Troubled Maryland plant told to toss part of the J&J vaccine ingredient it manufactured
Several batches of the J&J vaccine substance were deemed unsuitable, and other batches are under review.
WASHINGTON — Federal health regulators have instructed Maryland’s Emergent BioSolutions to scrap some batches of the Johnson & Johnson COVID-19 vaccine substance manufactured at the company’s troubled Baltimore plant, while clearing a small portion to be used in the U.S. or sent abroad.
Two batches of the J&J vaccine substance made in Baltimore were deemed “suitable for use” by U.S. Food and Drug Administration regulators, but “several other batches” were deemed not usable and other batches remain under review, according to an agency news release Friday.
Agency officials did not estimate how many doses are in those batches. The New York Times reported Friday that the equivalent of 10 million J&J vaccine doses was cleared for use, and roughly 60 million doses’ worth of ingredients would need to be discarded.
Previous estimates from company officials had projected that the drug substance that was quarantined for review could be used to produce more than 100 million doses.
“These actions followed an extensive review of records, including the production history of the facility and the testing performed to evaluate the quality of the product,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement.
“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.”
The FDA statement added that the agency is not yet authorizing Emergent’s facility to produce new J&J doses, and that company officials are continuing to “work through issues.”
Emergent BioSolutions chief executive officer Robert Kramer acknowledged during a hearing of the House Select Subcommittee on the Coronavirus Crisis in May that his company had not yet produced one vaccine dose usable in the United States, despite a multi-million-dollar federal contract.
The company’s struggles came to public view in late March, when quality control checks revealed cross-contamination at the Baltimore facility, which was producing substances to be used in vaccine doses from both J&J and AstraZeneca.
In April, FDA investigators flagged a series of shortcomings at the plant, including failure to properly disinfect equipment and improper training of employees.
Company officials have said the cross-contamination occurred when substances transported from the part of the facility that produces the AstraZeneca materials “came in the general vicinity” of where the J&J materials are produced.
AstraZeneca material is no longer produced at the Baltimore facility, and J&J officials also are now providing 24-7 oversight as Emergent works with federal regulators to resume production.
The situation also has prompted an investigation by congressional Democrats, who released a memo last month detailing Emergent’s $27 million-a-month federal contract, and documents showing that a Trump administration adviser flagged risks at the Emergent plant in June 2020.
The two batches that now will be available were cleared for use after FDA regulators reviewed facility records and results of quality testing, according to the agency.
If those doses are sent overseas, FDA officials said the agency will share relevant information about those batches with regulators in the countries receiving any doses.
The Biden administration has pledged to share at least 80 million vaccine doses with other countries by the end of June.