Vector Institute COVID-19 vaccine

Extended version of the vaccine

Vector Institute COVID-19 vaccine

Authorization

World Health Organization Emergency Use Listing Procedure

Not authorized.
Expression of interest under assessment [Last checked at WHO EUL official website on 18 April 2022].

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

Health Ministry of the Russian Federation
Authorized on 13 October 2021 [FEDERAL SERVICE FOR SUPERVISION IN THE FIELD OF CONSUMER RIGHTS PROTECTION AND HUMAN WELL-BEING, 2020 ].
Conditional marketing authorization for individuals 18 years of age and over.

Regulatory Authorities of Regional Reference in the Americas

National Administration of Drugs, Foods and Medical Devices (ANMAT, Argentina)
Not authorized.

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 (FDA)
Not authorized.

Federal Commission for the Protection against Sanitary Risk (COFEPRIS, Mexico)
Not authorized.

Authorization in jurisdictions in Latin America and the Caribbean
Not authorized.

Authorization in other jurisdictions
Cambodia
Russia
Turkmenistan
Venezuela

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

Manufacturing

Manufacturers
State Research Center of Virology and Biotechnology VECTOR (Vector Institute), Russia. The company is the main producter of the Vector Institute COVID-19 vaccine [RUSSIAN NEWS AGENCY RU SEARCH, 2021 ].

Other manufacturers
Not described.

General characteristics

The development process of the Vector Institute COVID-19 vaccine included in silico analysis, chemical synthesis of peptides and conjugation to a carrier protein [Ryzhikov A.B., 2021 ].

SARS-CoV-2 protein N was selected due to its high level of conservation and immunogenicity, and as a valuable source of CD4+ T-cell epitopes. Protein N would not to trigger virus-neutralizing responses but virus-specific T- and B-memory cells. Memory T cells might persist longer than antibodies or memory B cells, as it was observed for SARS-CoV [Ferretti AP, 2020 ], [Ryzhikov A.B., 2021 ].

Epitopes that can lead to antibody-dependent enhancement of infection or have local antigenic similarity to human proteins were excluded. Epitopes from the most conserved regions of the S protein were selected in order to to ensure the effect of the vaccine against possible mutations of the virus changing its antigenic properties [Ryzhikov A.B., 2021 ].

Synthesized peptides were covalently bound to the carrier protein MBP-6xHis-N-nCoV-2019 which contains the structures of SARS-CoV-2 N protein, the Escherichia coli maltose binding protein, and the 6xHis-tag required for purification with metal chelate affinity chromatography. SARS-CoV-2 N protein was chosen because it is well-conserved and contains virus-specific T-cell epitopes and thus should be also involved in the production of memory T cells [Ryzhikov A.B., 2021 ].

SARS-CoV-2 protein N was selected due to its high level of conservation and immunogenicity, and as a valuable source of CD4+ T-cell epitopes according. Protein N would not to trigger neutralization but virus-specific T- and B-memory cell responses. Memory T cells might persist longer than antibodies or memory B cells, as it was observed for SARS-CoV [Ferretti AP, 2020 ], [Ryzhikov A.B., 2021 ].

After the purification stage, the carrier protein was covered with covalently bound peptides and adsorbed on aluminum hydroxide used as adjuvant [Ryzhikov A.B., 2021 ].

 

Dosage form and ingredients

The pharmaceutical form is a suspension for intramuscular injection that is provided in a monodose vial of 0.5 mL.

The vaccine contains the following ingredients:


Active ingredient
Information not yet provided.


Excipients
Information not yet provided.

Risk considerations

Peptide-based vaccines have theoretical advantages over traditional whole-organism and other platforms. They allow the immune response to focus on the protective epitopes and to exclude non-relevant epitopes, including those reactogenic or allergenic, at the stage of vaccine design [Reche PA, 2014 ].

Dosing and schedule

There are no dose-finding studies that have yet reported data.

