The 60 million doses that must be discarded are in addition to the 15 million already thrown out that were contaminated by the AstraZeneca vaccine at the plant earlier this year, according to the knowledgeable person who spoke on the condition of anonymity because the individual was not authorized to discuss details. The person said the 60 million doses were made before and after the 15 million previously discarded and that the agency could not determine whether they were safe to use.
The decision about the 60 million doses being discarded was first reported by the New York Times.
The 10 million doses being released are expected to be sent overseas as part of President Biden’s effort to share vaccines with other nations. Millions of other doses that were made at the plant are still under review. The FDA has not yet authorized the facility to resume production of the single-shot Johnson & Johnson vaccine.
Peter Marks, director of the agency’s Center for Biologics Evaluation and Research, said in the statement, “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. 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.”
Europe’s drug regulator said Friday that batches of Johnson & Johnson’s coronavirus vaccine made for the region about the time when contamination issues were revealed at a U.S. manufacturing site would, as a precaution, not be used, according to Reuters.
South Africa’s Aspen Pharmacare, which was performing finish and fill of Johnson & Johnson vaccine, also was waiting for word on which of its doses would be cleared for use and which might have to be discarded, according to a local media report.
“This may pose another huge blow to African vaccine distribution,” said Zain Rizvi, law and policy researcher at the advocacy group Public Citizen.
The decision brings Johnson & Johnson closer to a resolution over a crisis that has frozen domestic production and distribution of its vaccine for months.
“Today’s decisions represent progress in our continued efforts to make a difference in this pandemic on a global scale, and we appreciate the close collaboration with the FDA and global health authorities,” Kathy Wengel, Johnson & Johnson’s executive vice president and chief global supply chain officer, said in a statement released by the company.
The company’s statement confirmed two batches of vaccine had been authorized for release. It did not address the question of the shots that were earmarked for disposal. Emergent also did not address the discarded doses. It said in a brief emailed statement it was pleased about the release of some doses but did not confirm the amount.
U.S. officials learned in April that up to 15 million doses of the Johnson & Johnson vaccine had been contaminated with the vaccine developed by Oxford and AstraZeneca, which was also being made at the facility. Federal authorities halted plant operations and directed Johnson & Johnson to assume a larger role in fixing the plant’s problems and managing it.
The Baltimore facility acted as a contract manufacturer for the Johnson & Johnson and AstraZeneca vaccines before the shutdown.
The release of the Johnson & Johnson doses comes as the White House responds to criticisms that it has not done enough to share vaccines with other countries. This week, the Biden administration said it is buying 500 million doses of the coronavirus vaccine developed by Pfizer, with German partner BioNTech, to donate to the world. Last week, the Biden administration announced details of a plan to share 25 million doses of vaccines globally in what officials described as a down payment on 80 million vaccines to be sent abroad by the end of the month.
A scathing FDA inspection report on the Emergent plant in April cited unsanitary conditions at the plant and a lack of adherence to basic protocols intended to prevent contamination of the vaccine.
The supply of the Johnson & Johnson vaccine has fluctuated. About 21 million doses have been delivered throughout the United States, of which about 11 million have been administered, according to the Centers for Disease Control and Prevention data. They were imported from the company’s operation in the Netherlands. No shots from the Emergent plant have been distributed.
With the Emergent plant failing to come online, supplies of Johnson & Johnson vaccine eventually began running short. The Biden administration in May stopped making new doses available to states. Even so, state officials still had the option of claiming unordered doses already allocated to them, in addition to using the millions of doses already delivered but not yet administered.
Over the weekend, the federal government began moving unclaimed doses to a stock for international donation, according to an administration official familiar with the developments who spoke on the condition of anonymity to discuss internal matters. The expectation is that new Johnson & Johnson vaccines will be available for states by next week, the official said.
About 100 million doses manufactured at Emergent before it was closed had been awaiting FDA clearance, according to Emergent.
Johnson & Johnson’s contract with the federal government had called for the company to have delivered 87 million doses by the end of May, worth $870 million in payments. A remaining 13 million doses were scheduled to be delivered by June 30.
After Emergent suspended vaccine production in April, Johnson & Johnson assumed a bigger role in managing the facility — a change dictated by the Biden administration. Officials also decided the facility would no longer make the AstraZeneca product when it resumed operations.
The House Oversight select subcommittee on the coronavirus crisis recently released a staff report that provided additional details about the Emergent debacle and how the Johnson & Johnson product was contaminated.
The panel also released an Emergent report saying a harmless virus from the AstraZeneca vaccine that is used to trigger immunity against the coronavirus was detected in a large batch of the Johnson & Johnson vaccine. The cross-contamination was detected by Johnson & Johnson on March 5 in a batch of vaccine manufactured between Jan. 19 and Feb. 21.
Emergent officials said the most likely route of contamination was during preparation of a growth medium for the Johnson & Johnson vaccine, which came into contact with the “waste path” from an area used to make the AstraZeneca vaccine.
During a hearing of the House subcommittee, Emergent officials were attacked for taking huge bonuses at the same time the factory failed to produce any vaccine that could be used in the United States or elsewhere.
Emergent’s CEO, Robert Kramer, told the House Oversight select subcommittee in testimony May 19 that Emergent has retained an independent quality oversight firm to monitor its performance. He said the company has performed cleaning, disinfection and repairs throughout the facility; improved waste-handling procedures; and boosted training for workers at the site.