JAKARTA - The Food and Drug Supervisory Agency (BPOM) has issued a Sinopharm Emergency Use Authorization (EUA) as the sixth vaccine used for booster doses in Indonesia.
"According to the requirements for emergency use, BPOM has evaluated the efficacy and safety aspects referring to the COVID-19 vaccine evaluation standard for the Sinopharm vaccine as a homologous booster dose for adults 18 years and over," said Head of BPOM Penny K Lukito in a written statement received in Jakarta. Jakarta, Wednesday 2 February.
The vaccine with the name SARS-CoV-2 Vaccine (Vero Cell), Inactivated, produced by the Beijing Bio-Institute Biological, China or known as the Sinopharm vaccine, has been registered by PT Kimia Farma for the use of homologous boosters in adults 18 years of age or older who have received the primary dose. completed at least six months in advance.
Based on the safety aspect, said Penny, the use of Sinopharm vaccine as a booster was generally well tolerated. The frequency, type, and severity of adverse reactions or adverse events after booster administration were lower than during the primary dose.
The unexpected events that often occur are local reactions such as pain at the injection site, swelling and redness as well as systemic reactions such as headaches, fatigue, and muscle pain, with a severity grade of 1-2, said Penny added.
Based on the study of the immunogenicity aspect, there was an increase in the humoral immune response for the measurement parameters of neutralizing antibody and anti-IgG by 8.4 times and 8 times, respectively, compared to before giving the booster.
He said the immune response after giving the Sinopharm booster vaccine was higher than the immune response produced during the primary vaccination.
"The EUA approval for the Sinopharm vaccine adds an alternative to the homologous booster vaccine for the inactivated virus platform," Penny wrote as quoted by Antara.
Penny expressed her appreciation to the Expert Team of the National Committee for Assessing the COVID-19 Vaccine including experts in pharmacology, research methodology and statistics, epidemiology, public policy, immunology, ITAGI and clinical associations for the collaboration that allowed the Sinopharm vaccine to be immediately released to the public.
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