Health Canada issues label change authorization for Pfizer-BioNTech COVID-19 vaccine
TDS News – Today, Health Canada issued a label change authorization to Pfizer-BioNTech to reflect that each vial of its COVID-19 vaccine contains six doses, rather than five. This follows an independent and thorough scientific review of a submission received from Pfizer-BioNTech on January 22, 2021. In its review, Health Canada determined that six full doses can be consistently obtained from vials with the use of low dead-volume syringes.
Health Canada had previously acknowledged that with the right technique and syringe it is possible to obtain a sixth dose from the vial. Health Canada and other international regulators require vaccine vials to include a certain amount of overfill to ensure there is sufficient vaccine in each vial to yield the expected doses. Health Canada has determined that there will still be an acceptable amount of overfill following the label change.
While the label change comes into effect immediately, shipments of Pfizer-BioNTech vaccine to provinces for this week have already begun and are calculated at five doses per vial. Future shipments of the vaccine to Canada will reflect the newly approved monograph. The Government of Canada will continue working with provinces to ensure they have the support and supplies they need to ensure effective implementation.
As part of this label change authorization, Health Canada has issued terms and conditions to Pfizer-BioNTech. The manufacturer is required to provide continued educational support to vaccine administration sites in Canada, if needed, to facilitate implementation of the six dose per vial label change, and to work closely with Public Services and Procurement Canada to acquire syringes, if required. A detailed list of terms and conditions is available here.