BPOM Approves Emergency Use of Russia's Sputnik V

TEMPO.CO, Jakarta - The Food and Drug Monitoring Agency (BPOM) issued an Emergency Use Authorization (EUA) for the Sputnik V Covid-19 Vaccine on Tuesday, August 24. The vaccine using non-replicating viral vectored platforms (Ad26-S and Ad5-S) was developed by the Russia-based Gamaleya National Center of Epidemiology and Microbiology.

“The EUA approval for Sputnik V has gone through an intensive study by the BPOM together with the National Committee for the Vaccine Special Assessment and the Indonesia Technical Advisory Group on Immunization (ITAGI),” said BPOM Head Penny K Lukito as quoted from the agency’s official page pom.go.id on Wednesday, August 25.

According to Penny, the assessment of the vaccine quality data also referred to the international guidelines. Based on the results of studies, she added, the side effects of the vaccine are considered at mild or moderate levels.

“The most common side effects are flu-like syndrome, which is indicated by fever, chills, joint pain (arthralgia), muscle pain (myalgia), weakness (asthenia), discomfort, headache, hyperthermia, or a local reaction at the injection site,” she explained.

Based on phase 3 clinical trial data, the vaccine’s efficacy reports is 91.6 percent (with a confidence interval ranging 85.6 percent - 95.2 percent).

Russia's Covid-19 vaccine is for use by individuals aged 18 years and above. It should be administered intramuscularly in two doses of 0.5 ml each with an interval of three weeks.

Sputnik V vaccine adds to the list of Covid-19 vaccines that have been approved by BPOM for emergency use. The others are Sinovac (CoronaVac), Bio Farma Covid-19 vaccine, AstraZeneca, Sinopharm, Moderna, and Comirnaty or Pfizer.

Read: Expert Addresses Indonesia's Plan to Produce Russia's Sputnik V Vaccine

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