2018/10/02 MVC Receives TFDA's Approval to Start Phase 3 Clinical Trial of Quadrivalent Influenza Vaccine

On October 1st, MVC received TFDA's IND approval to start a phase 3 clinical trial of quadrivalent influenza vaccine (QIV), after MVC obtaining the exclusive market right of GC Pharma's quadrivalent influenza vaccine, GC Flu™, in Taiwan earlier this year.
 
WHO finds that seasonal influenza results in 3~5 million cases of severe illness and 290,000 to 650,000 respiratory deaths every year. Based on Taiwan CDC's statistics data, the latest seasonal influenza season has caused 717 severe cases and 114 deaths from October 2017 to April 2018 in Taiwan, some were vaccinated with trivalent influenza vaccine (TIV). Since TIV only protects against 3 flu viruses (H1N1, H3N2 and one of the two types of influenza B), it offers limited protection when the other type of influenza B becomes dominant.
 
QIV offers broader protections by including all of TIV's virus strains plus another type of influenza B viruses. Therefore, many European countries, United States and Japan have adopted QIV in their EPI program. Taiwan government is also planning to switch from TIV to QIV, however, the plan has not yet being fully finalized.
 
MVC will provide finished influenza vaccine and aim to establish formulation and fill/finish capacity in Taiwan and sell QIV using MVC's brand name. MVC's goal is to have the capability to produce full spectrum of influenza vaccines, from mockup vaccine using MVC's cell culture platform, to seasonal influenza vaccine by cooperating with GC Pharma.

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