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Sputnik Light (Russian: Спутник Лайт, romanized: Sputnik Layt or Lajt[1]) is a single dose COVID-19 vaccine developed by the Gamaleya Research Institute of Epidemiology and Microbiology.[2] It consists of the first dose of the Sputnik V vaccine, which is based on the Ad26 vector, and it can be stored at a normal refrigerator temperature of 2–8 °C (36–46 °F).[3] The institute says this version would be ideally suited for areas with acute outbreaks, allowing more people to be vaccinated quickly.[4] It will also be used as a third (booster) dose for those who received Sputnik V at least 6 months earlier.[5]
Effectiveness
A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval.[6]
As of September 2021, no study on Sputnik Light reported confidence intervals, so it is not possible to know the accuracy of the estimates. Effectiveness is generally expected to slowly decrease over time.[7]
A real-world study with participants aged 60–79 years in Argentina found that the single-injection vaccine is 79% (95% CI, 75–82%) effective in preventing infections, 88% (95% CI, 80–92%) effective against hospitalization, and 85% (95% CI, 75–91%) against death.[8] A phase III clinical trial in Russia also found an efficacy of 79%.[9][10] According to Nextstrain, lineage B.1.1.317 was the dominant variant in Russia during the study period (5 December 2020 to 15 April 2021),[9] while in Argentina (29 December 2020 to 21 March 2021)[8] lineage N.5 dominated at first, but soon many lineages coexisted in similar proportions.
Preliminary data from a study in Moscow in July 2021 indicate that the vaccine is 70% (95% CI, 64–75%) effective against symptomatic disease from the Delta variant for three months after vaccination.[11]
Composition
Composition, manufacturing sites and procedures, logistics and concerns about adverse effects and quality control are the same as the first dose of the Sputnik V vaccine. As a result, issues related to the second dose, such as the possible presence of replication-competent particles, do not apply to Sputnik Light.
Clinical trials
In January 2021, Sputnik Light commenced phase I/II trials.[12]
In February, Sputnik Light commenced phase III trials.[10]
In August 2021, RDIF announced that preliminary results from a study on heterologous prime-boost vaccination indicate that it is safe to administer Sputnik Light as the first dose, then the Oxford–AstraZeneca, Moderna or Sinopharm BIBP vaccine as the second dose, as well as the homologous course consisting of Sputnik Light as the second dose.[13]
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Full authorization
Emergency authorization
Allowed for travel
Although Sputnik Light was not authorized by Ukraine or international organizations, tens of thousands of doses were shipped by Russia for use in non-government controlled parts of the eastern Donbas region from January 2021.[14] Ukrainian officials criticized the move.[15]
^Krause P, Fleming TR, Longini I, Henao-Restrepo AM, Peto R (September 2020). "COVID-19 vaccine trials should seek worthwhile efficacy". Lancet. 396 (10253): 741–743. doi:10.1016/S0140-6736(20)31821-3. PMC7832749. PMID32861315. WHO recommends that successful vaccines should show an estimated risk reduction of at least one-half, with sufficient precision to conclude that the true vaccine efficacy is greater than 30%. This means that the 95% CI for the trial result should exclude efficacy less than 30%. Current US Food and Drug Administration guidance includes this lower limit of 30% as a criterion for vaccine licensure.
^ ab"Single dose vaccine, Sputnik Light, authorized for use in Russia" (Press release). Russian Direct Investment Fund. 6 May 2021. Retrieved 29 June 2021. The single dose Sputnik Light vaccine demonstrated 79.4% efficacy according to analyzed data taken from 28 days after the injection was administered as part of Russia's mass vaccination program between 5 December 2020 and 15 April 2021.
^ abClinical trial number NCT04741061 for "Study to Evaluate Efficacy, Immunogenicity and Safety of the Sputnik-Light (SPUTNIK-LIGHT)" at ClinicalTrials.gov
^Dolzhikova IV, Gushchin VA, Shcheblyakov DV, Tsybin AN, Shchetinin AM, Pochtovyi AA, et al. (14 October 2021). "One-shot immunization with Sputnik Light (the first component of Sputnik V vaccine) is effective against SARS-CoV-2 Delta variant: efficacy data on the use of the vaccine in civil circulation in Moscow". medRxiv10.1101/2021.10.08.21264715v1.
^Clinical trial number NCT04713488 for "An Open Study on the Safety, Tolerability, and Immunogenicity of "Sputnik Light" Vaccine" at ClinicalTrials.gov
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