Health Canada to start real-time review of Medicago COVID-19 vaccine
A woman holds a small bottle labeled with a “Coronavirus COVID-19 Vaccine” sticker and a medical syringe in this illustration taken October 30, 2020. REUTERS/Dado Ruvic//File Photo
The Canadian health regulator has accepted Medicago’s application for a real-time review of its COVID-19 vaccine candidate, the drug developer said on Friday.
Medicago is conducting a late-stage study of its experimental COVID-19 vaccine combined with a booster from GlaxoSmithKline (GSK.L).
The company said it would submit safety and efficacy data for its COVID-19 vaccine to Canada’s health ministry under a rolling submission as and when it becomes available. The last portion of the rolling submission will be filed after safety and efficacy goals of its ongoing late-stage trial are reached. (https://refini.tv/3ayqCTX)
A rolling review allows researchers to submit findings in real time, without waiting for studies to conclude.
Health Canada will not make a decision on whether to authorize any vaccine under rolling review until it has received the necessary evidence to support the candidate’s safety, efficacy and quality, the company said.
Medicago expects to report results from a mid-stage trial of the vaccine in April.
The company’s vaccine uses a technology known as virus-like particles, which mimics the structure of the coronavirus, but contains no genetic material from it. read more
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