Canada and Mexico imported doses of AstraZeneca from the facility that were not fully inspected: Regulator – National



Canada and Mexico imported millions of doses of AstraZeneca’s COVID-19 vaccine and offered them to the public without proper inspection by health officials of the US manufacturer’s operations, according to inspection records and regulators involved.

Emergent BioSolutions Inc’s Baltimore plans produced vaccines for both AstraZeneca Plc and Johnson & Johnson under a contract with the US government worth $ 628 million.

In late March, under pressure to help other nations access COVID-19 vaccines, the Biden administration released 1.5 million doses of AstraZeneca to Canada and 2.5 million to Mexico.

European regulators had certified that the Emergent factory was in compliance with “good manufacturing practices,” and on that basis, both Canada and Mexico began using the vaccine, regulators in both countries told Reuters.

But the European Medicines Agency (EMA) told Reuters that the certification was based on a remote inspection that focused on a part of the facility that did not actually produce the AstraZeneca injections, a fact that had not been previously reported.

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The US Food and Drug Administration halted production at the factory three weeks later, after the J&J vaccine was found to be contaminated with the material used in AstraZeneca injections.

Subsequently, FDA inspectors documented unsanitary conditions and poorly trained personnel at the plant, which had been quickly screened to make vaccines during the pandemic. Production remains on hold, with tens of millions of doses of both vaccines in regulatory limbo.

No reports of illness have been linked to vaccines manufactured by Emergent, and regulators have not claimed that anyone has received contaminated vaccines. Emergent said there has been no evidence of contamination in the AstraZeneca intakes produced at its site.

But the details of the flawed approval process show blind spots that can develop when national regulators share responsibility for overseeing a complex global pharmaceutical industry. Those only got worse given the urgency of the pandemic.

“It is a risk, because who knows what are the standards that are being applied?” said Joel Lexchin, a Canadian professor and expert on drug regulation.

Health Canada generally relies heavily on foreign regulators, he said.

“It is a gap that exists outside of times of crisis.”

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Emergent said in a statement that it “has worked with health officials around the world to ensure that any vaccine drug substance we manufacture meets strict safety and quality requirements prior to launch.”

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AstraZeneca said the vaccines manufactured by Emergent underwent more than 40 tests to meet its requirements for safety, purity and quality, and that their manufacturing standards “are rigorously evaluated and independently verified by regulators.”

Health Canada told Reuters it was confident the vaccines it received were safe, pointing in part to AstraZeneca’s quality control systems. Mexico’s health regulator, COFEPRIS, said it remains “confident that the approval process was carried out with all the necessary rigor.”

Canada signed agreements to formally recognize the certifications of some other regulators as early as 2003, and the United States and Europe reached similar agreements in 2019.


At the beginning of the vaccine launch, the European Union was to receive doses of the J&J vaccine manufactured by Emergent.

In early February, Italian officials conducted a remote inspection of the plant that only focused on the areas where J&J was being produced “and not the AstraZeneca vaccine, which was not manufactured in Emergent for the EU market,” he said. EMA in a statement.

Health Canada said it assumed both products would be made to the same standard. “The quality systems evaluated by the EMA for this product would be applicable to all similar products manufactured on this site,” it said in a statement.

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This is the wrong approach, according to University of Ottawa professor Amir Attaran, who studies drug policy, including Health Canada’s reliance on foreign regulators.

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“It is precisely because they were similar (products) that cross contamination is a risk,” he said. Canada was “risky” in approving the facility’s AstraZeneca doses with the FDA, he said.

Health Canada said it reviewed the test results and quality control steps for each batch of vaccine shipped to Canada.

Initially, Mexico’s COFEPRIS told Reuters that the FDA was responsible for certifying US operations, but later confirmed that the factory had been certified by European regulators.

When Reuters shared the statement from European regulators that it had not evaluated AstraZeneca’s production specifically, COFEPRIS said it would review the file, but was confident of the approval process.

The Mexican regulator said the vaccines went through quality control systems at Emergent, and twice more during the vial-filling process handled by another contracted manufacturer.

“When evaluating vaccines, the product and its entire production process are considered and examined,” he said in a statement.

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Emergent’s contract with the US government is the focus of a Congressional investigation, which unearthed documents highlighting early concerns about the Baltimore plant.

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Shortly after the Trump administration announced Emergent’s contract last summer, its own vaccine officials visited the plant and wrote a report noting that staffing and training were inadequate. The report warned of the need to strengthen quality oversight, a process that “would require significant resources and commitment.”

The FDA, after a visit to the plant in February 2021, noted in a June memorandum that Emergent’s staff turnover was high and record-keeping was inadequate. While European regulators said they were aware of that visit, Health Canada said it didn’t find out until last month.

An FDA spokesperson said the agency works closely with international partners and notified various health authorities of its findings after its April 2021 inspection of the pop-up facility.

Emergent said it is still working with the FDA to release more batches of the already produced COVID-19 vaccine.

“We have manufactured tens of millions of doses that could be used to help vaccinate people around the world as the pandemic shows no signs of slowing down,” the company said.

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