Health Canada to start real-time review of Medicago COVID-19 vaccine

Health Canada 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.

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. 

A rolling review allows researchers to submit findings in real time, without waiting for studies to conclude.

“Health Canada has received a submission for authorization of the Medicago #COVID19 vaccine,” the federal regulatory body confirmed on Twitter on Friday.

“As data becomes available through this rolling submission process, the Department will review to make sure it meets our high standards for safety, efficacy and quality.”

Medicago said it 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.

View original article here Source

Related Posts