The announcements follow one another on the side of Medicago, which, after unveiling encouraging results at the beginning of the week, is launching the next stage of testing on humans, in the study of its candidate vaccine against COVID-19 produced on plants.
• Read also: COVID-19 vaccine: a very encouraging first phase at Medicago
• Read also: Pfizer vaccine: a dose of hope for the whole planet
The Quebec biopharmaceutical company said Thursday that it had obtained the approval of the Canadian regulatory authorities for the conduct of phase 2 and 3 clinical trials.
In the coming months, it will be testing a formulation of its vaccine candidate that contains GSK’s pandemic adjuvant in more people. The objective is to confirm that it is safe and that it induces an immune response.
The adjuvant is a compound which maximizes the immune response while reducing the amount of antigen required per dose. Thus, more doses can be produced.
Quebec’s experimental vaccine is the most advanced among all the coronavirus vaccine projects on which GSK is collaborating, noted the British multinational.
Medicago anticipates that two doses of its vaccine will need to be administered, as is likely to be the case for several other vaccines in development, including Pfizer’s.
Compared to the American giant, however, Medicago’s product has the advantage of being able to be stored at temperatures varying between 2 and 8 ° C, “facilitating the management of the cold chain in existing vaccine infrastructure”, according to the business.
Due to the new RNA technology on which it is based, Pfizer’s vaccine candidate needs to be stored at very low temperature, i.e. -70 ° C. A logistical challenge that led Quebec to procure around sixty freezers, we learned this week.
In two times
In Medicago’s Phase 2 clinical trial, approximately 600 people will receive either the candidate vaccine or a placebo across multiple sites in Canada and eventually the United States.
The Quebec company wants to start in parallel, by the end of 2020, the phase 3 clinical trial, the last step before the application for approval. This will be crucial in order to determine the protective power of the vaccine under real conditions.
If all goes as planned, vaccine distribution could begin in mid-2021, Medicago hopes.
“The results of the phase 1 clinical trials are very encouraging and justify the continuation of clinical trials,” said Nathalie Landry, executive vice president of scientific and medical affairs at Medicago, in a statement.
These provisional results, released on Tuesday, indicated that all of the participants who received the adjuvant-containing experimental vaccine developed a strong antibody and cellular immune response after two doses.