PUTRAJAYA: The National Pharmaceutical Regulatory Agency (NPRA) has approved a variation application from Pfizer (Malaysia) Sdn Bhd to update the shelf life of Covid-19 Comirnaty Concentrate for Dispersion for Injection vaccine.
Health Ministry Pharmacy Services senior director Norhaliza A Halim said the new shelf life is from 15 months to 18 months for vaccine vials stored at -90°C to -60°C.
She said the extension of the shelf life involved vaccines with registration numbers MAL21016022AZ, manufactured by Pfizer Manufacturing Belgium NV, and MAL21036039ASZ, by BioNTech Manufacturing GmbH, Germany.
"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 variation is approved," she said in a statement today.
Norhaliza said the ministry ensured that all pharmaceutical products, including the Covid-19 vaccine, had been assessed in terms of quality, safety and effectiveness.