Gamaleya Sputnik V; Sputnik Light COVID-19 vaccine

Extended version of the vaccine

Gamaleya Sputnik V; Sputnik Light COVID-19 vaccine

Authorization

World Health Organization Emergency Use Listing Procedure
Not listed for emergency use
Anticipated decision date: Will be determined when all data is submitted [Last checked at WHO EUL official website on 8 June, 2021].

European Commission (based upon the recommendation of the European Medicines Agency)
Not authorized

Health Ministry of the Russian Federation
Sputnik V: Authorized August 08, 2020 [State Drug Registry of Russia, 2020 ]
Sputnik Light: Authorized May 06, 2021 [RUSSIAN DIRECT INVESTMENT FUND, 2021 ]

Regulatory Authorities of Regional Reference in the Americas

National Administration of Drugs, Foods and Medical Devices (ANMAT, Argentina)
Authorized for emergency use: 23 December, 2020
[Ministerio de salud de la Argentina, 2020 ]

Brazilian Health Regulatory Agency (ANVISA, Brazil)
Not authorized

Health Canada
Not authorized

Public Health Institute (ISP, Chile)
Not authorized

National Institute of Food and Drug Monitoring (INVIMA, Colombia)
Not authorized

Center for the State Control of Drug Quality (CECMED, Cuba)
Not authorized

U.S. Food and Drug Administration
Not authorized

Federal Commission for the Protection against Sanitary Risk (COFEPRIS, Mexico)
Authorized for emergency use: 2 February, 2021 [Comisión Federal para la Protección contra Riesgos Sanitarios (Cofepris). Mexico, 2021 ]

Authorization in other jurisdictions in the Americas
Antigua and Barbuda
Bolivia
Ecuador
Guinea
Guyana
Honduras
Maldives
Nicaragua
Panama
Paraguay
San Vicente y las Granadinas
Venezuela
Authorization in other jurisdictions
Albania
Algeria
Angola
Armenia
Azerbaijan
Bahrain
Bangladesh
Belarus
Cameroon
Congo
Djibouti
Egypt
Gabon
Gambia
Ghana
Hungary
India
Iran
Iraq
Jordan
Kazakhstan
Kenya
Kyrgyzstan
Laos
Lebanon
Libya
Mali
Mauritius
Moldova
Mongolia
Montenegro
Morocco
Myanmar
Namibia
Nepal
North Macedonia
Oman
Pakistan
Philippines
Russia
San Marino
Serbia
Seychelles
Slovakia
Sri Lanka
Syria
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, China. 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
Sputnik V COVID-19 vaccine is composed of two different adenovirus, 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
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 ]

Dosage form and ingredients
Sputnik V COVID-19 vaccine
The pharmaceutical form is a solution for intramuscular injection that is administered as a series of two doses (0.5 mL each).
Sputnik Light COVID-19 vaccine
The pharmaceutical form is a solution for intramuscular injection that is administered as a single dose (0.5 mL each).

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 10^11 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 10^11 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 x 10^11 particles per dose [Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation, 2021 ].

Excipients:
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 ].
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.

Dosification and schedule

Dose-finding studies
There are no previous studies reporting on dose-finding studies of the Sputnik V and Sputnik Light COVID-19 vaccine. For more information on clinical trials see the ´Clinical studies- general characteristics`section of the Pharmacovigilance for COVID-19 vaccine dashboard.

