Gamaleya COVID-19 vaccine
Gamaleya Research Institute; Health Ministry of the Russian Federation
Sputnik V; Gam-COVID-Vac; Adeno-based (rAd26-S+rAd5-S) / Sputnik light
Authorization
World Health Organization Emergency Use Listing Procedure
Not listed for emergency use.
Anticipated decision date will be determined when all data is submitted [latest check of WHO EUL official website on January 12th 2023].
European Commission (based upon the recommendation of the European Medicines Agency)
Not authorized.
Health Ministry of the Russian Federation
Sputnik V: authorized on August 8th 2020 [State Drug Registry of Russia, 2020 ].
Sputnik Light: authorized on May 6th 2021 [RUSSIAN DIRECT INVESTMENT FUND, 2021 ].
Regulatory Authorities of Regional Reference in the Americas
National Administration of Drugs, Foods and Medical Devices (Argentina)
Authorized for emergency use on December 23rd 2020 [Ministerio de salud de la Argentina, 2020 ].
Brazilian Health Regulatory Agency
Authorized for exceptional importation under controlled conditions on June 14th 2021 [ANVISA, 2022 ].
Health Canada
Not authorized.
Public Health Institute (Chile)
Authorized for emergency use on July 21st 2021 [Instituto de salud pública de Chile, 2021 ].
National Institute of Food and Drug Monitoring (Colombia)
Not authorized.
Center for the State Control of Drug Quality (Cuba)
Not authorized.
U.S. Food and Drug Administration (FDA)
Not authorized.
Federal Commission for the Protection against Sanitary Risk (Mexico)
Authorized for emergency use on February 2nd 2021 [Comisión Federal para la Protección contra Riesgos Sanitarios (Cofepris). Mexico, 2021 ].
Authorization in jurisdictions in Latin America and the Caribbean
Antigua and Barbuda
Bolivia
Ecuador
Guatemala
Guyana
Honduras
Nicaragua
Panama
Paraguay
Peru
Saint Vincent and the Grenadines
Venezuela
Authorization in other jurisdictions in the Americas
Albania
Algeria
Angola
Armenia
Azerbaijan
Bahrain
Bangladesh
Belarus
Benin
Bosnia and Herzegovina
Cambodia
Cameroon
Djibouti
Egypt
Gabon
Ghana
Guinea
Hungary
India
Indonesia
Iran
Iraq
Jordan
Kazakhstan
Kenya
Kyrgyzstan
Lao People's Democratic Republic
Lebanon
Libya
Maldives
Mali
Mauritius
Moldova
Mongolia
Montenegro
Morocco
Myanmar
Namibia
Nepal
Nigeria
North Macedonia
Oman
Pakistan
Philippines
Russia
Rwanda
San Marino
Serbia
Seychelles
Slovakia
Sri Lanka
Syria
Tanzania
Tunisia
Turkey
Turkmenistan
United Arab Emirates
Uzbekistan
Vietnam
West Bank
Zimbabwe
Manufacturing
Manufacturer
Gamaleya Research Institute of Epidemiology and Microbiology, Russia. Developer and manufacturer of Sputnik V COVID-19 vaccine.
Other manufacturers
Binnopharm, Russia. Vaccine production in other countries in partnership with local sovereign wealth funds, including India, South Korea and Brazil, as well as, in China, Saudi Arabia and Turkey. It also participates in the filling and packaging process.
GENERIUM, Russia. Manufacturer, filling and packaging of the vaccine.
BIOCAD, Russia. Manufacturer, filling and packaging of the vaccine.
LEKKO, Russia. Manufacturer, filling and packaging of the vaccine.
Pharmstandard-UfaVITA, Russia. Manufacturer, filling and packaging of the vaccine.
RDIF, Russia. Finances the production of Sputnik V COVID-19 vaccine.
Dr. Reddy's Laboratories, India.
There are other manufacturers involved in the process
General characteristics
Sputnik V COVID-19 vaccine
The Sputnik V COVID-19 vaccine is composed of two different adenoviruses, Ad26 and Ad5 that have been modified to contain the gene that encodes the SARS-CoV-2 spike protein. The two adenoviruses are given separately: Ad26 is used in the first dose and Ad5 is used in the second to boost the vaccine’s effect. Once it has been given, the vaccine delivers the SARS-CoV-2 gene into the body cells that will synthesize the antigen to generate the immune response against the S protein. The vaccine is produced in the HEK293 cell line [Logunov DY, 2020 ].
The frozen solution appears as a dense, hardened whitish mass. After thawing it is a slightly opalescent colorless or yellowish homogeneous solution [Gobierno de México, 2021 ].
Sputnik Light COVID-19 vaccine
The Sputnik Light COVID-19 vaccine is the first component (rAd26) of the Sputnik V COVID-19 vaccine. Sputnik Light COVID-19 vaccine is based on a proven and well-studied platform of human adenoviral vectors, which cause the common cold and have been around for thousands of years, as demonstrated by the Russian Gamaleya Center during laboratory tests [Precision Vaccinations, 2021 ].
Ingredients
The vaccine contains the following ingredients:
Active ingredient
Sputnik V COVID-19 vaccine
The vaccine uses a combined non-replicative viral vector as a platform (human adenovirus 26 and human adenovirus 5, respectively for Component 1 and Component 2).
Component 1 (first dose): recombinant human adenovirus serotype 26 particles (rAd26-S), containing the protein S gene of the SARS-CoV-2 virus, in an amount of (1.0 ± 0.5) x 1011 particles /dose.
Component 2 (second dose): recombinant human adenovirus serotype 5 particles (rAd5-S), containing the SARS-CoV-2 virus protein S gene, in an amount of (1.0 ± 0.5) x 1011 particles/dose.
Sputnik Light COVID-19 vaccine
The vaccine uses a non-replicative viral vector as a platform (human adenovirus 26).
Sputnik Light COVID-19 vaccine is composed a single dose of adenovirus Ad26, containing SARS-CoV-2 protein S gene, in the amount of (1.0±0.5) х 1011 particles per dose [Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation, 2021 ].
Excipients for Sputnik V and Sputnik Light COVID-19 vaccine
Tris (hydroxylmethyl) aminomethane
Sodium chloride
Sucrose
Magnesium chloride hexahydrate
EDTA sodium salt dihydrate
Polysorbate
Ethanol 95%
Solvent for injections up to 0.5 mL
Given the diversity in the presentation color of the vials, it is recommended to read and identify the Component (1 or 2) according to the inscription present on the vaccine vial prior to application.
Risk considerations
Adenoviruses are considered a promising vector platform for the development of vaccines for infectious disease, largely due to their safety and ability to stimulate robust cellular and/or humoral immune responses in multiple species [Coughlan L, 2020 ].
The Sputnik V COVID-19 vaccine is based on a platform that uses two adenoviral vectors, Ad26 and Ad5.
Clinical experience with the Ad26 platform consists of the Ad26.ZEBOV/MVA-BN-Filo Ebola vaccine regimen, and investigational vaccines against Zika, filovirus, HIV, HPV, malaria, and respiratory syncytial virus. Ad26-based vaccines have been used to vaccinate 193,831 participants in different clinical studies and vaccination programs, with results that have shown acceptable clinical safety profile [FDA, 2021 ].
Clinical experience with the Ad5 platform is mixed. Two studies using an Ad5 vectored HIV-1 vaccine administered found an increased risk of HIV acquisition among vaccinated men. A consensus conference about Ad5 vectors held in 2013 warned that non-HIV vaccine trials that used similar vectors in areas of high HIV prevalence could lead to an increased risk of HIV-1 acquisition in the vaccinated population. The potential mechanism for this increased susceptibility is not completely clear but theories include dampening of HIV immunity, enhancing replication of the AIDS virus, or setting up more target cells for it [Buchbinder SP, 2020 ].
On the other hand, the same effect was not detected in a trial of a recombinant adenovirus type-5 vector-based Ebola vaccine tested in a population in Sierra Leone that had a relatively high HIV prevalence.
[Zhu FC ].
It is unknown what is the impact on this risk of the genetic engineering process that is applied to Ad5 by different vaccine producers.
Dosing and schedule
Sputnik V COVID-19 vaccine
Sputnik V COVID-19 vaccine is administered as a series of two doses (0.5 mL each) with an interval of 3 weeks.
The pharmaceutical form is a solution for intramuscular injection provided in a multidose vial of 5 doses (0.5 mL per dose).
The Sputnik V COVID-19 vaccine is provided in two components: (1) human adenovirus-26 for the first dose; and (2) human adenovirus-5 for the second dose.[Ministerio de Salud Argentina, 2021 ].
