WASHINGTON – After weeks of reviewing a troubled Baltimore plant, federal regulators have decided that about 60 million doses of the Johnson & Johnson coronavirus vaccine produced there should be discarded due to possible infection, according to people familiar with the situation.
The Food and Drug Administration plans to distribute approximately 10 million doses in the United States or to other countries, but with a warning that regulators can not guarantee that Emergent BioSolutions, the company that operates the plant, followed good manufacturing practices . The agency has not yet decided whether Emergent can reopen the factory, which has been closed for two months due to regulatory concerns.
The FDA has been trying for weeks to find out what to do with at least 170 million doses of vaccine that were dropped after the discovery of a major manufacturing accident involving two vaccines manufactured on 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 its workers had contaminated a Johnson & Johnson vaccine with a key ingredient used to make AstraZeneca. Federal officials then ordered the factory to suspend production, stripped Emergent of its responsibility to produce AstraZeneca’s vaccine and instructed Johnson & Johnson to establish direct control over its vaccine production.
Johnson & Johnson’s vaccine was once considered a potential game changer in the country’s vaccine supply because it required only one shot and was particularly useful in vulnerable communities. But the federal government now has enough vaccination from Pfizer-BioNTech and Moderna, the other two federally authorized vaccine developers, and no longer need Johnson & Johnson’s stock.
However, the loss of 60 million doses of Johnson & Johnson puts a dent in the Biden government’s plan to distribute vaccines to other countries that are still in the grip of the pandemic. The administration counted on the dose sharing of both Johnson & Johnson and AstraZeneca, but had to delay its plan while the FDA completed a review of the facility.
After arriving in Britain this week for the Group of 7 summit, President Biden announced that he had found another source for donations. Pfizer-BioNTech has now agreed to sell its administration 500 million doses in donation to low- and low-income countries next year. The World Health Organization estimates that 11 billion doses worldwide are needed to eradicate the epidemic.
The FDA’s actions are disappointing news for Emergent and Johnson & Johnson, who hired the firm as a subcontractor. According to people familiar with the situation, inspectors will still review the plant and are not expected to decide until later this month whether the company can reopen it. Regulators also remain in doubt as to whether the company, which was paid hundreds of millions of dollars by the federal government to manufacture coronavirus vaccines, has complied with manufacturing standards.
A Johnson & Johnson spokesman declined to comment.