Indications and contraindications

Indications
Sputnik V COVID-19 vaccine is indicated in adult individuals 18 years and older [Gobierno de México, 2021 ].
Sputnik Light COVID-19 vaccine is indicated in adult individuals 18 years and older [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
Severe allergic reaction (e.g., anaphylaxis) to a previous dose of any vaccine (not including Sputnik V or Sputnik Light COVID-19 vaccines).
Severe allergic reaction (e.g., anaphylaxis) to an injectable medication
Vaccination in people with acute SARS-CoV-2 infection should be postponed until recovery from acute illness (in people symptomatic) and until criteria for discontinuation of isolation have been met.
As with other intramuscular injections, the vaccine should be given with caution in individuals with bleeding disorders or other conditions that increase the risk of bleeding, such as anticoagulant therapy, thrombocytopenia and hemophilia.
Available data on administration in pregnant and lactating females are still insufficient to inform vaccine-associated risks. Health personal should advise females before vaccination, females may be vaccinated when the benefit of vaccination outweigh the risks [Ministerio de Salud Argentina, 2021 ].
The available data on Sputnik V COVID-19 vaccine on children are insufficient to assess vaccine efficacy since no clinical trial evaluating vaccines to prevent COVID-19 has included children [Ministerio de Salud Argentina, 2021 ].
The available data on Sputnik V COVID-19 vaccine on immunocompromised persons, including persons living with HIV, are insufficient to assess vaccine efficacy [Ministerio de Salud Argentina, 2021 ].
Although there are currently no medical contraindications on the vaccinating of a person with COVID-19, it is recommended to defer all vaccinations until complete recovery [PAHO, 2020 ].
Although there are currently no contraindications on the vaccinating of a person who has had contact with a COVID-19 case, it is recommended to defer vaccination until the quarantine has been completed (14 days after the last exposure) [PAHO, 2020 ].
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.

Close observation for at least 30 minutes is recommended following vaccination.

Storage and logistics

Storage
Sputnik V and Sputnik Light COVID-19 vaccine should be stored at a temperature below -18°C (-0.4 ° F), during transport and storage until use. The shelf life of the vaccine is 3 months from the date of production [Gobierno de México, 2021 ].
Sputnik V and Sputnik Light COVID-19 vaccine must be kept in its original packaging, protected from light.

Logistic at the time of administration [Gobierno de México, 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.
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.
The vial in use must be used within a maximum of 120 minutes (2 hours), from the moment of thawing of the vaccine.
Storage after first puncture
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 [Gobierno de México, 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 0.5ml 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 0.5ml 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

Randomized trials
RESIST, also known as V04-Gam-COVID-Vac-2020, is a randomized phase 3 trial (registered with the numbers NCT04530396 [Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation, 2020 ]) sponsored by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation that is being conducted in Russia [Logunov, Denis Y, 2021 ]. It was first registered in August 2020 and plans to enroll 40000 participants 18 years of age or older that will receive the vaccine comprising two vector components, rAd26-S and rAd5-S or a placebo. It is expected to run for until May 2021. An interim report when 21,977 participants had been randomized was published in February 2021 [Logunov, Denis Y, 2021 ].

RDI-GCV-001 is a randomized phase 2/3 trial (registered with the numbers NCT04640233 [Dr. Reddy's Laboratories Limited, 2020 ]) sponsored by Dr.Reddy's Laboratories Limited that is being conducted in India. It was first registered in November 2020 and plans to enrol 1600 participants 18 years of age or older that received 0.5 mL/dose of the vaccine which comprises two vector components, rAd26-S and rAd5-S. It is expected to run for until September 2021. The results of the trial have not been formally published in a scientific journal but a press release was issued in March 2021 [Dr. Reddy´s Laboratories Limited, 2021 ].

Ongoing randomized trials
SPUTNIK-UAE is an ongoing phase 3 randomized trial (registered with the number NCT04656613 [Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation, 2020 ]) sponsored by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation that is being conducted in the United Arab Emirates. It was first registered in December 2020 and plans to enroll 1000 adults 18 years of age or older that will receive Gam-COVID-Vac combined vector vaccine or a placebo vaccine. It is expected to run for until December 2021.

04-Gam-COVID-Vac-2020-RB is an ongoing phase 3 randomized trial (registered with the number NCT04564716 [Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation, 2020 ]) sponsored by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation that is being conducted in the Republic of Belarus. It was first registered in September 2020 and plans to enroll 100 adults 18 years or older that will receive Gam-COVID-Vac combined vector vaccine or a placebo comparator. It is expected to run for until April 2021.

