Health Canada greenlights Moderna's COVID vaccine
Health Canada has authorized a second vaccine against COVID-19, granting Moderna marketing authorization with conditions for the messenger RNA (mRNA) vaccine it co-developed with the US National Institutes of Health.The authorization for use in individuals aged 18 years and up follows Health Canada’s 9 December authorization of the mRNA COVID-19 vaccine developed by Pfizer and the German firm BioNTech. Both vaccines’ authorizations were issued under an interim order addressing drug importation, sale and advertising regulations during the COVID-19 pandemic. (RELATED: Health Canada authorizes Pfizer's mRNA vaccine under interim order, Regulatory Focus 09 December 2020)
Under the restricted marketing authorization, Moderna will have to submit monthly post-market safety monitoring reports detailing adverse events seen among vaccine recipients both in Canada and elsewhere. Additionally, the sponsor will have to submit ongoing and final clinical trials data, as well as additional quality data.
Canada’s National Advisory Committee on Immunization (NACI) has established recommendations and a framework for the use of COVID-19 vaccines; Moderna’s vaccine will be added to the Pfizer-BioNTech vaccine already covered in the NACI guidance.
Health Canada also required a risk management plan, as is standard for marketing authorizations granted by the agency. Canadian regulators are continuing to work with international regulatory counterparts, said the agency.
Health Canada