COVID-19: Medicago's Development Programs
Frequently Asked Questions (FAQ)
The COVID-19 pandemic is a global issue, and at Medicago, we are utilizing our plant-based technology to research and develop a potential vaccine. Here are some of the most frequently asked questions about our technology and vaccine candidate.
Why is Medicago developing a vaccine for COVID-19?
Our corporate mission is to create and deliver effective responses to emerging global health challenges. Responding effectively to the COVID-19 pandemic will require the efforts of vaccine developers around the world. Medicago is a leader in plant-based vaccine technology and we have already demonstrated our potential to be a first responder to pandemic situations with our work in quickly developing vaccine candidates for both H1N1 influenza and Ebola using our innovative platform.
• In 2016, we demonstrated that we could rapidly adapt our platform to produce an anti-Ebola MAbs cocktail for the Biomedical Advanced Research and Development Authority (BARDA); learn more here
• In 2012, Medicago delivered - under a contract with DARPA - 10 Million doses of a research-grade H1N1 pandemic influenza vaccine, within one month
• Our first product, a seasonal influenza vaccine, is currently under review by Health Canada; learn more here
At what stage of development is Medicago's COVID-19 vaccine candidate?
Medicago's vaccine candidate is currently in Phase 1 clinical trials. Based on positive results for Phase 1 and the green light to continue from regulatory authorities, we expect to launch Phase 2/3 trials in October 2020.
How does Medicago's plant-based approach differentiate from traditional vaccine development?
We use a plant-based platform to develop our vaccines. This approach uses living plants as bioreactors to produce non-infectious versions of viruses (called Virus-like Particles, or VLPs). Learn more about our proprietary plant-based platform here.
We use VLPs that mimic the architecture of a virus but are non-infectious. The VLPs present antigens to the individual's immune system in a highly efficient manner, eliciting a protective and long-lasting immune response.
We successfully produced a VLP of the coronavirus in early March 2020, just 20 days after obtaining the SARS-CoV-2 (the virus causing the COVID-19 disease), as announced here.
When will Medicago's COVID-19 vaccine be available?
Before launching a vaccine, it is essential to test its safety and efficacy during clinical trials. While standard vaccine development timelines can take 5 to 20 years, we plan to submit a COVID-19 vaccine to health authorities for regulatory reviews in 2021.
How is Medicago moving so quickly to test its COVID-19 vaccine candidate?
Governments and regulatory authorities around the world have demonstrated unprecedented cooperation to enable COVID-19-related clinical trials to begin as soon as possible. The safety of our vaccine candidate always remains our top priority.
How many doses of COVID-19 vaccines can Medicago produce?
Though the precise dosage for the vaccine in humans is not yet determined, based on previous experience we estimate that Medicago will be able to produce up to 100 million annual doses from 2021. When the construction of our large-scale factory in Quebec is complete in 2023, it will have the capability to produce more than 1 billion doses of COVID-19 vaccines per year.
In 2012, we produced 10 million research-grade doses of a H1N1 pandemic vaccine in one month for DARPA's Blue Angel program. This production yield has helped to inform our estimates.
Are you working with any partners to develop the vaccine?
Medicago will be evaluating its vaccine candidate alone and with two adjuvants separately – GSK's proprietary pandemic adjuvant technology and Dynavax's CpG 1018™.
The use of an adjuvant can be of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore contributing to protect more people.
How can I volunteer for the human clinical trials?
Trial recruitment is conducted by a specialized independent third-party clinical trial organization. To maintain the integrity of the trial, Medicago is not able to participate in recruitment. You can find more information, including clinical trials site contacts at ClinicalTrials.gov.
Is Medicago publicly traded?
Medicago is not publicly traded and has been privately held since 2013.
On March 12, 2020, Medicago announced the successful production of Virus-Like Particle (VLPs) of the coronavirus just 20 days after obtaining the SARS-CoV-2 (virus causing the COVID-19 disease) gene. Production of VLPs is the first step in developing a vaccine against COVID-19 before preclinical testing for safety and efficacy.
VLPs mimic the native structure of viruses, allowing them to be easily recognized by the immune system. However, they lack core genetic material which makes them non-infectious and unable to replicate.
The photos below were taken using an electron microscopy to illustrate the similarity of Medicago's Coronavirus VLP with a wild-type SARS-CoV-2 virus:
Depending on ongoing discussion with regulatory authorities, Medicago expects to initiate human trials by this summer (July/August 2020) for its COVID-19 vaccine candidate, with the objective of completing the development program and submitting a dossier to authorities by the end of next year (November 2021). This research is being partially funded by the Governments of Canada and Quebec.
In addition to the vaccine program, Medicago is using its technology platform to develop antibodies against SARS-CoV-2 in collaboration with the Laval University's Infectious Disease Research Centre. These SARS-CoV-2 antibodies could potentially be used to treat people infected by the virus. This research is being partially funded by the Canadian Institutes for Health Research (CIHR).
Disclaimer: These vaccine and antibody candidates are not approved for human use in ANY country or region and are currently under pre-clinical investigation.
Our VLP vaccine candidate for the coronavirus is currently in pre-clinical studies and the antibody is at the stage of research and development. We will investigate the safety and efficacy of these products when they reach the clinical stage of evaluation.