Health Canada has authorised the booster shot of Moderna’s Covid-19 vaccine, Spikevax, for individuals aged 18 years and above.
The 50µg booster shot will be given at least six months after receiving the first two doses of the vaccine.
The company noted that the neutralising antibody titers had waned by six months, especially against Covid-19 variants of concern.
The Covid-19 booster shot is intended to help people, who have already been fully vaccinated, to maintain their protection against the disease.
The approval for Spikevax is supported by the scientific evidence submitted by Moderna, including the data from the Phase II clinical trial.
In this trial, interested participants were given the mRNA-1273 booster shot six to eight months after their second shot.
The company stated that the third dose helped to boost neutralising titers significantly more than the Phase 3 benchmark.
The safety profile of the Covid-19 vaccine booster shot was similar to that seen after the second dose.
Moderna CEO Stéphane Bancel said: “We would like to thank Health Canada for this authorization and the Government of Canada for its continued confidence in our mRNA platform.
“We are grateful for the opportunity to provide Canadians with another layer of protection.”
In a separate development, the company announced positive data obtained from Phase IIa EPICCURE trial of AZD8601 in patients undergoing coronary artery bypass grafting (CABG) surgery.
The data from double-blind, randomised, multicentre, placebo-controlled, clinical trial showed that AZD8601 has met the primary goal of safety and tolerability in patients with heart failure.
An investigational mRNA therapy, AZD8601 encodes for vascular endothelial growth factor-A (VEGF-A).