The preferred site of injection is the deltoid muscle of the upper arm.
If administration of the second dose is inadvertently delayed beyond 3 weeks, it should be given as soon as possible.
Sputnik Light COVID-19 vaccine
Sputnik Light COVID-19 vaccine is administered as one dose of 0.5 mL [Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation, 2021 ].
The pharmaceutical form is a solution for intramuscular injection provided in a multidose vial of 5 doses (0.5 mL per dose).
The preferred site of injection is the deltoid muscle of the upper arm.
Booster dose [Ministerio de Salud Argentina, 2022 ]
A booster dose should be given at least 4 months after the primary scheme using an mRNA-based or viral vector vaccine.
Heterologous schedule
The Sputnik Light COVID-19 vaccine uses the same human adenovirus platform as the "Component 1" of the Sputnik V vaccine (rAd26-S).
According to the manufacturer, a mix-and-match scheme can be administered (i.e. using the first dose of Sputnik Light followed by Component 2 of Sputnik V) [Gamaleya National Center, 2021 ]
Vaccination schedule for immunocompromised persons [Ministerio de Salud Argentina, 2022 ]
ANMAT/Argentina recommends a primary schedule with Sputnik V, followed by an additional (third) dose 4 months after with Sputnik V.
Indications and contraindications
Indications
The Sputnik V COVID-19 vaccine is indicated for individuals 18 years and over [Dr. Reddy's, 2021 ].
The Sputnik Light COVID-19 vaccine is indicated in adult individuals 18 years and over [Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation, 2021 ].
Contraindications
Sputnik V and Sputnik Light COVID-19 vaccines are contraindicated in individuals with a known history of a severe allergic reaction to any component of the Sputnik V and Sputnik Light COVID-19 are contraindicated.
See General characteristics´read more`.
The second dose of Sputnik V COVID-19 vaccine should NOT BE GIVEN to those who have experienced anaphylaxis to the first dose of the vaccine.
Precautions
Allergic reactions
Persons with a history of anaphylaxis to any other vaccine or injectable therapy should be observed in health care settings where anaphylaxis can be immediately treated.
Pregnancy
The available data on Sputnik V and Sputnik Light COVID-19 are insufficient to assess vaccine efficacy in pregnancy since no clinical trials have included pregnant women.
Children and adolescents [Instituto de Salud Pública de Chile, 2022 ]
There are limited data on the efficacy or safety of persons below 18 years of age for this vaccine. Until more data are available, vaccination of individuals in this age range is not routinely recommended.
Older persons [Instituto de Salud Pública de Chile, 2022 ]
Vaccination is recommended for older persons without an upper age limit
Persons with previous SARS-CoV-2 infection
Vaccination may be offered regardless of a person’s history of symptomatic or asymptomatic SARS-CoV-2 infection.
Persons with current acute COVID-19
Persons with acute PCR-confirmed COVID-19 should not be vaccinated until after they have recovered from acute illness and the criteria for discontinuation of isolation have been met [PAHO, 2020 ].
Other precautions
Vaccination should be postponed in individuals suffering from acute severe febrile illness, or acute infection.
Co-administration with other vaccines
There should be a minimum interval of 14 days between the administration of this vaccine with any other vaccine in the immunization schedule, until data on co-administration with other vaccines are available.
Storage and logistics
Storage
The Sputnik V and Sputnik Light COVID-19 vaccine should be stored at a temperature below -18°C (-0.4°F) or below, during transport and storage until use. The shelf life of the vaccine is 6 months from the date of production [Dr. Reddy's, 2021 ], [Dr. Reddy's, 2021 ].
The Sputnik V and Sputnik Light COVID-19 vaccine must be kept in its original packaging, protected from light.
Administration logistics [Dr. Reddy's, 2021 ], [Dr. Reddy's, 2021 ], [Ministerio de salud de Argentina, 2021 ]
Thaw the vaccine at room temperature, for 2 to 5 minutes depending on the temperature. Take into account that the validity of the thawed vaccine is a maximum of 120 minutes at a temperature between 15 ºC to 25 ºC.
Thawed vaccine cannot be refrozen, and cannot be stored refrigerated at 2°C to 8°C (36°F to 46°F).
Verify that the vial to be used corresponds to the component to be administered.
Sputnik V: component I for the 1st dose and II for the 2nd dose.
Sputnik Light: only 1 dose of component I.
Observe the appearance of the vaccine, it should be a slightly opalescent colorless or yellowish homogeneous solution. If you notice cloudiness or strange coloration, do not use.
Invert the vial several times, to mix the 0.5 mL dose of the corresponding vaccine before each extraction. Do not shake the vial.
Storage after first puncture
The vial in use must be used within a maximum of 120 minutes (2 hours), from the moment of thawing of the vaccine [Dr. Reddy's, 2021 ], [Dr. Reddy's, 2021 ], [Ministerio de salud de Argentina, 2021 ].
Do not refreeze the vaccine, or keep it refrigerated.
To improve traceability, the name and batch number of the administered product should be clearly recorded.
Administration [Dr. Reddy's, 2021 ], [Dr. Reddy's, 2021 ], [Ministerio de salud de Argentina, 2021 ]
1. Expose site (deltoid of non-dominant arm) for administration.
2. Explain the procedure and inform that some pain on giving injection, discomfort at the site of injection, or fever after the injection, may happen.
3. Take vaccine vial/ampoule out of the vaccine carrier.
4. Open the vial by removing plastic cover/cap or opening the ampoule.
5. Take out a 0.5 mL syringe and remove needle cap.
6. Discard the cap in a safety box.
7. Insert the syringe needle through the top rubber pad of vaccine vial or into the opened ampoule.
8. Draw 0.5 mL of diluted vaccine from the vial/ampoule.
9. Inject intramuscularly at the site of injection at an angle of 90⁰ (right angle) following “No-touch technique”
10. Dispose of the syringe in the safety box.
11. Send the patient to an observation area for 30 minutes.
12. After 30 minutes if no acute adverse events are experienced by the patient , explain the next steps on a follow-up visit for the second dose.
Disposal
Due to the high risk that discarded vials of COVID-19 vaccines can be recovered, it is essential that they are guaranteed to be safely disposed at the site of use; or study the possibility of applying reverse logistics, if the safe treatment and disposal of vaccine residues cannot be guaranteed. Otherwise, consider the possibility that the discarded vaccine vials are shredded, if there is a safe way to do so [WHO, 2021 ].
Clinical studies - general characteristics
The following randomized clinical trials have reported vaccine efficacy and/or safety data:
Phase 3:
The RESIST trial (NCT04530396 [Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation, 2020 ]) conducted in Russia since August 2020 included 21,977 participants aged 18 years or older with no history of SARS-CoV-2 infection, who were randomized 3:1 to receive the vaccine comprising two viral vector components (rAd26-S and rAd5-S) or a placebo, in two doses administered 21 days apart [Logunov, Denis Y, 2021 ], [Logunov DY, 2021 ].
Vaccine efficacy and effectiveness
Efficacy of preclinical studies on the vaccine
Data on animal or other preclinical studies for this vaccine have not been published or released.
Efficacy of the vaccine in clinical trials
Main immunogenicity outcomes
Immunogenicity was evaluated in two non-randomized phase 1/2 studies (02-Gam-COVID-Vac-2020 and 03-Gam-COVID-Vac Lyo-2020) that included 76 healthy adult volunteers aged 18-60 years that received two formulations (frozen and lyophilized) of the vaccine between June 2020 and August 2020. All participants produced antibodies to SARS-CoV-2 glycoprotein (receptor binding domain-specific IgG titres at day 42: 14,703 with the frozen formulation and 11,143 with the lyophilized formulation) and neutralizing antibodies (49.25 with the frozen formulation and 45.95 with the lyophilized formulation). Seroconversion rate was 100%. Cellular responses were detected in all participants at day 28, with median cell proliferation of 2.5% CD4+ and 1.3% CD8+ with the frozen formulation, and 1.3%/1.1% with the lyophilized formulation [Logunov DY, 2020 ].
Main efficacy outcomes of Gamaleya COVID-19 vaccine
Key messages
Gamaleya COVID-19 vaccine reduces the risk of contracting COVID-19
Gamaleya COVID-19 vaccine reduces the risk of contracting severe COVID-19
Contracting COVID-19 (measured at least 21 days after the first dose)
The relative risk of contracting COVID-19 in the group that received Gamaleya COVID-19 vaccine versus the group that received placebo vaccine was 0.08 (95% CI 0.05 to 0.15). This means Gamaleya COVID-19 vaccine reduced the risk of contracting COVID-19 after the first dose in 92%, compared with the placebo vaccine.
