BPOM Issues Permit For Emergency Use Of Sputnik-V Vaccine For Over 18 Years Old

UNSPLASH ILLUSTRATION

JAKARTA - The Indonesian Food and Drug Administration (BPOM) has issued an Emergency Use Authorization (EUA) for the injection of the Sputnik-V brand of COVID-19 vaccine to people aged 18 years and over.

"As in the process of giving EUA to the previous COVID-19 vaccine, the provision of EUA for the COVID-19 Sputnik-V vaccine has been through an intensive study by BPOM with the National Committee for the Special Assessment of COVID-19 Vaccine and the Indonesia Technical Advisory Group on Immunization (ITAGI), " said Head of BPOM Penny K Lukito as quoted by Antara, Wednesday, August 25.

This permit adds variants of the COVID-19 vaccine in the country other than Sinovac (CoronaVac), Bio Farma's COVID-19 Vaccine, AstraZeneca COVID-19 Vaccine, Sinopharm, Moderna, and Comirnaty (Pfizer) which have already obtained EUA since January 2021.

Penny said the Sputnik-V COVID-19 vaccine is a vaccine developed by The Gamaleya National Center of Epidemiology and Microbiology in Russia using the Non-Replicating Viral Vector (Ad26-S and Ad5-S) platform.

This vaccine is registered by PT Pratapa Nirmala as the EUA holder and is responsible for ensuring the safety and quality of this vaccine in Indonesia.

Penny said the Sputnik-V vaccine is used with indications of preventing COVID-19 caused by SARS-CoV-2 for people aged 18 years and over.

Penny said the Sputnik-V vaccine was administered by intramuscular (IM) injection at a dose of 0.5 mL for two injections in a span of three weeks.

"This vaccine belongs to the group of vaccines that require storage at special temperature conditions, namely at temperatures in the range of minus 20 degrees Celsius to 2 degrees Celsius.

According to Penny, the assessment of the vaccine quality data has also referred to the internationally applicable vaccine quality evaluation guidelines.

Based on the results of studies related to its safety, said Penny, the side effects of using the Sputnik-V vaccine are side effects with mild or moderate severity. These results were reported in the clinical trial of the COVID-19 vaccine Sputnik-V (Gam-COVID-Vac) and other vaccine clinical trials of the same platform technology.

“The most common side effects experienced are flu-like symptoms (a flu-like syndrome), which is characterized by fever, chills, joint pain (arthralgia), muscle pain (myalgia), weakness (asthenia), discomfort, headache, hyperthermia. , or a local reaction at the injection site," he said.

As for its efficacy, said Penny, phase 3 clinical trial data showed the Sputnik-V COVID-19 vaccine provided 91.6 percent efficacy with a confidence interval range of 85.6 -95.2 percent.