Moderna Gets Full Approval Of COVID-19 Vaccine In Canada (Ahead Of US)

Moderna, Inc. MRNA received the first full approval for its COVID-19 vaccine, about eight months after the shot was first accorded emergency use authorization.

What Happened: Massachusetts-based Moderna said Health Canada, the nation's drug regulator, approved the new drug submission for its COVID-19 vaccine for active immunization to prevent COVID-19 in individuals 12 years of age and older.

The shot has been given the brand name Spikevax.

"Health Canada's approval of our COVID-19 vaccine is an important milestone as it is our first full approval for Spikevax. I would like to thank Health Canada for their hard work throughout the process," said CEO Stéphane Bancel.

Moderna's shot was originally authorized in Canada under an interim order for individuals 18 years of age and older granted by Health Canada on Dec. 23, 2020. The authorization was expanded on Aug. 27 to include adolescents 12 years of age and older.

Related Link: Moderna Shares Gain Amid R&D Day Presentations: What You Need To Know

Why It's Important: Full approval carries the regulator's strongest endorsement of safety and effectiveness. This will help win over vaccine hesitancy and thereby triggering a broader adoption.

It also allows the vaccine manufacturer to market the vaccine beyond the pandemic. With full approval, the vaccine can be used off-label.

While granting full approval, regulators take into account long-term effects, the potential for rare adverse events to arise, how vaccine efficacy translates into real-world effectiveness and manufacturing quality control and consistency.

Moderna's vaccine received the first emergency use authorization from the U.S. Food and Drug Administration on Dec. 18, and is yet to receive full approval in the U.S. The company completed the rolling submission of the biologic license application for full approval in the U.S. in late August.

MRNA Price Action: Moderna shares were 1.1% higher at $439.22 at publication time.