PUTRAJAYA, Jan 13 — The National Pharmaceutical Regulatory Agency (NPRA) has approved a variation application for the extension of the shelf life of seven Covid-19 vaccine products from April 28 to December 20 last year.
The Health Ministry’s Senior Director of Pharmacy Services Norhaliza A Halim said the new shelf life approved for Comirnaty Concentrate for Dispersion for Injection (MAL21016022A) manufactured by Pfizer Manufacturing Belgium NV and Comirnaty Concentrate for Dispersion for Injection (MAL21036039AS) by BioNTech Manufacturing GmbH is 15 months.
The new shelf life of the Comirnaty 10mcg Concentrate for Dispersion for Injection (MAL22016037AZ) vaccine also manufactured by BioNTech is 18 months, while the Comirnaty (Tris/Sucrose) 30 mcg Solution for Injection (MAL22016036AZ) also by BioNTech is 12 months.
The new shelf life for the vaccines MAL21016022A, MAL21036039AS, MAL22016037AZ, and MAL22016036AZ is when they are stored at -90 to -60 degrees Celsius, she said in a statement here today.
She said the extension of the new life span of the CoronaVac Suspension for Injection Covid-19 Vaccine (Vero Cell), Inactivated (MAL21036010AR) manufactured by Sinovac Life Sciences Co. Ltd., China and CoronaVac Suspension for Injection COVID19 Vaccine (Vero Cell), Inactivated (MAL21046125ACSZ) by Pharmaniaga LifeScience Sdn Bhd is 24 months when stored in a temperature of two to eight degrees Celsius.
She said the new shelf life of the Convidecia™ Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Solution for Injection (MAL21066050AZ) manufactured by Cansino Biologics Inc, China is 15 months when stored at a temperature of two degrees and eight degrees Celsius for both packs sizes of one dose/vial and three doses/vial.
“The approval of this shelf life extension is retrospective, meaning it also applies to all stocks including those received before this shelf life extension variation was approved,” Norhaliza said.
The shelf life of pharmaceutical products including vaccines was determined based on the stability study conducted by the manufacturer at a specific storage temperature in real-time.
The stability study involves a series of tests such as physical characteristics, potency, purity and sterility to confirm that the product still meets the specified specifications when stored for a certain period of time, and data collection for the stability study will usually be completed within two to three years.
She said since there is an urgent need for Covid-19 vaccines, conditional registration has been granted to the registered vaccines and the manufacturers have also been allowed to file rolling submissions of their products’ stability test data.
“The latest and most recent data will be submitted to NPRA through a variation application and this data will be evaluated to ensure that the quality of the vaccine remains the same as when it was approved.
“The shelf life of the vaccine product will change (be extended) if the evaluated data is found to meet regulatory requirements,” Norhaliza said.
The expiry date on the vaccine label; may indicate that the product has expired but consumers can check the actual expiry date which is after the extension at the NPRA website.
“The product is still safe to use as long as it has not passed the new expiry date,” she said.
Norhaliza added that MOH 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 and approved by the Drug Control Authority.
“The benefit-risk assessment for Covid-19 vaccines given conditional registration approval is carried out continuously based on the latest data from time to time,” she said.
— Bernama