There is no data available on the interchangeability of the Vector Institute COVID-19 vaccine with other COVID-19 vaccines to complete the vaccination series.

There is no evidence yet about the effects of the coadministration of the Vector Institute COVID-19 vaccine with other vaccines included in routine vaccination programs.

Indications and contraindications

Indications

Vector Institute COVID-19 vaccine is indicated in adult individuals from 18 years and over [Ryzhikov A.B., 2021 ].

Contraindications

The vaccine is contraindicated in individuals with a known history of a severe allergic reaction to any component of vaccines. (See the list of ingredients under 'General characteristics' in the extended version).

Precautions

Severe allergic reaction (e.g. anaphylaxis) to a previous dose of any vaccine (not including Vector Institute COVID-19 vaccine).

In general, persons with an immediate non-anaphylactic allergic reaction to the first dose should not receive additional doses, unless recommended after review by a health professional with specialist expertise.

Severe allergic reaction (e.g. anaphylaxis) to an injectable medication.

Vaccination should be postponed in individuals suffering from acute severe febrile illness, or acute infection.

Reactions related to stress or anxiety, such as syncope or hyperventilation may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting.

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.

The available data of Vector Institute COVID-19 vaccine 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 Vector Institute COVID-19 vaccine is insufficient to assess vaccine efficacy during pregnancy since no clinical trials evaluating vaccines to prevent COVID-19 have included pregnant women. The vaccine should only be given to pregnant women if the risks outweigh the benefit.

The available data of Vector Institute COVID-19 vaccine on lactating women are insufficient to assess whether the vaccine is excreted in human milk or if there is any associated risk.

Vaccination may be offered regardless of a person’s history of symptomatic or asymptomatic SARS-CoV-2 infection.

Although there are currently no medical contraindications to vaccinate a person with COVID-19, it is recommended to defer all vaccinations until complete recovery [PAHO, 2020 ].

Although there are currently no contraindications to vaccinate 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 ].

The interaction of concomitant administration of Vector Institute COVID-19 vaccine with other vaccines has not been studied.

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

Vector Institute COVID-19 vaccine must be stored refrigerated between 2°C to 8°C [35° to 46°F] [Ryzhikov A.B., 2021 ].
Vials should be protected from light and they must not be frozen.

Logistic at the time of administration

Inspect the vial before use.
The vial should be discarded if particles or differences are observed in the described appearance of the vaccine.
The vial should be shaken gently.

Storage after first puncture

After the first puncture of the vial, preferably use immediately.
Record the date and time the vial should be discarded.
To improve traceability, the name and batch number of the administered product should be clearly recorded.

Administration

1. Using aseptic technique, clean the vial stopper with a single-use antiseptic swab.
2. Use a 3 mL reuse prevention syringe (RUP) or a 5 mL RUP syringe, and a 21G or narrower needle.
3. Gently invert the vial to mix, and withdraw the 0.5 mL dose. If the amount of vaccine remaining in the vial cannot provide a full 0.5 mL dose, discard the vial and the remaining volume.
4. Administer the vaccine intramuscularly, preferably into the deltoid muscle. Do not administer the vaccine intravascularly, subcutaneously, or intradermally.

Disposal

Due to the high risk that discarded vials of COVID-19 vaccines may be recovered, it is essential that they are guaranteed to be safely disposed of 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, so that they are transferred to the place established for that purpose. 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

COV/pept-01/20 was a phase 1/2 randomized trial, sponsored by Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector" and conducted in Russia. It was registered with registry number NCT04527575 [Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector", 2020 ]. The aim of the study was to evalate the safety, reactogenicity and immunogenicity parameters of the EpiVacCorona COVID-19 vaccine in healthy volunteers aged 18-60 years, who were randomly assigned in a 1:1 ratio to receive vaccine or placebo. It was first registered in August 2020 and enrolled 100 participants. The study finished on May 2021. The results of the trial were formally published in a scientific journal in May 2021 [Ryzhikov A.B., 2021 ].

