Vector Institute COVID-19 vaccine

Extended version of the vaccine

Alternative names:
EpiVacCorona; EpiVakKorona

Authorization

World Health Organization Emergency Use Listing Procedure

Not authorized.
Expression of interest under assessment [Last checked at WHO EUL official website on January 12th 2023].

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 older.

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
Venezuela

Authorization in other jurisdictions
Cambodia
Russia
Turkmenistan

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 [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 ].

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

The Vector Institute COVID-19 vaccine is administered as a series of two doses (0.5 mL each) with an interval of 3 weeks [Ministry of Health of the Russian Federation, 2021 ].

The pharmaceutical form is a suspension for intramuscular injection.
The preferred site of injection is the deltoid muscle of the upper arm.

If administration of the second dose is inadvertently delayed beyond 3 weeks, it should be given as soon as possible.

Booster dose
Current recommendations do not suggest that individuals receive more than two doses of the Vector Institute COVID-19 vaccine.

Heterologous COVID-19 vaccine schedules
Individuals starting a series with the Vector Institute COVID-19 vaccine must complete the series with the same product.
There is no available data to support the interchangeability between the Vector Institute vaccine and other vaccines against COVID-19.

Indications and contraindications

Indications

Vector Institute COVID-19 vaccine is indicated for individuals 18 years of age and older [Ministry of Health of the Russian Federation, 2021 ].

Contraindications [Ministry of Health of the Russian Federation, 2021 ].

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).

A subsequent dose of the vaccine should NOT BE GIVEN to those who have experienced anaphylaxis to a previous dose.

Pregnancy and breastfeeding
The available data on EpivacCorona COVID-19 vaccine is insufficient to assess vaccine efficacy in pregnancy and breastfeeding since no clinical trials have included pregnant or breastfeeding women [Ministry of Health of the Russian Federation, 2021 ].

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

Precautions

Allergic reactions
Persons with a history of anaphylaxis to any other vaccine or injectable therapy should be observed in health care settings where anaphylaxis can be immediately treated.

Pregnancy and breastfeeding
The available data on EpivacCorona COVID-19 vaccine is insufficient to assess vaccine efficacy in pregnancy and breastfeeding since no clinical trials have included pregnant or breastfeeding women [Ministry of Health of the Russian Federation, 2021 ].

Children and adolescents [Ministry of Health of the Russian Federation, 2021 ].
There are limited data on the efficacy or safety of persons below 18 years of age for this vaccine. Until more data are available, vaccination of individuals in this age range is not routinely recommended.

Older persons [Ministry of Health of the Russian Federation, 2021 ].
Vaccination is recommended for older persons without an upper age limit

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

Persons with current acute COVID-19
Persons with acute PCR-confirmed COVID-19 should not be vaccinated until after they have recovered from acute illness and the criteria for discontinuation of isolation have been met [PAHO, 2020 ].

Other precautions
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.
Data on the administration of the EpivacCorona COVID-19 vaccine are currently insufficient to allow the assessment of efficacy for persons living with HIV.
Vaccination should be postponed in individuals suffering from acute severe febrile illness, or acute infection.

Co-administration with other vaccines
There should be a minimum interval of 14 days between the administration of this vaccine with any other vaccine in the immunization schedule, until data on co-administration with other vaccines are available.

When administered concomitantly, the vaccines should be injected at separate sites, preferably different extremities.

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.

Administration logistics

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

The following randomized clinical trials have reported vaccine efficacy and/or safety data:

Phase 1/2:

The clinical trial COV/pep-01/20 (NCT04527575, [Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector", 2020 ]) conducted in Russia started in July 2020 and included 100 individuals. 14 and 86 participants were assigned non-randomly and randomly 1:1 to receive two doses of EpivacCorona vaccine or placebo 21 days apart [Ryzhikov A.B., 2021 ].

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 ].
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, therefore 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, therefore no data are available for this subgroup [Ryzhikov A.B., 2021 ].

Breastfeeding
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, therefore 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, therefore no data are available for this subgroup [Ryzhikov A.B., 2021 ].

