
NPRA senior director (Pharmaceutical Services) Norhaliza A Halim said the new approved shelf life is from 15 months to 18 months, when stored at a temperature of 2° Celsius to 8° Celsius.
She said the extension of the shelf life involved the MAL21066050AZ vaccine, manufactured at CanSino Biologics Inc, China, and MAL22126013ASZ, manufactured at Solution Biologics, 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 those that were received before this shelf life extension was approved,” she said in a statement today.
Norhaliza said 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 their quality, safety and effectiveness by the NPRA.