PUTRAJAYA – The National Pharmaceutical Regulatory Agency (NPRA) has approved an application from Solution Biologics Sdn Bhd, regarding the extension of the shelf life of the COVID-19 vaccine, Convidecia Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Solution for Injection.
NPRA senior director (Pharmaceutical Services), Norhaliza A Halim, said that the new approved shelf life is from 15 months to 18 months when stored at a temperature of 2 degrees Celcius to 8 degrees Celsius.
She said that the extension of the shelf life involves the MAL21066050AZ vaccine, manufactured at CanSino Biologics Inc, China, and MAL22126013ASZ manufactured at Solution Biologics Sdn Bhd, Malaysia.
“The extension of the product’s shelf life has been given based on the latest stability data submitted by the manufacturer.
“The approval of this shelf life extension is retrospective, meaning that this approval also applies to all stocks, including all stocks that have been received before this shelf life extension was approved,” she said in a statement today.
Norhaliza said that the Health Ministry is always committed to ensuring that all pharmaceutical products, including the COVID-19 vaccines supplied in Malaysia, have been assessed in terms of quality, safety and effectiveness by the NPRA. – Bernama