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The more the merrier!

  • Writer: Compliance Insight
    Compliance Insight
  • Feb 22, 2021
  • 2 min read

HEALTH CANADA ISSUES LABEL CHANGE AUTHORIZATION FOR PFIZER-BIONTECH COVID-19 VACCINE



In their effort to administer as many vaccine doses to the Canadian population as possible, “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.” The decision was based on review of a submission from Pfizer-BioNTech in late January 2021. This label change was also adopted by the FDA, stated in an amendment letter dated January 6, 2021 that authorized each vial contains six doses after standard dilution with sterile 0.9% sodium chloride injection USP. The label change will still allow the internationally regulated amount of vial overfill be maintained to ensure sufficient and effective doses per vial.


Health Canada’s labeling monograph goes into effect immediately, although shipments already distributed from facilities will maintain their current labeling stating five doses. Pfizer-BioNtech has been given terms and conditions that require they provide updated patient fact sheets, “continued educational support to vaccine administration sties in Canada 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.”


To successfully extract 6 full doses from each vial, low dead-space syringes should be used with each vaccination administered. Low dead-space syringes have as little as 2 microliters of space available in the hub of the syringe (the space between the needle and the barrel), whereas standard hypodermic needles have as much as 84 microliters of space. This means

that low dead-space syringes can allow for an increase of 2-19% of additional vaccine doses and, in turn, a decrease in drug waste. Reducing drug waste is vital in global pandemics to maximize the limited number of vaccinations due to manufacturing demand and constrained materials.



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