 

Ongoing randomized trials

COV/pept-03/20 (phase 3/4) is an ongoing randomized study (registered with the number NCT04780035) sponsored by Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector" that is being conducted in Russia [Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector", 2020 ]. It was first registered in March 2021 and plans to enroll 3 000 healthy adults aged 18 and above that will receive two doses of the vaccine intramuscularly, 21 to 28 days apart, at a dose of 0.5 mL. It is expected to run until September 2021.

 

Other ongoing registered studies

COV/pept-02/20 is an ongoing phase 3-4 non-randomized study (registered with the number NCT05021016) sponsored by Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector" that is being conducted in Russia [Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector", 2020 ]. It was first registered in August 2021 and plans to enroll 150 volunteers aged 60 years and above that will receive EpiVacCorona. It is expected to run until January 2021.

Methods used to assess efficacy

There are no phase 3 randomized trials that have yet reported outcome data.

Safety evaluation methods

There are no phase 3 randomized trials that have yet reported outcome data.

Vaccine efficacy and effectiveness

Efficacy of preclinical studies on the vaccine

To assess the immunogenicity of the vaccine, hamsters were injected a dose of 260 μg of the vaccine. Two weeks following the second inoculation, geometric mean titers of antibodies to vaccine antigens in the sera of hamsters vaccinated were 1:11943. By the same time, 100% of vaccinated ferrets developed high levels of specific antibodies, with geometric mean titers ranging from 1:9051 to 1:10159 in three groups of ferrets immunized with three series of the vaccine [Ryzhikov A.B., 2021 ].

Immunogenicity was also tested in non-human primates (rhesus macaques and green monkeys). The vaccine induced high titers of antibodies to the vaccine antigens and the whole-virion antigen of coronavirus in 100% of animals 2-3 weeks following the first vaccination. Four weeks following the first vaccination, geometric mean titers to the vaccine antigen reached 1:12800 and 1:11143, in rhesus macaques and green monkeys, respectively [Ryzhikov A.B., 2021 ] .

After the coronavirus challenge of vaccinated animals, none of the primates showed focal infiltrative changes in lungs typical for viral pneumonias, while placebo animals showed extensive lung tissue damage and signs of viral pneumonia (pleurisy, cardiomegaly) [Ryzhikov A.B., 2021 ].

Efficacy of the vaccine in clinical trials

Main immunogenicity outcomes

COV/pept-01/20 phase 1/2 trial evaluated a two-dose (0.5 µg), 21 days apart, vaccination scheme in 100 participants (14 in phase 1 and 86 in phase 2) aged 18-60 years. The vaccination scheme induced specific antibodies and neutralizing antibodies in titers ≥ 1:20 at day 21 in 100% of the vaccinated volunteers. No seroconversion was reported in the placebo vaccine group [Ryzhikov A.B., 2021 ].


Main efficacy outcomes of Vector Institute COVID-19 vaccine

Key messages

There is no evidence available at this moment to assess the efficacy of Vector Institute COVID-19 vaccine.

Contracting COVID-19

There are no phase 3 randomized trials that have yet reported outcome data, so it is not possible to estimate the effect for this outcome.

Contracting severe COVID-19

There are no phase 3 randomized trials that have yet reported outcome data, so it is not possible to estimate the effect for this outcome.

Efficacy and effectiveness of the vaccine in subgroups

Sex

Randomized trials

There are no phase 3 randomized trials that have yet reported outcome data.

The proportion of men and women in the COV/pept-01/20 were 60.5% and 39.5%, respectively [Ryzhikov A.B., 2021 ].

The differential efficacy of the vaccine in sex groups was not reported in the phase 1/2 trial COV/pept-01/20 [Xia, Shengli, 2021 ].

