Russia OKs single-dose Sputnik Light vaccine

The two-dose Sputnik V vaccine will continue to remain Russia’s main source of vaccination, Russian Direct Investment Fund (RDIF) chief executive officer Kirill Dmitriev said in a statement, adding Sputnik Light will be exported to its international partners to help increase the rate of vaccinations in a number of countries battling the pandemic and new strains of coronavirus.

In India, Dr Reddy’s Laboratories is the marketing partner for Sputnik V vaccine through a pact with RDIF, which has also signed pacts with five other companies—Hetero Biopharma, Gland Pharma, Virchow Biotech, Stelis Biopharma and Panacea Biotec—to together manufacture about 850 million doses per year. Dr Reddy’s distribution pact is for 250 million doses.

However, while Sputnik V has been given an authorization in India, and the first batch of 150,000 doses has already been imported by Dr Reddy’s from Russia on Saturday, it remains to be seen whether the company will apply for an authorization for the single-dose Sputnik Light.

Sputnik Light will not qualify for an expedited authorization in India under the government’s revised regulations as the Russian drug regulator is not among the five regulators — World Health Organization, US Food and Drug Administration, UK Medicines and Healthcare products Regulatory Agency, Japan’s Pharmaceuticals and Medical Devices Agency and European Medicines Agency—based on whose authorizations the vaccine becomes automatically eligible in India.

The efficacy rate of Sputnik Light is based on an analysis of real-world data obtained from Russians who had been given only a single dose between 5 December and 15 April, RDIF said. The analysis was done on the 28th day following the injection.

The vaccine’s developers—Moscow’s Gamaleya National Research Center of Epidemiology and Microbiology—also started a parallel phase 1 and 2 study in January and interim results of it were received on 10 March. The results showed that the vaccine produced antibodies in 96.9% of volunteers on the 28th day after immunization while virus-neutralizing antibodies had developed in 91.67% of the volunteers. No serious adverse events were seen in the phase 1 and 2 studies, RDIF said.

In February, Gamaleya and RDIF also launched a global phase 3 study of Sputnik Light involving 7,000 people in multiple countries including Russia, the UAE, Ghana and others to determine the efficacy of the single-shot vaccine. Interim results are expected this month.

“The single-dose regimen solves the challenge of immunizing large groups in a shorter time, which is especially important during the acute phase of the spread of coronavirus, achieving herd immunity faster. The characteristics of the vaccine provide for simple storage and logistics, while Sputnik Light has an affordable price of less than $10 ( ₹750)," Dmitriev said in the statement.