Windsor Star


Canada imports unaffected: Health Canada


Canada imported 1.5 million doses of Astrazenec­a's COVID-19 vaccine made at a factory in the U.S. that American authoritie­s say was rife with quality-control problems, Health Canada confirmed Thursday.

The U.S. Food and Drug Administra­tion said this week it will not allow the release of any vaccine made under contract at an Emergent Biosolutio­ns plant in Baltimore, Md. — and still in the States — until it's been tested.

But Health Canada said Astrazenec­a has assured the government that the contaminat­ion event at the Emergent plant that led to a recent FDA inspection had no impact on its vaccine.

“All products in Canada met authorized specificat­ions before they were released to the market,” Anna Madison, a spokeswoma­n for the department, said in a statement.

“COVID-19 vaccines are subjected to the same independen­t, rigorous scientific reviews, quality standards, testing and post-market surveillan­ce as all other vaccines approved for use in Canada.”

Madison said the last of the 1.5 million doses of Astrazenec­a vaccine made at the Emergent plant were distribute­d to the provinces the week of April 5.

Though uptake on that particular shot was slow at first, its use has surged in recent days after some provinces made it available to a broader age range of Canadians. B.C. authoritie­s said Thursday they had all but expended their allotment.

Canada also obtained 500,000 Astrazenec­a doses made under contract by a company in India, and 300,000 manufactur­ed in South Korea through the COVAX project.

Astrazenec­a said in a statement Thursday the vaccine it sent to Canada in March was done so at the request of the U.S. government and “met the stringent requiremen­ts” the firm must follow.

“Required safety tests and quality control measures are carried out at each step of the production process,” the company said. “All checks were met prior to the release of the batches.”

The Food and Drug Administra­tion released a report Wednesday that outlined a number of issues with Emergent's Bayview plant in Baltimore that it said could potentiall­y affect the quality of the products it made.

They ranged from inadequate training of staff to not cleaning equipment at appropriat­e intervals to “prevent contaminat­ion that would alter the safety, identity, strength, quality or purity of the drug substance.”

Emergent had earlier agreed with the agency to halt production at the plant until the problems are fixed.

In the meantime, the FDA said that none of the vaccine made at the factory so far would be distribute­d in the United States.

“For the vaccines already manufactur­ed, the products will undergo additional testing and will be thoroughly evaluated to ensure their quality before any potential distributi­on,” the agency said in a news release. “We will not allow the release of any product until we feel confident that it meets our expectatio­ns for quality.”

Amir Attaran, a law professor and drug-policy expert at the University of Ottawa, said any of the Emergent-made vaccine not already administer­ed in Canada should now be shelved.

And he said he's not even sure if potential problems could be uncovered by an inspection after the fact.

“It is impossible to `inspect in' high quality to a product that started life as low quality,” charged Attaran. “There is absolutely no option but to throw these doses away, like the other doses manufactur­ed in that factory which the Americans are not allowing to be used. No way should Canadians be offered these doses.”

Emergent has manufactur­ed vaccine under contract for both Astrazenec­a and Johnson & Johnson.

Controvers­y first erupted in March when it was revealed that cross-contaminat­ion at the Baltimore plant had ruined 15 million doses of the J&J product.

U.S. media reports indicated that the contaminat­ion came from the harmless virus used in the Astrazenec­a vaccine being manufactur­ed in the same facility.

The companies agreed after the incident to no longer make Astrazenec­a's shot at the plant to avoid any cross-contaminat­ion, while the FDA carried out an extensive inspection of the facility that finished on Tuesday.

The resulting report outlined a number of issues around the company's investigat­ion into the Johnson & Johnson incident, saying it had failed to thoroughly probe the “unexplaine­d discrepanc­ies.”

But the report, citing security camera footage and other evidence, also detailed several other, broader concerns about how the facility operated.

It said the building was not maintained in a “clean and sanitary condition,” saying for instance that waste is not properly decontamin­ated before being taken through the warehouse for disposal.

There were also areas of peeling paint and damaged wall boards, which would undermine Emergent's ability to clean and disinfect the area.

The warehouse was also overcrowde­d with materials destined for the manufactur­ing process and samples for quality control, said the report.

Among other concerns, it also said Emergent had failed to adequately train workers involved in manufactur­ing, quality control and other areas to “prevent cross contaminat­ion of bulk drug substances.”

Astrazenec­a's vaccine has been clouded somewhat by suspicions it is linked to a rare blood-clotting problem. But scientists say the benefits of taking the shot — and avoiding seriously COVID-19 illness — easily outweigh the slim risks.

 ?? SAUL LOEB / AFP VIA GETTY IMAGES ?? The U.S. Food and Drug Administra­tion says it will not allow the release of any vaccine made under contract at an Emergent Biosolutio­ns
plant in Baltimore, Md., above, until it's been tested.
SAUL LOEB / AFP VIA GETTY IMAGES The U.S. Food and Drug Administra­tion says it will not allow the release of any vaccine made under contract at an Emergent Biosolutio­ns plant in Baltimore, Md., above, until it's been tested.

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