WASHINGTON — After weeks of reviewing a troubled Baltimore factory, federal regulators have decided that nearly 60 million doses of the Johnson & Johnson coronavirus vaccine should be discarded because of potential contamination, according to people familiar with the situation.
The Food and Drug Administration plans to allow about 10 million doses to be distributed in the United States or shipped to other countries, but with the caveat that regulators cannot guarantee that the company that operates the plant, Emergent Biosolutions, Adheres to good manufacturing practices. People said the agency has not yet decided whether Emergent can reopen the factory, which has been closed for two months due to regulatory concerns.
For weeks the FDA has been trying to figure out what to do about at least 170 million doses of the vaccine following the discovery of a major production accident involving two vaccines manufactured at the site.
More than 100 million doses of Johnson & Johnson and at least 70 million doses of AstraZeneca were halted in March after Emergent discovered that its employees had used a batch of Johnson & Johnson vaccines to produce AstraZeneca. Was contaminated with a major component to be used. Federal officials then ordered the plant to halt production, removed Emergent from its responsibility for producing AstraZeneca’s vaccine, and directed Johnson & Johnson to claim direct control over manufacturing of its vaccine.
Johnson & Johnson’s vaccine was once considered a potential game-changer in the nation’s vaccine stock because it required only one shot and was particularly useful in vulnerable communities. But the federal government now has a substantial supply of vaccines from Pfizer-BioNtech and Moderna, two other federally authorized vaccine developers, and Johnson & Johnson no longer needs supplies.
Still, Johnson & Johnson’s loss of 60 million doses puts a dent in the Biden administration’s plan to distribute the vaccine to other countries still hard hit by the pandemic. The administration was counting on both Johnson & Johnson and AstraZeneca sharing supplements, 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 for donations. Pfizer-BioNtech has now agreed to sell 500 million doses to its administration for donation to low- and lower-middle-income countries over the next year. The World Health Organization estimates that 11 billion doses are needed globally to seal the pandemic.
The FDA’s action is disappointing news for Emergent and Johnson & Johnson, which hired the firm as a subcontractor. According to people familiar with the situation, inspectors are still reviewing the plant and are not expected to decide whether the company can reopen it until the end of this month. Regulators are also casting doubts over whether the company, which has been paid hundreds of millions of dollars by the federal government to make a coronavirus vaccine, adheres to manufacturing standards.
A Johnson & Johnson spokesman declined to comment.