Well being Canada has accepted Medicago’s utility for a real-time overview of its COVID-19 vaccine candidate, the drug developer stated on Friday.
Medicago is conducting a late-stage examine of its experimental COVID-19 vaccine mixed with a booster from GlaxoSmithKline.
The corporate stated it will submit security and efficacy knowledge for its COVID-19 vaccine to Canada’s well being ministry beneath a rolling submission as and when it turns into obtainable. The final portion of the rolling submission will probably be filed after security and efficacy targets of its ongoing late-stage trial are reached.
A rolling overview permits researchers to submit findings in actual time, with out ready for research to conclude.
“Well being Canada has obtained a submission for authorization of the Medicago #COVID19 vaccine,” the federal regulatory physique confirmed on Twitter on Friday.
“As knowledge turns into obtainable via this rolling submission course of, the Division will overview to ensure it meets our excessive requirements for security, efficacy and high quality.”
Medicago stated it expects to report outcomes from a mid-stage trial of the vaccine in April.
The corporate’s vaccine makes use of a expertise often called virus-like particles, which mimics the construction of the coronavirus, however accommodates no genetic materials from it.