FDA to authorize 2 batches of J&J vaccine made at troubled Baltimore plant

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BALTIMORE — Federal regulators at the U.S. Food and Drug Administration will authorize the use of millions of doses of Johnson & Johnson’s COVID-19 vaccine manufactured at the troubled Baltimore facility temporarily shut down earlier this year due to critical production errors.

About 10 million doses have been authorized under the FDA’s emergency use authorization, a source familiar with the decision said. The source could not say how quickly those doses would be shipped out from Emergent BioSolution’s Baltimore plant. The person also said federal regulators have recommended that more doses produced at the facility would have to be thrown out but could not immediately say how many.

The New York Times was reporting Friday that 60 million doses would need to be destroyed due to potential contamination.

Johnson & Johnson confirmed the authorization of the two batches Friday afternoon, saying the decision would allow the company to continue its efforts in mitigating the coronavirus pandemic on a global scale.

“The Company continues to substantially expand its global vaccine manufacturing network as we work with regulatory and health authorities to supply our COVID-19 vaccine worldwide,” it said in a statement.

As COVID-19 continues to impact countries and cause untold suffering worldwide, our commitment has never been stronger to contribute to a global solution to this public health crisis. We believe that a single-shot, easy to distribute COVID-19 vaccine is an essential tool to combat the pandemic globally.

Dr. William Moss, executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health, said the inability to use those doses underscores the tension between scaling up production of a life-saving biologic product and adhering to best scientific methods and practices.

“It’s obviously very tragic that an additional 60 million will have to be discarded at this plant, at this time of a huge global shortage of vaccines,” Moss said.

Production at the Emergent Biosolutions plant near Johns Hopkins Bayview Hospital was shut down in April due to mix-up of ingredients for the Johnson & Johnson vaccine. The FDA put Johnson & Johnson in charge of the plant and launched a review of the facility, which was largely paid for by the federal government to handle such needs.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the moves at the bulk vaccine production facility followed an extensive review that included the “production history of the facility and the testing performed to evaluate the quality of the product.”

“This review has been taking place while Emergent BioSolutions prepares to resume manufacturing operations with corrective actions to ensure compliance with the FDA’s current good manufacturing practice requirements,” Marks said.

Inspection reports of the facility made public in April show a range of problems at the Baltimore plant, including cleaning and sterilization failures; lack of adherence to protocols; and potential cross-contamination in multiple areas.

Johnson & Johnson subsequently assumed control of the plant at the request of federal officials.

Friday’s announcement by the FDA also included a decision to extend the shelf life for the refrigerated Johnson & Johnson vaccine to 4.5 months instead of 3 months, which could expand opportunities for its distribution in the U.S. and elsewhere.

It’s not clear where the useable doses will be shipped, though they could be sent overseas as the United States has ample supply of two other COVID-19 vaccines from Pfizer/BioNTech and Moderna and providers have adjusted to using them. Some providers also had switched to other vaccines when federal regulators temporarily paused use of the Johnson & Johnson vaccine to investigate a rare blood clotting condition, sowing further doubt in the public about its use.

A federal database shows that no doses of Johnson & Johnson’s vaccine have shipped since early May.

The one-dose Johnson & Johnson inoculation had been hailed earlier this year as particularly good option for certain vulnerable population such as those who are homeless because they would not have to return for a second dose and people who live far away from health care facilities. It also could be administered more easily in a mobile clinic because it needs only be store at refrigeration temperatures and not in a deep freeze like the other vaccines.

Moss said the vaccine offered a number of strategic advantages, but may not significantly influence the uptake in the U.S. given the widespread prevalence of the Pfizer and Moderna immunizations.

Maryland health officials confirmed they were not getting new doses earlier this month, but some providers said said they were still able to get some doses.

Officials with Emergent BioSolutions did not immediately comment Friday.