KUALA LUMPUR, July 16 — Duopharma Biotech Bhd’s (Duopharma) wholly-owned unit, Duopharma (M) Sdn Bhd (DMSB), has been granted conditional registration approval by the Drug Control Authority (DCA) for the Covid-19 Sinopharm vaccine developed by China National Biotec Group Co Ltd.
In a statement with Bursa Malaysia today, Duopharma said approval for the vaccine – an inactivated virus vaccine registered under the name COVILO Suspension for Injection Covid-19 Vaccine (Vero Cell), Inactivated – was granted to DMSB following an application for product registration.
“The conditional registration approval requires continued data gathering on the quality, safety and efficacy of the vaccine, as well as monitoring and evaluation based on the latest data on a regular basis.
“This is to ensure the benefit over risk comparison for the said vaccine remains positive,” it said.
Duopharma said Health Ministry director-general Tan Sri Dr Noor Hisham Abdullah had made this announcement in a separate statement earlier today following a DCA meeting.
— Bernama