Vaccine effectiveness (other comparative 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

Efficacy and effectiveness against SARS-CoV-2 variants

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

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

Effectiveness outcomes
Delta (B.1.617.2)
Barchuk et al conducted a test-negative case-control study in Russia, to estimate vaccine effectiveness against any volume of involved lung parenchyma and severe lung injury detected on computer tomography and associated with COVID-19, during Delta and Omicron variants predominance period. Among 23,996 patients in the primary analysis, 13,372 (55.7%) had any lung injury, and 338 (1.4%) had severe lung injury. Effectiveness of vaccination against any lung injury, in the Delta period was -35% (95% CI, −100% to 9%) for EpiVacCorona. [Barchuk A, 2022 ]

Barchuk A et al was a population-based case-control study conducted in Russia that aimed to estimate the effectiveness of the Russian COVID-19 vaccines against symptomatic SARS-CoV-2 during the Delta predominance period in October 2021. The final analysis included 1,254 cases and 2,747 controls. Adjusted vaccine effectiveness against symptomatic PCR-confrmed SARS-CoV-2 for individuals vaccinated with EpiVacCorona was -58% (95% CI, -225% to 23%) and -30% (95% CI, -165% to 37%) for lung injury [Barchuk A, 2022 ].

Omicron (B.1.1.529.1)
Barchuk et al conducted a test-negative case-control study in Russia, to estimate vaccine effectiveness against any volume of involved lung parenchyma and severe lung injury detected on computer tomography and associated with COVID-19, during Delta and Omicron variants predominance period. Among 23,996 patients in the primary analysis, 13,372 (55.7%) had any lung injury, and 338 (1.4%) had severe lung injury. Effectiveness of vaccination against any lung injury, in the Omicron period was 5% (95% CI, −43% to 37%) for EpiVacCorona. [Barchuk A, 2022 ]

Vaccine efficacy and effectiveness for booster dose

Immunogenicity outcomes
No studies reported or assessed this outcome

Vaccine efficacy and effectiveness for heterologous schedule

Immunogenicity outcomes
No studies reported or assessed this outcome

Vaccine efficacy and effectiveness for heterologous booster schedule

Immunogenicity outcomes
No studies reported or assessed this outcome

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 ].

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, therefore 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 trial, therefore no data are available for this subgroup [Ryzhikov A.B., 2021 ].

Breastfeeding
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, therefore 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 trial, therefore no data are available for this subgroup [Ryzhikov A.B., 2021 ].

Safety of the vaccine post-authorization

Comparative studies
None available

Non-comparative studies
None available

Monitoring

WHO indicates that after a vaccine is approved for use, regulators conduct robust monitoring of efficacy, as well as monitoring of safety and risk minimization (pharmacovigilance) activities. They need to continually monitor the safety of the vaccine to ensure that the benefits of the vaccine continue to outweigh the risks. [WHO, 2022 ]

Regarding safety surveillance and monitoring, serious adverse events, anaphylaxis and other severe allergic reactions, Bell's palsy, cases of multisystem inflammatory syndrome, cases of COVID-19 after vaccination resulting in hospitalization or death should be identified and recorded.

Regarding the effectiveness of the vaccine, the following should be monitored:
− Efficacy of the vaccine over time and whether protection can be prolonged with booster doses.
− Studies to investigate whether this vaccine reduces the transmission and viral spread of SARS-CoV-2.
− Evaluation and notification of vaccine failures and information on viral sequences.

Regarding the subgroups of interest
− Prospective studies on the safety of the COVID-19 vaccine in pregnant and lactating females.
− Occasional controlled trials on the safety and security of vaccination in children under 18 years of age.
− Safety data from vaccination in immunosuppressed people, including patients living with HIV and autoimmune diseases.

