Indonesia’s Drug Agency Extends Shelf-Life of 6 Covid Vaccines to 6 Months

JAKARTA, KOMPAS.com – Indonesia’s Food and Drug Monitoring Agency (BPOM) has extended the expiration dates on six types of Covid-19 vaccines from six months to a maximum of 12 months.

This shelf life extension was done under the international standards of stability test data required in the emergency use authorization (EUA).

The six types of Covid-19 vaccines are as follows:

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• The Bio Farma’s Covid-19 vaccine has a 12-month shelf life.
• Pack of single-dose prefilled syringe produced by Sinopharm Covid-19 has a 12-month shelf life.
• Zifivax vaccine has a 12-month shelf life.
• Sinopharm Covid-19 vaccine packed into two doses/vials has a 9-month shelf life.
• Certain batches of AstraZeneca Covid-19 vaccine manufactured by Catalent Anagni S.R.L., Italy has a 9-month shelf life.
• Pfizer-BioNTech Covid-19 Vaccine (Comirnaty) produced in Pfizer Manufacturing site in Puurs, Belgium has a 9-month shelf life.

The drug agency explained that the shelf life extension of the Covid-19 vaccine was carried out according to the international standards by evaluating vaccine stability test data reported by the pharmaceutical industry in the process of applying for EUA to BPOM.

Based on the international standard, the Covid-19 vaccine can be extended to three months. However, following the evaluation based on the international standard, BPOM decided to extend the shelf life to six months, said its website on Monday, March 14.

The expiration dates on the Covid-19 vaccine could be extended if new data were available and could prove that the quality and safety of the vaccines still meet the requirements before it is expired.

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“As long as the vaccine is stored following the specified conditions,” said the BPOM.
Besides, BPOM said it would continue to monitor the implementation of the long-term stability test carried out by vaccine manufacturers.

BPOM has also called on the vaccine manufacturers to complete the latest long-term stability data. “Monitoring the expiration dates on the Covid-19 vaccine is the responsibility of the vaccine manufacturer for EUA and is carried out in collaboration with the ministry of health and the local administrations and government agencies,” the statement said.

The EUA holders are also required to ensure that the vaccines used in the national vaccination program meet the requirements for safety, efficacy, and quality.

(Writer: Haryanti Puspa Sari | Editor: Diamanty Meiliana)

Source: https://nasional.kompas.com/read/2022/03/14/14171151/bpom-6-jenis-vaksin-covid-19-diperpanjang-masa-kedaluwarsanya?page=all#page2.