Canada Approves SpikeVax COVID-19 Vaccine

Today, Massachusetts-based Moderna, Inc. announced that Health Canada had Approved the New Drug Submission for SPIKEVAX™, known as COVID-19 Vaccine Moderna.

SpikeVax is now Apporved for active immunization to prevent COVID-19 in individuals 12 years of age and older.

The Moderna COVID-19 vaccine was initially authorized in Canada under an Interim Order for individuals 18 years of age and older granted by Health Canada on December 23, 2020. On August 27, 2021, Health Canada expanded the Interim Order authorization for the Moderna COVID-19 vaccine to include adolescents 12 years of age and older.

Health Canada approved the New Drug Submission for SPIKEVAX based on clinical data from the Phase 3 COVE study of the Moderna COVID-19 vaccine, which enrolled more than 30,000 participants in the U.S.

In the final analysis of Phase 3 COVE study data, SPIKEVAX showed 93% efficacy, with the efficacy remaining durable through six months after administering the second dose.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology, and manufacturing. It has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and auto-immune diseases. To learn more, visit www.modernatx.com.