Figure - Forest plot of risk ratio meta-analysis. Outcome: contracting COVID-19. Comparison: Gamaleya COVID-19 vaccine versus placebo vaccine
In the available trial, 62 people not receiving Gamaleya COVID-19 vaccine out of 4902 presented this outcome (13 per 1000) versus 16 out of 14964 in the group that did receive it (1 per 1000). In other words, 12 less people per 1000 did not develop the outcome because of the vaccine. This is the same as saying that the intervention led to an absolute risk reduction of 1.2%, or that the intervention reduced the risk of contracting COVID-19 by 1.2 percentage points. Another way of presenting the same information about the absolute effects is the number needed to treat for an additional beneficial/harmful outcome (NNTB/H), the number of participants who need to receive the intervention for one of them to experience the outcome. In this case, the NNTB is 83.
Applying the GRADE approach [Logunov, Denis Y, 2021 ], we assessed the certainty of the evidence for this outcome as high.
Contracting COVID-19 after the second dose (>7d) (measured at least 7 days after the second dose)
The relative risk of contracting COVID-19 after the second dose (>7d) in the group that received versus the group that received placebo vaccine was 0.09 (95% CI 0.05 to 0.17). This means Gamaleya COVID-19 vaccine reduced the risk of contracting COVID-19 after the second dose (>7d) by 91%, compared with placebo vaccine.
Figure - Forest plot of risk ratio meta-analysis. Outcome: contracting COVID-19 after the second dose (>7d). Comparison: Gamaleya COVID-19 vaccine versus placebo vaccine
In the trial identified in this review, 47 people not receiving Gamaleya COVID-19 vaccine out of 4601 presented this outcome (10 per 1000) versus 47 out of 14094 in the group that did receive it (1 per 1000). In other words,10 less to 8 less people per 1000 did not develop the outcome because of the vaccine. This is the same as saying that the intervention led to an absolute risk reduction of 0.9%, or that the intervention reduced the risk of contracting COVID-19 after the second dose (>7d) by 0.9 percentage points. Another way of presenting the same information about the absolute effects is the number needed to treat for an additional beneficial/harmful outcome (NNTB/H), the number of participants who need to receive the intervention for one of them to experience the outcome. In this case, the NNT is 111. Which means that 250 people need to receive the vaccine for one of them to not contracting COVID-19 after the second dose (>7d)
Applying the GRADE approach [The GRADE Working Group, 2013 ], we assessed the certainty of the evidence for this outcome as moderate certainty evidence.
Contracting severe COVID-19 (measured at least 21 days after the first dose)
The relative risk of contracting severe COVID-19 in the group that received Gamaleya COVID-19 vaccine versus the group that received placebo vaccine was 0.01 (95% CI 0 to 0.13). This means Gamaleya COVID-19 vaccine reduced the risk of contracting severe COVID-19 in 99%, compared with placebo vaccine.
Figure - Forest plot of risk ratio meta-analysis. Outcome: contracting severe COVID-19. Comparison: Gamaleya COVID-19 vaccine versus placebo vaccine
In the available trial, 20 people not receiving Gamaleya COVID-19 vaccine out of 4902 presented this outcome (4 per 1000) versus 0 out of 14964 in the group that did receive it (0 per 1000). In other words, 4 less people per 1000 did not develop the outcome because of the vaccine. This is the same as saying that the intervention led to an absolute risk reduction of 0.4%, or that the intervention reduced the risk of contracting severe COVID-19 by 0.4 percentage points. Another way of presenting the same information about the absolute effects is the number needed to treat for an additional beneficial/harmful outcome (NNTB/H), the number of participants who need to receive the intervention for one of them to experience the outcome. In this case, the NNTB is 250.
Applying the GRADE approach [Logunov, Denis Y, 2021 ], we assessed the certainty of the evidence for this outcome as moderate. The reason for downgrading the certainty of the evidence is the risk of bias due to losses to follow up and imprecision. No reasons for concern were detected in relation to inconsistency, indirect evidence or publication bias.
Efficacy of the vaccine in subgroups
Contracting COVID-19 (men subgroup) (measured at least 21 days after the first dose)
The relative risk of contracting COVID-19 (men subgroup) in the group that received Gamaleya COVID-19 vaccine versus the group that received placebo vaccine was 0.06 (95% CI 0.03 to 0.13). This means Gamaleya COVID-19 vaccine reduced the risk of contracting COVID-19 (men subgroup) by 94%, compared with placebo vaccine.
Figure - Forest plot of risk ratio meta-analysis. Outcome: contracting COVID-19 (men subgroup). Comparison: Gamaleya COVID-19 vaccine versus placebo vaccine
In the trial identified in this review, 39 people not receiving Gamaleya COVID-19 vaccine out of 3015 presented this outcome (13 per 1000) versus 39 out of 9143 in the group that did receive it (1 per 1000). In other words,13 less to 11 less people per 1000 did not develop the outcome because of the vaccine. This is the same as saying that the intervention led to an absolute risk reduction of 1.2%, or that the intervention reduced the risk of contracting COVID-19 (men subgroup) by 1.2 percentage points. Another way of presenting the same information about the absolute effects is the number needed to treat for an additional beneficial/harmful outcome (NNTB/H), the number of participants who need to receive the intervention for one of them to experience the outcome. In this case, the NNT is 83. Which means that 250 people need to receive the vaccine for one of them to not contracting COVID-19 (men subgroup)
Applying the GRADE approach [The GRADE Working Group, 2013 ], we assessed the certainty of the evidence for this outcome as moderate certainty evidence.
Contracting COVID-19 (women subgroup) (measured at least 21 days after the first dose)
The relative risk of contracting COVID-19 (women subgroup) in the group that received Gamaleya COVID-19 vaccine versus the group that received placebo vaccine was 0.13 (95% CI 0.06 to 0.27). This means Gamaleya COVID-19 vaccine reduced the risk of contracting COVID-19 (women subgroup) by 87%, compared with placebo vaccine.
Figure - Forest plot of risk ratio meta-analysis. Outcome: contracting COVID-19 (women subgroup). Comparison: Gamaleya COVID-19 vaccine versus placebo vaccine
In the trial identified in this review, 23 people not receiving Gamaleya COVID-19 vaccine out of 1887 presented this outcome (12 per 1000) versus 23 out of 5821 in the group that did receive it (2 per 1000). In other words,11 less to 9 less people per 1000 did not develop the outcome because of the vaccine. This is the same as saying that the intervention led to an absolute risk reduction of 1%, or that the intervention reduced the risk of contracting COVID-19 (women subgroup) by 1 percentage points. Another way of presenting the same information about the absolute effects is the number needed to treat for an additional beneficial/harmful outcome (NNTB/H), the number of participants who need to receive the intervention for one of them to experience the outcome. In this case, the NNT is 100. Which means that 250 people need to receive the vaccine for one of them to not contracting COVID-19 (women subgroup)
Applying the GRADE approach [The GRADE Working Group, 2013 ], we assessed the certainty of the evidence for this outcome as moderate certainty evidence.
Contracting COVID-19 (>60y) (measured at least 21 days after the first dose)
The relative risk of contracting COVID-19 (>60y) in the group that received Gamaleya COVID-19 vaccine versus the group that received placebo vaccine was 0.08 (95% CI 0.02 to 0.39). This means Gamaleya COVID-19 vaccine reduced the risk of contracting COVID-19 (>60y) by 92%, compared with placebo vaccine.
Figure - Forest plot of risk ratio meta-analysis. Outcome: contracting COVID-19 (>60y). Comparison: Gamaleya COVID-19 vaccine versus placebo vaccine
In the trial identified in this review, 8 people not receiving Gamaleya COVID-19 vaccine out of 533 presented this outcome (15 per 1000) versus 8 out of 1611 in the group that did receive it (1 per 1000). In other words,15 less to 9 less people per 1000 did not develop the outcome because of the vaccine. This is the same as saying that the intervention led to an absolute risk reduction of 1.4%, or that the intervention reduced the risk of contracting COVID-19 (>60y) by 1.4 percentage points. Another way of presenting the same information about the absolute effects is the number needed to treat for an additional beneficial/harmful outcome (NNTB/H), the number of participants who need to receive the intervention for one of them to experience the outcome. In this case, the NNT is 71. Which means that 250 people need to receive the vaccine for one of them to not contracting COVID-19 (>60y)
Applying the GRADE approach [The GRADE Working Group, 2013 ], we assessed the certainty of the evidence for this outcome as moderate certainty evidence.
