Canada Approves Pfizer COVID-19 Vaccine Label Change to 6 Doses

Health Canada has authorized a label change to Pfizer–BioNTech’s COVID-19 vaccine that will allow six doses of the precious drug to be extracted per vial.

Up until now, Canada has been extracting five doses from a single vial of the vaccine.

The pharmaceutical company recently pushed Health Canada to amend the label information on vials in Canada, as it did with the U.S. and Europe.

The results of the review determined that “six full doses can be consistently obtained from vials with the use of low dead volume syringes.”

The change will help Pfizer fulfill its contract to ship four million doses of its vaccine to Canada by March — but by sending fewer vials.

Canada expects to receive the same number of vials it was expecting from Pfizer next week.

However, those vials will be counted as 400,000 doses, rather than 336,000 doses, according to Maj.-Gen. Dany Fortin, who is overseeing logistical planning for Canada’s vaccine distribution efforts.

Getting the sixth dose also requires the use of a special syringe.

Canada had already begun procuring and distributing this needle — a low dead space syringe — in anticipation of the approval. Procurement Canada said it had ordered 64 million syringes in total.

Those syringes have “already arrived in Canada in sufficient quantities” and are being delivered to provinces, said Fortin.

Delivery of those special syringes will continue through May 2021, he said.

The dosing change is effective with shipments the week of Feb. 15. Fortin said the delivery of these important syringes will coincide with those shipments.

Health Canada says the batch of 70,000 doses scheduled for this week have been calculated as five doses and will not have the label change applied.

Dr. Howard Njoo, Canada’s deputy chief public health officer, acknowledged that it’s not as easy to extract six doses from the vial, rather than five. It requires a “certain level of experience,” he said in the past.

The Public Health Agency of Canada (PHAC) plans on addressing that through a series of webinars for vaccinations. In conjunction with the National Advisory Committee on Immunization (NACI), public health will provide training on the label change and the use of low dead volume syringes.

The first webinar will be on February 10 and the second on Feb. 12. A follow-up on the “foundational” aspects of vaccination amid COVID-19 will also be held the following week for vaccinators, he said.

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