Medicine:Sputnik Light

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Short description: Vaccine against COVID-19
Sputnik Light
Vaccine description
Target diseaseSARS-CoV-2
Typeviral
Clinical data
Routes of
administration		Intramuscular
Legal status
Legal status
  • RU: Registered on 6 May 2021
Full list of Sputnik Light authorizations

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 Template:Estimate effective in preventing infections, Template:Estimate effective against hospitalization, and Template:Estimate 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 Template:Estimate 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

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

  1. ↑ "В России зарегистрировали вакцину "Спутник Лайт"" (in ru). 6 May 2021. https://www.rbc.ru/society/06/05/2021/6093db399a79472862355b11. 
  2. ↑ "Russia Approves Single-Dose Sputnik Light Covid Vaccine For Use". Agence France-Presse. NDTV Coronavirus. 6 May 2021. https://www.ndtv.com/world-news/russia-approves-single-dose-sputnik-light-covid-19-vaccine-for-use-2436470. 
  3. ↑ "Single dose vaccine, Sputnik Light, authorized for use in Russia" (Press release). Russian Direct Investment Fund. 2021-05-06. Retrieved 2021-05-07.
  4. ↑ "Russia authorises single-dose Sputnik Light COVID vaccine for use -RDIF". Reuters (Moscow). 2021-05-06. https://www.reuters.com/business/healthcare-pharmaceuticals/russia-authorises-single-dose-sputnik-light-covid-vaccine-use-rdif-2021-05-06/. 
  5. ↑ "Russia launches Sputnik Light vaccine into wide circulation". reuters (Moscow). 2021-06-29. https://www.reuters.com/world/europe/russia-launches-sputnik-light-vaccine-into-wide-circulation-kommersant-2021-06-25/. 
  6. ↑ "COVID-19 vaccine trials should seek worthwhile efficacy". Lancet 396 (10253): 741–743. September 2020. doi:10.1016/S0140-6736(20)31821-3. 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.". 
  7. ↑ "Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection". Nature Medicine 27 (7): 1205–1211. May 2021. doi:10.1038/s41591-021-01377-8. ISSN 1546-170X. PMID 34002089. 
  8. ↑ 8.0 8.1 "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. 2021-10-01. doi:10.1016/j.eclinm.2021.101126. ISSN 2589-5370. PMID 34541480. 
  9. ↑ 9.0 9.1 "Single dose vaccine, Sputnik Light, authorized for use in Russia" (Press release). Russian Direct Investment Fund. 2021-05-06. Retrieved 2021-06-29. 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.
  10. ↑ 10.0 10.1 Clinical trial number NCT04741061 for "Study to Evaluate Efficacy, Immunogenicity and Safety of the Sputnik-Light (SPUTNIK-LIGHT)" at ClinicalTrials.gov
  11. ↑ 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. 2021-10-14. doi:10.1101/2021.10.08.21264715. https://www.medrxiv.org/content/10.1101/2021.10.08.21264715v1. 
  12. ↑ Clinical trial number NCT04713488 for "An Open Study on the Safety, Tolerability, and Immunogenicity of "Sputnik Light" Vaccine" at ClinicalTrials.gov
  13. ↑ "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.
  14. ↑ "Moscow Plays Up Donbas As Part Of The Ukraine Conflict" (in en-GB). 2021-07-30. https://warsawinstitute.org/moscow-plays-donbas-part-ukraine-conflict/. 
  15. ↑ "Residents of ORDLO can become 'guinea pigs' for Russian pharmacists - Defense Ministry" (in en). https://en.interfax.com.ua/news/general/759489.html. 




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