Today, Health Canada authorized Novavax’s Nuvaxovid COVID-19 vaccine for the prevention of COVID-19 in adults 18 years of age and older. This is the fifth COVID-19 vaccine authorized in Canada. After a thorough, independent review of the evidence, the Department has determined that this vaccine meets Canada’s stringent safety, efficacy and quality requirements.
Nuvaxovid is a protein-based vaccine that is administered as a two-dose regimen of 5 mcg per dose, 21 days apart.
Based on the clinical trials overall, Nuvaxovid is 90% effective at preventing symptomatic COVID-19 and 100% effective at preventing severe disease.
While additional confirmatory data is needed, preliminary and exploratory data shows that Nuvaxovid does produce neutralizing antibodies against the Omicron variant. As a term and condition associated with the authorization, Novavax is required to provide data regarding protection against current and emerging variants of concern as soon as it is available.
Health Canada has also placed terms and conditions on this authorization requiring the manufacturer to continue providing information to Health Canada on the safety, efficacy and quality of the vaccine to ensure its benefits continue to be demonstrated through market use.
Health Canada received an initial application for authorization from Novavax under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 on January 29, 2021. Novavax subsequently filed a submission under the amended Food and Drug Regulations on August 27, 2021, to support a permanent authorization.
In keeping with the Department’s commitment to openness and transparency, Health Canada is publishing a number of documents related to its decision, including a high-level summary of the evidence it reviewed to support the authorization of the vaccine. More detailed information will be available in the coming weeks, including a detailed scientific summary and the full clinical trial results that support the use of this vaccine.
Health Canada and the Public Health Agency of Canada will closely monitor the safety of this vaccine once it is on the market and will not hesitate to take action if any safety concerns are identified.
Share on Facebook «||»
Share on Twitter «||»
Share on Reddit «||»
Share on LinkedIn
Novavax COVID-19 vaccine Nuvaxovid approved by MHRA: Nuvaxovid, the COVID-19 vaccine developed by Novavax, has today been given regulatory approval by the Medicines and Healthcare products Regulatory Agency (MHRA). Nuvaxovid becomes the fifth COVID-19...
Health Canada releases assessment report on effects of climate change on health: The price of climate change is real. This crisis has already taken lives in extreme heat waves, and is increasing risks to Canadians from flooding,...
Government of Canada shares results of public consultations on the future of quantum technology in Canada : Quantum science is leading the way in finding solutions to some of the most complex problems in communications, computing, health care, navigation and other key...
Canada Raising Awareness on Zero-Emission Vehicles in Canada: February 8, 2022 Toronto, Ontario Natural Resources Canada Reducing emissions...
First Covid vaccine for children under 5: Pfizer seeks US approval: If the Food and Drug Administration (FDA) authorizes the two-shot regimen, it will become the first Covid vaccine available to this age group in the...
COVID-19 Vaccine Uptake: Five Arrested For Green Card Racketeering In Bauchi: The Security and Vigilance Community of the COVID-19 Taskforce comprising representatives from all the security agencies operating in the state, consequently, arrested five people for...
SAHPRA registers Chinese Sinopharm COVID-19 vaccine: The South African Health Products Regulatory Authority (SAHPRA) announced on Monday that it has registered the MC Pharma also known as Sinopharm COVID-19 vaccine. Initially...
Doctors Without Borders call on South Africa’s government to revoke Eli Lilly and Moderna’s COVID-19 and mRNA vaccine: The international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) and the People’s Health Movement (PHM) are calling on the South African government to...
COVID-19: 83% Africans yet to receive single dose vaccine- WHO: World Health Organisation reports that 83 per cent of people in Africa are yet to receive a single dose of the COVID-19 vaccine. READ ALSO: Poorer...
High Court Slams Anti-Vaxxers’ Attempt to Halt Covid Vaccine as Baseless Application Unravels: In a resounding decision, the High Court has unequivocally dismissed an application filed by anti-vaxxers seeking to obstruct the ongoing Covid vaccine rollout. The court...