Gamaleya COVID-19 vaccine

Extended version of the vaccine

Gamaleya 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 18 April 2022].

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

Health Ministry of the Russian Federation
Sputnik V: Authorized 8 August 2020 [State Drug Registry of Russia, 2020 ].
Sputnik Light: Authorized 6 May 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 on 23 December 2020 [Ministerio de salud de la Argentina, 2020 ].

Brazilian Health Regulatory Agency (ANVISA, Brazil)
Authorized for exceptional importation under controlled conditions on 14 June 2021 [ANVISA, 2022 ].

Health Canada
Not authorized.

Public Health Institute (ISP, Chile)
Authorized for emergency use on 21 July 2021 [Instituto de salud pública de Chile, 2021 ].

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 (FDA)
Not authorized.

Federal Commission for the Protection against Sanitary Risk (COFEPRIS, Mexico)
Authorized for emergency use on 2 February 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
Guinea
Guyana
Honduras
Maldives
Nicaragua
Panama
Paraguay
St. Vincent and the Grenadines
Venezuela

Authorization in other jurisdictions in the Americas
Albania
Algeria
Angola
Armenia
Azerbaijan
Bahrain
Bangladesh
Belarus
Bosnia and Herzegovina
Brazil
Cambodia
Cameroon
Congo
Djibouti
Egypt
Gabon
Gambia
Ghana
Hungary
India
Indonesia
Iran
Iraq
Jordan
Kazakhstan
Kenya
Kyrgyzstan
Lao People's Democratic Republic
Libya
Maldives
Mali
Mauritius
Moldova
Mongolia
Montenegro
Morocco
Myanmar
Namibia
Nepal
Nigeria
North Macedonia
Oman
Pakistan
Philippines
Republic of Moldova
Republic of the Congo
Russia
Rwanda
Saint Vincent and the Grenadines
San Marino
Serbia
Seychelles
Slovakia
Sri Lanka
Syria
Syrian Arab Republic
Tunisia
Turkey
Turkmenistan
United Arab Emirates
Uzbekistan
Vietnam
West Bank
Zimbabwe

The Emergency Use Authorization does not constitute marketing authorization in the country.

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 ].

 

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 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

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 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

The available data on Sputnik V and Sputnik Light COVID-19 vaccines on children are insufficient to assess vaccine efficacy since no clinical trial evaluating vaccines to prevent COVID-19 has included children.

The available data on Sputnik V and Sputnik Light COVID-19 vaccines on pregnant women are insufficient to assess vaccine efficacy in pregnancy since no clinical trial evaluating vaccines to prevent COVID-19 has included pregnant females.

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

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.

Logistic at the time of administration [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

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 40,000 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 1,600 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 1,000 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 6,000 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 1011 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 2,000 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 11,515 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 2,558 General population that received Sputnik V. Based on email self-reported adverse event data between 4 February. March to April 8, 2021.

Gonzalez Lopez Ledesma MM et al. was a non-comparative study conducted in Argentina [Gonzalez Lopez Ledesma MM, 2022 ], evaluating immunogenicity results from adult individuals who had received two doses of Sputnik V COVID-19 vaccine.

7 vaccines against COVID 19 is an ongoing prospective Cohort study (registered with the number NCT05228912 [Hospital Clinica Nova, 2021 ]) sponsored by Hospital Clinica Nova that is being conducted in Mexico. It was first registered in February 2022 and plans to enroll 1870 Children, Adult and Older Adult that will receive Pfizer-BioNTech, Moderna, Gamaleya, Cansino, Sinovac, Astrazeneca and Janssen COVID-19 vaccines. It is expected to run until October 2024. 

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 [Karamano?lu 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 3,000 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

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.

Safety evaluation methods

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.

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

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% (7,708 out of 19,866 participants) [Logunov, Denis Y, 2021 ]. The relative risk of contracting COVID-19 in women that received the Sputnik V COVID-19 vaccine versus the group that received the placebo vaccine was 0.13 (95% CI 0.06 to 0.27). This means Sputnik V COVID-19 vaccine reduced the risk of contracting COVID-19 87%, compared with the placebo vaccine. This estimate is not statistically different from the estimate for this outcome in the overall population of the trial.