 
Age

Randomized trials

There are no phase 3 randomized trials that have yet reported outcome data. In phase 1/2 of the COV/pept-01/20 trial the average age was 33 years [Ryzhikov A.B., 2021 ].

Adults older than 60 years were not included in the phase 1/2 trial.

Efficacy in the different age groups included was not reported [Ryzhikov A.B., 2021 ].

 
Children and adolescents

Randomized trials

There are no phase 3 randomized trials that have yet reported outcome data.

Children were excluded from the COV/pept-01/20, so no data are available for this subgroup [Ryzhikov A.B., 2021 ].

 
Pregnancy

Randomized trials

There are no phase 3 randomized trials that have yet reported outcome data.

Pregnant females were excluded from the COV/pept-01/20, so no data are available for this subgroup [Ryzhikov A.B., 2021 ].

 
Breast-feeding

Randomized trials

There are no phase 3 randomized trials that have yet reported outcome data.

Breastfeeding females were excluded from the COV/pept-01/20, so no data are available for this subgroup [Ryzhikov A.B., 2021 ].

 
Immunocompromised persons

Randomized trials

There are no phase 3 randomized trials that have yet reported outcome data.

Immunocompromised participants were excluded from the COV/pept-01/20, so no data are available for this subgroup [Ryzhikov A.B., 2021 ].

Other data on vaccine efficacy and effectiveness

Main effectiveness outcomes of Vector Institute COVID-19 vaccine (Other studies)

Contracting COVID-19

No studies reported or assessed this outcome. 

Contracting severe COVID-19

No studies reported or assessed this outcome. 

Transmission

No studies reported or assessed this outcome.

 
SARS-CoV-2 variants

Immunogenicity outcomes 

To date, no studies assessed the vaccine immunogenicity outcomes against SARS-CoV-2 Variants.

 Randomized trials 

To date, no studies assessed the vaccine immunogenicity outcomes against SARS-CoV-2 Variants.

Other studies 

To date, no studies assessed the vaccine immunogenicity outcomes against SARS-CoV-2 Variants.

 
Booster dose

Immunogenicity outcomes

To date, no studies assessed the vaccine immunogenicity outcomes on a booster regimen.

 
Heterologous vaccine regimens

Immunogenicity outcomes

To date, no studies assessed the vaccine immunogenicity outcomes on heterologous regimen.

 
Heterologous-booster regimens

Immunogenicity outcomes

To date, no studies assessed the vaccine immunogenicity outcomes on a heterologous-booster regimen.

Safety of the vaccine

Safety of the vaccine in preclinical studies

Safety data was not reported in preclinical studies conducted in hamsters, ferrets and non-human primates [Ryzhikov, Aleksandr, 2021 ].

Data on safety on animal or other preclinical studies for this vaccine have not been published or released [Ryzhikov A.B., 2021 ].

Safety of the vaccine in clinical trials

Any adverse event

There are no phase 3 randomized trials that have yet reported outcome data.

In the phase 1/2 trial COV/pept-01/20, the most common adverse reaction was local pain at the injection site (observed in 4 out of 43 volunteers after the first injection and in 2 more patients after the second injection). All local reactions were mild to moderate and resolved in a 2-day period. One systemic adverse reaction was reported in the study but it was not attributed to vaccination [Ryzhikov A.B., 2021 ].




Serious adverse events

There are no phase 3 randomized trials that have yet reported outcome data.

In the phase 1/2 trial COV/pept-01/20, serious adverse events were not observed [Ryzhikov A.B., 2021 ].

Non-serious adverse events

There are no phase 3 randomized trials that have yet reported outcome data.

In the phase 1/2 trial COV/pept-01/20, non-serious adverse events related to immunization were not reported [Ryzhikov A.B., 2021 ].

Safety of the vaccine in subgroups

Sex

Randomized trials

There are no phase 3 randomized trials that have yet reported outcome data.

The proportion of males and females in the COV/pept-01/20 were 60.5% and 39.5%, respectively [Ryzhikov A.B., 2021 ].

