AstraZeneca vaccine has been shipped to Canada and Mexico prior to appropriate factory inspections

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A vial reading “AstraZeneca coronavirus disease (COVID-19) vaccine” is placed on the AstraZeneca logo displayed in this illustration taken on March 24, 2021. REUTERS / Dado Ruvic / Illustration

July 29 (Reuters) – Canada and Mexico imported millions of doses of the COVID-19 vaccine from AstraZeneca and offered them to the public without health officials properly examining the U.S. manufacturer’s operations, according to inspection records and relevant regulators.

The Baltimore plant of Emergent BioSolutions Inc (EBS.N) was producing vaccines for AstraZeneca Plc (AZN.L) and Johnson & Johnson (JNJ.N) under a $628 million US government contract.

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

European regulators have stated that the Emergent plant is complying with “good manufacturing practices,” and on that basis both Canada and Mexico have started using the vaccine, regulators in both countries told Reuters.

But the European Medicines Agency (EMA) told Reuters the certification was based on a remote examination that focused on a part of the facility that was not actually producing AstraZeneca shots – a fact that had not previously been reported.

The U.S. Food and Drug Administration halted production at the plant three weeks later, after the J&J vaccine was found to be contaminated with substances used in AstraZeneca shots.

Food and Drug Administration inspectors later documented the unsanitary conditions and poorly trained staff at the plant, which was quickly reformed to make vaccines during the pandemic. Read more Production remains halted, with tens of millions of doses of the two vaccines in a regulatory stalemate.

No reports of the disease have been linked to vaccines made by Emergent, and regulators have not claimed that the contaminated vaccines were given to anyone. Emergent said there was no evidence of contamination in AstraZeneca shots that were 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 the complex global pharmaceutical industry. Those problems have been exacerbated by the urgency of the epidemic.

“It’s a risk, because who knows what standards are applied?” said Joel Lakeshin, Canadian professor and expert on drug regulation. He said Health Canada usually relies heavily on foreign regulators. “It’s a gap that exists outside of times of crisis.”

Emergent said in a statement that it “worked with health officials around the world to ensure that any vaccine material we make meets stringent safety and quality requirements before it is released.”

AstraZeneca said vaccines made by Emergent have undergone more than 40 tests to meet safety, purity and quality requirements, and that its manufacturing standards are “rigorously evaluated and independently verified by regulators.”

Health Canada told Reuters it was confident the vaccines it had received were safe, citing in part AstraZeneca’s quality control systems. Mexico’s health organization COFEPRIS said it remained “confident that the approval process was carried out with all necessary precision”.

Canada signed deals to formally recognize certifications from some other regulators as early as 2003, and the US and Europe reached similar deals in 2019.

European inspection

Early in the vaccine rollout, the European Union was due to receive doses of Emergent’s J&J vaccine. In early February, Italian officials conducted a remote inspection of the plant that focused only on areas where J&J was being produced “and not the AstraZeneca vaccine, which was not manufactured in Emergent for the EU market,” EMA said in a statement.

Health Canada said it is assuming that both products will be manufactured to the same standard. “The quality regulations evaluated by EMA for this product will be applicable to all similar products made at this location,” it said in a statement.

That’s the wrong approach, according to University of Ottawa professor Amir Al-Atran, who studies drug policy, including Health Canada’s reliance on foreign regulators.

“Precisely because they (products) were similar, cross-contamination is a risk,” he said. He said Canada was “out of the ordinary” in approving AstraZeneca doses from the facility before the Food and Drug Administration.

Health Canada said it has reviewed test results and quality control steps for every batch of vaccine sent to Canada.

Mexico’s COFEPRIS initially told Reuters that the Food and Drug Administration was responsible for certifying the US operations, but later confirmed that the plant had been certified by European regulators.

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

The Mexican regulator said the vaccines went through Emergent’s quality control systems, and two more times during the vial filling process that were handled by another contract manufacturer.

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

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

Shortly after the Trump administration announced Emergent’s contract last summer, vaccine officials visited the plant and wrote a report citing insufficient staffing and training. The report warned of the need to strengthen quality control, a process that requires “significant resources and commitment”.

The Food and Drug Administration, after a visit to the plant in February 2021, indicated in a June memo that Emergent’s employee turnover was high and that record keeping was insufficient. While European regulators said they were aware of the visit, Health Canada said it did not learn about it until last month.

A spokesperson for the US Food and Drug Administration said the agency is working closely with international partners, and that it notified various health authorities of its findings following its April 2021 inspection of the start-up facility.

Emergent said it is still working with the U.S. Food and Drug Administration to release more combinations of COVID-19 vaccines already in production.

“We have made tens of millions of doses that can be used to help vaccinate people around the world as the epidemic shows no signs of slowing,” the company said.

Additional reporting by Alison Martell in Toronto, Emilio Parodi in Milan, Francesco Guaracchio in Brussels, Karl O’Donnell in New York, Cassandra Garrison in Mexico City; Editing by Michael Gershberg and Bill Bercrot

Our Standards: Thomson Reuters Trust Principles.

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