The Food and Drug Administration (BPOM) has issued an updated explanation regarding the extension of the expiration date for 18 million doses of the COVID-19 vaccine.
The expiry date of a vaccine is part of the guarantee of safety, effectiveness, and quality which is determined based on the data on the stability test of the vaccine product. Therefore, it is an indication of the end of the quality assurance limit for the use of the vaccine if it is stored under conditions in accordance with the stability test conditions.
In the process of applying for an Emergency Use Authorization (EUA) to the Food and Drug Administration, the pharmaceutical industry must submit the results of the stability tests to determine the expiration limit. According to international standards, the minimum stability test data requirement for EUA drugs and vaccines is three months.
The Food and Drug Administration 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 three-month stability evaluation, the Food and Drug Administration sets the vaccine expiration limit according to international standards, which is twice the time for carrying out the stability test.
Thus, all newly-produced COVID-19 vaccines have stability test data with a duration of three months so are given approval for a six month expiration period. This expiration date can be extended if new data becomes available that can prove that the quality and safety of the vaccine still meets the requirements when it is nearing expiration, as long as the vaccine is stored in accordance with the specified conditions.
For this reason, the Food and Drug Administration continues to monitor the implementation of long-term stability tests carried out by vaccine manufacturers who have been granted an EUA. Vaccine manufacturers are therefore asked to complete the latest or long-term stability data.
Quoting a press statement on Monday 14th March 2022, based on the results of the Food and Drug Administration’s evaluation of stability data, the following are the results of the approval for the extension of the expiration date for the COVID-19 vaccine from six months to the following:
- Bio Farma’s COVID-19 vaccine – the domestically processed Sinovac vaccine, now has an expiration date of 12 months
- Sinopharm’s COVID-19 vaccine packs with a one-dose prefilled syringe now has an expiration date of 12 months
- Zifivax’s vaccine now has an expiration date of 12 months
- Sinopharm’s COVID-19 vaccine in two doses or vials now has an expiration limit of nine months
- Certain batches of AstraZeneca’s COVID-19 vaccine manufactured by Catalent Anagni S.R.L., Italy, now has an expiration date of nine months
- Pfizer-Biontech’s COVID-19 Vaccine – Comirnaty – that were produced in Pfizer Manufacturing Belgium, Puurs, Baxter released by Biontech and Mibe released by Biontech, now have an expiration date of nine months
Monitoring the expiration date of the COVID-19 vaccines in circulation is the responsibility of EUA holder vaccine manufacturers and is carried out in collaboration with the Health Ministry and the provincial, district, and city health offices. EUA owners must ensure that the COVID-19 vaccine used in the COVID-19 vaccination programme continues to meet safety, efficacy, and quality requirements.
The Health Ministry confirmed that the extension of the COVID-19 vaccines had been based on an assessment by the Food and Drug Supervisory Agency (BPOM). Therefore, it is certain that the COVID-19 vaccine product is suitable for public use.
Meanwhile, the COVID-19 Task Force previously explained this to prevent vaccine stocks from being used up, to no avail.
“This is done carefully by the government through in-depth discussions with experts and drug manufacturers so that it is feasible and passes the expiration extension test,” explained the spokesman for the COVID-19 Task Force Wiku Adisasmito in a press conference on Tuesday 8th March. “So the main key is to use good vaccines with distribution to the community.”