Virus-Like Particle Flu Vaccine Enters Phase 3 Clinical Study

A Canadian biopharmaceutical company announced the start of a Phase 3 efficacy study for its seasonal quadrivalent influenza vaccine (QIV) candidate.
Phase 3 clinical trials typically are the last step with humans before a medicinal product or technology is submitted for approval to the Food and Drug Administration.
This QIV candidate is produced using a virus-like particle (VLP) technology, which represent a new approach to vaccine development and production.
VLPs mimic the native structure of viruses, allowing them to be easily recognized by the immune system.
The Medicago technology implants genetic material into tobacco leaves that produce flu-like particles containing antigens, which trigger immune responses.
However, according to researchers, they lack the core genetic material, rendering them non-infectious and unable to replicate.
In other words, they are safe and highly effective as they induce an immune response similar to a natural infection.
This efficacy study is in support of Medicago's flu program and expected launch of the vaccine in time for the 2020 influenza season in Canada, USA and Europe.
An alternative to egg-based and cell-based production systems, Medicago's manufacturing platform brings many advantages, including much shorter lead time, reliability and versatility.
It currently takes only 5-6 weeks for the company to produce a clinical-grade vaccine, compared to 5-6 months using egg-based production methods.
With influenza viruses constantly mutating, this technology enables the creation of a vaccine that precisely matches the specific strain in circulation.
During a Phase 2 study, the antibody and cell-mediated immunity (CMI) responses to Medicago's VLP vaccine were higher than the responses using a comparator vaccine.
"We are excited to demonstrate the efficacy of the VLP vaccine during a large-scale field trial and prove the benefits of the unique immune response induced by this innovative product," said Nathalie Landry, Medicago's Executive Vice President of Scientific and Medical Affairs.
Most pharmacies offer flu vaccines. The CDC vaccine price list can be found here.
To find discounts on flu vaccines, please visit this webpage.
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