Medigen Vaccine Submits Application to Expand EV71 Vaccine Indication to Children Under 10, Stock Rises to Hold Above 5-Day Line

Medigen Vaccine (6547-TW) has formally submitted an application to Taiwan's Food and Drug Administration (TFDA) to amend the age indication for its enterovirus 71 (EV-A71) vaccine. The proposal seeks to expand the current indication—'from 2 months of age to under 6 years'—to include children 'from 2 months to under 10 years of age.' This move has driven Medigen's stock upward today (31st), as it attempts to stabilize above the 5-day moving average.

CEO Szu-Hsien Lee stated that while enterovirus 71 has traditionally posed the highest risk to children under 6, clinical data and public health practices indicate that school-aged children over 6 still face risks of severe illness or death from infection. Following consultations with the Center for Drug Evaluation (CDE) and TFDA, the company initiated a Phase III clinical trial last year to evaluate the vaccine in this extended age group.

Medigen emphasized that the current application for a label change is based on positive results from the Phase III trial. The data support the safety and immunogenicity of the EV-A71 vaccine in children aged 6 to under 10, justifying the proposed expansion to a broader pediatric population.

In trading, Medigen opened at NT$46.25 this morning, peaking at NT$47.20—a rise of over 3%. As of midday, the stock was trading at NT$46.35, up more than 1%, with trading volume exceeding 1,000 shares. The positive market reaction reflects investor confidence in the company's clinical progress and expanded market potential.