After a production breakdown in a US plant, corona vaccine manufacturer Johnson & Johnson has to destroy millions of vaccine doses.
Several batches of several million doses each are unusable due to possible contamination, the FDA announced on Friday.
Neither the FDA nor the manufacturer gave an exact number.
The New York Times newspaper reported, citing informed sources, that 60 million doses of vaccine were affected.
The company Emergent BioSolutions, which produces the corona vaccine for J&J in a plant in Baltimore, Maryland, stopped production in April by order of the FDA after the ingredients of the preparation were accidentally exchanged for those of the Astrazeneca vaccine were.
AstraZenenca vaccine may also be affected
It is currently being tested to ensure that 60 million doses of the Astrazeneca vaccine produced in Baltimore meet quality standards.
The FDA has given clearance for ten million doses of Johnson & Johnson's vaccine.
Canada also announced on Friday that it would not use 300,000 doses of the J&J vaccine from the Baltimore plant.
"Due to concerns, (...) Health Canada will not distribute the received supplies to protect the health and safety of Canadians," said the Department of Health in Ottawa on Friday.
J & J's vaccine, which was initially produced exclusively in the Netherlands, received emergency approval in the USA at the end of February and is being administered intensively there.
Canada approved the drug in March, but did not inoculate the 300,000 doses received due to quality concerns.
It is also not yet in use in the EU, where the vaccine has been approved for almost three months.
In contrast to the other corona vaccines approved to date, the Johnson & Johnson vaccine only requires one injection syringe for comprehensive protection. In addition, storage and delivery are comparatively easy. The J&J vaccine was therefore increasingly used in the USA and is also intended to help accelerate vaccination campaigns in the EU.