THE National Pharmaceutical Regulatory Agency (NPRA) has approved an application from Solution Biologics Sdn Bhd regarding the shelf-life extension of a Covid-19 vaccine (Convidecia Recombinant Novel Coronavirus Vaccine “Adenovirus Type 5 Vector” Solution for Injection).

NPRA senior director Norhaliza A. Halim said its shelf life is now between 15 and 18 months when stored at a temperature between 2ºC and 8ºC.

She said the extension 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 was approved based on the latest stability data submitted by the manufacturer.

“The approval of this shelf life extension is retrospective, meaning this approval applies to all stock, including stock received before the extension was approved,” she said in a statement today.

Norhaliza said the Health Ministry is committed to ensuring all pharmaceutical products, including Covid-19 vaccines supplied in Malaysia, have been assessed for quality, safety and effectiveness by the NPRA. – Bernama, January 21, 2023.