The manufacturing facility, known as Bayview, saw 15 million doses of Johnson & Johnson’s vaccine go to waste after a dosage mix-up last month. The U.S. FDA recently ran an investigation at the facility, and as a result, “cited a number of observations concerning whether the facility’s processes met our requirements and standard,” per a statement issued last week.
The FDA said the facility agreed to “pause new production” while it works with the FDA to correct quality issues. The facility does not have the FDA’s approval to develop or distribute J&J jabs in the U.S.; states have thus far received J&J shipments developed in the Netherlands, where regulators have fully approved operations, The New York Times reported.
“Health Canada is aware of the U.S. Food and Drug Administration’s (FDA) recent inspection of the Emergent BioSolutions facility in Baltimore, Maryland, which noted multiple areas of concern,” reads a statement from Health Canada posted Sunday. “Health Canada would like to reassure Canadians that all AstraZeneca vaccines imported into Canada from this facility are safe and of high quality. Janssen vaccines produced at this site have not entered the country.”
Canadian authorities said 1.5 million doses of AstraZeneca vaccine from the facility met “quality specifications.”
“The Department reviewed test results of all vaccine lots that came into Canada, as well as the company’s quality control steps implemented throughout the manufacturing process to mitigate potential risks of contamination,” the statement continues. “Janssen vaccines anticipated to come into the country next week do not come from this facility.”
Canada has authorized COVID-19 vaccines developed by Moderna, Pfizer, AstraZeneca and J&J, and expects to have enough supply for all adults by September 2021. Over 24% of the population, or some 9.1 million people, have received at least one dose, according to the government’s latest figures.