Health Canada authorizes Pfizer's mRNA vaccine under interim order

Regulatory NewsRegulatory News
| 09 December 2020 | By Kari Oakes 

Health Canada has authorized the use of the COVID-19 vaccine co-developed by Pfizer and the German firm BioNTech for use in individuals 16 years of age and up. The authorization was made under the country’s interim order regarding drug importation, sale and advertising during the COVID-19 pandemic.
The first vaccine doses may be administered within days of the 9 December authorization, depending on transit and delivery logistics required to ship the first doses from Belgium to the 14 Canadian health centers that will first receive the messenger RNA (mRNA) vaccine, said Maj-Gen Dany Fortin, speaking at a 9 December press conference.
Health Canada officials delved into logistical and policy considerations involved in meting out limited doses of a critical vaccine with finicky storage and transport requirements, giving a window into the nitty-gritty of vaccine deployment that regulators and health officials worldwide must sort out in the coming weeks and month.
Fortin, vice president of logistics and operations for Health Canada’s COVID-19 vaccine efforts, said that a “dry run” performed in conjunction with the vaccine’s sponsors earlier this week went smoothly; UPS, the firm under contract with the sponsors for transport of the vaccines, was able to maintain the ultra-cold storage required for vaccine stability throughout the delivery chain.
Fortin said that total end-to-end transit time during the dry run ranged from about 24-36 hours, though Canadians are still waiting on one of the simulated vaccine boxes to arrive. “This is very much like when you order stuff online that comes from overseas,” he said.
Canada’s national immunization advisory group has recommended that four priority groups be given first access to limited vaccines: older adults; residents and staff of long-term care facilities; health care workers, especially those involved in direct patient care; and indigenous peoples.
In Canada, as in the US, doses will be allocated on a per capita basis, with vaccine shipments being proportional to the populations of the provinces and territories receiving them. Deciding exactly where those first doses go, said Fortin, is a “very tight collaboration between public health and the logistics side of the house.”
Howard Njoo, MD, deputy chief public health officer for Health Canada, said that given the ultra-cold storage temperatures required, “It doesn’t make sense to use the Pfizer vaccine in the territories up north…the territories will receive Moderna, or another vaccine without such stringent requirements.” Health officials in Canada’s territories and in other more remote regions are content to await authorization of and access to vaccines more amenable to the real-world conditions of those regions, said Njoo.
To date, Health Canada has received applications for authorization under the interim order from Moderna for the mRNA vaccine it has co-developed with the US National Institutes of Health, as well as from Janssen and AstraZeneca.
Canada is expected to receive up to 249,000 doses of the Pfizer-BioNTech vaccine by the end of 2020, with up to 76 million more forthcoming.
Health Canada


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