Canadian Sponsors: Think Carefully About Including Elderly in Blinded Randomized COVID-19 Vaccine Trials

Canadian Sponsors Thinks Carefully About Including Elderly in Blinded Randomized COVID-19 Vaccine Trials

Thinking about enrolling the elderly into your COVID-19 vaccine clinical trial? Think carefully as this action could raise ethical questions about your study. Given that there are now vaccine candidates deemed effective and thus authorized by health authorities on an emergency basis, the inclusion of senior citizens into more randomized, blinded trials might not only not make sense but actually violate ethical standards. After all, seniors are by far the hardest hit in this pandemic. For example, in Canada, mortality rates for COVID-19 involving people 80 and above now stands at 70%. Studies covering patients in multiple countries find similar results

Ethicist Point of View

Recently reported in the Canadian press, Kerry Bowman, PhD, is an Assistant Professor in the Faculty of Medicine at the University of Toronto. Professor Bowman, a Canadian bioethicist, recently declared that there is absolutely no justification for enrolling the elderly into 100% blinded COVID-19 vaccine clinical trials. Emphasizing this point, Professor Bowman recently declared, “We can’t fully quantify the risks, which I think is important.” Continuing, “Variants now represent the unpredictable map. We don’t even know which direction this is heading. The whole situation could get worse quickly.”

While Bowman acknowledges those volunteers that are in good health could represent an exception, any trial would need to be well-designed, mitigating risk to a bare minimum.

While infectious disease physician Zain Chagla suggests the appropriateness of comparing vaccines at the trial stage with the candidates currently under emergency authorization in Canada such as both Moderna’s mRNA-1273 and Pfizer/BioNTech’s BN162b2. The professor of medicine at Hamilton’s McMaster University shared, “It’s hard for a researcher to say he’s not causing harm if he denies a patient a proven drug or vaccine,” as reported in Inspired Traveler.

Leading Trial Site Perspective

In the meantime, Karri Venn heads up the prominent research organization in Canada known as LMC Manna Research. Ms. Venn, who has been interviewed by TrialSite in the past, emphasized that any and all clinical trials must pass rigorous ethical and protocol reviews, all subject to the laws and ethical standards promulgated by Health Canada (equivalent of U.S. FDA in the neighbor to the north). That patient safety “remains paramount,” reports Venn whose firm is working on the experimental vaccine from Medicago.

A Home Grown Vaccine Candidate

As it turns out, Medicago inked a deal with the Canadian government back in October. The Quebec City-based biotech company will supply Canada’s government with up to 76 million doses, assuming of course, the candidate successfully survives the clinical trials pipeline and achieves regulatory approval by Health Canada.

This particular Virus-Like Particle (VLP) vaccine candidate is derived from a plant-based platform. It turns out to differ from other vaccine classes as it uses living plants as bioreactors to yield a non-infectious particle that mimics the target pathogen, precluding any use of live virus.

The firm announced positive results in November for their Phase 1 clinical trial. 

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