Page 14 - 020222_Badan POM Terbitkan Persetujuan Penggunaan Darurat Vaksin Sinopharm sebagai Dosis Booster

Judul : BPOM issues EUA for Sinopharm as booster shot

Nama Media : antaranews.com

Tanggal : 2 Februari 2022
Halaman/URL : https://en.antaranews.com/news/212881/bpom-issues-eua-for-
sinopharm-as-booster-shot

Tipe Media : Online

The National Agency of Drug and
Food Control (BPOM) has issued
emergency use authorization (EUA)
for Sinopharm as the sixth vaccine
brand to be used as a booster dose in
Indonesia.

"The BPOM has evaluated the
efficacy and safety of the Sinopharm
vaccine as a homologous booster
dose (against COVID-19) for adults
aged 18 years and older," BPOM Head Penny K. Lukito stated here on Wednesday.

The Sinopharm vaccine, or the "SARS-CoV-2 Vaccine (Vero Cell), Inactivated," is
produced by Beijing Bio-Institute Biological, China, and has been administered by the
state pharmaceutical firm PT Kimia Farma as a homologous booster dose for adults
aged 18 years and above at least six months after the completion of the primary doses.

Based on safety aspects, Lukito affirmed that the use of the Sinopharm vaccine as a
booster shot can be well tolerated by its recipients. Its frequency, type, and severity of
unexpected side effects after injection are lower than after the primary dose.

Some unexpected side effects that often occur include pain at the injection site,
swelling and irritation, headache, fatigue, and muscle pain, with severity grades
ranging from 1 to 2, she remarked.

Meanwhile, based on the immunogenicity study on Sinopharm as a booster shot, the
humoral immune response to the parameters of antibody neutralization measurement
and anti-IgG increased by 8.4 times and eight times respectively as compared to
before the booster, Lukito stated.

The recipient's immune system responds more strongly after being given a Sinopharm
booster shot than the primary doses, she stated.

"The EUA for Sinopharm added an alternative for homologous booster vaccine in the
inactivated virus platform," Lukito pointed out.