People who took part in vaccine trial worried they can't get Ontario's immunization passport

Ontario residents who participated in a Canadian company's COVID-19 vaccine trial fear they won't be eligible for the province's vaccine passport and will soon be barred from indoor dining, gyms and other public spaces. 

Lenora Shortt signed up for the third phase of the Quebec company Medicago's plant-based vaccine trial in March.

At that time, it was still unclear when the 56-year-old Toronto resident would be eligible to receive approved shots from Pfizer, Moderna or AstraZeneca. And Shortt said she wanted to get protected as soon as possible because she cares for an 88-year-old woman with Alzheimer's disease.

She also said she was interested in supporting the "wonderful" Canadian technology and thinks it would be an attractive option for those who are hesitant to get an mRNA vaccine, like herself.

Shortt got both shots this spring with minimal side effects and is confident in the vaccine's efficacy, but is now frustrated she's not eligible for the province's vaccine passport announced this week.

"I'm doing something for Canada," Shortt said. "Why are we not even being recognized when our own government has pushed through this vaccine for Phase 3 clinical trials?" 

Trial participants may drop out

According to its vaccine passport guidelines, the province considers people fully vaccinated if they've received a full series of a COVID-19 vaccine or a combination of vaccines approved by the World Health Organization (WHO).

The WHO considers a vaccine after its been approved by the national regulatory authority, according to its guidelines. So far it's cleared seven vaccines for emergency use. But in Medicago's case, the company is still waiting for approval from Health Canada, which lists the application as under review, a spokesperson confirmed.

The Ministry of Health declined to answer CBC Toronto's question on whether it's considering an exemption for vaccine trial participants, instead deferring to Health Canada.

"The Medicago vaccine trial is a Health Canada exercise under federal jurisdiction," said spokesperson David Jensen. "Ontario is not part of this process so we cannot comment on the vaccine trial or those participating in it."

Health Canada said it can't provide a timeframe for when it might approve the vaccine.

Brian Dunn, a 36-year-old Mississauga resident, also participated in the trial, eager to help with the Canadian-led research. 

"There's going to be, sadly, future pandemics, hopefully not as terrible as this, but we need domestic manufacturing [of vaccines]," he said. "So, I really want Medicago to succeed. And it's pretty cool to be part of this." 

While Dunn said he can live for some weeks without a vaccine passport, he's considering dropping out and getting an approved vaccine if no exception is made in the coming months.

"I still really want to be part of this study, and the more people that drop out because they're frustrated than the longer this vaccine is going to be delayed or not approved," Dunn said. 

Quebec, U.K. make exception

Medicago's trial will enrol 30,000 participants and has so far included people from Canada, the U.S., the U.K. and Brazil. Phase 2 showed those who took the vaccine had 10 times more COVID antibodies than those who'd been infected and were recovering from the virus, research suggests. 

Medicago's medical officer Dr. Brian Ward said in a statement to CBC News that the company is working with provinces and other countries where it's conducting clinical trials to have its vaccine recognized as valid once it's approved by health authorities. 

The Quebec government recently announced an exception for Medicago trial participants, ensuring they're eligible for the province's vaccine passport. In June, the U.K made a similar commitment for all vaccine trial volunteers.

Kerry Bowman, a University of Toronto bioethics professor, said the Ontario government needs to do the same.

"These people are giving benefits to all of Canadian society and global society and they're doing that without getting rich," Bowman said. 

"They're doing that because they're good people making sacrifices. And the government needs to stand up for them."

He said he's concerned that the bureaucracy surrounding Ontario's vaccine passport is leading to conflicting rules.

For example, people who've received the Medicago vaccine — which Bowman describes as "looking very, very good — won't be allowed to dine indoors, but an 11-year-old child who isn't yet eligible for the COVID vaccine will.

"I think it will generate a lot of bad feeling and could further erode trust in the whole vaccine passport system."