FDA clears release of J&J vaccine from troubled Baltimore factory

The Food and Drug Administration on Friday announced that it approved the distribution of two batches of the Johnson & Johnson’s COVID-19 vaccine from a troubled Baltimore factory.

That’s about 10 million doses to be released from the Emergent BioSolutions facility, which came under fire after reports that factory employees accidentally contaminated a batch of vaccines.

“Before making this decision, the FDA conducted a thorough review of facility records and the results of quality testing performed by the manufacturer. Based on this review and considering the current COVID-19 public health emergency, the FDA concluded these batches are suitable for use,” the agency said in a statement.

The FDA said it is not ready to include the Emergent BioSolutions plant as an authorized manufacturing facility to produce Johnson & Johnson’s COVID-19 vaccine and that it is continuing to work through issues at the factory.

Although the FDA approved two batches for release, material to make many more doses could be thrown out due to possible contamination. Several other batches are not suitable for use, the FDA said, but additional batches are still under review.

About 100 million doses of the bulk vaccine produced at Emergent’s factory, including the two approved batches, had been set aside for additional review following the contamination of batches, the Associated Press reported.

The factory shut down in mid-April due to the contamination, prompting the FDA to send inspectors to the factory and to review security camera footage. In addition to employees mishandling vaccine materials, the inspectors reported poorly trained workers, unsanitary conditions and other problems.

Mishaps at the factory have caused Johnson & Johnson to miss supply commitments and forced the company to import millions of doses from its factory in the Netherlands to the U.S.

Emergent’s factory has been cited by the FDA in the past for issues such as mold, dirty walls and floors, inadequately trained workers and a weak strategy for preventing contamination.

On Thursday, the FDA extended the expiration date for refrigerated Johnson & Johnson’s COVID-19 vaccine by another six weeks. The one-dose vaccine can be stored at 35 to 46 degrees Fahrenheit for 18 weeks instead of 12 weeks.

• This article includes wire service reports.