NPRA approves shelf-life extension for Pfizer, Sinovac vaccines

 

The National Pharmaceutical Regulatory Agency (NPRA) has approved shelf-life extensions for Covid-19 vaccines developed by Sinovac and Pfizer-BioNTech.

Health director-general Dr Noor Hisham Abdullah (above) said the decision was made after Pfizer (Malaysia) Sdn Bhd and Sinovac’s local partner Pharmaniaga Lifescience Shd Bhd both submitted additional stability data for their respective vaccines.

The shelf life for Sinovac’s Coronavac vaccine is extended from six months to 12 months when stored between 2°C to 8°C.

For Pfizer’s Comirnaty vaccine, the shelf-life is extended from six months to nine months when stored between -90°C and -60°C.

“The shelf-life extension is given based on latest stability data provided by the manufacturers […]

“The approval of the extension also applies retrospectively to all stocks before this variation is made. Manufacturers are given six months from the approval of the variation application to update the expiry date printed on the (vaccine) vial labels on the vaccines they produce,” Noor Hisham said in a statement today.

The extension also affects 76 batches of Coronavac vaccines and 20 batches of Comirnaty vaccines that are already in the ministry’s stockpile (see list in the embedded document at the end of this article). Vaccines that are due for delivery soon are affected too.

Stability testing is a process that generally entails storing vaccines or other pharmaceuticals at various temperatures and testing their potency at regular intervals. The purpose is to ensure that the drug remains viable after being stored for a certain duration and temperature.

Many regulators elsewhere have already approved more relaxed storage and shelf-life requirements for Covid-19 vaccines as more stability data is gathered over time.

For example, when first approved last year, the European Medicines Agency stipulated that Comirnaty can be stored at -90°C and -60°C for up to six months. This was based on the limited stability data available at the time.

Once thawed, it said it can be stored in a regular refrigerator between 2°C to 8°C for up to five days.

With more data being submitted, it now allows the Comirnaty vaccine to be stored up to nine months in ultra-cold temperatures, during which it can be transported at -25°C to -15°C for up to two weeks at a time as long as it is returned to ultra-cold storage afterwards.

Once thawed, it said it can be stored for up to one month instead of five days at 2°C to 8°C as long as the nine-month shelf-life is not exceeded. - Mkini