BPOM Issues Official Permit for AstraZeneca Vaccine

By Office of Assistant to Deputy Cabinet Secretary for State Documents & Translation
Date 9 Maret 2021
Category: News
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The arrival of AstraZeneca COVID-19 Vaccine at Soekarno-Hatta International Airport in Tangerang, Banten, on Monday (08/03). [Photo by: Press Bureau of Presidential Secretariat/Rusman]

As part of the COVID-19 vaccination program in Indonesia, three types of COVID-19 vaccine have obtained an emergency user authorization (EUA), an official permit from the Food and Drugs Monitoring Agency (BPOM).

Those three types of vaccine are CoronaVac vaccine by Sinovac, COVID-19 vaccine by state-owned pharmaceutical holding firm PT. Bio Farma and the most recently on 22 February 2021 the BPOM also issued an EUA for the Oxford-AstraZeneca vaccine.

This AstraZeneca COVID-19 vaccine, which previously had obtained a Special Access Scheme (SAS) on 6 March 2021 before arrived in Indonesia, was immediately sent to be stored at PT Bio Farma Head Office in Bandung. This vaccine will be physically examined by an authorized team to check the storage temperature, expiration date, and other aspects.

Head of the BPOM Penny K. Lukito said that there were two mechanisms in registering the AstraZeneca Vaccine.

First, a vaccine secured by Indonesia via a bilateral cooperation between pharmaceutical company PT. AstraZeneca Indonesia, AstraZeneca UK and biopharmaceuticals manufacturer Sioam Bioscience in Thailand.

Second, a vaccine secured by Indonesia via multilareal cooperation between COVAX facility, South Korean vaccine developer SK Bioscience Co. Ltd. and PT. Bio Farma.

Several countries have already approved the AstraZeneca vaccine, including in the UK, European Union, Canada, Saudi Arabia, Egypt, Malaysia, the United Arab Emirates, Bahrain and Morocco. This vaccine is also the second vaccine registered in the WHO’s Emergency Use Listing (EUL).

The BPOM, according to Penny, has conducted an evaluation process for the safety, efficacy and quality of the AstraZeneca vaccine in which the evaluation process was carried out together with members of the National Drug Evaluation Committee, Indonesian Technical Advisory Group on Immunization (ITAGI), and other experts.

Based on the safety evaluation results of clinical trials, two doses of AstraZeneca vaccine in an interval of 4-12 weeks to 23.745 subjects was declared safe. As reported by the efficacy evaluation results, this vaccine showed an efficacy of 62,10 percent which means a good ability to stimulate antibodies, both in adult and elderly. It passed over minimum efficacy standard set by WHO – 50 percent. And in line with the quality evaluation results, this vaccine has generally met the requirements for vaccination.

Penny also underscored that the BPOM would collaborate with Ministry of Health and the National and Regional Commission on Post-Immunization Accidents (Komnas and Komda KIPI) to take measures to safeguard the quality of this vaccine during its distribution, starting from from leaving the pharmaceutical industry into being delivered to the public through vaccination.

Nevertheless, even though vaccination program is already under way, Penny urged the public to remain disciplined in observing health protocols (5M) by wearing a face mask, maintaining physical distancing, washing hands, reducing mobility if not necessary, and avoiding crowds. (HUMAS BPOM/UN) (AP/EP)

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