#HealthCanada; #Novavax; #NuvaxovidCOVID19vaccine, #ClinicalTrials
CMEDIA: Health Canada authorized today the fifth COVID-19 vaccine, Nuvaxovid produced by Novavax, an American biotechnology company based in Gaithersburg, MD, for the prevention of COVID-19 in adults 18 years of age and older.
The Department has determined that this vaccine meets Canada’s stringent safety, efficacy, and quality requirements after a thorough, independent review of the evidence
Nuvaxovid’s 90 percent efficacy at preventing symptomatic COVID-19 and its 100 percent effectiveness at preventing severe disease is based on clinical trials.
In the event of the need for additional confirmatory data, preliminary and exploratory data reveals that Nuvaxovid does produce neutralizing antibodies against the Omicron variant.
Terms and conditions on this authorization have been placed by Health Canada requiring the manufacturer’s continued information on the demonstrated safety, efficacy, and quality of the vaccine through market use.
On January 29, 2021, 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.
Novavax subsequently filed a submission under the amended Food and Drug Regulations on August 27, 2021, to support a permanent authorization.
Adhering to its commitment to openness and transparency, Health Canada is publishing a number of documents to support its decision, including a high-level summary of the evidence it reviewed to support the authorization of the vaccine.
More detailed information including a detailed scientific summary and the full clinical trial results that support the use of this vaccine will be available in the coming weeks,
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 take action if any safety concerns are identified.