Summary of findings (iSoF)
Efficacy and effectiveness of the vaccine in subgroups
Sex
Randomized trials
The proportion of females in the RESIST trial was 38.8% (7,708 out of 19,866 participants) [Logunov, Denis Y, 2021 ]. The relative risk of contracting COVID-19 in females that received Sputnik V COVID-19 vaccine versus the group that received placebo vaccine was 0.08 (95% CI 0.02 to 0.39). This means Sputnik V COVID-19 vaccine reduced the risk of contracting COVID-19 in 92%, compared with the placebo vaccine. This estimate is not statistically different from the estimate for this outcome in the overall population of the trial.
Age
Randomized trials
The RESIST trial [Logunov, Denis Y, 2021 ] included 2,144 participants older than 60 years (1,611 in the vaccine group and 533 in the placebo group. The relative risk of contracting COVID-19 in participants older than 60 years that received Sputnik V COVID-19 vaccine versus the group that received placebo vaccine was 0.08 (95% CI 0.02 to 0.39). This means Sputnik V COVID-19 vaccine reduced the risk of contracting COVID-19 in 92%, compared with the placebo vaccine. This estimate is not statistically different from the estimate for this outcome in the overall population of the trial.
Children and adolescents
Randomized trials
Children were excluded from the RESIST trial [Logunov, Denis Y, 2021 ].
Pregnancy
Randomized trials
Pregnant females were excluded from the RESIST trial [Logunov, Denis Y, 2021 ].
Breastfeeding
Randomized trials
Women who were breastfeeding were excluded from the RESIST trial [Logunov, Denis Y, 2021 ].
Immunocompromised persons
Randomized trials
Immunocompromised persons were excluded from the RESIST trial [Logunov, Denis Y, 2021 ].
Other comparative studies
Gushcin et al was a retrospective cohort study to assess the effectiveness of the standard Sputnik V vaccination regimen in 24,423 HIV+ Moscow residents during spring - summer 2021 with estimation of hospitalization and severe illness rates in vaccinated and unvaccinated patients. Data were extracted from the Moscow anti-COVID-19 vaccination and COVID-19 incidence Registries. The main results showed that vaccine effectiveness was 79.42%, avoiding hospitalization in 90.12% cases and protecting from the development of moderate or severe disease in 97.06%. For delta variant in this group the efficiency was 65.35%, avoiding the need for hospitalization in 75.77% cases and protecting from the development of moderate or severe disease in 93.05% of patients [Gushchin VA, 2022 ].
Vaccine effectiveness (other comparative studies)
Contracting COVID-19
Mirahmadizadeh A et al. was a cohort study conducted in Iran. The study enrolled 1,882,148 participants: 881,638 vaccine group; 1,000,510 control group. Based on data derived from administrative repositories during mass-vaccination campaigns or programs between February 09, 2021, and the end of follow-up on October 22, 2021; the study results showed vaccine effectiveness of 74.7% (95%CI 71.0 to 78.4%) against infection, 67.5% (95%CI 59.5 to 75.6%) against hospitalization and 100% against death. [Alireza Mirahmadizadeh, 2022 ]
Rearte A et al. was a case-control study conducted in Argentina. The study included 687,167 individuals in the analysis of the rAd26-rAd5 vaccine: 218,417 in the case group and 468,750 in the control group. The study assessed the effectiveness of three vaccines (rAd26-rAd5, ChAdOx1 nCoV-19, and BBIBP-CorV) on SARS-CoV-2 infection and risk of death in people with RT-PCR-confirmed COVID-19, using data from the National Surveillance System (SNVS 2.0). All individuals aged 60 years or older reported to SNVS 2.0 as being suspected to have COVID-19 who had disease status confirmed with RT-PCR were included in the study. The odds ratio of the rAd26-rAd5 vaccine on the risk of SARS-CoV-2 infection in individuals with only one dose was OR 0.61 (95% CI 0.60 to 0.61). After the second dose was OR 0.36 (95% CI 0.0.35 to 0.37). [Rearte A, 2022 ]
Petrovic V et al. was a study conducted in Serbia, including data from 7,037 participants with two Sputnik V vaccines and 241,166 controls. Based on data from the surveillance registry from Vojvodina and the nationwide COVID-19 vaccine registry, participants aged 60 and above, between December 24, 2020 and April 28, 2021. The overall effectiveness of Sputnik was 95% (95% CI 92.4 to 96.7) and 94.7% (95% CI 91.6 to 96.7) against mild COVID-19. [Petrovi? V, 2022 ]
Horvath et al. was a study conducted in Hungary, including data from 2,808,893 participants with two Sputnik V vaccines. Based on data from the Hungarian Notifiable Disease Surveillance System, between 2021 up to January 24 2022. The overall efectiveness of the was 1.1% (95% CI -11.4 to 12.1) in the 18-24 age group, 49.5% (95% CI 46.6 to 52.3) in the 25-49 age group, 68% (95% CI 64.4 to 71.3) in the 50-59 age group, 71.1% (95% CI 67.3 to 74.4) in the 60-69 age group, 75.1% (95% CI 71.4 to 78.3) in the 70-79 age group and 61.1% (95% CI 56 to 65.7) in participants aged 80 and above. [Krisztina J. Horvath, 2022 ]
Sukhikh GT et al was a comparative cohort study in Russia to estimate vaccine effectiveness (VE) against COVID-19, before and during the Delta predominance period. The study included 1,624 participants with at least one Sputnik dose, 819 cases and 805 controls, based on data from medical workers employed at the Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology of the Ministry of Health. Data from November 2020 to February 2022. The overall VE was 89.1% (95% CI, 86.9% to 91%) for the entire period irrespective of the number of doses. [Sukhikh GT, 2022 ]
Bello-Chavolla OY et al was a retrospective cohort study conducted in Mexico, including 793,487 vaccinated and 4,792,388 unvaccinated individuals. This study estimated vaccine effectiveness (VE) against infection and hospitalization, based on data from the COVID-19 surveillance system between December 2020 and September 2021. Among 39,952 participants vaccinated with Sputnik, VE against infection was 78.75% (95% CI, 78.17% to 79.31%), and VE against hospitalization was 81.38% (95% CI, 79.45% to 83.13%) [Bello-Chavolla OY, 2023 ].
Contracting severe COVID-19
Mukherjee S et al. was a comparative study conducted in Bahrain. The study enrolled 1,242,279 participants that received the Sputnik-V COVID-19 vaccine. Based on data from the centralized country-specific Information system (ISEHA) with all medical history of individuals and is, anonymized electronic health records were retrieved for the study period December 9th, 2020 - July 17 202. The outcome was measured starting at ≥ 14 days after vaccination. Results showed a vaccine hospitalization rate of 2.24%, an ICU admission rate of 0%, and a death rate of 0.09%. [Mukherjee S, 2021 ]
Barchuk et al. was a case-control study conducted in Russia, to assess the vaccine effectiveness (VE) against referral to hospital. The study recruited 13,893 participants (1,291 complete vaccination status and 495 were referred to the hospital) who received the Sputnik-V or Sputnik light COVID-19 vaccines. Based on individual-level patient data from two outpatient triage centers of the Medical Institute named after Berezin Sergey (MIBS) between July 3rd and August 9th, 2021. The adjusted VE against referral to the hospital was 81% (95% CI, 68% to 88%) for complete vaccination. The VE against referral to the hospital was more pronounced in women (84%, 95% CI, 66% to 92%) compared to men (76%, 95% CI, 51% to 88%). Vaccine protective effect increased with increasing lung injury categories, from 54% (95% CI, 48% to 60%) against any sign of lung injury to 76% (95% CI, 59% to 86%) against more than 50% lung involvement. A sharp increase was observed in the probability of hospital admission with age for non-vaccinated patients in relation to an almost flat relationship for the completely vaccinated group. [Barchuk A, 2022 ]
Mirahmadizadeh A et al. was a cohort study conducted in Iran. The study enrolled 1,882,148 participants: 881,638 vaccine group; 1,000,510 control group. Based on data derived from administrative repositories during mass-vaccination campaigns or programs between February 09, 2021, and the end of follow-up on October 22, 2021; the study results showed vaccine effectiveness of 74.7% (95%CI 71.0 to 78.4%) against infection, 67.5% (95%CI 59.5 to 75.6%) against hospitalization and 100% against death. [Alireza Mirahmadizadeh, 2022 ]
Petrovic V et al. was a study conducted in Serbia, including data from 7,037 participants with two Sputnik V vaccines and 241,166 controls. Based on data from the surveillance registry from Vojvodina and the nationwide COVID-19 vaccine registry, participants aged 60 and above, between December 24, 2020 and April 28, 2021. The effectiveness of Sputnik V was 95.9% (95% CI 89 to 98.5) against severe COVID-19. [Petrovi? V, 2022 ]
Heidarzadeh et al was a test-negative case-control study to estimate the effectiveness of COVID-19 vaccines against hospitalization and death in the Guilan Province of Iran, from May to December 2021. This study included population aged 5 years and above by extracting information from local databases (MCMC and SIB). The total study population was 42,084 including 19,500 cases and 22,586 controls. For the Sputnik + Sputnik schedule, Vaccine Effectiveness (VE) against hospitalization (temporary admission) was 76% (95% CI, -77% to 97%) within 1-30 days and 95% (95% CI, 79% to 99%) ≥ 151 days after the second dose. VE against hospitalization (regular admission) was 84% (95% CI, 57% to 94%) within 1-30 days and 93% (95% CI, 88% to 96%) ≥ 151 days after the second dose. VE against hospitalization (ICU admission) was 51% (95% CI, -2.58 to 94%) within 91-120 days and 18% (95% CI, -1.36 to 71%) ≥ 151 days after the second dose. VE against death was 25% (95% CI, -1.49 to 78%) within 31-60 days and 93% (95% CI, 47% to 99.1%) ≥ 151 days after the second dose. [Heidarzadeh A, 2022 ]
Bello-Chavolla OY et al was a retrospective cohort study conducted in Mexico, including 793,487 vaccinated and 4,792,388 unvaccinated individuals. This study estimated vaccine effectiveness (VE) against infection and hospitalization, based on data from the COVID-19 surveillance system between December 2020 and September 2021. Among 39,952 participants vaccinated with Sputnik, VE against infection was 78.75% (95% CI, 78.17% to 79.31%), and VE against hospitalization was 81.38% (95% CI, 79.45% to 83.13%) [Bello-Chavolla OY, 2023 ].
