AstraZeneca COVID-19 vaccine shipped to Canada, Mexico before adequate plant inspections cdnpoli
The Baltimore plant belonging to Emergent BioSolutions Inc was producing vaccines for both AstraZeneca Plc and Johnson & Johnson under a $628 million U.S. government contract.
FDA inspectors later documented unsanitary conditions and poorly-trained staff at the plant, which had been rapidly overhauled to make vaccines during the pandemic. Production had remained halted, with tens of millions of doses of both vaccines in regulatory limbo. "It's a risk, because who knows what the standards are that are being applied?" said Joel Lexchin, a Canadian professor and expert in drug regulation. Health Canada typically relies heavily on foreign regulators, he said. "It's a gap that exists outside of crisis times."
Canada signed deals to formally recognize some other regulators' certifications as early as 2003, and the United States and Europe reached similar deals in 2019.Early in the vaccine rollout, the European Union was due to receive doses of the J&J vaccine made by Emergent.
Health Canada said it reviewed test results and quality control steps for every vaccine lot sent to Canada. "When evaluating vaccines, the product and its entire production process are considered and examined," it said in a statement.
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