The US Food and Drug Administration (FDA) has informed Johnson & Johnson (J&J) that several million doses of Covid-19 vaccine produced in the affected plant cannot be used due to possible contamination, the FDA said on Friday.
Several batches of vaccines manufactured at the Emergent BioSolutions plant in Baltimore are unfit for use, the FDA said.
Each batch contains several million doses.
Neither the FDA nor J&J have revealed the exact number of doses, but the New York Times reports, citing an informed source, that these are 60 million doses.
Emergent BioSolutions was ordered in April to suspend production for several weeks after it was discovered that batches of the substance used in the production of the J&J vaccine were contaminated with AstraZeneca vaccine ingredients. As a result, 15 million doses of J&J vaccine have been damaged, according to media reports.
The FDA continues to evaluate whether to allow the plant to resume operations.
The six million doses of AstraZeneca vaccine produced at the plant, which are to be donated abroad, are currently undergoing a quality check before being shipped.
All J&J vaccines distributed and used in the United States have so far been manufactured in the Netherlands and not in Baltimore.
At the same time, the FDA has given the green light to two batches of J&J vaccine produced in this factory, a source that is familiar with the situation said. These are ten million doses of the vaccine.
Other batches of J&J vaccine are being evaluated.
Canada said on Friday it would not distribute 300,000 doses of the J&J vaccine produced at the Baltimore plant due to quality concerns.
Health services in Canada are planning to inspect the plant this summer.
“Until this inspection is completed, Canada will not accept the products or ingredients manufactured by this company,” the Canadian Department of Health said in a statement.
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