BPOM Issues EUA for Sinopharm Vaccine as Booster Shot

By Office of Assistant to Deputy Cabinet Secretary for State Documents & Translation     Date 2 Februari 2022
Category: News
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The Food and Drug Monitoring Agency (BPOM) has officially issued an Emergency Use Authorization (EUA) for Sinopharm vaccine developed by the Beijing Bio-Institute of Biological Products (BBIBP) to be used as a booster shot.

“In accordance with requirements for the EUA, the BPOM has evaluated the efficacy and safety aspects referring to national and international standards for COVID-19 vaccine so that Sinopharm vaccine can be administered as a homologous booster dose for adults aged 18 and older,” Head of the BPOM Penny K. Lukito said in a written statement, Wednesday (02/02).

The issuance of the EUA has made Sinopharm vaccine the sixth vaccine to be used as a booster dose in the country.

The five booster vaccines that have obtained the EUA from the BPOM are CoronaVac produced by PT Bio Farma, Pfizer, AstraZeneca, Moderna, and Zifivax.

This Sinopharm vaccine has been registered by PT Kimia Farma to be used as a homologous booster for those aged 18 and older who have received a complete primary vaccine series at least six months ago.

On the safety aspect, the use of Sinopharm as a booster vaccine is generally well tolerated. The frequency, type, and severity of adverse reactions after booster vaccination are lower than that of the primary series.

The adverse events that often occur include local reactions such as pain at the injection site, swelling, and redness, as well as systemic reactions such as headache, fatigue, and muscle aches with a grade of 1-2 severity.

On the immunogenicity aspect, there is an increase in the humoral immune response for neutralizing antibody measurement parameters and anti-IgG, which reaches 8.4 times and 8 times higher respectively, compared to the humoral immune response before booster administration. The immune response after the booster shot is higher than the immune response produced during primary vaccination.

“The EUA of Sinopharm vaccine has added an alternative to the homologous booster vaccines for inactivated virus platform. Therefore, we again extend our appreciation to a team of experts consisting of members from the National Committee for COVID-19 Vaccine Evaluator, including experts in pharmacology, research methodologies and statistics, epidemiology, public policy, immunology, Indonesia Technical Advisory Group of Immunization (ITAGI), and clinical associations for their collaboration so that the vaccine can be immediately released to the public,” Penny said. (PR of BPOM/UN) (RIF/MMB)

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