Transmission
No studies reported or assessed this outcome.
Efficacy and effectiveness against SARS-CoV-2 variants
Immunogenicity outcomes
Alpha (B.1.1.7)
Satoshi Ikegame et al. was a non-comparative study (neutralizing capacity from recipients' sera), which included 12 recipients of the Sputnik V vaccine. The study reported data from 1 month post immunization. The results showed that the Gamaleya Sputnik V Ad26 / Ad5 vaccine sera effectively neutralized the S: WT and S: B.1.1.7 viruses; although with highly variable titles (1 / IC50 GMT 49.4, 23.4 to 105) [Satoshi Ikegame, 2021 ].
María M et al. conducted a non-comparative study (neutralizing capacity from recipients' sera), which included 118 recipients of the Sputnik V vaccine. The study reported data from 42 days post immunization. The results showed a decrease in neutralizing activity against the Alpha variant in comparison with the Wuhan related pseudotyped virus (2.5-fold) [Gonzalez Lopez Ledesma MM et al., 2021 ].
Gushchin VA et al. It was a non-comparative study (neutralizing capacity from recipients' sera), which included 13 recipients of the Sputnik V vaccine. The study reported data from 1 month post immunization. The results showed that the neutralizing properties of Sputnik V induced sera are not changed by B.1.1.7 variant [Gushchin VA, 2021 ].
Beta (B.1.351)
Satoshi Ikegame et al. was a non-comparative study (neutralizing capacity from recipients' sera), which included 12 recipients of the Sputnik V vaccine. The study reported data from 1 month post immunization. The results showed that the Gamaleya Sputnik V Ad26 / Ad5 recipients sera exhibited moderate and markedly reduced neutralization titers against S: B.1.351 (Median/IQR = 0.4965 / 0.2880 to 1.186) (Median 6.8- and 2.8-fold) [Satoshi Ikegame, 2021 ].
María M et al. conducted a non-comparative study (neutralizing capacity from recipients' sera), which included 118 recipients of the Sputnik V vaccine. The study reported data from 42 days post immunization. The results showed Gamaleya Sputnik V Ad26 / Ad5 vaccine sera were less effective at neutralizing the Beta (19.2-fold) [Gonzalez Lopez Ledesma MM et al., 2021 ].
Gushchin VA et al. It was a non-comparative study (neutralizing capacity from recipients' sera), which included 13 recipients of the Sputnik V vaccine. The study reported data from 1 month post immunization. The results showed that the three-fold decrease in the viral-neutralizing activity of B.1.351 variant was recorded for sera of the patients vaccinated with Sputnik V for Spike-pseudotyped lentivirus and a 3.1-fold decrease for a live viral isolat [Gushchin VA, 2021 ].
Byazrova et al conducted a comparative study in Russia that recruited 58 individuals who were all vaccinated with two injections of Gam-COVID-Vac (first Ad26, second Ad5) between January and April 2021. All received their booster vaccination, cohort 1 (n=48) received Gam-COVID-Vac (Ad26) and cohort 2 (n=10) received Pfizer-BioNTech. Neutralizing antibodys (NAb) against Alfa variant in the homologous boost showed a 4.0-fold increase. In the heterologous vaccination group receiving an mRNA-based boost, anti-SARS-CoV-2 NAb levels against Alfa showed a 31.6-fold increase. [Byazrova MG, 2022 ]
Gamma (P.1)
Blanco S et al. was a cohort study conducted in Argentina. The study enrolled 285 participants, mainly health-care workers, assessing vaccine immunogenicity outcomes against gamma variant measured 14 and 42 days after-vaccination. The study results showed Median (IQR) neutralizing titres of 1/80 (1/20 - 1/320) [Blanco S, 2021 ].
Gonzalez Lopez Ledesma MM et al. included 118 Sputnik V vaccine recipients. Data were collected 21, 42, 120, and 180 days after the first vaccination. The study showed that There was a reduction in neutralizing activity compared to Wuhan virus. Neutralizing activity fold change compared to Wuhan virus was -2.5 (42 days) and -2.9 (120 days) against the Alpha variant; -19.2 (42 days) and -9.7 (120 days) against the Delta variant; -13.8 (42 days) and -4.2 (120 days) against the Gamma variant; and finally, -5.1 (42 days) and -3.4 (120 days) against the Delta variant [Gonzalez Lopez Ledesma MM, 2022 ].
Delta (B.1.617.2)
Gonzalez Lopez Ledesma MM et al. included 118 Sputnik V vaccine recipients. Data were collected 21, 42, 120, and 180 days after the first vaccination. The study showed that There was a reduction in neutralizing activity compared to Wuhan virus. Neutralizing activity fold change compared to Wuhan virus was -2.5 (42 days) and -2.9 (120 days) against the Alpha variant; -19.2 (42 days) and -9.7 (120 days) against the Delta variant; -13.8 (42 days) and -4.2 (120 days) against the Gamma variant; and finally, -5.1 (42 days) and -3.4 (120 days) against the Delta variant [Gonzalez Lopez Ledesma MM, 2022 ].
Byazrova et al conducted a comparative study in Russia that recruited 58 who were all vaccinated with two doses of Gam-COVID-Vac (first Ad26, second Ad5) between January and April 2021. All received their booster vaccination, cohort 1 (n=48) received Gam-COVID-Vac (Ad26) and cohort 2 (n=10) received Pfizer-BioNTech. Neutralizing antibodies (NAb) against Delta variant in the homologous boost showed a 2.3-fold increase. In the heterologous vaccination group receiving an mRNA-based boost, anti-SARS-CoV-2 NAb levels against Delta showed a 15.2-fold increase. [Byazrova MG, 2022 ]
Omicron (B.1.1.529.1)
Byazrova et al conducted a comparative study in Russia that recruited 58 individuals. All participants were vaccinated with two doses of Gam-COVID-Vac (first Ad26, second Ad5) between January and April 2021. All received their booster vaccination, cohort 1 (n=48) received Gam-COVID-Vac (Ad26) and cohort 2 (n=10) received Pfizer-BioNTech. Neutralizing antibodies (NAb) against the Omicron variant in the homologous boost showed a 3.9-fold increase. In the heterologous vaccination group receiving an mRNA-based boost, anti-SARS-CoV-2 NAb levels against Omicron showed a 47.0-fold increase. [Byazrova MG, 2022 ]
Effectiveness outcomes
Delta (B.1.617.2)
Anton Barchuk et al. was a case-control study conducted in Russia. The study enrolled 3,945 participants: 2,555 vaccine group; 1,390 control group and assessed the effectiveness of Gamaleya Sputnik vaccine against symptomatic infection with Delta variant during the outbreak caused by the Delta VOC in October 2021 in St. Petersburg, Russia. The study results showed an effectiveness against symptomatic infection of 50% (95% CI 30 to 64) with one dose and 58% (95% CI 50 to 64) with Two doses [Anton Barchuk, 2022 ].
