Medicago’s vaccine candidate is 75.3% effective against infections caused by the Delta variant according to the phase 3 study. The Quebec company will seek approval from Health Canada in the coming days.
“If the vaccine candidate is approved, it would be the first vaccine to have been developed in Canada in the past 20 years,” said Nathalie Charland, senior director of scientific and medical affairs at Medicago, whose head office is located in Quebec.
The candidate vaccine has been shown to be 75.3% effective against COVID-19, regardless of its severity, caused by the Delta variant. The efficacy was 88.6% against the Gamma variant. The Omicron variant was not circulating during the study.
“We are very satisfied with the results. The efficacy of our vaccine candidate is very good against all the variants that were circulating, ”says Mr.me Charland.
Medicago will seek regulatory approval from Health Canada in the coming days. “For several months, have provided Health Canada with the data we obtain. Now, we will complete the submission with the results of efficiency, ”says the director.
In October 2020, the Government of Canada reached an agreement with Medicago to purchase 20 million doses of the vaccine, with the option of procuring another 56 million.
“Our goal is to deliver doses to the Government of Canada, after approval by Health Canada. It will then be up to the government to decide whether they want to distribute it to other countries, via the COVAX platform for example, ”she indicates.
The Quebec company has also started regulatory submissions to the Federal Food and Drug Administration (FDA), the United States and the Medicines and Health Products Regulatory Agency (MHRA) in the United States. United. A preliminary discussion is underway with the World Health Organization (WHO) for the preparation of the submission of the dossier.
Few side effects
Phase 3, launched on March 16, aimed to measure the efficacy and safety of the candidate vaccine compared to placebo. The study took place with 24,000 participants in Canada, the United States and the United Kingdom, Mexico, Argentina and Brazil.
No serious event was reported in the group of people vaccinated. Mild side effects have been observed 1 to 3 days after vaccination.
“Some had pain at the place of injection or a little headache or fatigue, as we often see with the more famous vaccines,” says Mme Charland. Less than 10% of participants had a fever after their vaccination.
In early 2022, Medicago will begin studies for a booster dose, especially for people who have received two doses of a vaccine already approved by Health Canada. “We would like to be able to give our vaccine as a third dose,” says Mme Charland.
Unique technology
The development of Medicago vaccines is characterized by the use of living plants to produce a particle that mimics the virus, without any live virus.
Nicotiana benthamiana, the plant used is a species of tobacco native to Australia. The proteins that mimic the virus are then injected into humans to induce an immune response similar to that of a natural infection.
“If the vaccine is approved, it’ll be the first plant-produced vaccine for human use,” says Mme Charland.
Medicago plans a two-dose vaccination 21 days apart. The vaccine is stored at 2 ° C to 8 ° C.