WASHINGTON – Federal regulators have told Johnson & Johnson that, according to people familiar with the situation, approximately 60 million doses of its coronavirus vaccine, made in a troubled Baltimore factory, cannot be used due to possible contamination.
The Food and Drug Administration plans to distribute or ship to other countries approximately 10 million doses in the United States, but with warnings that regulators cannot guarantee that Emergent BioSolutions, the company that operates the facility, has good manufacturing practices followed.
The agency has not yet decided whether Emergent can reopen the factory, which has been closed for two months due to regulatory concerns, people said.
The doses previously administered by Johnson & Johnson in the United States were manufactured at the company’s facility in the Netherlands and not by Emergent. For weeks, the FDA has been trying to figure out what to do with at least 170 million doses of vaccine that have remained pending after the discovery of a major manufacturing accident involving two vaccines made at the Baltimore factory.
More than 100 million doses of Johnson & Johnson and at least 70 million doses of AstraZeneca were put on hold after Emergent discovered in March that its employees contaminated a batch of Johnson & Johnson’s vaccine with a key ingredient used to make AstraZeneca . Federal officials then ordered the plant to suspend production, removed AstraZeneca’s responsibility for manufacturing the vaccine from Emergent, and directed Johnson & Johnson to take direct control of the manufacture of its vaccine there.
Johnson & Johnson’s vaccine was once considered a potential turning point in the country’s vaccine inventory as it required only one shot and was particularly useful in vulnerable communities. But the federal government now has adequate supplies of vaccines from Pfizer-BioNTech and Moderna, the other two state-approved vaccine developers, and no longer needs supplies from Johnson & Johnson.
Still, the loss of 60 million Johnson & Johnson doses undermines the Biden government’s plan to distribute vaccines to other countries still affected by the pandemic. The government had expected to share the Johnson & Johnson and AstraZeneca cans but had to postpone its plan while the FDA completed a review of the facility.
After President Biden arrived in the UK for the Group 7 Summit this week, he announced that he had found another source of funds. Pfizer-BioNTech has now agreed to sell its 500 million doses administration to low and middle income countries at cost over the next year. The World Health Organization estimates that 11 billion doses will be needed worldwide to eradicate the epidemic.