Medicago participants find themselves in a Quebec COVID-19 vaccine grey zone

MONTREAL -

Isabelle Pelletier wanted to be a good citizen, protect her mother, and help Quebec gain a modicum of vaccine independence when she signed up to be a participant in the development of the Medicago COVID-19 vaccine.

Now, it seems, she finds herself in the vaccine passport grey zone, as Medicago is not one of the four approved vaccines that the passport app will accept.

"I consider myself vaccinated," she told CTV News. "There are blind spots in the vaccine passport."

Pelletier received her first shot in December 2020, before Quebec had begun its mass vaccination rollout.

"At that point, we had no idea when we would have any access to vaccine," she said.

Pelletier's mother was in treatment for breast cancer, and she wanted to be sure she could help.

"I thought I would give a better protection for my mother to accompany her on her treatments, so I joined the research in phase II," she said.

She received a second shot in 2021, and did follow-ups in person where blood samples were taken, kept a digital diary and received regular phone call check-ins where researchers asked various health questions.

The follow-ups continue today.

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As half the participants received a placebo and half the vaccine, Medicago authorized participants to request which group they were in.

Pelletier received a written confirmation that she had received two vaccine doses.

She opted not to receive the passport-approved Pfizer, Moderna, Astra-Zeneca or Johnson and Johnson vaccines, as she did not want to jeopardize Medicago’s research.

"I think it's worthwhile to consider exceptions to allow people to function at a minimum level in Quebec while we're waiting for the research to be completed," she said. "If I withdraw from the research to receive two doses of a recognized vaccine I have an ethical dilemma."

By withdrawing, Pelletier feels she will be slowing down the possibility that Quebec develops a vaccine as she is in Phase 3 of the study.

"It'll mean that I'll have received four doses of vaccine within the same year, and that's never been documented," she said. "I want to also give the time to Medicago to finish Phase 3 and receive an approval from Health Canada...Ethically it poses a problem for me because, as a citizen, I'm playing a role in participating in the research."

Medicago said participants should not be disadvantaged when having to prove they were vaccinated.

"Medicago is actively working with the Quebec government to find a solution for trial participants," said Medicago medical officer Dr. Brian Ward.

Medicago said Phase 3 should be completed by the fall, and the company will then submit the data to health authorities.

Quebec Health Minister Christian Dube said Friday that Medicago needs all the support it can get and that the government is looking at making an exception for the around 300 Quebecers that are in the study.

"It`s not a lot of people if we need to make some arrangements," said Dube. "We are looking at this right now. We've been able to make a lot of arrangements in last 18 months, so I just want to assure them we're trying to find something for them."

Executive vice-president for scientific and medical affairs for Medicago Nathalie Landry said in May the vaccine appears to produce 10 times the antibodies as are seen in people who have had COVID-19.

"Based on these results, let's say we're quietly confident that we will be in a position to demonstrate good efficacy of the vaccine," said Landry at the time.

Pelletier, like many Quebecers, wants greater medical independence in the province and hopes a solution can be found.

"I think it's a worthwhile cause, and I find myself in a grey zone as far as the vaccine passport is concerned," she said.

-- This is a developing story and will be updated.