Health Canada Does Not Release 300,000 Doses of J&J Vaccine Due to Potential Quality Control Issue
TORONTO – Health Canada has said it “will not release” the 300,000 doses of the Johnson & Johnson COVID-19 vaccine that arrived in the country in April due to a possible quality control issue.
In a statement released Friday, Health Canada said it has completed its review of the quality of the shipment and decided not to distribute them to provinces to “protect the health and safety of Canadians” due to concerns over the facility. of Baltimore, part of the vaccine was produced. at.
Doses of the J&J vaccine were previously held for review after arriving in Canada after learning that a drug substance used in the vaccine had been produced at the Baltimore facility of Emerging BioSolutions. The factory had an error in March that resulted in millions of J&J doses being ruined.
The agency said the drug substance produced at the Emergent BioSolutions facility was used in the manufacture of the Canadian Janssen vaccine shipment, but noted that the final vaccines were manufactured at a different site outside the states. -United.
“Health Canada has not been able to determine that this shipment of Janssen vaccine meets the ministry’s stringent quality standards,” the statement said.
The announcement comes after the United States Food and Drug Administration (FDA) said on Friday that J&J had to throw away millions of doses of its COVID-19 vaccine that were manufactured at the Baltimore plant.
Production of J&J’s vaccine at the Baltimore site was halted by the FDA after it discovered that ingredients in AstraZeneca’s COVID-19 vaccine – also produced at the plant at the time – contaminated a batch of vaccine from AstraZeneca. NOT A WORD. An FDA inspection also revealed sanitary issues and poor manufacturing practices at the plant.
AstraZeneca’s injection is no longer manufactured at the Baltimore facility, and Health Canada previously stated that the 1.5 million doses of AstraZeneca it imported from that facility were safe and met the specifications of quality.
To ensure the safety of “any future vaccine supply” to the facility, Health Canada said it is planning an on-site inspection of the plant this summer.
“Until this inspection is completed, Canada will not accept any products or ingredients manufactured at this site,” Health Canada said.
The agency assured Canadians that all COVID-19 vaccines will not be released to the public until Health Canada is “satisfied that they meet the Department’s high standards for quality, safety and efficacy.” .