The proportion of females in the RESIST trial was 61.1% (12,158 out of 19,866 participants) [Logunov, Denis Y, 2021 ]. The relative risk of contracting COVID-19 in men that received the Sputnik V COVID-19 vaccine versus the group that received the placebo vaccine was 0.06 (95% CI 0.03 to 0.13). This means Sputnik V COVID-19 vaccine reduced the risk of contracting COVID-19 94%, 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 60 years of age and over that received the Sputnik V COVID-19 vaccine versus the group that received the placebo vaccine was 0.08 (95% CI 0.02 to 0.39). This means the Sputnik V COVID-19 vaccine reduced the risk of contracting COVID-19 in 92% compared with the placebo vaccine.

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 ].

 
Breast-feeding

Randomized trials

Females who were breast-feeding 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 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 data on vaccine efficacy and effectiveness

Main effectiveness outcomes of Gamaleya Sputnik V; Sputnik Light COVID-19 vaccine (Other studies)

Contracting COVID-19

Alireza Mirahmadizadeh 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 in October 22, 2021; the study results showed a 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 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 ].

 

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%, ICU admission rate of 0% and death rate of 0.09%. [Mukherjee S, 2021 ].

Anton Barchuk et al. was a comparative study conducted in Russia. The study enrolled 13,893 participants (1,739 Vaccine group; 12,154 Control group) that 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), a private medical facility contracted by the city government to provide triage service for nearly half of the city districts between July 3 – August 9, 2021 in St. Petersburg, Russia. The outcome was measured starting at ≥ 14 days after vaccination. Results showed vaccine effectiveness of 35% 95%CI 21 to 65 for Sputnik light and 81% 95%CI 68 to 88 for Sputnik-V. [Anton Barchuk, 2021 ].

Leveau, Carlos Marcelo et al. was a comparative study conducted in Argentina. The study analyzed the Spatio-temporal variations between mortality due to COVID-19 in older adults and vaccination against COVID-19, using data from 134 geographic clusters in the province of Buenos Aires between December 29, 2020 and June 30, 2021. The study results showed an association between vaccination with the first dose of Sputnik V vaccine in the population older than 70 years and a decrease in mortality in this same age group, with vaccine effectiveness of 85% (no CI reported) [Leveau, Carlos Marcelo, 2021 ]

Alireza Mirahmadizadeh 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 in October 22, 2021; the study results showed a 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 ].

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 an 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 efficiency 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 ].

Transmission

No studies reported or assessed this outcome.

 

SARS-CoV-2 variants

Immunogenicity outcomes

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 ].

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 ].

Blanco S et al. was a cohort study conducted in Argentina. The study enrolled 285 participants, mainly healthcare 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 ].

 

Randomized trials

Currently, there are no studies that have assessed the vaccine efficacy outcomes against SARS-CoV-2 Variants.

Other studies

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 ].

 

Booster dose

Immunogenicity outcomes

Currently, there are no studies that have assessed the vaccine immunogenicity outcomes on a booster regimen.

 

Heterologous vaccine regimens

Macchia et al. was a non-inferiority randomized clinical trial conducted in Argentina. The study compared the immune response generated by the homologous Sputnik V regimen to the heterologous regimens of Sputnik V vaccine with either Moderna, Sinopharm BIBP or AstraZeneca vaccines [Macchia A, 2022 ].

Macchia et al. 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 ].

Immunogenicity outcomes

Two randomized clinical trials have included heterologous vaccine schemes [Ministerio de Salud de Ciudad Autónoma de Buenos Aires, 2021 ], [Ministry of Public Health, Argentina, 2021 ], but their results are still not published.

 

Heterologous-booster regimens

Immunogenicity outcomes

Currently, there are no studies that have assessed the vaccine immunogenicity outcomes on a heterologous-booster regimen.

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

The available data are insufficient to assess vaccine safety by sex. Available randomized clinical trial has not included a safety analysis by sex groups.

 

Age

Randomized trials

The proportion of participants >60 years of age in the RESIST trial was 10.8% (2,144 out of 19,866 participants) [Logunov, Denis Y, 2021 ].
There were 1,369 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 1,029 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 women were excluded from the RESIST trial [Logunov, Denis Y, 2021 ].

