Penny K. Lukito, the head of the Food and Drug Supervisory Agency (BPOM), during a press conference at the State Palace in Jakarta. (Photo courtesy of the Cabinet Secretariat)
Russian Sputnik-V Secures EUA in Indonesia, Opening Path for More Vaccine Supplies
BY :JAKARTA GLOBE
AUGUST 27, 2021
Jakarta. Indonesian drug authority has issued an emergency use authorization for the Russia-made Covid-19 vaccine, Sputnik-V, early this week, as the country seeks to increase supply to accelerate its vaccination drive.
Sputnik-V would follow China-made Sinovac and Sinopharm vaccines, as well as American Moderna, Pfizer, and Anglo-American AstraZeneca vaccines, which are already available in Indonesia.
Penny K. Lukito, the head of the Food and Drug Supervisory Agency (BPOM), said the agency's reviews on Sputnik-V performance conclude that the vaccine satisfied internationally applicable vaccine quality evaluation guidelines.
"The phase 3 clinical trial data shows the Sputnik-V COVID-19 vaccine provides an efficacy of 91.6 percent, with a confidence interval range of 85.6-95.2 percent," Penny said in a statement from the Cabinet Secretariat on Thursday.
Based on studies related to its safety, side effects from using this vaccine are mild or moderate severity, she said.
“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,” Penny said.
The Sputnik-V vaccine, developed by the Gamaleya National Center of Epidemiology and Microbiology in Russia, uses the non-replicating viral vector platform, similar to the one used by AstraZeneca in its vaccine.
BPOM said Jakarta-based pharmaceutical company Pratapa Nirmala was the EUA holder of the Russian-made vaccine in Indonesia and would ensure the safety and quality of this vaccine in the country.
So far, only people aged 18 years and over were allowed to receive Sputnik-V shots, prescribed for two injections within a period of three weeks, the agency said.
Penny said she hoped Sputnik-V could help further accelerate the government's vaccination program to meet its target.
"BPOM will continue to support the government according to its main duties and functions in drug control so that the public can access the COVID-19 vaccine that has met the required standard qualifications immediately," she said.
Health Minister Budi Gunadi Sadikin said earlier that the government wants to deliver complete shots to 208,5 million people by January next year, three months earlier than its previous target. That would require the country to inject about two million doses per day, starting this month.
The country has delivered 92.7 million vaccine doses, with only 33.4 million people already receiving two vaccine shots since the vaccination program began in January. On average, the country injected 910,000 doses of vaccine per day in the past week. At that pace, it would only finish the vaccination in Juli next year, according to the Globe calculation.
Budi said limited vaccine supply in the early days had forced the government to rations the shots to avoid a period of vaccination between vaccine deliveries. From a public communication standpoint, that could erode confidence in the vaccination program, Budi said.
Today, the government grew confident of meeting the target as it has secured more supplies from global vaccine manufacturers. The country would receive 80.7 million vaccine doses next month, topping up 99.5 million it already has in stock today.