To review more information on the topic [WHO, 2022 ],[World Health Organization, 2021 ], [Organización Mundial de la Salud, 2022 ]

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.
[Ministry of Health of the Russian Federation, 2021] Ministry of Health of the Russian Federation. Vaccination of adults against COVID-19. 2021; Ministry of Health of the Russian Federation. Vaccination of adults against COVID-19. 2021;
[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;
[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.
[Barchuk A, 2022] Barchuk A, Bulina A, Cherkashin M et al. Gam-COVID-Vac, EpiVacCorona, and CoviVac effectiveness against lung injury during Delta and Omicron variant surges in St. Petersburg, Russia: a test-negative case-control study. Respiratory research. 2022;23(1):276 Barchuk A, Bulina A, Cherkashin M et al. Gam-COVID-Vac, EpiVacCorona, and CoviVac effectiveness against lung injury during Delta and Omicron variant surges in St. Petersburg, Russia: a test-negative case-control study. Respiratory research. 2022;23(1):276
[Barchuk A, 2022] Barchuk A, Bulina A, Cherkashin M et al. COVID-19 vaccines effectiveness against symptomatic SARS-CoV-2 during Delta variant surge: a preliminary assessment from a case-control study in St. Petersburg, Russia. BMC public health. 2022;22(1):1803. Barchuk A, Bulina A, Cherkashin M et al. COVID-19 vaccines effectiveness against symptomatic SARS-CoV-2 during Delta variant surge: a preliminary assessment from a case-control study in St. Petersburg, Russia. BMC public health. 2022;22(1):1803.
[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.
[WHO, 2022] WHO. Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness (Revised March 2022). WHO - Reports. 2022; WHO. Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness (Revised March 2022). WHO - Reports. 2022;
[WHO, 2022] WHO. Coronavirus disease (COVID-19): Vaccines safety. World Health Organization - Q&A. 2022;(February). WHO. Coronavirus disease (COVID-19): Vaccines safety. World Health Organization - Q&A. 2022;(February).
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[Organización Mundial de la Salud, 2022] Organización Mundial de la Salud. Interim statement on the use of additional booster doses of Emergency Use Listed mRNA vaccines against COVID-19. WHO - News. 2022; Organización Mundial de la Salud. Interim statement on the use of additional booster doses of Emergency Use Listed mRNA vaccines against COVID-19. WHO - News. 2022;

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Vaxzevria of AstraZeneca/ SK Bioscience CO. Ltd	Click to see the list
VidPrevtyn Beta New	European Union (based upon the recommendation of the European Medicines Agency)
WIBP-CorV of Wuhan Institute of Biological Products; China National Pharmaceutical Group (Sinopharm)	Click to see the list
Zifivax of Anhui Zhifei Longcom	Click to see the list
ZyCoV-D of Zydus Cadila	India

COVID-19 vaccines

Country

Abdala of Center for Genetic Engineering and Biotechnology (CIGB)

