Russia authorizes first dose of Sputnik V as standalone vaccine 'Sputnik Light'

Russia's Health Ministry has authorized the use of a single-dose vaccine under the Sputnik Light banner, making it the only second one-shot Covid vaccine after Johnson & Johnson.

Gamaleya Institute, which developed the Sputnik-V Covid vaccine, says the single-dose variant has demonstrated 79.4 percent efficacy in a real-world study as part of Russia’s mass vaccination campaign.

The vaccine however is not a new one. Sputnik Light is the first component of the two-dose Sputnik-V vaccine that has already been registered for use in over 60 countries.

Sputnik V is a heterologous vaccine regimen, which means it uses two different adenoviruses for the prime (first) and booster (second) vaccine dose. The prime dose is rAd26 and the booster is rAd5.

Sputnik V’s prime dose rAd26 is Sputnik Light and has been authorized as a standalone vaccine.

In a statement, Sputnik V’s developers, the Russian Direct Investment Fund, said as per data obtained 28 days after the first dose of Sputnik-V injection was administered as part of Russia's mass vaccination program between December 2020 and April 2021, the efficacy was 79.4 percent. This puts Sputnik Light ahead of the other vaccines like J&J’s single-shot jab or Astrazeneca’s 2-dose Covishield.

The 2-dose Sputnik V has demonstrated 92 percent efficacy.

The study focused only on Russians who were not administered the second dose for any reason. The developers have however not revealed details on how many people were studied to arrive at the efficacy numbers.

The developer has added that during laboratory tests, Sputnik Light has proven effective against all new strains of coronavirus. Interim data from Ph 1/2 shows virus-neutralizing antibody generation and boosted IgG antibodies in those with pre-existing immunity owing to infection. The trial results are yet to be published.

Russia says the single-dose regimen will allow for the immunization of a larger number of people in a shorter time frame.

RDIF CEO Kirill Dmitriev said that while the two-dose Sputnik V remains the main source of vaccination, Sputnik Light will double vaccination rates. It will be “exported to our international partners to help increase the rate of vaccinations in the face of the ongoing fight against the pandemic and new strains of coronavirus.”

The single-shot vaccine will be priced at less than $10.

India has already approved the 2-dose Sputnik-V vaccine and the first batch of 1.5 lakh doses of the imported vaccine have arrived in Hyderabad with partner Dr Reddy’s Labs. Sputnik V has a tie-up with 5 Indian vaccine makers to produce over 850 million doses of Sputnik V vaccine. The drug makers include Dr Reddy’s, Gland Pharma, Hetero Pharma, Stellis Bio, Virchow Biotech

In a webinar on Thursday, Dmitriev said “since Sputnik Light is the same as the first dose of Sputnik V, we believe that by June the one-shot vaccine will be registered pretty much in most of the countries that registered Sputnik V.”

He added that the vaccine may also work as “a booster shot” to other Covid-19 vaccines in protecting against mutations of the virus. Additional clinical trials to ascertain this claim still needs to be conducted.

Gamaleya says Phase-3 trials for Sputnik Light are being conducted using data from 7,000 people across multiple countries including Russia, the UAE and Ghana. Interim results are expected in May 2021.