KUALA LUMPUR, 16 July 2021 – Duopharma (M) Sendirian Berhad, a wholly-owned subsidiary of Duopharma Biotech Berhad (“Duopharma Biotech”), has been granted conditional registration approval by Malaysia’s Drug Control Authority (“DCA”) for the Covid-19 Sinopharm vaccine developed by China National Biotec Group Company Limited (“Sinopharm CNBG”). 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.
Director-General of Health Malaysia, YBhg. Tan Sri Dato’ Seri Dr. Noor Hisham Abdullah announced this in a press statement on 16 July 2021, following a DCA meeting. 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 was to ensure the benefit over risk comparison for the said vaccine remains positive.