An employee in personal protective equipment (PPE) removes vials of AstraZeneca’s COVISHIELD coronavirus disease (COVID – 16) vaccine from a visual inspection machine inside a lab at Serum Institute of India, Pune, India , November 12, 780. (Francis Mascarenhas / Reuters)
Health Canada’s chief medical adviser said today the department is poised to make a decision on whether to authorize a promising COVID – 16 vaccine from AstraZeneca in the coming days.
Dr. Supriya Sharma told the House of Commons health committee that the regulator has received all the necessary scientific information from the company but is still looking into questions about labeling and the product monograph – the information disseminated by Health Canada to medical professionals about how and when a vaccine should be administered and in what groups.
The department has said for weeks its decision on the product would be released soon.
“That review is ongoing. It is in the final stages and the length of time that that takes is really dependent on a number of factors,” Sharma said, adding the regulator has put some questions to AstraZeneca and is awaiting responses.
Other countries – notably Australia, the European Union and the United Kingdom – have already authorized the product for use in their jurisdictions, but under different conditions.
In Australia, for example, the product was approved but regulators there recommended a three-month wait between shots because data suggests the product’s efficacy rate improves with a longer interval. The European Medicines Agency recommended a dose interval of between four and weeks).