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 into 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.
Doses set to expire
States are already scrambling to use up millions of Johnson & Johnson doses set to expire within the next few weeks. In Virginia, health officials reported at least 42,300 unused doses amid a sharp dropoff in demand for all vaccines.
Those doses were initially set to expire on June 23, according to Melissa Gordon, a spokeswoman for the Virginia Department of Health. But on Thursday, the FDA announced it was extending the shelf life of Johnson & Johnson vaccines — which originally ended after three months of storage — by about a month and a half.
That gives states more time to redistribute the doses, though it’s unclear whether demand can keep up. Virginia has administered far fewer doses of Johnson & Johnson that it has of Pfizer or Moderna, according to VDH data. Administrations struggled to recover after federal agencies ordered a temporary pause on the vaccine as they investigated rare reports of serious blood clots before resuming use of the vaccine.
As of June 9, administrations of Johnson & Johnson doses in Virginia dropped to zero. Gordon said the state developed a survey for providers and compared it with new vaccine orders in an effort to redistribute some of the unused doses. “Four redistributions amounting to approximately 3,225 doses have been coordinated,” she wrote in a Thursday email.
If the roughly 39,000 remaining doses aren’t used in the next month and a half, though, they’ll likely be thrown away.
“All providers who dispose of doses in this manner are required to report them to VDH so that VDH is able to keep track of this data,” Gordon wrote.