01V-Gam-COVID-Vac-2020 is an ongoing phase 3 randomized trial (registered with the number NCT04642339 [Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation, 2020 ]) sponsored by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation that is being conducted in Venezuela. It was first registered in November 2020 and plans to enroll 2000 adults 18 years of age or older that will receive Gam-COVID-Vac combined vector vaccine or a placebo comparator. It is expected to run for until December 2021.

SPUTNIK-LIGHT is an ongoing phase 3 randomized trial (registered with the number NCT04741061 [Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation, 2021 ]) sponsored by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation that is being conducted in Russia. It was first registered in February 2021 and plans to enroll 6000 adults 18 years of age or older that will receive Sputnik-Light vector vaccine (recombinant adenovirus serotype 26 particles containing the SARS-CoV-2 protein S gene, in the amount of 1.0±0.5 х 10^11 viral particles per dose). It is expected to run for until January 2022.

SPUTNIK-LIGHT is an ongoing phase 3 randomized study (registered with the number PACTR202104601572565 [Limited Liability Company Human Vaccine part of the group of the entities of JointStock Company Management Company of Russian Direct Investment Fund, 2021 ]) sponsored by Limited Liability Company Human Vaccine, part of the group of the entities of JointStock Company Management Company of Russian Direct Investment Fund that is being conducted in Ghana. It was first registered in April 2021 and plans to enroll 2000 adults aged 18 to 80 years that will receive Sputnik Light Vector vaccine and placebo. It is expected to run for until December 2021.

Other studies providing efficacy or safety data

02-Gam-COVID-Vac-2020 was a phase 1/2 non-randomized study (registered with the number NCT04436471 [Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation, 2020 ]) sponsored by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation that was conducted in Russia. It was first registered in June 2020 and enrolled 38 healthy volunteers 18 years of age or older that received a single dose of each component or a prime-boost scheme. The results were published on September 2020 [Logunov DY, 2020 ].

03-Gam-COVID-Vac Lyo-2020 is a phase 1/2 non-randomized study (registered with the number NCT04437875 [Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation, 2020 ]) sponsored by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation that is being conducted in Russia. It was first registered in June 2020 and enrolled 38 healthy volunteers 18 years of age or older that received a lyofilizate as a single dose of each component of the vaccine or as a prime-boost scheme. The results were published on September 2020 [Logunov DY, 2020 ].
Jarynowski A et al. was a retrospective analysis conducted in Russia. The study enrolled 11515 participants that received Sputnik V. Based on data from a self-reported Sputnik V vaccine AEs posted on the Telegram group between December 9, 2020 to April 17, 2021
Pagotto V et al. was a cohort study conducted in Argentina. The study enrolled 683 healthcare workers that received Sputnik V. Based on email self-reported adverse event data after 72 hours of Sputnik V vaccination, between January 5 and January 20, 2021.
Mehraeen E et al. was a retrospective analysis conducted in Iran. The study enrolled 30 healthcare workers that received Sputnik V. Based on data in healthcare workers who reported adverse events during study.
Montalti M et al. was a cohort study conducted in Italy. The study enrolled 2558 General population that received Sputnik V. Based on email self-reported adverse event data between 4 February. March to April 8, 2021.

Other ongoing registered studies

Sputnik-HD is an ongoing prospective cohort study (registered with the number NCT04805632 [Saint Petersburg State University, Russia, 2021 ]) sponsored by Saint Petersburg State University, Russia that is being conducted in Russia. It was first registered in March 2021 and plans to enroll 42 patients in hemodialysis or peritoneal dialysis that will receive two doses of Gam-COVID-Vac vaccine. It is expected to run for until October 2021.

05-Gam-COVID-Vac-2020 is an ongoing single group assignment study (registered with the number NCT04587219) sponsored by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation that is being conducted in Russia [Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation, 2020 ]. It was first registered in October 2020 and plans to enroll 110 adults 60 years of age or older that will receive the vaccine as a prime-boost scheme with component 1 (Ad26) on day 1 and component 2 (Ad5) on day 21. It is expected to run for until April 2021.

