June 13, 2021- 2:40 p.m.
Canada’s health products regulator has rejected the country’s first and only shipment of Johnson & Johnson’s Covid vaccine because of contamination issues at the U.S. plant that produced it.
The 300,000 doses had been held in storage since April to allow Health Canada to conduct a safety review. The regulator, in a statement issued on Friday evening, said that Emergent BioSolutions had made those doses at the same time as other batches of the Johnson & Johnson vaccine that were found to be contaminated with the harmless virus used to manufacture the AstraZeneca vaccine.
Health Canada said its review was unable to determine that the vaccines sent to Canada met “the department’s rigorous quality standards.” The regulator also said that it would not approve the use of any vaccines or vaccine ingredients made at the factory until it sends inspectors there, most likely in the summer.
The announcement came after the Food and Drug Administration told Johnson & Johnson that 60 million doses of vaccine produced at the Baltimore factory cannot be used because of contamination. The F.D.A., however, will allow about 10 million other doses of the Johnson & Johnson vaccine to be distributed in the United States or other countries, with the warning that it cannot guarantee that Emergent followed good manufacturing practices.
U.S. regulators have put the Baltimore facility under a microscope since March, when they discovered that a major production mishap had resulted in the contamination of a batch of Johnson & Johnson vaccines. Emergent later discarded the equivalent of 15 million doses. The New York Times has documented months of problems at the plant, including failures to properly disinfect equipment and to protect against viral and bacterial contamination.
The Emergent factory remains closed.
