The Therapeutic Goods Administration (TGA) in Australia has determined that an additional COVID-19 vaccine, the two dose course of the Gamaleya Institute vaccine (Sputnik V, Russian Federation) would be 'recognised' for the purpose of establishing a traveller's vaccination status.

Last week the TGA obtained additional information demonstrating this vaccine provides protection and potentially reduces the likelihood that an incoming traveller would transmit COVID-19 infection to others while in Australia or become acutely unwell due to COVID-19. The supporting information was based on published studies provided to the TGA by the Russian Government with the assistance of the Australian embassy in Moscow.

The data indicated that two doses of the Sputnik V showed an average efficacy against symptomatic infection of 89% and against hospitalisation or death of 98-100%. As for most studies on the efficacy of the TGA approved or recognised COVID-19 vaccines, these studies were conducted prior to the emergence of the Omicron variant of COVID-19.

Real-world studies assessing the effectiveness of a range of vaccines against Omicron are currently underway in many countries. The single dose course of the Gamaleya vaccine (Sputnik Light) is not currently recognised by the TGA.

Recognition of the two dose course of the Sputnik vaccine by the TGA follows on from recognition in late 2021 by the TGA of two major Chinese-manufactured vaccines - BBIBP-CorV (Sinopharm, for those under 60 years old) and Coronavac (Sinovac) and two major Indian-manufactured vaccines - Covaxin (Bharat Biotech) and Covishield (Serum Institute of India /AstraZeneca).