BPOM Issues Emergency Use Authorization for Sputnik-V COVID-19 Vaccine
Date 26 Agustus 2021
The Food and Drug Monitoring Agency (BPOM) on Tuesday (24/08) issued an Emergency Use Authorization (EUA) for Sputnik-V COVID-19 Vaccine,
Head of the BPOM Penny K. Lukito said that the EUA for Sputnik-V Vaccine was issued after an intensive assessment conducted by the BPOM, the National Committee for Special Assessment of COVID-19 Vaccine and the Indonesia Technical Advisory Group on Immunization (ITAGI). The assessment of the vaccine quality data was based on the international 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 as quoted by the official BPOM website, Thursday (26/08).
Based on the results of studies related to its safety, the side effects of using this vaccine are mild or moderate. The results were reported in the Sputnik-V (Gam-COVID-Vac) COVID-19 Vaccine clinical trials and other vaccine clinical trials of the same platform technology.
Regarding vaccine production facilities, Penny added, onsite inspections have been carried out at the Sputnik-V COVID-19 Vaccine production facilities in Russia, namely Generium and Biocad as vaccine bulk production facilities, and Ufavita as a fill and finish facility for ready to use products. Based on the inspection results, the vaccine production has met the standards of Good Manufacturing Practices (GMP) and standard requirements for vaccine quality.
With the addition of the Sputnik-V vaccine, the BPOM has issued a total of seven EUAs for the COVID-19 vaccine. The other six vaccines are Sinovac (CoronaVac), Bio Farma COVID-19 Vaccine, AstraZeneca COVID-19 Vaccine, Sinopharm, Moderna, and Comirnaty (Pfizer).
“The BPOM will continue to support the Government measures so that the public can immediately access COVID-19 vaccine that has met the required standard qualifications,” she said.
On that occasion, Penny also expressed her appreciation to all stakeholders, including the National Committee for Special Assessment of COVID-19 Vaccine and the ITAGI for supporting the provision of safe, efficacious, and high quality vaccines for the public.
She also expressed hope that the technology transfer process for domestic vaccine manufacturing will continue in order to support self-sufficiency of the national pharmaceutical industry. (PR of the BPOM/UN) (RI/MMB)