BPOM Issues Emergency Use Authorization for Bio Farmas COVID-19 Vaccine
Date 17 Februari 2021
On Tuesday (16/02/2021), the Food and Drug Monitoring Agency (BPOM) issued the Emergency Use Authorization (EUA) for COVID-19 vaccine produced by state-owned pharmaceutical company PT Bio Farma.
Head of the BPOM Penny K. Lukito said that the EUA issuance was based on the evaluation results of stability tests, validation documents of production processes and analysis methods, as well as specifications of product and packaging.
The vaccine number EUA2102907543A1 named COVID-19 Vaccine is made of inactivated virus.
Available in 5 ml vials, each vial contains 10 doses of vaccine, packed in a box containing 10 vials, and remain stable when stored at 2-8 degrees Celsius. Each vial has a 2D barcode that shows the identity of each vial and functions to track and prevent the distribution of fake vaccines, Penny stated, cited from pom.go.id page, Wednesday (17/02/2021).
In December 2020, Indonesia through PT Bio Farma imported 3 million doses of vaccine produced by Sinovac Life Science, Co. Ltd, Beijing. The vaccine obtained EUA from the BPOM on 11 January 2021. The import also included raw materials of vaccine in bulk, ready to be filled and packed at the production facilities of PT Bio Farma.
The COVID-19 Vaccine produced by PT Bio Farma has the same content and efficacy, as well as safety profile as the CoronaVac vaccine produced by Sinovac Beijing, Penny explained.
In addition, due to different production facilities and the change in packaging from single dose to multiple doses, the vaccine had to be registered to obtain the EUA.
Before the product is used, the BPOM conducted tests for lot release. Until 15 February 2021, BPOM has issued lot release certificates for 5 batches of vaccine, each consists of approximately 1 million doses.
Since the lot release certificate has been issued, the vaccine is ready to use for the vaccination program, she said.
Furthermore, Penny stated that the BPOM will continue to oversee vaccine quality during distribution, starting from the shipping out of the factory until the use for vaccination. It is closely related to the nature of vaccines as cold-chain products, which require specific storage temperature.
BPOMs Technical Implementation Unit (UPT) will keep supervising and providing assistance to Health Agencies in the distribution and storage of vaccines in order to comply with good distribution practices for pharmaceutical goods, Penny asserted.
BPOMs UPT throughout the country also supervises and monitors the quality of distributed vaccines by conducting sampling and risk-based tests.
Product sampling can be carried out at the facilities of the industry, distributors, and governments pharmaceutical installations at province level and regency or city level, as well as health centers used as COVID-19 vaccination location.
The BPOM has committed to supervise vaccine security in coordination with Ministry of Health as well as National Commission and Regional Commission on Adverse Events Following Immunization (Komnas and Komda KIPI) to manage the side effects of immunization.
The supervision is carried out based on reports from health care workers, vaccine manufacturers, or the public. The BPOM also cooperates with Komnas and Komda KIPI to conduct surveillance, investigation, and study on immunization side effects, as regulated in Regulation of Minister of Health Number 12 of 2017 on Immunization.
Additionally, Penny reminded that we need adequate amount of vaccine to create herd immunity and time to achieve it although the vaccination program has begun.
Therefore, we ask everyone to keep adhering to health protocols by implementing 5M measures: wear a mask, wash hands, keep a safe distance, avoid crowds, and reduce mobility, said Head of BPOM. (PR of BPOM/AIT/UN) (DH/MMB)