VIDO-InterVac prepares for human trials with COVID-19 vaccine

It’s the kind of start to a new year that researchers at Saskatoon’s VIDO-InterVac were hoping for.

CEO Volker Gerdts says they are days away from the first human testing with the COVID vaccine they’ve been working on for months.

“What is happening now is a bit of finalizing the last of the paperwork, then the screening of volunteers, so that’s all going to happen over the next few days and we’re hoping to start the first vaccinations in seven to eight days,” Gerdts told Gormley on Monday.

Gerdts said Phase 1 of the trial is happening in Halifax at the Canadian Centre for Vaccinology. He says 108 people have volunteered for the initial testing.

Gerdts says the screening includes looking at the volunteers’ blood to see if they have been exposed to COVID unknowingly or if they have received any other vaccines yet.

He says Phase 1 is all about safety.

“It’s all about monitoring how they respond to the vaccine, so we’re looking for any possible adverse reactions to the vaccine that we haven’t seen in any of the animal studies that we’ve done,” said Gerdts.

He said the first group to take part in Phase 1 is the middle group, people aged 18 to 54. Next will be those aged 55 to 65 and after that those older than 65.

“While (trials) are going on, as soon as we have data coming from the first group saying there are no adverse reactions, we can then begin our Phase 2 trials and that’s where we begin monitoring how well these individuals are responding to the vaccines,” said Gerdts.

He said that’s when researchers will look at the volunteers’ immune response and how well they are responding to making some antibodies and T-cells. Gerdts says Phase 2 of the trial will be much larger, with about 1,500 volunteers at multiple sites across the country including Saskatoon.

Gerdts says Phase 3 will begin based on the data that comes in. There is a data review board that examines the data as it becomes available and, depending on what’s found, would give permission to move to the next phase.

“So it’s going to take our Phase 1 and Phase 2 a few months to run through this. They all start staggered so we start with the mid-age group first, then we add the older age groups so it’s a staggered approach that will probably run over the next four to five months,” Gerdts said.

Gerdts said while there is a vaccine manufacturing facility being built at VIDO-InterVac, it won’t be ready in time to manufacture the vaccine.

“We’ve been working with another manufacturer in Toronto, in Mississauga and we’ve been working with them to determine for manufacturing later next year,” said Gerdts. “They have to do a lot of work upfront to be ready to do that so that’s on the way now.”