2021-04-30T1 is an ongoing observational, non-randomized study (registered with the number NCT04895007 [Karamanoğlu Mehmetbey University, 2021 ]) sponsored by Karamanoğlu Mehmetbey University that is being conducted in Turkey. It was first registered in May 2021 and plans to enroll 1500 individuals vaccinated with Sinovac, Sputnik V, or Pfizer/BionTEC COVID-19 vaccine. The study will evaluate anti-SARS-CoV-2 IgG antibody and neutralizing antibody response in different vaccine groups: Sinovac, Sputnik V, and Pfizer/BionTEC. It is expected to run until June 2022.

Pagotto V et al is an ongoing cohort study (registered with the number NCT04738435 [Hospital Italiano de Buenos Aires, 2021 ]) sponsored by Hospital Italiano de Buenos Aires that is being conducted in Argentina. It was first registered in February 2021 and plans to enroll 600 health personnel aged 18 years and older who received the two components of the Sputnik V vaccine. It is expected to run for until March 2021.

128/36-21-23 is an ongoing observational, case-only study (registered with the number NCT0487184 [Karaganda Medical University, 2021 ]) sponsored by Karaganda Medical University that is being conducted in Kazakhstan. It was first registered in May 2021 and plans to enroll 70 healthy adults aged 18 years and older Ad26-S prime at day 0 and rAd5-S boost at day 21. It is expected to run for until December 2021.

06 - Sputnik Light - 2020 is an ongoing phase 1/2 non-randomized study (registered with the number NCT04713488 [Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation, 2021 ]) sponsored by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation that is being conducted in Russia. It was first registered in January 2021 and plans to enroll 110 healthy volunteers aged 18 years and older that will receive "Sputnik Light" vaccine . It is expected to run for until July 2021.
EC 022/2564 is an ongoing phase ii, non-randomized study (registered with the number TCTR20210517006) sponsored by Chulabhorn Royal Academy that is being conducted in Thailand [Chulabhorn Royal Academy, 2021 ]. It was first registered in May 2021 and plans to enroll 3000 healthy adults 18 years of age and older that will receive Gam-COVID-Vac, CoronaVac, or ChAdOx1. It is expected to run for until July 2022.
OLSTAD is an ongoing phase 2/3 non-randomized study (registered with the number NCT04954092 [Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation, 2021 ]) sponsored by Gamaleya Research Institute of Epidemiology and Microbiology and Health Ministry of the Russian Federation that is being conducted in Russia. It was first registered in July 2021 and plans to enroll 350 participants 12-17 years of age that will receive Gam-COVID-Vac. It is expected to run for until December 2023.

Methods used to assess efficacy and effectiveness

The following methods were used to assess efficacy in the phase 3 trials evaluating the vaccine:
RESIST trial [Logunov, Denis Y, 2021 ]
The primary outcome was the proportion of participants with COVID-19 confirmed by PCR from day 21 after receiving the first dose. The secondary outcomes were severity of COVID-19; changes in antibody levels against SARS-CoV-2 and neutralizing antibodies; changes in antigen-specific cellular immunity.

Methods used to assess safety

The following methods were used to assess safety in the phase 3 trials evaluating the vaccine:
RESIST trial [Logunov, Denis Y, 2021 ]
Safety assessments included: incidence and severity of adverse events. Serious adverse events were diagnosed on the basis of the event requiring hospital admission. The trial reports preliminary results on the primary outcome measure, incidence and severity of adverse events and safety.

Efficacy and effectiveness of the vaccine

Efficacy of the vaccine in preclinical studies

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

The efficacy of presented here was estimated from the RESIST trial, the only phase 3 randomized trial with data available until now [Logunov, Denis Y, 2021 ], based on information from 21977 participants.

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. No reasons for concern were detected in relation to risk of bias, inconsistency, indirect evidence, imprecision or publication bias.

