Sunday, February 27, 2022

Canada to buy COVID vaccine made in Research Triangle Park. Here’s how it’s different.

Richard Stradling
Sat, February 26, 2022, 

A new plant-based COVID-19 vaccine that will be made in Research Triangle Park has been approved by health regulators in Canada, where the government has agreed to buy millions of doses.

The vaccine, COVIFENZ, was developed by GlaxoSmithKline and Medicago, a Canadian biopharmaceutical company based in Quebec City. Medicago will begin manufacturing the vaccine at its plant in RTP later this spring, said Brian Ward, the company’s medical officer.

Ward said the company has a contract to supply up to 76 million doses of the vaccine to the Canadian government and expects to ship 20 million doses this year.

Medicago uses plants to produce what it calls “virus-like particles” that mimic the structure of viruses and trigger an immune response in the body. The company says because the particles lack core genetic material they are non-infectious and unable to reproduce.

Health Canada, the Canadian version of the Food and Drug Administration, approved COVIFENZ on Thursday for use in adults ages 18 to 64. It cited clinical trials that showed the vaccine was safe and 71% effective against all variants of the COVID-19 virus except for omicron, which wasn’t circulating during the study period.

Clinical studies measuring the response against the omicron variant should be finished in the coming weeks, according to spokeswoman Lindsey Bailys. Nearly all new cases of COVID-19 in the United States are caused by the omicron variant, according to the Centers for Disease Control and Prevention.

Medicago and GSK are also seeking approval for COVIFENZ from the FDA, the World Health Organization and health regulators in the United Kingdom.

Like the Pfizer-BioNTech and Moderna vaccines, two doses of COVIFENZ are needed to be fully effective. Pfizer and Moderna both reported that two doses of their vaccines were more than 90% effective against COVID-19, though that effectiveness waned over time, prompting both companies and public health officials to urge booster shots.

COVIFENZ arrives more than a year after the Pfizer and Moderna vaccines became available and at a time when many people are acting as if the coronavirus pandemic is over.

But the virus has not shown signs of going away, and Medicago says there’s still a strong market for vaccines, especially one that might appeal to different people because of how it’s made.

“COVIFENZ is the first COVID-19 plant-based vaccine, which diversifies the pool of vaccines available to help improve public health and protect more people,” Ward wrote in an email. “We are in discussion with several countries regarding supply,” though he declined to name them because the discussions are “confidential in nature.”

Medicago opened its RTP plant and greenhouses in 2010 using a grant from the U.S. Defense Advanced Research Projects Agency, or DARPA. At the time, the agency was looking for ways to make large quantities of vaccine to respond to epidemics, bioterrorist attacks and other public health emergencies.

The company employed about 200 in RTP as of December and is looking to fill about 40 positions as it gears up to produce COVIFENZ.


In this Aug. 14, 2014, photo, biotech greenhouse specialist
 Maggie Cole waters tobacco seedlings at Medicago in Research Triangle Park.

Canada Approves First Plant-Based COVID-19 Vaccine


Vandana Singh
Fri, February 25, 2022


As Sanofi SA (NASDAQ: SNY) and GlaxoSmithKline Plc's (NYSE: GSK) COVID-19 vaccine finally heads to regulators, another shot using GSK's pandemic adjuvant has won its first global approval.


Mitsubishi Tanabe Pharma Corporation-backed Medicago's recombinant COVID-19 vaccine, dubbed Covifenz, has snagged a green light in Canada in individuals 18 to 64 years of age.


The vaccine 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 Medicago and the first nod for a COVID shot using GSK's pandemic adjuvant.


Related: Medicago, GSK's Plant-Based COVID-19 Vaccine Candidate Hits 75% Efficacy Against Delta Strain.


In a Phase 3 trial conducted in more than 24,000 adults, Covifenz showed a 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.


The virus-like particles platform allows Covifenz to be stored at normal refrigeration conditions from 2 degrees Celsius to 8 degrees Celsius. Two doses of the vaccine are given intramuscularly 21 days apart.


Also See: Sanofi-GSK Prepare Regulatory Filings For COVID-19 Vaccine After Booster Data.


Price Action: GSK shares are up 1.53% at $41.82 during the premarket session on the last check Friday.

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