FDA authorizes additional batch of Johnson & Johnson vaccine from troubled Baltimore plant

The U.S. Food and Drug Administration has authorized an additional batch of COVID-19 vaccine produced by Johnson & Johnson at an East Baltimore plant where regulators previously determined several million doses of vaccine were unusable.

It is not clear how many doses the new batch contains, but regulators said in a Wednesday letter that they meet the agency’s standards for safety and effectiveness.


Meanwhile, the vaccine being produced at the facility, owned and operated by the Gaithersburg-based Emergent BioSolutions, still has not been authorized fully under the FDA’s emergency use authorization, said Marion Gruber, director of the office of vaccines research and review center for biologics evaluation and research, who signed the letter.

Emergent spokesman Matt Hartwig said the single-shot J&J vaccine produced in Baltimore is an important tool in the continued fight against COVID-19.


“We remained focused on helping secure the release of additional batches of vaccine drug substance under FDA review and returning to full production of J&J’s vaccine drug substance as soon as possible,” he said in a statement.

After the FDA stopped production at the Emergent plant last spring amid quality problems, federal regulators gave the facility the green light to resume operations in July, owing to the public health crisis.

The federal government invested hundreds of millions of dollars in the plant’s development to prepare for a possible pandemic and produce vaccine during times of need.

The Emergent facility, located next to Johns Hopkins Bayview Hospital, also had contracted to produce COVID-19 vaccines for AstraZeneca, which has not been authorized for use in the United States. Officials said production of that vaccine had been moved elsewhere.

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The plant’s problems embroiled the contractor and Johnson & Johnson in chaos after an FDA inspection shed light on cross-contamination and procedural errors happening routinely inside the facility.

An inspection report released by FDA officials in April showed significant sanitation and procedural errors at the facility, 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.

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.

An estimated 75 million single-shot vaccines at the plant have been rendered useless, but about 50 million have been cleared for use, Hartwig said previously.


Only a small portion of the COVID-19 vaccines that have been administered in the U.S. so far has been the Johnson & Johnson vaccine, but it remains a key part of the global vaccination campaign, given that inoculations are scarce in many parts of the world, and variants are presenting a new threat.

The single-shot vaccines, which do not require the same ultracold storage as those made by Pfizer/BioNTech and Moderna, are more suitable for some populations than others, such as patients in small doctors’ offices, those who live in remote areas, and people who are experiencing homelessness.

The troubles at the plant have caused shocks to Emergent BioSolutions’ stock price. Its shares, which closed over $125 each in February, have fallen since, closing Thursday at $58.50, down $1.35 for the day.