Sputnik Light
Vaccine against COVID-19
- J07BN02 (WHO)
- RU: Registered on 6 May 2021
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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]
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.[13]
Authorizations
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]
References
- ^ Filipenok A, Gubernatorov E (6 May 2021). "В России зарегистрировали вакцину "Спутник Лайт"" [Sputnik Light vaccine registered in Russia]. RBC (in Russian). Retrieved 7 May 2021.
- ^ "Russia Approves Single-Dose Sputnik Light Covid Vaccine For Use". NDTV Coronavirus. Agence France-Presse. 6 May 2021.
- ^ "Single dose vaccine, Sputnik Light, authorized for use in Russia" (Press release). Russian Direct Investment Fund. 6 May 2021. Retrieved 7 May 2021.
- ^ "Russia authorises single-dose Sputnik Light COVID vaccine for use -RDIF". Reuters. Moscow. 6 May 2021. Retrieved 29 June 2021.
- ^ "Russia launches Sputnik Light vaccine into wide circulation". reuters. Moscow. 29 June 2021. Retrieved 25 June 2021.
- ^ 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. PMC 7832749. PMID 32861315.
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.
- ^ Khoury DS, Cromer D, Reynaldi A, Schlub TE, Wheatley AK, Juno JA, et al. (May 2021). "Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection". Nature Medicine. 27 (7): 1205–1211. doi:10.1038/s41591-021-01377-8. ISSN 1546-170X. PMID 34002089. S2CID 234769053.
- ^ a b González S, Olszevicki S, Salazar M, Calabria A, Regairaz L, Marín L, et al. (1 October 2021). "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". eClinicalMedicine. 40: 101126. doi:10.1016/j.eclinm.2021.101126. ISSN 2589-5370. PMC 8435263. PMID 34541480.
- ^ a b "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.
- ^ a b Clinical 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". medRxiv 10.1101/2021.10.08.21264715v1.
- ^ Clinical trial number NCT04713488 for "An Open Study on the Safety, Tolerability, and Immunogenicity of "Sputnik Light" Vaccine" at ClinicalTrials.gov
- ^ "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" (Press release). Moscow: Russian Direct Investment Fund. 4 August 2021. Retrieved 5 August 2021.
- ^ "Moscow Plays Up Donbas As Part Of The Ukraine Conflict". Warsaw Institute. 30 July 2021. Retrieved 4 August 2021.
- ^ "Residents of ORDLO can become 'guinea pigs' for Russian pharmacists - Defense Ministry". Interfax Ukraine. Retrieved 4 August 2021.
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Named for Nikolay Gamaleya and founded by Felix Blyumental | ||
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Medical and health organizations based in Russia | ||
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