Adopted Name	Name	EUL holder and NRA responsable	Authorized sites (Finished product - countries)
Pfizer-BioNTech COVID-19 vaccine 2BNT162b2; Tozinameran; Comirnaty	COMIRNATY® COVID-19 mRNA Vaccine (nucleoside modified)	Holder: BioNTech Manufacturing GmbH, Alemania NRA responsable: European Medicines Agency (EMA) Effective date: 31/12/2020 Reference Link:http://bit.ly/3NwlDFa	Authorized site: EE.UU. NRA Food and Drug Administration (FDA), USA Efective date: 16/7/2021 Reference Link: https://bit.ly/3wPb0Hr
Pfizer-BioNTech COVID-19 vaccine 2BNT162b2; Tozinameran/riltozinameran	COMIRNATY®Original/Omicron BA.1 COVD-19 mRNA Vaccine (nucleoside modified)	Holder: BioNTech Manufacturing GmbH, Alemania NRA responsable: European Medicines Agency (EMA) Effective date: 19/10/2022 Reference Link: https://extranet.who.int/pqweb/vaccines/comirnaty-originalomicron-ba1
Pfizer-BioNTech COVID-19 vaccine Tozinameran/famtozinameran New	COMIRNATY®Original/Omicron BA.4-5 COVD-19 mRNA Vaccine (nucleoside modified)	Holder: BioNTech Manufacturing GmbH, Alemania NRA responsable: European Medicines Agency (EMA) Effective date: 11/11/2022 Reference Link: https://extranet.who.int/pqweb/vaccines/comirnaty-originalomicron-ba4-5
EU Nodes-AstraZeneca/ Oxford COVID-19 vaccine; Vaxzevria in Europe (formerly AZD1222 and ChAdOx1)*	Vaxzevria COVID-19 Vaccine (ChAdOx1-S [recombinant])	Holder: AstraZeneca/SK Bioscience Co. Ltd, Republica de Corea NRA responsable: Ministry of Food and Drug Safety Effective date: 15/2/2021 Reference Link: http://bit.ly/3NxXKNg
EU Nodes-AstraZeneca/ Oxford COVID-19 vaccine; Vaxzevria in Europe (formerly AZD1222 and ChAdOx1)*	Vaxzevria COVID-19 Vaccine (ChAdOx1-S [recombinant])	Holder: AstraZeneca AB NRA responsable: European Medicines Agency EMA Effective date: 15/4/2021 Reference Link: https://bit.ly/3KDGlkr	Authorized sites: (1) Italia, Japón RNA responsable: Ministry of Health, Labour and Welfare, Japon Efective date (1): 09/7/2021 Reference Link site: https://bit.ly/3iQGepq Authorized sites: (2) EE.UU, Italia, Reino Unido, Alemania, Australia, Tailandia RNA responsable: Therapeutic Goods Administration, Australia Efective date (2): 09/7/2021 Reference Link site: https://bit.ly/3wOMhTL Authorized sites: (3) Italia, Reino Unido, Alemania, Australia, EE.UU RNA responsable: Health Canadá Efective date (3): 21/8/2021 Reference Link site: https://bit.ly/3Loo0Ic Authorized sites: (4) Argentina, México RNA responsable: COFEPRIS, México; ANMAT, Argentina Efective date (4): 23/12/2021 Reference Link site: https://bit.ly/3uCVCeB
Serum Institute of India COVID-19 vaccine; Covishield in India*	COVISHIELD™ COVID-19 Vaccine (ChAdOx1-S [recombinant])	Holder: Serum Institute of India Pvt. Ltd. NRA responsable: Central Drugs Standard Control Organization Effective date: 15/4/2021 Reference Link: https://bit.ly/3KDGlkr
Janssen COVID-19 vaccine JNJ-78436735; Ad26.COV2-S (recombinant).	COVID-19 Vaccine (Ad26.COV2-S [recombinant])	Holder: Janssen–Cilag International NV. NRA responsable: European Medicines Agency EMA Effective date: 12/3/2021 Reference Link: https://bit.ly/382QkkW
Moderna COVID-19 vaccine mRNA-1273*	Spikevax COVID-19 mRNA Vaccine (nucleoside modified)	Holder: Moderna Biotech NRA responsable: European Medicines Agency EMA Effective date: 30/4/2021 Reference Link: https://bit.ly/3DsvHum	Authorized sites: República de Korea RNA responsable: Ministry of Food and Drug Safety (MFDS), Republic of Korea Efective date: 23/12/2021 Reference Link: https://bit.ly/3wORR8F
Moderna COVID-19 vaccine mRNA-1273*	Spikevax COVID-19 mRNA Vaccine (nucleoside modified)	Holder: Moderna TX,Inc. RNA responsable: FDA, USA Effective date: 6/8/2021 Reference Link: https://bit.ly/3wR7BrW
Sinopharm/ BIBP COVID-19 vaccine Inactivated SARS-CoV-2-vaccine (Vero cell); BBIBP-CorV	Inactivated COVID-19 Vaccine (Vero Cell)	Titular: Beijing Institute of Biological Products Co., Ltd. (BIBP) ARN responsable: National Medicinal Products Association Effective date: 7/5/2021 Reference Link: https://bit.ly/3K0A56k
Sinovac COVID-19 vaccine CoronaVac; adsorbed COVID-19 vaccine	CoronaVac COVID-19 Vaccine (Vero Cell), Inactivated	Titular: Sinovac Life Sciences Co., Ltd. China ARN responsable: National Medicinal Products Association Effective date: 1/6/2021 Reference Link: https://bit.ly/3NysEFh
Bharat Biotech COVID-19 vaccine; Covaxin; BBV152 Suspension of supply	COVAXIN® Covid-19 vaccine (Whole Virion Inactivated Corona Virus vaccine)	Holder: Bharat Biotech International Limited RNA responsable: Central Drugs Standard Control Organization Effective date: 3/11/2021 Reference Link: https://bit.ly/36EjcQg
Novavax vaccine COVID-19; NVX-CoV2373	COVOVAX™ COVID-19 vaccine (SARS-CoV-2 rS Protein Nanoparticle [Recombinant])	Holder: Serum Institute of India Pvt. Ltd RNA responsable: Central Drugs Standard Control Organization Effective date: 17/12/2021 Reference Link: https://bit.ly/3uAxHwq
Novavax vaccine COVID-19; NVX-CoV2373	NUVAXOVID™ COVID-19 Vaccine (SARS-CoV-2 rS [Recombinant, adjuvanted])	Holder: Novavax CZ a.s RNA responsable: European Medicines Agency EMA Effective date: 20/12/2021 Reference Link: https://bit.ly/3qPVFmp
COVID-19 Vaccine, (Ad5.CoV2-S [Recombinant])	Convidecia COVID-19 Vaccine, (Ad5.CoV2-S [Recombinant])	Holder: CanSino Biologics Inc. RNA responsable: National Medical Products Administration (NMPA) Effective date: 19 May 2022 Reference Link: https://extranet.who.int/pqweb/vaccines/convidecia