The differential safety of the vaccine in sex groups was not reported in the phase 1/2 trial COV/pept-01/20 [Xia, Shengli, 2021 ].

 
Age

Randomized trials

There are no phase 3 randomized trials that have yet reported outcome data. Adults older than 60 years were not included in the phase 1/2 COV/pept-01/20 trial [Ryzhikov A.B., 2021 ].

The average age was 25.1 and 35.1 years in the phase 1 and phase 2 components of the COV/pept-01/20 trial, respectively.

Safety in the different age groups included in this trial was not reported [Ryzhikov A.B., 2021 ].

Other studies

No data are available because there are no studies assessing the safety of the vaccine in this group.

 
Children and adolescents

Randomized trials

There are no phase 3 randomized trials that have yet reported outcome data.

Children were excluded from the COV/pept-01/20 trial, so no data are available for this subgroup [Ryzhikov A.B., 2021 ].

Other studies

No data are available because there are no studies assessing the safety of the vaccine in this group.

 
Pregnancy

Randomized trials

There are no phase 3 randomized trials that have yet reported outcome data. Pregnant females were excluded from the COV/pept-01/20 trial, so no data are available for this subgroup [Ryzhikov A.B., 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

There are no phase 3 randomized trials that have yet reported outcome data.

Breastfeeding females were excluded from the COV/pept-01/20 trial, so no data are available for this subgroup [Ryzhikov A.B., 2021 ].

Other studies

No data are available because there are no studies assessing the safety of the vaccine in this group.

 
Immunocompromised persons

Randomized trials

There are no phase 3 randomized trials that have yet reported outcome data.

Immunocompromised participants were excluded from the COV/pept-01/20 trial, so no data are available for this subgroup [Ryzhikov A.B., 2021 ].


Other studies

No data are available because there are no studies assessing the safety of the vaccine in this group.

Safety of the vaccine post-authorization

Post-authorization studies

Comparative studies
None available.

Non-comparative studies
None available. 

 

 

 

