“When evaluating vaccines, the product and its entire production process are considered and examined,” Cofepris said in a statement.
Canada and Mexico imported millions of doses of AstraZeneca vaccines against Covid-19 and offered them to their populations without the health authorities properly inspecting the manufacturer’s operations in the United States, according to a review of records and the intervention of regulators.
The Baltimore plant owned by Emergent BioSolutions Inc was producing Covid vaccines from both AstraZeneca Plc and Johnson & Johnson, under the terms of a $ 628 million contract with the US government.
In late March, under pressure to help other nations access vaccines, the administration of President Joe Biden released 1.5 million doses of the AstraZeneca formula for Canada and 2.5 million doses for Mexico.
European regulators had certified Emergent’s factory as complying with “good manufacturing practices” and on that basis, both Canada and Mexico began using the vaccine, authorities 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.
The US Food and Drug Administration (FDA) halted production at the factory three weeks later, after the J&J vaccine was found to be contaminated with the material used for 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 disease have been linked to vaccines manufactured by Emergent, and regulators have not alleged that contaminated vaccines have been administered to anyone. Emergent said there has been no evidence of contamination in the AstraZeneca doses 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. These 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.”
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 distribution.”
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 authorization process was carried out with all the necessary rigor.”
European inspection
At the beginning of the vaccine’s distribution, the European Union (EU) was to receive doses of J&J manufactured by Emergent. In 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,” EMA said in a statement.
Health Canada stated that it assumed that both products would be manufactured 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.
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.
“It is precisely because they were similar (products) that cross-contamination is a risk,” he said. Canada was “venturing” in approving the facility’s AstraZeneca doses with the FDA, he said.
Health Canada countered that it reviewed the test results and quality control steps for each batch of vaccines shipped to Canada.
Initially, Mexico’s Cofepris assured 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 they had not evaluated AstraZeneca’s production specifically, Cofepris said it would review the file but was confident of the approval process.
The Mexican regulator assured that 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,” Cofepris said in a statement.
Emergent’s contract with the US government is the focus of a Congressional investigation, which unearthed documents highlighting early concerns about the Baltimore plant.
Shortly after the administration of former President Donald Trump announced Emergent’s contract last summer, his 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 inspection of Emergent’s facilities in April 2021.
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 firm said.
Source: eleconomista.com.mx