Contracting COVID-19 after the first dose (measured at least 14 days after the first dose)

The relative risk of contracting COVID-19 after the first dose in the group that received Gamaleya COVID-19 vaccine versus the group that received placebo vaccine was 0.13 (95% CI 0.08 to 0.19). This means Gamaleya COVID-19 vaccine reduced the risk of contracting COVID-19 after the first dose in 87%, compared with placebo vaccine.

Figure - Forest plot of risk ratio meta-analysis. Outcome: contracting COVID-19 after the first dose (>14d). Comparison: Gamaleya COVID-19 vaccine versus placebo vaccine

In the available trial, 79 people not receiving Gamaleya COVID-19 vaccine out of 4950 presented this outcome (16 per 1000) versus 30 out of 14999 in the group that did receive it (2 per 1000). In other words, 14 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 after the first dose 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 NNTB is 71.

Applying the GRADE approach [Logunov, Denis Y, 2021 ], we assessed the certainty of the evidence for this outcome as high. No reasons for concern were detected in relation to risk of bias, inconsistency, indirect evidence, imprecision or publication bias.

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.

Summary of findings (iSoF)

Efficacy and effectiveness of the vaccine on subgroups

Subgroup analyses of the primary efficacy endpoint in the RESIST trial, the only phase 3 randomized trial available, showed similar efficacy point estimates across different sex and age groups [Logunov, Denis Y, 2021 ].

Sex

Randomized trials
The proportion of females in the RESIST trial was 38.8% (7708 out of 19866 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 2144 participants older than 60 years (1611 in the vaccine group
and 533 in the placebo group [Logunov, Denis Y, 2021 ].
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.
Other studies
This group (adults 60 years of age or older) is being studied in the 05-Gam-COVID-Vac-2020 ongoing study [Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation, 2020 ].

Children and adolescents

Randomized trials
Children were excluded from the RESIST trial [Logunov, Denis Y, 2021 ].
Other studies
The OLSTAD study is currently evaluating the immunogenicity and safety of the use of Gam-COVID-Vac in study subjects 12-17 years old in the prevention of coronavirus infection caused by the SARS-CoV-2 virus
[Deborah O'Connor, 2021 ].

Pregnancy

Randomized trials
Pregnant females were excluded from the RESIST trial [Logunov, Denis Y, 2021 ].
Other studies
No data are available because there are no studies assessing the vaccine efficacy in this group.

Breast-feeding

Randomized trials
females who were breast-feeding were excluded from the RESIST trial [Logunov, Denis Y, 2021 ].
Other studies
No data are available because there are no studies assessing the vaccine efficacy in this group.
Immunocompromised persons

Randomized trials
Immunocompromised persons were excluded from the RESIST trial [Logunov, Denis Y, 2021 ].
Other studies
This group is being studied in the Sputnik-HD study (see 'ongoing registered studies') [Saint Petersburg State University, Russia, 2021 ].

People living with HIV

Randomized trials
People living with HIV were excluded from the RESIST trial [Logunov, Denis Y, 2021 ].
Other studies
The available data are insufficient to assess vaccine safety since no clinical trial has included this group

Obesity

Randomized trials
The available data are insufficient to assess vaccine efficacy, since the RESIST trial did not perform an analysis in this subgroup [Logunov, Denis Y, 2021 ].

Other data from vaccine efficacy and effectiveness

Duration of protection

Randomized trials
The exact duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials.

Comparative studies
None available

Non-comparative studies
None available

Limitations of vaccine effectiveness

Individuals may not be fully protected until 14 days after their second dose. As with all vaccines, vaccination with Sputnik Light COVID-19 vaccine may not protect all vaccine recipients.

SARS-CoV-2 variants

Comparative studies
None available

Other studies
Ikegame et al tested serum samples from 12 recipients of Sputnik V COVID-19 vaccine in a replication-competent EGFP-reporter vesicular stomatitis virus system (which encodes S from SARS coronavirus 2) coupled with a clonal HEK-293T ACE2 TMPRSS2 cell line. The results showed a response indicative of failure to neutralize B.1.351, success to neutralize B.1.1.7 and moderately reduced activity against E484K substitution alone [Ikegame S, 2021 ],[Satoshi Ikegame, 2021 ].

