SPIKEVAX Government of Canada health professional risk communication 

June 16, 2022
 

The Government of Canada has released important information for healthcare providers regarding a new presentation of Moderna’s SPIKEVAX COVID-19 vaccine. A new presentation of the SPIKEVAX vaccine was approved by Health Canada on June 1, 2022. The new presentation has a concentration of 0.10mg/mL in a 2.5mL multidose vial with a royal blue cap. The original presentation of this vaccine has a concentration of 0.20mg/mL in a 5mL multidose vial with a red cap. It is important for pharmacists to be aware that there are now two presentations of the SPIKEVAX vaccine available in Canada and the volume required for primary series and booster dosing will be different depending on the presentation used. 

Pharmacists must also be aware that the new 0.10mg/mL presentation is NOT intended for preparation of the 100mcg dose. Patient populations requiring the 100mcg dose include adults 18 years of age or older for their primary series, and children 12 to 17 years of age for their primary series. These specific populations must have their dose prepared using the original 0.20mg/mL presentation. Children ages 6 to 11 years old requiring a 50mcg dose for their primary series can have their dose prepared from either the 0.10mg/mL or 0.20mg/mL presentation. Adults 18 years of age or older requiring a 50mcg booster dose can have their dose prepared from either the 0.10mg/mL or 0.2mg/mL presentation. 

Healthcare providers are also advised that there is important Canadian-specific information absent from the vial and carton labels, and current vials and cartons contain English only labels, due to providing rapid access to the new SPIKEVAX presentation. However, Canadian-specific labelling information can be accessed here (Canada | SPIKEVAX™ Information (modernacovid19global.com)) and Canadian product monograph for SPIKEVAX in English and French can be found in Canada’s Drug Product Database. 

The full Government of Canada health professional risk communication can be accessed here:

Distribution of a New Presentation of SPIKEVAX (elasomeran) COVID-19 Vaccine (0.10 mg/mL in 2.5 mL multidose vial) with English-only Vial and Carton Labels - Canada.ca