Olga Matveeva et al. was a retrospective cohort study conducted in Russia. The study included over 300,000 cases of COVID-19 and assesed the effectiveness of Sputnik V vaccine against severe infection and death in Delta variant cases during June and July 2021 in Moscow. The study showed an effectiveness against severe infection of 89% (95% CI 81 to 94) in the 18-50 age group, 76% (95% CI 70 to 81) in the 51-70 age group and 42% (95% CI 32 to 51) in the 70+ age group. [Matveeva O, 2022 ].
Horvath et al. was a study conducted in Hungary, including data from 2,808,893 participants with two Sputnik V vaccines. Based on data from the Hungarian Notifiable Disease Surveillance System, between 2021 up to January 24 2022 during the Delta variant surge period. The overall effectiveness was 1.1% (95% CI -11.4 to 12.1) in the 18-24 age group, 49.5% (95% CI 46.6 to 52.3) in the 25-49 age group, 68% (95% CI 64.4 to 71.3) in the 50-59 age group, 71.1% (95% CI 67.3 to 74.4) in the 60-69 age group, 75.1% (95% CI 71.4 to 78.3) in the 70-79 age group, and 61.1% (95% CI 56 to 65.7) in participants aged 80 and above [Krisztina J. Horvath, 2022 ].
Barchuk et al conducted a test-negative case-control study in Russia, to estimate vaccine effectiveness (VE) against any volume of involved lung parenchyma and severe lung injury detected on computer tomography and associated with COVID-19, during Delta and Omicron. Among 23,996 patients in the primary analysis, 13,372 (55.7%) had any lung injury, and 338 (1.4%) had severe lung injury. Effectiveness of vaccination against any lung injury, according to Delta period were 59% (95% CI, 55–62) for two-dose Gam-COVID-Vac (Sputnik V) and 57% (95% CI, 48–64) for three-dose Gam-COVID-Vac (booster). [Barchuk A, 2022 ]
Barchuk A et al was a population-based case-control study conducted in Russia. This study aimed to estimate the efectiveness of the Russian COVID-19 vaccines against symptomatic SARS-CoV-2 during the recent outbreak caused by the Delta VOC in October 2021. 1,254 cases and 2,747 controls were included in the final analysis. Adjusted vaccine effectiveness against symptomatic PCR-confrmed SARS-CoV-2 for individuals with 2 doses of Sputnik V was 56% (95% CI 48 to 63) and 49% (95% CI 29 to 63) for participants with one dose of Sputnik Light. Adjusted vaccine effectiveness against symptomatic PCR-confrmed SARS-CoV-2 for individuals vaccinated with EpiVacCorona was -58% (95% CI -225 to 23). Adjusted vaccine effectiveness against lung injury for individuals with 2 doses of Sputnik V was 69% (95% CI 62 to 74) and 58% (95% CI 37 to 72) for participants with one dose of Sputnik Light. Adjusted vaccine effectiveness against lung injury for individuals vaccinated with EpiVacCorona was -30% (95% CI -165 to 37). [Barchuk A, 2022 ]
Sukhikh GT et al conducted a comparative cohort study in Russia, to estimate vaccine effectiveness (VE) against COVID-19, before and during delta predominance. The study included 1,624 participants with at least one Sputnik dose, 819 cases and 805 controls, based on data from medical workers employed at the Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology of the Ministry of Health. From November 2020 to February 2022. The VE during the delta period was 78.8% (95% CI, 49.2–91.1) after one dose, 81.8% (95% CI, 73.1–87.6) after two doses and 100% after three or four doses. [Sukhikh GT, 2022 ]
Omicron (B.1.1.529.1)
Barchuk et al conducted a test-negative case-control study in Russia, to estimate vaccine effectiveness (VE) against any volume of involved lung parenchyma and severe lung injury detected on computer tomography and associated with COVID-19, during Delta and Omicron. Among 23,996 patients in the primary analysis, 13,372 (55.7%) had any lung injury, and 338 (1.4%) had severe lung injury. Effectiveness of vaccination against any lung injury, according to Omicron period were 38% (95% CI, 32–44) for two-dose Gam-COVID-Vac (Sputnik V), 57% (95% CI, 51–63) for three-dose Gam-COVID-Vac (booster) and 5% (95% CI, −43 to 37) for EpiVacCorona. [Barchuk A, 2022 ]
Soledad Gonzalez et al was a test-negative, case-control study conducted in Argentina. The study included 422,144 individuals ≥50 years: 221,933 with positive test and 200,211 with negative test. The aim of the study was to estimate the protection against laboratory-confirmed SARS-CoV-2 infection, hospitalisations, and death after homologous or heterologous third-dose (booster) in individuals with primary vaccination schemes with rAd26-rAd5, ChAdOx1nCoV-19, BBIBP-CorV or heterologous combinations, during the period of Omicron BA.1 predominance. Odds ratio of booster dose against confirmed SARS-CoV-2 infections were 0.64 (95% CI 0.61 to 0.67) for ChAdOx1 primary schedule and mRNA booster (≤ 60 days), 0.97 (95% CI 0.93 to 1.01) for ChAdOx1 primary schedule and vectored booster (≤ 60 days), 0.62 (95% CI 0.55 to 0.69) for BBIBP-CorV primary schedule and mRNA booster (≤ 60 days), 0.71 (95% CI 0.67 to 0.75) for BBIBP-CorV primary schedule and vectored booster (≤ 60 days), 0.66 (95% CI 0.63 to 0.69) for rAd26-rAd5 primary schedule and mRNA booster (≤ 60 days) and 0.94 (95% CI 0.90 to 0.97) for rAd26-rAd5 primary schedule and vectored booster (≤ 60 days). Odds ratio of booster dose against hospitalizations were 0.14 (95% CI 0.03 to 0.77) for ChAdOx1 primary schedule and mRNA booster (≤ 60 days), 0.28 (95% CI 0.22 to 0.37) for ChAdOx1 primary schedule and vectored booster (≤ 60 days), 0.22 (95% CI 0.09 to 0.51) for BBIBP-CorV primary schedule and mRNA booster (≤ 60 days), 0.24 (95% CI 0.17 to 0.34) for BBIBP-CorV primary schedule and vectored booster (≤ 60 days), 0.24 (95% CI 0.17 to 0.32) for rAd26-rAd5 primary schedule and mRNA booster (≤ 60 days) and 0.34 (95% CI 0.28 to 0.41) for rAd26-rAd5 primary schedule and vectored booster (≤ 60 days). [Soledad Gonzalez, 2022 ]
Vaccine efficacy and effectiveness for booster dose
Immunogenicity outcomes
AlMadhi et al. conducted a phase II non-randomized, non-blinded observational community trial to investigate the reactogenic and immunogenetic response of heterologous (Pfizer; 428 participants) versus homologous (Sputnik V; 351 participants) COVID-19 vaccine boosting of participants who previously received two doses of Sputnik V. Adverse events were more frequent in the heterologous arm (p<0.001). No serious adverse events were reported in either arm. Amongst 577 individuals who completed the study, Anti-S antibodies were 14.8 times higher after heterologous boosting, and 3.1 times higher after homologous boosting (p<0.001). Similarly, heterologous boosting showed a 2-fold increase in neutralizing antibodies, compared to a 1.6-fold increase in homologous boosting (p<0.001). [Marwa Almadhi, 2022 ]
Byazrova et al conducted a comparative study in Russia that recruited 58 individuals. All participants were vaccinated with two doses of Gam-COVID-Vac (first Ad26, second Ad5) between January and April 2021. All received their booster vaccination, cohort 1 (n=48) received Gam-COVID-Vac (Ad26) and cohort 2 (n=10) received Pfizer-BioNTech. Gam-COVID-Vac revaccination resulted in a 2.5-fold increase in RBD-specific IgG levels (median = 582 ng/mL, p <0 .0001) and seroprevalence 94% (45/48). Neutralizing antibodies against Alfa, Epsilon, Delta, and Omicron variants of concern in the homologous boost showed a fold increase of 4.0, 2.4, 2.3, and 3.9, respectively.[Byazrova MG, 2022 ]
Effectiveness outcomes
Barchuk et al conducted a test-negative case-control study in Russia, to estimate vaccine effectiveness (VE) against any volume of involved lung parenchyma and severe lung injury detected on computer tomography and associated with COVID-19, during Delta and Omicron predominance periods. Among 23,996 patients in the primary analysis, 13,372 (55.7%) had any lung injury, and 338 (1.4%) had severe lung injury. The VE adjusted for age, sex, and triage center against any lung injury were 56% (95% CI 54% to 59%) for two-dose Gam-COVID-Vac (Sputnik V) and 71% (95% CI, 68% to 74%) for three-dose Gam-COVID-Vac (booster). VE estimates against severe lung injury were 76% (95% CI, 67% to 82%) for two-dose Gam-COVID-Vac (Sputnik V) and 87% (95% CI, 76% to 93%) for three-dose Gam-COVID-Vac. [Barchuk A, 2022 ]
Sukhikh GT et al conducted a comparative cohort study in Russia to estimate vaccine effectiveness (VE) against COVID-19, before and during the Delta predominance period. The study included 1,624 participants with at least one Sputnik dose, 819 cases, and 805 controls, based on data from medical workers employed at the Kulakov National Medical Research Center for Obstetrics, Gynecology, and Perinatology of the Ministry of Health. Data from November 2020 to February 2022. The VE during the Delta period was 100% after three or four doses. [Barchuk A, 2022 ]
Vaccine efficacy and effectiveness for heterologous schedule
Immunogenicity outcomes
Macchia et al, was a non-inferiority randomized clinical trial conducted in Argentina. The study compared the immune response generated by homologous Sputnik V regimen to the heterologous regimens of Sputnik V vaccine with either Moderna, Sinopharm BIBP or AstraZeneca vaccines. The study recruited 540 individuals with no history of COVID-19 infection who had received a first dose of the Sputnik V vaccine (component rAd26) at least 30 days prior. Participants were randomized to receive a second dose of either Sputnik V (component rAd26 or rAd5), AstraZeneca, Moderna or Sinopharm BIBP vaccines. The study showed all but the Moderna regimen were statistically inferior to the standard Sputnik V regimen (rAd26/rAd5). The Moderna regimen showed a 3.53 fold increase in antibody concentrations compared to the standard Sputnik V regimen [Macchia A, 2022 ].
