vaccine bulk substance to resume, the company said Thursday, July 29. The Baltimore factory was shut down by the FDA in mid-April due to contamination problems that forced the company to trash the equivalent of tens of millions of doses of vaccine it was making under contract for Johnson & Johnson. (AP Photo/Mary Altaffer, File) FILE - In this April 8, 2021 file photo, the Johnson & Johnson COVID-19 vaccine is seen at a pop up vaccination site in the Staten Island borough of New York. The U.S. Food and Drug Administration is allowing the problem-plagued factory of contract manufacturer Emergent BioSolutions to resume production of COVID-19 vaccine bulk substance to resume, the company said Thursday, July 29. The Baltimore factory was shut down by the FDA in mid-April due to contamination problems that forced the company to trash the equivalent of tens of millions of doses of vaccine it was making under contract for Johnson & Johnson. (AP Photo/Mary Altaffer, File)

By LINDA A. JOHNSON / AP Medical Writer July 30, 2021 3 min read

The U.S. Food and Drug Administration is allowing the problem-plagued factory of contract manufacturer Emergent BioSolutions to resume production of COVID-19 vaccine, the company said Thursday.

The Baltimore factory was shut down by the FDA in mid-April due to contamination problems that forced the company to trash the equivalent of tens of millions of doses of vaccine it was making under contract for Johnson & Johnson. The bulk vaccine was contaminated with an ingredient for AstraZeneca’s COVID-19 vaccine, which was being made in the same factory.

The process of restarting operations began Thursday, but it will take time for the factory to ramp up and reach the production level of before the shutdown, according to Emergent spokesman Matt Hartwig.

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.