	Anhui Zhifei Longcom COVID-19 vaccine: Zifivax	AstraZeneca/ Oxford; SK BIO; Serum Institute of India COVID-19 vaccine: Vaxzevria; Covishield	Bharat Biotech COVID-19 vaccine: Covaxin (suspended supply)	CanSino COVID-19 vaccine: Convidecia	CIGB COVID-19 vaccine: Abdala	Finlay Institute COVID-19 vaccine: Soberana 02; Soberana Plus	Gamaleya COVID-19 vaccine: Sputnik V; Gam-COVID-Vac; Spuntik Light	Janssen COVID-19 vaccine: Jcovden	Moderna COVID-19 vaccine: Spikevax	Novavax COVID-19 vaccine: Nuvaxovid; Covovax	Pfizer-BioNTech COVID-19 vaccine: Comirnaty	Sinopharm/BIBP COVID-19 vaccine: Covilo	Sinopharm/WIBP COVID-19 vaccine	Sinovac COVID-19 vaccine: CoronaVac	Valneva COVID-19 vaccine	Vector Institute COVID-19 vaccine: EpiVacCorona
Alpha B.1.1.7	88.3% (66.8% to 97.0%) [1]	70% (44% to 84%) [2]	-	-	-	-	-	70.2% (35.3% to 87.6%) [11]	92% (86% to 96%) [15]*	86% (71% to 94%) [19]	83% (69% to 91.3%) to 88% (85% to 90%) [21], [22]*	-	-	65.0% (0% to 75%) [27]*	-	-
Beta B.1.351	-	10% (0% to 55%) [3]	-	-	-	-	-	51.9% (19.1% to 72.2%) [11]	-	51% (0% to 76%) [20]	100% (54% to 100%) [23]	-	-	-	-	-
Gamma P.1	-	63.6% (0.00% to 87.00%) [4]*	-	-	-	-	-	36.5% (14.1% to 53.3%) [11]	-	-	93% (78% to 98%) [22]*	-	-	41.6% (26.9% to 53.3%) [28]*	-	-
Delta B.1.617.2	76.1% (70.0% to 81.2%) [1]	44.3% (43.2% to 45.4%) to 74.5% (23.7% to 51.5%) [5], [6]*	65% (33% to 83%) [8]	61.5% (9.5% to 83.6%) [9]*	-	-	57% (51% to 63%)[10]*	39.3% (36.1% to 42.4%) to 72% (64% to 78%) [12], [13]*	72% (57% to 82%) to 98% (97% to 99%) [15], [16]*	-	62.4% (59.4% to 65.1%) to 95% (93% to 96%) [16], [24]*	63.5% (37.2% to 89.8%) [26]*	-	-	-	-
Omicron B.1.1.529	-	38.5% (20.2% to 52.6%) [7]*	-	-	-	-	-	37.3% (32.9% to 41.5%) [14]*	37.9% (34.4%-41.2%) to 75.1% (70.8% to 78.7%) [17], [18]*	-	37.0% (35.6% to 38.3%) to 91% (83% to 95%) [17], [25]*		-	-0.3% (-2.7 to -2.1) to 77.8% (49.6 to 90.2) [29], [30]*	-	-

