Aug 8, 2017
MVC obtains TFDA’s approval to initiate EV71 vaccine’s phase 3 CT
MVC obtains TFDA’s conditional approval to initiate EV71 vaccine’s phase 3 CT. The subject recruitment will be started after submitting the rest of technical document to complete the application package.
Newborn babies obtains EV71 virus’ neutralizing antibodies from their mothers, however, the antibody concentration drops to non-observable level 6 months after birth, making the babies very vulnerable to EV71 infection. MVC develops the world’s first EV71 vaccine to protect children under 6 months old, also designs 2+1 booster vaccination to extend babies’ immunity to later age.
EV71 virus transmits through fecal-oral route and respiratory secretions. Common clinical systems include hand-foot-mouth disease and herpangina. Adults show little to no symptoms whereas children are at increased risk to develop severe complications that may lead to death. According to CDC, the fatality of severe case ranges from 3.8% to 25.7%. Based on the research conducted by Dr. Gantt in 2013, children under 6 months old have the highest relative case severity rate and fatality rate among children under 10 years old.
Taiwan CDC’s surveillance system showed that the weekly EV71 outpatient clinic visit has reached 11, 592 last month, exceeding the epidemic threshold (11,000) first time this year, indicating an EV71 epidemic has ensued.
Source： Medigen Biotechnology Corp.
http://www.medigen.com.tw/en/mvc-obtains-tfdas-approval-to-initiate-ev71-vaccines-phase-3-ct/