Pfizer-BioNTech COVID-19 vaccine: Health Canada recommendations for people with serious allergies

Issue

Health Canada has followed up on the two reports of anaphylactoid reactions to Pfizer BioNTech’s COVID-19 vaccine in the U.K. These reactions occurred on December 8, 2020. Both individuals in the U.K. had a history of severe allergic reactions and carried adrenaline auto injectors. They both were treated and have recovered. As vaccine roll-out begins in Canada, Canadians may be wondering about the risks of allergic reactions. In Canada, all vaccines carry a warning about the risk of serious allergic reactions, including anaphylaxis, and immunization clinics are equipped to manage these rare events. People with allergies to any of the ingredients of the vaccine are currently cautioned against receiving it. This caution is already noted in the Canadian Product Monograph (prescribing information) for the Pfizer-BioNTech COVID-19 vaccine. The vaccine’s ingredients are as follows: Medicinal ingredient: mRNA Non-medicinal ingredients: ALC-0315 = ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide 1,2-Distearoyl-sn-glycero-3-phosphocholine cholesterol dibasic sodium phosphate dihydrate monobasic potassium phosphate potassium chloride sodium chloride sucrose water for injection Health Canada has reviewed the available evidence and has concluded that the current Product Monograph and available public health guidance are appropriate, and is not recommending any changes to the product’s use at this time. Health Canada continues to work with the U.K. Medicines and Healthcare products Regulatory Agency and with the manufacturer to monitor the situation. Health Canada will take action if any new safety issues are confirmed.

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