Moderna Inc. (NASDAQ: MRNA) has announced the approval of the New Drug Submission for SPIKEVAX from Health Canada for immunization of children above 12 years. SPIKEVAX or elasomeran mRNA vaccine is the company’s COVID-19 vaccine.
Moderna vaccine approved for adolescents in Canada
CEO Stephane Bancel said, “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. I would also like to thank the Government of Canada for the partnership they have built with us and for their confidence in our mRNA platform in addressing the COVID-19 pandemic.”
SPIKEVAX’s New Drug Submission received Health Canada’s approval based on clinical results from the company’s COVID-19 Phase 3 COVE vaccine study, which included over 30,000 people in the United States. Interestingly, SPIKEVAX exhibited 93% efficacy in the final analysis of the third phase COVE study data, with efficacy lasting for six months after the second dose was given. Also, the safety profile as per the extended safety follow-up was similar to the preliminary results of the third phase COVE study.
Moderna vaccine approved in 50 countries
Moderna’s COVID-19 vaccine was first approved in Canada through an Interim Order issued by Health Canada on December 23, 2020, for those aged 18 and up. Health Canada extended the Interim Order approval for the Moderna COVID-19 vaccination to adolescents aged 12 and above on August 27, 2021.
The company’s SPIKEVAX vaccine is an mRNA vaccine against SARS-CoV-2, which encodes for a prefusion stabilized version of the Spike (S) protein. The US FDA) approved the vaccine’s emergency use in people above 18 years on December 18, 2020. Also, Moderna has gained emergency use authorization from health organizations in over 50 countries for the use of the vaccine in adults and an Emergency Use Listing (EUL) from the WHO.