Vaccine efficacy and effectiveness for heterologous booster schedule
Immunogenicity outcomes
AlMadhi et al. conducted a phase II non-randomized, non-blinded observational community trial to investigate the reactogenic and immunogenetic response of heterologous (Pfizer; 428 participants [54.9%]) versus homologous (Sputnik V; 351 participants [45.1%]) COVID-19 vaccine boosting of participants who previously received two doses of Sputnik V. Adverse events were more frequent in the heterologous arm (p<0.001). No serious adverse events were reported in either arm. Amongst 577 individuals who completed the study, Anti-S antibodies were 14.8 times higher after heterologous boosting, and 3.1 times higher after homologous boosting (p<0.001). Similarly, heterologous boosting showed a 2-fold increase in neutralizing antibodies, compared to a 1.6-fold increase in homologous boosting (p<0.001). [Marwa Almadhi, 2022 ].
Byazrova et al conducted a comparative study in Russia that recruited 58 individuals who were all vaccinated with two doses of Gam-COVID-Vac (first Ad26, second Ad5) between January and April 2021. All received their booster vaccination, cohort 1 (n=48) received Gam-COVID-Vac (Ad26) and cohort 2 (n=10) received Pfizer-BioNTech. A pronounced increase in RBD-specific IgGs was observed in the heterologous vaccination group (8.7-fold change, p = 0.0039) [Byazrova MG, 2022 ]
Effectiveness outcomes
Gonzalez S et al was a test-negative, case-control study conducted in Argentina. The study included 422,144 individuals ≥50 years: 221,933 with a positive test and 200,211 with a negative test. The aim of the study was to estimate the protection against laboratory-confirmed SARS-CoV-2 infection, hospitalizations, and death after homologous or heterologous third-dose (booster) in individuals with primary vaccination schemes with rAd26-rAd5, ChAdOx1nCoV-19, BBIBP-CorV or heterologous combinations, during the period of Omicron BA.1 predominance. The odds ratio of booster dose against confirmed SARS-CoV-2 infections were 0.64 (95% CI 0.61 to 0.67) for ChAdOx1 primary schedule and mRNA booster (≤ 60 days), 0.97 (95% CI 0.93 to 1.01) for ChAdOx1 primary schedule and vectored booster (≤ 60 days), 0.62 (95% CI 0.55 to 0.69) for BBIBP-CorV primary schedule and mRNA booster (≤ 60 days), 0.71 (95% CI 0.67 to 0.75) for BBIBP-CorV primary schedule and vectored booster (≤ 60 days), 0.66 (95% CI 0.63 to 0.69) for rAd26-rAd5 primary schedule and mRNA booster (≤ 60 days) and 0.94 (95% CI 0.90 to 0.97) for rAd26-rAd5 primary schedule and vectored booster (≤ 60 days). The odds ratio of booster dose against hospitalizations were 0.14 (95% CI 0.03 to 0.77) for ChAdOx1 primary schedule and mRNA booster (≤ 60 days), 0.28 (95% CI 0.22 to 0.37) for ChAdOx1 primary schedule and vectored booster (≤ 60 days), 0.22 (95% CI 0.09 to 0.51) for BBIBP-CorV primary schedule and mRNA booster (≤ 60 days), 0.24 (95% CI 0.17 to 0.34) for BBIBP-CorV primary schedule and vectored booster (≤ 60 days), 0.24 (95% CI 0.17 to 0.32) for rAd26-rAd5 primary schedule and mRNA booster (≤ 60 days) and 0.34 (95% CI 0.28 to 0.41) for rAd26-rAd5 primary schedule and vectored booster (≤ 60 days). [Soledad Gonzalez, 2022 ]
Safety of the vaccine
Safety of the vaccine in preclinical studies
Data on animal or other preclinical studies for this vaccine have not been published or released.
Safety of the vaccine in clinical trials
Main safety outcomes of Gamaleya COVID-19 vaccine
The safety of Main immunogenicity outcomes presented here was estimated from the report of the RESIST trial, the only phase 3 randomized trial with available data at this moment [Logunov, Denis Y, 2021 ], based on data from 12,296 participants.
Any adverse event
The risk of any adverse event has not been reported, so it was not possible to estimate the effect for this outcome [Logunov, Denis Y, 2021 ].
Non-serious adverse events
The total number of non-serious adverse events was not reported, so it was not possible to estimate the effect for this outcome [Logunov, Denis Y, 2021 ].
The most common adverse events were flu-like illness, injection site reactions, headache, and asthenia.
Serious adverse event
The relative risk of serious adverse events in the group that received Gamaleya COVID-19 vaccine versus the group that received placebo vaccine was 0.65 (95% CI 0.39 to 1.07). This means that the group that received Gamaleya COVID-19 vaccine within the trial reported 35% less serious adverse events than the group that received the placebo vaccine.
Figure - Forest plot of risk ratio meta-analysis. Outcome: serious adverse events. Comparison: Gamaleya COVID-19 vaccine versus placebo vaccine
In the available trial, 23 people not receiving Gamaleya COVID-19 vaccine out of 5435 presented this outcome (4 per 1000) versus 45 out of 16427 in the group that did receive it (3 per 1000). In other words, the group receiving the vaccine reported less serious adverse effects than the group that received the placebo vaccine.
Applying the GRADE approach [Logunov, Denis Y, 2021 ], we assessed the certainty of the evidence for this outcome as low. The reasons for downgrading the certainty of the evidence were the risk of bias due to losses to follow up and the imprecision of the result as a consequence of the low number of events. No reasons for concern were detected in relation to inconsistency, indirect evidence or publication bias.
Summary of findings (iSoF)
Safety of the vaccine in subgroups
Sex
Randomized trials
In the RESIST trial. the relative risk of contracting COVID-19 in the women subgroup was 0.13 (95% CI 0.06 to 0.27). This means Gamaleya COVID-19 vaccine reduced the risk of contracting COVID-19 in women by 87%, compared with placebo vaccine. The relative risk of contracting COVID-19 in the men subgroup was 0.06 (95% CI 0.03 to 0.13). This means Gamaleya COVID-19 vaccine reduced the risk of contracting COVID-19 in menby 94%, compared with placebo vaccine [Logunov, Denis Y, 2021 ].
Age
Randomized trials
The proportion of participants >60 years of age in the RESIST trial was 10.8% (2144 out of 19866 participants) [Logunov, Denis Y, 2021 ]. There were 1369 participants older than 60 years included in the safety analysis.The most common adverse events were flu-like illness in 156 (15.2%) and local reaction in 56 (5.4%) of 1029 participants in the vaccine group, while 30 (8.8%) and four (1.2%) of 340 participants presented the adverse events in the placebo group, respectively.
