A promising new COVID vaccine would be made in RTP, if regulators approve it
A partnership between a Canadian company and GlaxoSmithKline says it has developed a safe and effective plant-based vaccine against COVID-19 and will make it in the Triangle if regulators authorize its use.
Medicago, a biopharmaceutical company based in Quebec City, says it will seek approval for the vaccine from Health Canada, the Canadian version of the Food and Drug Administration. The partnership is also seeking FDA approval and will complete its application with full data in the coming months, according to spokeswoman Lindsey Bailys.
If approved by either or both agencies, Medicago says it will manufacture the vaccine at its plant in Research Triangle Park.
On Tuesday, the two companies released preliminary results of Phase 3 clinical trials that they say showed the vaccine was 71% effective against all variants of the COVID-19 virus except for omicron, which wasn’t circulating during the study period. They say it was 75% effective against the delta variant of the virus, which emerged last summer and now accounts for nearly all new cases in the U.S.
The trials involved 24,000 people over the age of 18, some of whom received a placebo, in six countries, including the U.S. The companies say none of the participants had “serious adverse” side effects, and that fewer than 10% had a low fever.
The companies say the full results of the trials will be published in a peer-reviewed journal soon.
Like the Pfizer-BioNTech and Moderna vaccines, the GSK/Medicago vaccine must be received in two doses to be effective. The shots are given three weeks apart.
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.
“The results of our clinical trials show the power of plant-based vaccine manufacturing technology,” Takashi Nagao, the company’s president and CEO, said in a written statement. “If approved, we will be contributing to the world’s fight against the COVID-19 pandemic with the world’s first plant-based vaccine for use in humans.”
Medicago opened its RTP plant and greenhouses in 2010 using a grant from the U.S. Defense Advanced Research Projects Agency, or DARPA, which at the time was looking for ways to make large quantities of vaccine to respond to epidemics, bioterrorist attacks and other public health emergencies. The company grew its virus-like cultures on the leaves of a type of tobacco, though not the kind used to make cigarettes.
Medicago employs about 200 people in RTP, according to Bailys.
This story was originally published December 9, 2021 at 1:27 PM.
