Indonesia Issues Emergency Permit for AstraZeneca Covid-19 vaccine

photo: Setpres

Jakarta, MINA – The Indonesian Food and Drug Administration (BPOM) has issued an emergency use authorization (EUA) for AstraZeneca’s Covid-19 vaccine.

The vaccine was developed by Oxford University in collaboration with the British pharmaceutical company, AstraZeneca.

The Head of BPOM Penny Lukito said that he had evaluated the safety, efficacy and quality of this vaccine.

“Based on this evaluation and consideration of the benefits and risks, BPOM has issued an approval for the use of the emergency period or EUA on February 22, 2021,” said Penny in a virtual press conference in Jakarta on Tuesday.

For safety evaluation, clinical trial data show that the administration of AstraZeneca vaccine in two doses at intervals of four to 12 weeks to 23,745 subjects is considered safe and well tolerated.

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In terms of efficacy, administration of the AstraZeneca vaccine can stimulate the formation of antibodies in the population aged 18-60 years 32 times and 21 times over 65 years.

Penny said the efficacy of this vaccine was 62.1 percent, calculated from 15 days of giving the second dose to monitoring for two months.

“This is in accordance with the efficacy requirements for receiving EUA set by WHO (World Health Organization), which is at least 50 percent efficacy,” said Penny.

As for the quality aspect, BPOM stated that AstraZeneca vaccines generally met the requirements.

As of Monday, 1,113,600 doses of AstraZeneca’s Covid-19 vaccine arrived in Jakarta.

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It is the second vaccine brand to arrive in the country, after Indonesia previously received 38 million doses of the CoronaVac vaccine produced by a Chinese pharmaceutical company, Sinovac.

Indonesian Foreign Minister Retno Marsudi said the vaccine was obtained through multilateral cooperation from the Global Alliance for Vaccines and Immunization (GAVI) Covax Facility.

Overall, Indonesia will receive 11.7 million doses of vaccine from the first batch of Covax Facility scheme which will be sent gradually until May 2021. (T/RE1)

Mi’raj News Agency (MINA)