	Anhui Zhifei Longcom COVID-19 vaccine: Zifivax [1]	AstraZeneca/ Oxford; SK BIO; Serum Institute of India COVID-19 vaccine: Vaxzevria; Covishield [2]	Bharat Biotech COVID-19 vaccine: Covaxin (suspended supply)[3]	CanSino COVID-19 vaccine: Convidecia [4]	CIGB COVID-19 vaccine: Abdala	Finlay Institute of vaccines COVID-19 vaccine: Soberana 02; Soberana Plus [5]	Gamaleya COVID-19 vaccine: Sputnik V; Gam-COVID-Vac; Spuntik Light [6]	Janssen COVID-19 vaccine: Jcovden [7]	Moderna COVID-19 vaccine: Spikevax [8]	Novavax COVID-19 vaccine: Nuvaxovid; Covovax [9],[10]	Pfizer-BioNTech COVID-19 vaccine: Comirnaty [11]	Sinopharm/BIBP COVID-19 vaccine: Covilo [12]	Sinopharm/WIBP COVID-19 vaccine [13]	Sinovac COVID-19 vaccine: CoronaVac [14],[15]	Valneva COVID-19 vaccine	Vector Institute COVID-19 vaccine: EpiVacCorona
Contracting COVID-19*	75.7% (71% to 80%)	64% (39% to 79%)	77% (65% to 85%)	57% (40% to 70%)	92% (86% to 96%)	71% (59% to 80%)	91% (83% to 95%)	64% (36% to 79%)	93% (90% to 94%)	90% (84% to 93%)	91% (89% to 93%)	74% (61% to 82%)	64% (49% to 75%)	71% (7% to 91%)	Has not been measured or reported	Has not been measured or reported
Symptomatic COVID-19 infection**	75.7% (71% to 80%)	67% (57% to 74%)	68% (47% to 83%)	64% (53% to 72%)	92% (85% to 96%)	Has not been measured or reported	91% (83% to 95%)	64% (36% to 79%)	93% (90% to 94%)	90% (80% to 95%)	91% (89% to 93%)	78% (65% to 86%)	73% (58% to 82%)	71% (7% to 91%)	Has not been measured or reported	Has not been measured or reported
Asymptomatic COVID-19 infection***	Has not been measured or reported	Has not been measured or reported	64% (29% to 82%)	Has not been measured or reported	Has not been measured or reported	Has not been measured or reported	Has not been measured or reported	Has not been measured or reported	57% (50% to 64%)	Has not been measured or reported	Has not been measured or reported	52% (1% to 78%)	Has not been measured or reported	Has not been measured or reported	Has not been measured or reported	Has not been measured or reported
Contracting severe COVID-19	88% (70% to 96%)	91% (7% to 99%)	93% (49% to 99%)	96% (70% to 99%)	94% (59% to 99%)	78% (41% to 78%)	99% (87% to 100%)	77% (41% to 91%)	98% (92% to 100%)	93% (46% to 99%)	96% (68% to 99%)	80% ( 0% to 99%)	80% ( 0% to 99%)	94% (58% to 99%)	Has not been measured or reported	Has not been measured or reported
Mortality	Not estimated****	Not estimated****	Not estimated****	Not estimated****	Not estimated****	Not estimated****	Not estimated****	Not estimated****	Not estimated****	Not estimated****	Not estimated****	Not estimated****	Not estimated****	Not estimated****	Not estimated****	Not estimated****

