Vaccine shelf life extension based on stability tests: BPOM

Self Care

The extension of the shelf life of COVID-19 vaccines has been carried out based on data from the results of vaccine stability tests by manufacturers holding emergency-use permits.

Head of the Food and Drug Supervisory Agency (BPOM), Penny K. Lukito, delivered the statement during a hearing meeting with Commission IX of the House of Representatives (DPR) on Wednesday.

“Pharmaceutical companies will provide data for the extension of the use of vaccines because the companies continue to test the stability of their products,” Lukito said.

The vaccine shelf life is the period of time during which a vaccine still meets the specifications and requirements for use. The shelf life of a vaccine is determined based on the results of product stability testing.

Meanwhile, the expiration period, which is usually shown on the vaccine packaging, indicates that the vaccine is still stable and meets the quality requirements specified under the storage conditions listed on the package.

“BPOM has determined the shelf life of vaccines according to international standards, which is based on real-time stability data on a commercial scale,” Lukito informed.

The process of determining the vaccine shelf life and its extension is being carried out according to the ASEAN Variation Guideline For Pharmaceutical Products and European, Australian, and World Health Organization (WHO) pharmaceutical product standards, she said.

The process of extending vaccine shelf life includes the submission of new data on the results of long-term stability tests conducted by vaccine manufacturers, she added.

“The determination of the extension of the vaccine expiration date is in accordance with the stability data with the results that meet the requirements,” she said.

The extension permit is given per facility but for the same vaccine brand, she revealed. Based on the stability test data, BPOM inspects production facilities and evaluates the extension of the expiration time.

Vaccine shelf life extension is commonly undertaken in several countries based on the latest data from stability test results submitted by pharmaceutical companies holding permits for emergency use or vaccine distribution permits, Lukito said.

Pharmaceutical companies holding permits for emergency vaccines are responsible for monitoring the shelf life of COVID-19 vaccines and relabeling the vaccine packaging that was circulated before the shelf life extension, she explained.

In Indonesia, COVID-19 vaccine products that have received approval for shelf life extension of 12 months include the vaccine made by Bio Farma, a vaccine made by Sinopharm in one-dose prefilled syringe packaging, and the one-dose CoronaVac vial.

They further include COVID-19 vaccines made by AstraZeneca, which are being produced by Catalent Anagni SRL, Italy, and Pfizer-BioNTech COVID 19 Vaccine (Comirnaty) produced at Pfizer Manufacturing Belgium, Puurs, Baxter, whose shelf life has been extended by nine months, and the COVID-19 vaccine of Sinopharm, packaged in two doses, with an extended shelf life of 11 months.

Source: Antara News