WASHINGTON – After weeks of examining a struggling factory in Baltimore, federal regulators have decided that about 60 million doses of the Johnson & Johnson coronavirus vaccine produced there should be discarded due to a possible contamination, according to people familiar with the situation.
The Food and Drug Administration plans to allow approximately 10 million doses to be distributed in the United States or shipment to other countries, but with a warning that regulators cannot guarantee that Emergent BioSolutions, the company who operates the plant, followed good manufacturing practices. The agency has yet to decide whether Emergent can reopen the plant, which has been closed for two months due to regulatory issues, residents said.
For weeks, the FDA has been trying to figure out what to do with at least 170 million doses of vaccine that were left in limbo after the discovery of a major production incident involving two vaccines manufactured at the site.
More than 100 million doses of Johnson & Johnson and at least 70 million doses of AstraZeneca were suspended after Emergent discovered in March that his employees had contaminated a batch of Johnson & Johnson vaccines with a key ingredient used to produce AstraZeneca. Federal officials then ordered the plant to halt production, relieved Emergent of its responsibility to produce AstraZeneca’s vaccine, and asked Johnson & Johnson to exercise direct control over the manufacture of its vaccine there. .
Johnson & Johnson’s vaccine was once seen as a potential change in the country’s vaccine stock, as it only required one injection and was especially useful in vulnerable communities. But the federal government now has an adequate supply of vaccines from Pfizer-BioNTech and Moderna, the other two federally licensed vaccine developers, and no longer needs the supply from Johnson & Johnson.
Yet the loss of 60 million doses of Johnson & Johnson puts the brakes on the Biden administration’s plan to distribute vaccines to other countries still in the grip of the pandemic. The administration had been relying on dose sharing from Johnson & Johnson and AstraZeneca, but had to delay its plan while the FDA completed a review of the facility.
After arriving in Britain for the Group of 7 summit this week, President Biden announced he had found another source of donations. Pfizer-BioNTech has now agreed to sell its 500 million-dose administration at cost for donation to low- and lower-middle-income countries within the next year. The World Health Organization estimates that 11 billion doses are needed worldwide to eradicate the epidemic.
The FDA’s action is disappointing news for Emergent and Johnson & Johnson, which has hired the company as a subcontractor. Inspectors are still examining the plant and are unlikely to decide whether the company can reopen it until the end of the month, according to people familiar with the situation. Regulators also continue to cast doubt on whether the company, which has been paid hundreds of millions of dollars by the federal government to make coronavirus vaccines, has adhered to manufacturing standards.
A spokesperson for Johnson & Johnson declined to comment.