BPOM Extends Expiration Limit For 6 COVID-19 Vaccine Products

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JAKARTA - The Indonesian Food and Drug Supervisory Agency (BPOM) has extended the expiration limit of six COVID-19 vaccine products circulating in Indonesia based on the fulfillment of quality and safety requirements.

Reported by Antara, Monday, March 14, the six vaccines whose expiration dates were extended are products that originally obtained an emergency marketing permit in Indonesia for six months.

The vaccines in question are Bio Farma's COVID-19 vaccine with an extended expiration date to 12 months, Sinopharm packaging 1 dose of 'prefilled syringe' with an expiration limit of 12 months, Zifivax with an expiration limit of 12 months.

Sinopharm COVID-19 vaccine in two-dose/vial packs with an expiration limit of 9 months, certain AstraZeneca batches produced by Catalent Anagni SRL, Italy with an expiration date of 9 months and Pfizer-Biontech COVID-19 Vaccine (Comirnaty) with a production site at Pfizer Manufacturing Belgium, Puurs, Baxter released Biontech and Mibe released Biontech with an expiration date of 9 months.

In the official statement, it is explained that the expiration date of a vaccine is part of the guarantee of safety, benefit and quality that is determined based on the data on the stability of the vaccine product.

The expiration date provides an indication of the end of the quality assurance limit for the use of the vaccine if it is stored under conditions according to the stability test.

In the process of applying for an Emergency Use Authorization (EUA) to BPOM, the Pharmaceutical Industry must submit the results of the stability test to determine the expiration limit.

According to international standards, the minimum stability test data requirement for EUA drugs and vaccines is 3 months. BPOM then evaluates the quality data and stability test results which include, among others, identification, potency, sterility, impurities, endotoxins and pH of the final vaccine product.

Based on the results of the 3-month stability evaluation, BPOM set a vaccine expiration limit according to international standards, which is twice the time for carrying out the stability test (2n).

Accordingly, all COVID-19 vaccines that are newly produced vaccines and have stability test data with a duration of 3 (months, are given an approval period of 6 months).

In the statement, it was stated that the expiration date could be extended if new data were available that could prove that the quality and safety of the vaccine still met the requirements when it was nearing expiration, as long as the vaccine was stored in accordance with the stipulated conditions.

For this reason, BPOM continues to monitor the implementation of long-term stability tests carried out by vaccine manufacturers who have been granted an emergency use permit (EUA). BPOM has asked vaccine manufacturers to complete the latest or long-term stability data.

Spokesperson for the Ministry of Health, Siti Nadia Tarmizi, said that as of March 8, 2022, there were 18 million vaccines whose expiration date had been extended by BPOM because they met product safety criteria.

"So we call it expired vaccine, which means it's not expired in terms of factory quality, but because the emergency use has expired," he said.