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

[FEDERAL SERVICE FOR SUPERVISION IN THE FIELD OF CONSUMER RIGHTS PROTECTION AND HUMAN WELL-BEING, 2020] FEDERAL SERVICE FOR SUPERVISION IN THE FIELD OF CONSUMER RIGHTS PROTECTION AND HUMAN WELL-BEING. On the registration of the vaccine FBSI SSC VB "Vector" Rospotrebnadzor "EpiVacCorona". ??????????? ?????? ?? ??????? ? ????? ?????? ???? ???????????? ? ????? FEDERAL SERVICE FOR SUPERVISION IN THE FIELD OF CONSUMER RIGHTS PROTECTION AND HUMAN WELL-BEING. On the registration of the vaccine FBSI SSC VB "Vector" Rospotrebnadzor "EpiVacCorona". ??????????? ?????? ?? ??????? ? ????? ?????? ???? ???????????? ? ?????
[RUSSIAN NEWS AGENCY RU SEARCH, 2021] RUSSIAN NEWS AGENCY RU SEARCH. Russia to manufacture 500,000 EpiVacCorona vaccine doses in February, says developer. 2021; RUSSIAN NEWS AGENCY RU SEARCH. Russia to manufacture 500,000 EpiVacCorona vaccine doses in February, says developer. 2021;
[Ryzhikov A.B., 2021] Ryzhikov A.B., Bogryantseva M.P., Usova S.V. et al. A single blind, placebo-controlled randomized study of the safety, reactogenicity and immunogenicity of the “EpiVacCorona” vaccine for the prevention of COVID-19, in volunteers aged 18–60 years (Phase I– Ryzhikov A.B., Bogryantseva M.P., Usova S.V. et al. A single blind, placebo-controlled randomized study of the safety, reactogenicity and immunogenicity of the “EpiVacCorona” vaccine for the prevention of COVID-19, in volunteers aged 18–60 years (Phase I–
[Ferretti AP, 2020] Ferretti AP, Kula T, Wang Y et al. Unbiased Screens Show CD8+ T Cells of COVID-19 Patients Recognize Shared Epitopes in SARS-CoV-2 that Largely Reside outside the Spike Protein. Immunity. 2020;53(5):1095-1107.e3. Ferretti AP, Kula T, Wang Y et al. Unbiased Screens Show CD8+ T Cells of COVID-19 Patients Recognize Shared Epitopes in SARS-CoV-2 that Largely Reside outside the Spike Protein. Immunity. 2020;53(5):1095-1107.e3.
[Reche PA, 2014] Reche PA, Fernandez-Caldas E, Flower DR, Fridkis-Hareli M, Hoshino Y. Peptide-based immunotherapeutics and vaccines. Journal of immunology research. 2014;2014:256784. Reche PA, Fernandez-Caldas E, Flower DR, Fridkis-Hareli M, Hoshino Y. Peptide-based immunotherapeutics and vaccines. Journal of immunology research. 2014;2014:256784.
[PAHO, 2020] PAHO. The Immunization Program in the Context of the COVID-19 Pandemic, 26 March 2020. PAHO/FPL/IM/COVID-19/20-0005. 2020; PAHO. The Immunization Program in the Context of the COVID-19 Pandemic, 26 March 2020. PAHO/FPL/IM/COVID-19/20-0005. 2020;
[WHO, 2021] WHO. COVID-19 vaccination: supply and logistics guidance: interim guidance, 12 February 2021. WHO/2019-nCoV/vaccine_deployment/logistics/2021.1. 2021; WHO. COVID-19 vaccination: supply and logistics guidance: interim guidance, 12 February 2021. WHO/2019-nCoV/vaccine_deployment/logistics/2021.1. 2021;
[Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector", 2020] Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector". Study of the Safety, Reactogenicity and Immunogenicity of "EpiVacCorona" Vaccine for the Prevention of COVID-19. clinicaltrials.gov. 2020; Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector". Study of the Safety, Reactogenicity and Immunogenicity of "EpiVacCorona" Vaccine for the Prevention of COVID-19. clinicaltrials.gov. 2020;
[Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector", 2020] Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector". Study of the Tolerability, Safety, Immunogenicity and Preventive Efficacy of the EpiVacCorona Vaccine for the Prevention of COVID-19. clinicaltrials.gov. Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector". Study of the Tolerability, Safety, Immunogenicity and Preventive Efficacy of the EpiVacCorona Vaccine for the Prevention of COVID-19. clinicaltrials.gov.
[Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector", 2020] Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector". Study of the EpiVacCorona Vaccine With the Involvement of Volunteers Aged 60 Years and Above. clinicaltrials.gov. 2020; Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector". Study of the EpiVacCorona Vaccine With the Involvement of Volunteers Aged 60 Years and Above. clinicaltrials.gov. 2020;
[Xia, Shengli, 2021] Xia, Shengli, Zhang, Yuntao, Wang, Yanxia et al. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial. The Lancet Infectious Diseases. 2021;21(1):39-51. Xia, Shengli, Zhang, Yuntao, Wang, Yanxia et al. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial. The Lancet Infectious Diseases. 2021;21(1):39-51.
[Ryzhikov, Aleksandr, 2021] Ryzhikov, Aleksandr, Ryzhikov, Evgenii, Bogryantseva, Marina et al. Immunogenicity and protectivity of the peptide candidate vaccine against SARS-CoV-2. Annals of the Russian academy of medical sciences. 2021;76:5-19. Ryzhikov, Aleksandr, Ryzhikov, Evgenii, Bogryantseva, Marina et al. Immunogenicity and protectivity of the peptide candidate vaccine against SARS-CoV-2. Annals of the Russian academy of medical sciences. 2021;76:5-19.
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