 

Breast-feeding

Randomized trials

Breast-feeding women were excluded from the RESIST trial [Logunov, Denis Y, 2021 ].

 

Safety of the vaccine post-authorization

Post-authorization studies

Comparative studies

No comparative studies reported or assessed this outcome.

Non-comparative studies

Jarynowski A et al. was a retrospective study that enrolled 11,515 participants that received the 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 the 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 ].

Mehraeen E et al. carried out a non-comparative study in Iran, which included 30 health workers. In this study, we observed that 15/18 (83%) of the children of Sputnik V recipients became symptomatic and developed transient fever and chills for 1-2 days starting 2-5 days after their parents' vaccination. that may be related to adenovirus infection. This is the first study to report symptoms in the offspring of Sputnik V recipients, and the results need to be validated by larger studies [Mehraeen E, 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% 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. 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. 2,558 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. First dose appeared to be more reactogenic than 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 ].

Monitoring

WHO recommends the following research and post-authorization monitoring activities:

Safety surveillance and monitoring
- Serious adverse events, anaphylaxis and other serious allergic reactions, Bell’s palsy, cases of multisystem inflammatory syndrome following vaccination, cases of COVID-19 following vaccination that result in hospitalization or death.

Vaccine effectiveness
− 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.

Subgroups
− Prospective studies on the safety of 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 people, including patients living with HIV and autoimmune disease.

Vaccination logistics
− 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.

References

[State Drug Registry of Russia, 2020] State Drug Registry of Russia. FSBI "NITsEM is named after N.F. Gamaleya" of the Russian Ministry of Health ("Medgamal" Branch of FSBI "NITsEM is named after N.F. 2020; State Drug Registry of Russia. FSBI "NITsEM is named after N.F. Gamaleya" of the Russian Ministry of Health ("Medgamal" Branch of FSBI "NITsEM is named after N.F. 2020;
[RUSSIAN DIRECT INVESTMENT FUND, 2021] RUSSIAN DIRECT INVESTMENT FUND. Single dose vaccine, Sputnik Light, authorized for use in Russia. 2021; RUSSIAN DIRECT INVESTMENT FUND. Single dose vaccine, Sputnik Light, authorized for use in Russia. 2021;
[Ministerio de salud de la Argentina, 2020] Ministerio de salud de la Argentina. El Ministerio de Salud de la Nación autorizó la vacuna SPUTNIK V. 2020; Ministerio de salud de la Argentina. El Ministerio de Salud de la Nación autorizó la vacuna SPUTNIK V. 2020;
[ANVISA, 2022] ANVISA. Sputnik. 2022; ANVISA. Sputnik. 2022;
[Instituto de salud pública de Chile, 2021] Instituto de salud pública de Chile. ISP aprueba uso de emergencia e importación de la vacuna Sputnik V. 2021; Instituto de salud pública de Chile. ISP aprueba uso de emergencia e importación de la vacuna Sputnik V. 2021;
[Comisión Federal para la Protección contra Riesgos Sanitarios (Cofepris). Mexico, 2021] Comisión Federal para la Protección contra Riesgos Sanitarios (Cofepris). Mexico. Cofepris grants authorization for emergency use of Sputnik V vaccine. Press release - COFEPRIS - 02 de febrero de 2021. 2021; Comisión Federal para la Protección contra Riesgos Sanitarios (Cofepris). Mexico. Cofepris grants authorization for emergency use of Sputnik V vaccine. Press release - COFEPRIS - 02 de febrero de 2021. 2021;
[Logunov DY, 2020] Logunov DY, Dolzhikova IV, Zubkova OV et al. Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia. Lancet (London, England). 2020; Logunov DY, Dolzhikova IV, Zubkova OV et al. Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia. Lancet (London, England). 2020;
[Gobierno de México, 2021] Gobierno de México. GUÍA TÉCNICA PARA LA APLICACIÓN DE LA VACUNA SPUTNIK V CONTRA EL VIRUS SARS-CoV-2. Marzo, 2021. 2021; Gobierno de México. GUÍA TÉCNICA PARA LA APLICACIÓN DE LA VACUNA SPUTNIK V CONTRA EL VIRUS SARS-CoV-2. Marzo, 2021. 2021;
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