FDA authorizes additional Johnson & Johnson batches from Baltimore facility

Two more batches of Johnson & Johnson’s COVID-19 vaccine have been released from the troubled Baltimore plant where millions of doses were ruined and production was halted last spring due to procedural errors.

The U.S. Food and Drug Administration now has authorized a total of eight batches of Johnson & Johnson vaccine from the Emergent BioSolutions plant near Johns Hopkins Bayview Hospital. It also has cleared three batches of AstraZeneca vaccine, though those are not authorized for use in the United States.


Emergent BioSolutions spokesperson Matt Hartwig did not specify how many doses of vaccine were in each batch, but previously said that tens of millions of them were under review. An estimated 75 million were rendered useless due to quality control and cross-contamination problems, and 50 million more have been authorized for use.

“We are proud that vaccine material produced at our facility in Baltimore is now helping vaccinate millions of people around the world as the pandemic continues to rage on,” Hartwig said in a statement.


The federal government has invested tens of millions of dollars in facilities for the Gaithersburg-based contractor to prepare for a possible pandemic and produce vaccine during times of need. Emergent had contracted with both Johnson & Johnson and AstraZeneca, but officials said production of the latter vaccine had been moved elsewhere.

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In a Tuesday letter, Marion Gruber, the FDA’s director of the office of vaccines research and review center for biologics evaluation and research, said the Baltimore plant still does not have emergency use authorization. But the federal agency removed authorization requirements for these batches so they could be shipped out.

Federal regulators gave the facility the green light to resume operations in July, owing to the public health crisis. Only a small portion of Americans have received the single-shot J&J vaccine. But the immunization has several advantages compared to the vaccines produced by Pfizer/BioNTech and Moderna, which require ultracold storage and two doses each, several weeks apart.

Johnson & Johnson’s vaccine remains a key component of the global vaccination effort and could help vaccinate people who live in remote areas or who lack easy access to health care providers. Less than half the global population has received at least one dose.

Emergent halted production at the Bayview plan last spring at the request of FDA officials after an inspection found significant sanitation and procedural errors there, including subpar facility maintenance and upkeep; hazardous handling of waste materials and other substances; improper showering and de-gowning procedures; and insufficient training of personnel to prevent cross-contamination, according to FDA report released in April.

Records obtained by The Baltimore Sun also highlighted problems at another Emergent facility in Baltimore near the Camden Yards stadium complex. The Camden plant, which did not produce any COVID-19 vaccines but did make monoclonal antibody therapies, had documented quality issues in recent years that required the company to make improvements.

The plant’s troubles have caused shocks to Emergent BioSolutions’ stock price. Its shares, which closed over $125 each in February, have fallen since, trading Thursday at $57.14, down 10 cents for the day.