Vaccines and treatments for COVID-19: Clinical trials

On this page

• Clinical trials for vaccines
• Clinical trials for treatments
• Applying to conduct a clinical trial
• Videos, posters and infographics to share

Clinical trials for vaccines

Clinical trials determine if COVID-19 vaccines are safe and effective.

Vaccines are complex biological products. There are strict evidence requirements that need to be met before they can be authorized for use in healthy people. Large clinical trials are required to demonstrate a vaccine’s safety and effectiveness.

There are more than 150 potential COVID-19 vaccines at different stages of development around the world.

A number of vaccines are being developed in Canada. Healthy volunteers and COVID-19 patients in Canada may be able to participate in clinical trials. It isn’t necessary for clinical trials to be conducted in Canada for the vaccine to be authorized for use here.

Generally, a vaccine development process involves a number of clinical trial phases. Researchers use the results from one phase to plan the next based on the evidence.

For potential COVID-19 vaccines, manufacturers are using many processes to fast-track their development. This includes decreasing the time between trial phases by:

• using trial processes that test multiple vaccines at the same time
• running trials at the same time rather than doing them individually, which reduces the:
  • number of trials and steps needed
  • time it takes to collect and assess the data
• launching trials in areas affected the most by the pandemic (highest number of cases and severe illness)
• increasing collaboration with research networks, manufacturers and other partners here in Canada and around the world

With these processes, manufacturers are able to speed up development without compromising safety and effectiveness (how well it works).

Clinical trials for treatments

Clinical trials for treatments include testing:

• new drugs
• existing drugs that are already used for treating other medical conditions but may be effective for treating COVID-19

These clinical trials follow the same phases as vaccine trials.

There are many types of treatments that are being reviewed in Canada and around the world. Learn about clinical trials for COVID-19 treatments.

Applying to conduct a clinical trial

Companies, academic research centres and physicians (known as sponsors) can apply to conduct a clinical trial. An application can be made under either of the following:

• the new COVID-19 interim order for clinical trials
  • this process was set up to respond to the urgent need for research and development of COVID-19 drugs during the pandemic
• the Food and Drug Regulations

We review applications to make sure the:

• vaccine used in the clinical trial doesn’t endanger the health of people taking part in the trial
• trial’s scientific goals can be met

If all requirements are met, we’ll authorize the clinical trial.

Videos, posters and infographics to share

• The facts about COVID-19 vaccines (poster)
• COVID-19: How vaccines are developed (video)
• Vaccine development and approval in Canada (infographic)

Related links

• Drugs and vaccines for COVID-19
• Regulating vaccines for human use in Canada
• Health Canada’s regulatory response to COVID-19
• COVID-19: International research and development

For industry

• Applications for COVID-19 drug and medical device clinical trials under the Interim Order: Notice release of guidance documents
• Applications for drug clinical trials under the Interim Order: Guidance document
• Guidance document: Management of drug submissions and applications
• Summary basis of decision documents
• Regulatory decision summaries of drugs and health products
• Notice of clarification to drug manufacturers and sponsors: Risk management plans
• National Microbiology Laboratory’s role in the COVID-19 response