Australia will now recognise the vaccine status of travellers who have received two doses of the Russian Sputnik V vaccine, according to the country’s drug regulatory body on Monday.
Currently, non-citizens entering the border need to be fully vaccinated.
The Therapeutic Goods Administration (TGA) said it obtained more information showing Sputnik V provided “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 recognition of Sputnik will expand options for the return of international students, travel of skilled and unskilled workers to Australia, and travel by business people and elite sportspeople to our country,” the body said in a statement.
According to data from the Russian government, two doses of Sputnik V provided 98 to 100 percent protection against hospitalisation or death and was on average 89 percent effective against symptomatic infection.
However, the TGA also noted that the studies were undertaken prior to the Omicron outbreak, and real-world studies examining the efficacy of a range of vaccines against the new variant were ongoing in many countries.
The single-dose ‘Sputnik Light’ is not currently recognised by the TGA.
Paul Stronski, a senior fellow in Carnegie’s Russia and Eurasia Program, said developers of Sputnik V at Moscow’s Gamaleya Institute have been “slow to share scientific data with international regulators and researchers for reasons that remain unclear,” which he believed had “fed doubts about the 91–97 percent efficacy they have claimed at various times.”
“The decision to rush Sputnik V to the market before the completion of broad-based Stage III trials also damaged the vaccine’s image inside Russia and overseas,” Stronski wrote in the Carnegie Endowment for International Peace, a non-partisan international affairs think tank.
The Russian Ministry of Health has authorised the vaccine for use on Aug. 11, 2020, more than a month before phase I and II trial results were published and before the phase III trial had even begun.
The international roll-out of the Russian vaccine has also encountered some roadblocks, with Brazil’s health regulator denying an application to import Sputnik V in April last year, citing safety, quality, and effectiveness issues. However, Sputnik V was later approved for healthy adults.
The TGA’s decision to approve Sputnik V follows its recognition in late 2021 of two major Chinese-manufactured vaccines—Sinopharm (for those under 60 years old) and Sinavac, as well as two major Indian-manufactured vaccines – Bharat Biotech and AstraZeneca.
Federal Health Minister Greg Hunt on Jan. 15 said Australia had achieved a 95 percent first-dose vaccination rate for those aged 16 and older, while New South Wales, Victoria, and Australian Capital Territory authorities are hoping the current Omicron outbreak begins reaching its peak.