Bio Farma Vaccine Granted Emergency Use Approval

KOMPAS/RONY ARIYANTO NUGROHO

A medical officer prepares a vaccine injection for health workers when a mass Covid 19 vaccination is held at Bogor Senior Hospital, Tajur, Bogor City, West Java, Thursday (11/2/2021).

JAKARTA, KOMPAS – The Food and Drug Monitoring Agency (BPOM) issued emergency use authorization (EUA) for the COVID-19 vaccine produced by PT Bio Farma. With this permit, at least 7.5 million doses of the vaccine, whose raw materials were sent from Sinovac Biotech, China, will be ready to be distributed to support the national vaccination program.

BPOM head Penny K. Lukito said an EUA still had to be issued for vaccines produced by PT Bio Farma even though a permit had already been issued for the CoronaVac vaccine produced by Sinovac, China. This is due to differences in production location and the vaccine’s packaging.

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“Although the COVID-19 vaccine produced at PT Bio Farma has the same content, quality, efficacy and safety as the CoronaVac vaccine, which has been issued an EUA, this [vaccine] requires separate testing, evaluation, as well as a separate EUA, according to international and national regulations,” he said in Jakarta, Tuesday (16/2/2021).

Evaluations were carried out based on stability test data results, production documents, analysis validation methods, product specifications and criteria for the vaccine’s packaging made by PT Bio Farma. As a result, the BPOM issued an EUA for the COVID-19 vaccine made by Bio Farma on February 16.

The BPOM has dispatched technical units across Indonesia to supervise and monitor the quality of vaccines through risk-based sampling and testing

The vaccine with the product name COVID-19 vaccine has a dosage of 5 millimeters (ml). Each vial contains 10 doses of the vaccine. The vaccine must be stored at a temperature of between 2 and 8 degrees Celsius. Each vial is also equipped with a two-dimensional barcode to prevent counterfeiting.

“After the EUA was issued, the BPOM oversees every distribution channel for the vaccine, starting from when the vaccine leaves the pharmaceutical industry to vaccinations being administered in the community. The BPOM has dispatched technical units across Indonesia to supervise and monitor the quality of vaccines through risk-based sampling and testing,” said Penny.

KOMPAS/RONY ARIYANTO NUGROHO

One of the health workers received an injection of the Covid 19 vaccine at Bogor Senior Hospital, Tajur, Bogor City, West Java, Thursday (11/2/2021).

Bio Farma director Honesti Basyir said that in February 2021, 7.5 million doses had been targeted to be distributed to priority areas for vaccinations other than health workers. “This vaccine is for the second phase of the vaccination program, namely the 16.9 million public service workers,” he said.

Health Ministry vaccination spokesperson Siti Nadia Tarmizi asked the public not to hesitate to be vaccinated. The government guarantees its safety, the BPOM has issued an EUA, and the Indonesian Ulema Council (MUI) has issued a halal fatwa.

The second phase of the vaccination program begins in the third week of February. To mark the start of the second phase of vaccinations for the elderly and public service workers, vaccines will be distributed to 55,000 traders of Tanah Abang Market, Central Jakarta, starting Wednesday (17/2).

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However, a number of traders in the market are unaware of the conditions and the location for receiving the vaccination. Hari (24), a mukena (women’s prayer gown) trader in Blok F Tanah Abang Market, for example, only learned about the vaccination plan from other traders and the media. No explanation was provided by the market manager.

According to the COVID-19 handling task force, as of February 16, a total of 10,029 new COVID-19 cases were reported, with 229 deaths reported. With daily examinations of 26,156 people, the positivity rate is 38.3 percent.

This article was translated by Kesya Adhalia.