"The approval of our COVID-19 vaccine is a significant milestone for Canada in the fight against the pandemic. We appreciate Health Canada's timely review," said Takashi Nagao, President and CEO at Medicago. "We're also grateful for the Government of Canada's support in the development of this new vaccine, and we are manufacturing doses to start fulfilling its order."
Roger Connor, President of GSK Vaccines, added, "This first approval is an important milestone in our approach of pairing GSK's well-established pandemic adjuvant with promising antigens to develop protein-based, refrigerator-stable COVID-19 vaccines to help protect people against COVID-19 disease. We look forward to working with Medicago to make the vaccine available in Canada and to progress further regulatory submissions."
The Government of Canada has a contract with Medicago (the Marketing Authorization Holder) to supply the COVID-19 vaccine.
"As one of our government's top priority has been to reverse the 40-year decline faced by Canada's biomanufacturing sector, we are pleased to see Medicago's vaccine approval. It is a great milestone for Canada's biotechnology sector and for homegrown innovation. We will continue to support companies that want to produce vaccines in Canada and join the growing national biomanufacturing sector." said the Honourable François-Philippe Champagne, Minister of Innovation, Science and Industry.
Health Canada based its decision on scientific data shared by Medicago as part of their rolling submission that began in April 2021 under an Interim Order, and concluded with the filing of a New Drug Submission-CV.
"Today is a great day for Medicago as COVIFENZ becomes its first approved vaccine. I'd like to thank the Clinical Investigators involved in our trials as well as Medicago's passionate and curious team of over 500 scientific experts and employees. Today only reinforces our commitment to using our technology to provide rapid responses to emerging global health challenges, and to advancing therapeutics against life-threatening diseases worldwide." said Yosuke Kimura, Chief Scientific Officer at Medicago.
Read Also - GSK, MS Dhoni join hands for 6 in 1 vaccination awareness campaign
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.