COVID-19

Request for approval in the coming days | Medicago vaccine more than 75% effective

Medicago’s candidate vaccine 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.

Alice Girard-Bossé

Alice Girard-Bossé
Press

“If the candidate vaccine is approved, it would be the first vaccine developed in Canada in the last 20 years,” said Nathalie Charland, senior director of medical and scientific affairs for Medicago, headquartered 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. Our candidate vaccine has very good efficacy against all the variants that were circulating, ”says Ms Charland.

Medicago will seek regulatory approval from Health Canada in the coming days. “For several months, we have provided Health Canada with the data that we obtain. Now, we will complete the presentation with the efficiency results ”, 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 to purchase another 56 million.

“Our goal is to deliver the doses to the Government of Canada, after approval from Health Canada. Then it will be the government who decides if it wants to distribute it to other countries, through the COVAX platform for example, “he says.

The Quebec company has also initiated regulatory filings with the Federal Food and Drug Administration (FDA), the United States, and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United States. A preliminary discussion is taking place with the World Health Organization (WHO) to prepare 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 was carried out with 24,000 participants in Canada, the United States and the United Kingdom, Mexico, Argentina and Brazil.

No serious events were reported in the vaccinated group. Mild side effects have been observed 1 to 3 days after vaccination.

“Some people had pain at the injection site or a little headache or fatigue, as we often see with the more popular vaccines,” says Charland. Less than 10% of the participants had a fever after 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 Charland.

Unique technology

The development of Medicago vaccines is characterized by the use of live 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. 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 will be the first plant-produced vaccine for human use,” says Charland.

Medicago plans a two-dose vaccine 21 days apart. The vaccine is stored between 2 ° C and 8 ° C.

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