Food and Drug Supervisory Agency: The Extension Of Vaccine Life Based On Stability Test Results

JAKARTA - Head of the Food and Drug Supervisory Agency (BPOM) Penny K Lukito said the extension of the shelf life of the COVID-19 vaccine was carried out based on data from the results of vaccine stability tests carried out by manufacturers holding permits for emergency vaccines.

"Pharmaceutical companies are providing data for the extension of the use of vaccines, because there is a commitment that the company will continue to test the stability of their products," said Penny in a hearing with Commission IX of the House of Representatives (DPR), reported by Antara, Wednesday, April 6.

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

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

"The BPOM determines the shelf life of vaccines according to international standards, which is based on real-time stability data on a commercial scale," said Penny.

The process of determining the shelf life of vaccines and their extension, according to him, is carried out referring to the ASEAN Variation Guideline for Pharmaceutical Products and European, Australian, Australian, and World Health Organization (WHO) pharmaceutical product standards.

Penny explained that the process of extending the shelf life of vaccines includes the submission of new data on the results of long-term stability tests conducted by vaccine manufacturers.

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

"The extension permit is given per facility but with the same vaccine brand. With the stability test data, we inspect the production facilities, because this is the producer who submits the stability test data, we evaluate for an extension of the expiration time," he explained.

According to him, extending the shelf life of vaccines is something that is commonly done in various countries based on the latest data from stability test results submitted by the pharmaceutical industry holding permits for emergency or vaccine distribution permits.

Penny said that the pharmaceutical industry holding permits for emergency vaccines is responsible for monitoring the shelf life of COVID-19 vaccines and re-labeling vaccine product packaging that has been circulated before extending the shelf life.

In Indonesia, COVID-19 vaccine products that have received approval to extend the shelf life for 12 months include vaccines made by Bio Farma, vaccines made by Sinopharm in one-dose prefilled syringes, and CoronaVac vials one-dose.

In addition, there are COVID-19 vaccine products made by AstraZeneca which are produced by Catalent Anagni S.R.L., Italy, as well as Pfizer-Biontech COVID 19 Vaccine (Comirnaty) which is produced at Pfizer Manufacturing Belgium, Puurs, Baxter which has an extended shelf life of nine months and the COVID-19 vaccine. Sinopharm is packaged in two doses (vials) with an extended shelf life of 11 months.