(Reuters) – Canada’s health department said on Friday Johnson & Johnson’s COVID-19 vaccines will only be cleared for distribution after quality checks, following concerns raised by the U.S. Food and Drug Administration (FDA).
The FDA halted production of the vaccines at a U.S. manufacturing plant owned by Emergent BioSolutions earlier this month as it investigates an error that led to millions of doses being ruined in March.
Health Canada said that a drug substance, an active ingredient that undergoes further processing before becoming the final product, produced at the Emergent site was used in the manufacturing of the initial JNJ vaccines received on April 28 and intended for use in Canada.
Health Canada is working with the FDA and JNJ to obtain all the necessary information before releasing the vaccines for distribution in the country, it said.
The JNJ vaccines expected to come into the country do not come from the Emergent facility, Health Canada had said in an earlier statement.
The final vaccines were manufactured at a different site located outside of the United States, it said on Friday.
It remains confident that the 1.5 million doses of AstraZeneca Plc vaccine imported into Canada from the Emergent facility meet quality specifications.
(Reporting by Trisha Roy in Bengaluru; Editing by Devika Syamnath)
