As Sanofi and GlaxoSmithKline's COVID-19 vaccine finally heads to regulators, another shot using GSK’s pandemic adjuvant has taken home its first global approval.
Medicago’s recombinant COVID-19 vaccine, now dubbed Covifenz, has snagged a green light in Canada, the company’s home country. The shot uses a plant-based virus-like particles technology to mimic the coronavirus’ spike protein and is combined with GSK’s pandemic adjuvant.
Covifenz marks the first approved vaccine for Quebec City-based Medicago and the first nod for a COVID shot using GSK’s pandemic adjuvant.
In a phase 3 trial conducted in more than 24,000 adults across six countries, Covifenz showed a solid 71% efficacy against COVID-19 by various SARS-CoV-2 variants, though not omicron because the now-dominant variant wasn’t present at the time of the study.
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The virus-like particles platform allows Covifenz to be stored at normal refrigeration conditions from 2 degrees Celsius (35.6 degrees Fahrenheit) to 8 degrees Celsius (46.4 degrees Fahrenheit). Two doses of the vaccine are given intramuscularly 21 days apart.
Covifenz gives the Canadian government an opportunity to drive COVID immunization from a home-developed vaccine. Its approval is a welcome event as “one of our government’s top priorities has been to reverse the 40-year decline faced by Canada’s biomanufacturing sector,” François-Philippe Champagne, the country’s Minister of Innovation, Science and Industry, said in a statement.
Before Covifenz's approval, the Canadian government locked in mRNA COVID-19 vaccine doses from Pfizer/BioNTech and Moderna for 2022 and 2023. It has also signed supply contracts with Medicago, Novavax, Sanofi-GSK and others.
Meanwhile, Sanofi’s protein-based vaccine using the GSK adjuvant showed 57.9% efficacy against any symptomatic COVID-19 disease after two doses, or 100% efficacy against severe disease and hospitalizations. The Sanofi-GSK trial stretched into a period when omicron became prevalent. A booster shot after those primary series also significantly boosted neutralizing antibodies against the coronavirus.
Based on the data, Sanofi and GSK are seeking regulatory approval for their shot as a two-dose series and as a booster.