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

Subgroup analyses of the primary efficacy endpoint in the RESIST trial, the only phase 3 randomized trial available, showed similar efficacy point estimates across different sex and age groups [Logunov, Denis Y, 2021 ].

Sex

Randomized trials
The proportion of females in the RESIST trial was 38.8% (7708 out of 19866 participants) [Logunov, Denis Y, 2021 ].
The proportion of females that experienced adverse effects with Sputnik Light COVID-19 vaccine versus the group that received placebo vaccine was not reported in detail. However, it was reported that no specific safety concerns were identified in this subgroup.

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
Other studies
This group (adults 60 years of age or older) is being studied in the 05-Gam-COVID-Vac-2020 ongoing study [Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation, 2020 ].

Children and adolescents

Randomized trials
Children were excluded from the RESIST trial [Logunov, Denis Y, 2021 ].
Other studies
The OLSTAD study is currently evaluating the immunogenicity and safety of the use of Gam-COVID-Vac in study subjects 12-17 years old in the prevention of coronavirus infection caused by the SARS-CoV-2 virus
[Deborah O'Connor, 2021 ].

Pregnancy

Randomized trials
Pregnant females were excluded from the RESIST trial [Logunov, Denis Y, 2021 ].
Other studies
No data are available because there are no studies assessing the safety of the vaccine in this group.

Breast-feeding

Randomized trials
females who were breast-feeding were excluded from the RESIST trial [Logunov, Denis Y, 2021 ].
Other studies
The available data are insufficient to assess vaccine safety, since no clinical trial has included this group

Safety of the vaccine post-authorization

Post-authorization studies

Comparative studies
None available
Non-comparative studies
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 ].

Jarynowski A et al. was a retrospective study that enrolled 11515 participants that received Sputnik V; data from participants was obtained from the self-reported Sputnik V vaccine AEs reported on Telegram. Analysis revealed that fever (47%) and generalized pain (46%) were the most commonly reported adverse events. Local reactions like pruritus (1.7%), erythema (2.7%), and swelling (1.8%) were the most commonly reported [Andrzej Jarynowski, 2021 ].

Pagotto V et al. was a cohort study that enrolled 683 healthcare workers that received Sputnik V COVID-19 vaccine. The study reported adverse events. 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 ].
Case reports and case series
None available

Spontaneous report data
Disclaimer: Reporting suspected adverse reactions after authorization of the medicinal product is important because it allows continuous monitoring of the benefit/risk balance of the vaccines. However, they do not indicate a causal association between the vaccine and the observed effects. Furthermore, this information should not be used to estimate the frequency of adverse events in people receiving the vaccine or to make comparisons between different vaccines. The information emerging about possible adverse effects needs to be carefully evaluated in order to first establish if the adverse effect might have been caused by the vaccine.

Monitoring

WHO recommends the following research and post-authorization monitoring activities:
- Monitoring of serious adverse events.
− vaccine effectiveness over time and whether protection can be prolonged by booster doses.
− studies to investigate whether this vaccine reduces SARS-CoV-2 transmission and viral shedding.
− assessment and reporting of vaccination failures and virus sequence information.
− prospective studies on the safety of Sputnik Light COVID-19 vaccine in pregnant and lactating females.
− randomized controlled trials on efficacy and safety of vaccination in children below the age of 18 years.
− safety data on vaccination in immunocompromised persons, including persons living with HIV and persons with autoimmune disease.
− immunogenicity and safety studies of co-administration with other vaccines, including influenza and pneumococcal vaccines, to adults and older persons.
− safety, immunogenicity, and impact of a delayed second dose, as currently implemented by certain countries.
− stability of the vaccine under alternative cold-chain distribution and storage conditions.
− effectiveness of the proposed strategies for the prevention and management of anaphylactic reactions.
− interchangeability studies within and across COVID-19 vaccine platforms.

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