Children and adolescents
Randomized trials
Children were excluded from the RESIST trial [Logunov, Denis Y, 2021 ].
Pregnancy
Randomized trials
Pregnant women were excluded from the RESIST trial [Logunov, Denis Y, 2021 ].
Breastfeeding
Randomized trials
Breastfeeding women were excluded from the RESIST trial [Logunov, Denis Y, 2021 ].
Safety of the vaccine post-authorization
Post-authorization studies
Comparative studies
AlMadhi et al. conducted a phase II non-randomized, non-blinded observational community trial to investigate the reactogenetic and immunogenetic response of heterologous (Pfizer; 428 participants [54.9%]) versus homologous (Sputnik V; 351 participants [45.1%]) COVID-19 vaccine boosting of participants who previously received two doses of Sputnik V. Adverse events were more frequent in the heterologous arm (p<0.001). No serious adverse events were reported in either arm [Marwa Almadhi, 2022 ]
Non-comparative studies
Jarynowski A et al. was a retrospective study that enrolled 11,515 participants that received Sputnik V; data from participants was obtained from the self-reported Sputnik V vaccine adverse events (AEs) reported on Telegram. Users complained mostly about pain (5461/11,515, 47.43%), fever (5363/11,515, 46.57%), fatigue (3862/11,515, 33.54%), and headache (2855/11,515, 24.79%). Women reported more AEs than men (1.2-fold, P<.001). In addition, there were more AEs from the first dose than from the second dose (1.1-fold, p<0.001), and the number of AEs decreased with age (β=0.05 per year, p<0.001). The results also showed that Sputnik V AEs were more similar to other vector vaccines (132 units) than to messenger RNA vaccines (241 units) according to the average Euclidean distance between the vectors of AE frequencies. Elderly Telegram users reported significantly more (5.6-fold on average) systemic AEs than their peers. [Jarynowski A, 2021 ]
Pagotto V et al. was a cohort study that enrolled 683 healthcare workers that received the Sputnik V COVID-19 vaccine. The study reported adverse events. The most local adverse reactions were injection site pain (57%), redness, and swelling (11%). The reported systemic reactions were; muscle pain (58%), fever (40%), and diarrhea (5%). Serious adverse events were reported in 5% of the participants, including one person requiring hospitalization [Pagotto V, 2021 ].
Pagotto V et al. was a non-comparative study carried out in Argentina, which included 707 vaccinated health workers. Among local reactions, 54% reported injection site pain, 11% redness and swelling. Among systemic reactions, 40% reported fever, 5% diarrhea, and 68% had new or worse muscle pain. Five percent had serious adverse events that required medical evaluation and one patient was hospitalized. The rate of events supposedly attributed to vaccines and immunizations (ESAVI) was higher among women (65.4% vs 50%; HR 1.38, 95% CI 1.13-5.38) and in those under 55 years of age (72.8% vs 32%; HR 2.66, 95% CI 1.32-1.68) [Pagotto, V., 2021 ].
Babamahmoodi F et al. conducted a non-comparative study in Iran, which included 13,435 healthcare workers who were vaccinated with the Sputnik vaccine between February and April 2021. The most common side effect was injection site pain (56.9%), fatigue (50.9%), body aches (43.9%), headache (35.7%), fever (32, 9%), joint pain (30.3%), chills (29.8%) and drowsiness (20.3%). Side effects from the vaccine were significantly more common in women and younger individuals. Among a total of 238 participants, more than 90% after the first and second doses of vaccine had a detectable level of SARS-CoV-2 RBD antibody and SARS-CoV-2 neutralizing antibody [Babamahmoodi F, 2021 ].
Montalti M, reported a nationwide study conducted on San Marino's population. 2558 adults aged 18–89 years who received one or two doses of Sputnik V between 25 February and 8 April 2021 were included in this study. Results showed that the presence of first-dose adverse events following immunization was 53.3%, while second-dose adverse events following immunization incidence were 66.8%. In general, 76.0% of two-dose recipients reported some adverse events following immunization after either vaccine dose, and 2.1% suffered severe reactions. In 60- to 89-year-olds, adverse events following immunization incidence was 70.0%, with 53.0% of subjects describing systemic reactions and 0.8% reporting severe symptoms. The most frequent symptoms were local pain, asthenia, headache, and joint pain [Montalti, Marco, 2021 ].
Kadyrova I et al. was a prospective cohort study conducted in Kazakhstan. The study enrolled 143 participants and assessed the reactogenicity and immunologic outcomes of Sputnik-V vaccination, between April and May 2021. The study results showed that most participants (>50%) reported mild-to-moderate injection site or systemic reactions to vaccination. No severe or potentially life-threatening conditions were reported. The first dose appeared to be more reactogenic than the second dose, with fatigue and headache more frequent in participants with prior COVID-19 exposure [Kadyrova, I., 2022 ].
Nasergivehchi S et al. was a cohort study conducted in Iran. The study enrolled 334 healthcare workers who had contracted COVID-19 of different intensities and were vaccinated with different types of COVID-19 vaccine (Astrazeneca 12.9%, Sinopharm 16.2%, Sputnik 62.3%, Bharat Covaxin 6.9%) at least one month following recovery from the virus, between April 2021 and September 2021. The study assessed the incidence of headache following injection, showing that 39.2% of participants reported post-vaccination headache, with the highest rates reported for AstraZeneca, followed by Sputnik V [Nasergivehchi S, 2022 ].
Houshmand B et al. was a cross-sectional study conducted in Iran. The study included 1,205 respondents of a multicenter electronic questionnaire via an online platform over a 1-week period among vaccinated dental staff and dental students inquiring whether they experienced vaccine-related side effects after vaccine administration. The majority of respondents received AstraZeneca (51.1%) and Sputnik (37.6%). The symptoms most frequently reported after vaccination were fatigue (79%), local pain in the injection site (77.4%), malaise (73%), and body pain (71.1%). Enrollees reported more onset of reactions on 0–12 h (44.1%) and 12–24 h (29.0%) after vaccine administration [Houshmand B, 2022 ].
Toledo-Salinas et al. conducted a nationwide observational study among recipients of 61,414,803 doses of seven different COVID-19 vaccines, between December 2020 - October 2021 in Mexico, to identify the observed incidence of anaphylaxis in recipients of different anti-SARS-CoV-2 vaccines. The unadjusted incidence of anaphylaxis per million doses administered was 0.60 (95% CI 0.17–2.21) for Ad26-rAd5. [Toledo-Salinas C, 2022 ].
García-Grimshaw M was a non-comparative study conducted in Mexico that reported the incidence of Guillain-Barré syndrome (GBS) following COVID-19 vaccination. The study informed the adverse events of 81,842,426 first or second doses of seven COVID-19 vaccines (Coronavac, Moderna, Pfizer, AstraZeneca, Sputnik V, CanSino, and Janssen), with 5,812,864 doses corresponding to the Sputnik V vaccine. 97 cases of GBS were identified through passive epidemiological surveillance, 6 of them related to the Sputnik V vaccination, with an unadjusted incidence of 1.03 (95% CI 0.47-2.25) per million doses administered [García-Grimshaw M, 2022 ].
Monitoring
WHO indicates that after a vaccine is approved for use, regulators conduct robust monitoring of efficacy, as well as monitoring of safety and risk minimization (pharmacovigilance) activities. They need to continually monitor the safety of the vaccine to ensure that the benefits of the vaccine continue to outweigh the risks. [WHO, 2022 ]
Regarding safety surveillance and monitoring, serious adverse events, anaphylaxis and other severe allergic reactions, Bell's palsy, cases of multisystem inflammatory syndrome, cases of COVID-19 after vaccination resulting in hospitalization or death should be identified and recorded.
Regarding the effectiveness of the vaccine, the following should be monitored:
− Efficacy of the vaccine over time and whether protection can be prolonged with booster doses.
− Studies to investigate whether this vaccine reduces the transmission and viral spread of SARS-CoV-2.
− Evaluation and notification of vaccine failures and information on viral sequences.
Regarding the subgroups of interest
− Prospective studies on the safety of the COVID-19 vaccine in pregnant and lactating females.
− Occasional controlled trials on the safety and security of vaccination in children under 18 years of age.
− Safety data from vaccination in immunosuppressed people, including patients living with HIV and autoimmune diseases.
To review more information on the topic [WHO, 2022 ],[World Health Organization, 2021 ], [Organización Mundial de la Salud, 2022 ]
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