Around 1.53 million doses of COVID-19 vaccines potentially hit their expiration date in April this year, according to state-owned vaccine manufacturer PT Bio Farma (Persero).
During a virtual COVID-19 Vaccine Work Committee Meeting on Wednesday, Bio Farma president director Honesti Basyir informed that the potentially expired COVID-19 vaccines comprise 1.095 million AstraZeneca doses and 436,730 Moderna doses.
Meanwhile, the number of COVID-19 vaccines that reached their expiration date as of March 25, 2022, stood at 19.32 million doses, he added.
The vaccines comprised 18.68 million doses obtained through the GAVI scheme or donations and 0.64 million doses obtained through the B2B (business-to-business) procurement scheme, he said.
There are four aspects that must be examined to ensure that the quality of COVID-19 vaccines meets the applicable standards, he noted.
These four aspects are determined by quality, safety, efficacy, and stability trials.
“This is what we do as the license holder of COVID-19 vaccines,” Basyir remarked.
During the event, head of the National Agency of Drug and Food Control (BPOM), Penny K. Lukito, said that a vaccine’s expiration limit is part of the safety, benefit, and quality guarantees.
These guarantees are determined based on vaccine trial data, in accordance with the specified standards.
The minimum trial data requirement for medicines and vaccines’ emergency-use authorization (EUA) is three months, she added.
BPOM evaluates the quality and stability trial result data that encompasses identification, potential, sterility, and particulate parameters.
“If it remains stable for more than three months, there is a possibility that it can receive shelf life extension,” she informed.
BPOM determines the shelf life of vaccines in accordance with the international standards, namely based on commercial-scale real-time stability data, she added.
Source: Antara News