Sputnik Light

A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval.{{cite journal | vauthors = Krause P, Fleming TR, Longini I, Henao-Restrepo AM, Peto R | title = COVID-19 vaccine trials should seek worthwhile efficacy | journal = Lancet | volume = 396 | issue = 10253 | pages = 741–743 | date = September 2020 | pmid = 32861315 | pmc = 7832749 | doi = 10.1016/S0140-6736(20)31821-3 | quote = 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. }}

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.{{Cite journal |display-authors=6 |vauthors=Khoury DS, Cromer D, Reynaldi A, Schlub TE, Wheatley AK, Juno JA, Subbarao K, Kent SJ, Triccas JA, Davenport MP |date=May 2021 |title=Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection |journal=Nature Medicine |volume=27 |issue=7 |pages=1205–1211 |doi=10.1038/s41591-021-01377-8 |issn=1546-170X |pmid=34002089 |s2cid=234769053 |doi-access=free }}

A real-world study with participants aged 60–79 years in Argentina found that the single-injection vaccine is {{Estimate|79|75|82|unit=%|mini=no}} effective in preventing infections, {{Estimate|88|80|92|unit=%|mini=no}} effective against hospitalization, and {{Estimate|85|75|91|unit=%|mini=no}} against death.{{cite journal |vauthors=González S, Olszevicki S, Salazar M, Calabria A, Regairaz L, Marín L, Campos P, Varela T, Martínez VV, Ceriani L, Garcia E |display-authors=6 |date=2021-10-01 |title=Effectiveness of the first component of Gam-COVID-Vac (Sputnik V) on reduction of SARS-CoV-2 confirmed infections, hospitalisations and mortality in patients aged 60-79: a retrospective cohort study in Argentina |journal=eClinicalMedicine |volume=40 |page=101126 |doi=10.1016/j.eclinm.2021.101126 |pmid=34541480 |issn=2589-5370|pmc=8435263 }} A phase III clinical trial in Russia also found an efficacy of 79%.{{cite press release |date=2021-05-06 |title=Single dose vaccine, Sputnik Light, authorized for use in Russia |url=https://rdif.ru/Eng_fullNews/6763/ |publisher=Russian Direct Investment Fund |quote=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. |access-date=2021-06-29}}{{ClinicalTrialsGov|NCT04741061|Study to Evaluate Efficacy, Immunogenicity and Safety of the Sputnik-Light (SPUTNIK-LIGHT)}} 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), while in Argentina (29 December 2020 to 21 March 2021) 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 {{Estimate|70|64|75|unit=%|mini=no}} effective against symptomatic disease from the Delta variant for three months after vaccination.{{Cite medRxiv |vauthors=Dolzhikova IV, Gushchin VA, Shcheblyakov DV, Tsybin AN, Shchetinin AM, Pochtovyi AA, Komissarov AB, Kleymenov DA, Kuznetsova NA, Tukhvatulin AI, Zubkova OV |display-authors=6 |date=2021-10-14 |title=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 |medrxiv=10.1101/2021.10.08.21264715v1}}

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.

In January 2021, Sputnik Light commenced phase I/II trials.{{ClinicalTrialsGov|NCT04713488|An Open Study on the Safety, Tolerability, and Immunogenicity of "Sputnik Light" Vaccine}}

In February, Sputnik Light commenced phase III trials.

{{See also|COVID-19 vaccine clinical research#Heterologous prime-boost vaccination|Sputnik V COVID-19 vaccine#Heterologous prime-boost vaccination}}

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.{{cite press release |date=4 August 2021 |title=Combination of the first component of Sputnik V vaccine (Sputnik Light vaccine) with vaccines by AstraZeneca, Sinopharm and Moderna demonstrates high safety profile during the study in Argentina's Buenos-Aires province |url=https://rdif.ru/Eng_fullNews/7035/ |location=Moscow |publisher=Russian Direct Investment Fund |access-date=5 August 2021}}

{{See also|List of COVID-19 vaccine authorizations#Sputnik Light}}

{{#section:List of COVID-19 vaccine authorizations|sputniklightauthmap}}

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.{{Cite web|date=2021-07-30|title=Moscow Plays Up Donbas As Part Of The Ukraine Conflict|url=https://warsawinstitute.org/moscow-plays-donbas-part-ukraine-conflict/|access-date=2021-08-04|website=Warsaw Institute|language=en-GB}} Ukrainian officials criticized the move.{{Cite web|title=Residents of ORDLO can become 'guinea pigs' for Russian pharmacists - Defense Ministry|url=https://en.interfax.com.ua/news/general/759489.html|access-date=2021-08-04|website=Interfax Ukraine|language=en}}

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