COVID-19 vaccines	Other Names	Platform	SAGE/WHO Indication	Administration	Presentation	Diluent	Adjuvant	Preservatives
Anhui Zhifei Longcom COVID-19 vaccine	ZIFIVAX; ZF-UZ-VAC 2001; ZF2001	Protein subunit	Has not been recommended	IM	Monodose vial (0.5 mL)	No	Aluminium hydroxide-based adjuvant	Not yet available
AstraZeneca/Oxford; SK BIO; Serum Institute of India COVID-19 vaccine (EUL)	Vaxzevria in Europe (formerly AZD1222 and ChAdOx1); Covishield in India; ChAdOx1-S [recombinant]	Viral vector (non-replicating)	Individuals aged 18 years and over, pregnancy (if the benefits of vaccination to the pregnant person outweigh the potential risks) and breastfeeding	IM	Multidose vials of 2, 8 or 10 doses (0.5 mL each). Vial volume: 1, 4, or 5 mL, respectively.	No	No	No
Bharat Biotech COVID-19 vaccine (EUL, suspended supply)	Covaxin; BBV152	Inactivated virus	Individuals aged 18 years and over, pregnancy (if the benefits of vaccination to the pregnant person outweigh the potential risks) and breastfeeding.	IM	Monodose (0.5 mL) or multidose vials of 5, 10 and 20 doses (2.5, 5, and 10 mL, respectively).	No	IMDG (Imidazo quinolin gallamide) and alum	Phenoxy ethanol
CanSino COVID-19 vaccine	Convidecia; PakVac; Ad5-nCoV	Viral vector (non-replicating)	Individuals aged 18 years and over, pregnancy (if the benefits of vaccination to the pregnant person outweigh the potential risks) and breastfeeding.	IM	Monodose (0.5 mL) or multidose vials of 3 doses (1,5 mL).	No	No	No
CIGB (Centro de Ingeniería Genética y Biotecnología) COVID-19 vaccine	Abdala; CIGB-66	Protein subunit	Has not been recommended	IM	Multidose vial of 10 doses (0.5 mL each). Vial volume: 5 mL.	No	Aluminium hydroxide-based adjuvant	Thiomersal
Finlay Institute of vaccines COVID-19 vaccine	FINLAY-FR-2, SOBERANA 02; SOBERANA 02 ST; SOBERANA PLUS; SOBERANA PLUS ST	Protein subunit	Has not been recommended	IM	Soberana 02 and Soberana Plus: multidose vial of 10 doses (0.5 mL each). Vial volume: 5 mL. Every 10-dose vial contains thiomersal; Soberana 02 ST and Soberana plus ST: monodose vial without thimerosal.	No	Aluminium hydroxide-based adjuvant	Soberana 02 and Soberana Plus: Thiomersal
Gamaleya COVID-19 vaccine	Sputnik V; Gam-COVID-Vac; Adeno-based (rAd26-S+rAd5-S) / Sputnik light	Viral Vector (non-replicating)	Has not been recommended	IM	Sputnik V: multidose vial of 5 doses (0.5 mL each). Vial volume: 2.5 mL. Sputnik Light: multidose vial of 5 doses (0.5 mL each). Vial volume: 2.5 mL.	No	No	No
Janssen COVID-19 vaccine (EUL)	JCOVDEN; JNJ-78436735; Ad26.COV2-S (recombinant)	Viral vector (non-replicating)	Individuals aged 18 years and over, pregnancy (if the benefits of vaccination to the pregnant person outweigh the potential risks) and breastfeeding	IM	Multidose vial of 5 doses (0.5 mL each). Vial volume: 2.5 mL.	No	No	No
Moderna COVID-19 vaccine (EUL)	Spikevax (original); TAK-919; elasomeran; mRNA-1273	RNA-based vaccine	Individuals aged 6 months and over, pregnancy and breastfeeding.	IM	Multidose vials of 10 or 15 doses (0.5 mL each). Vial volume: 5, or 7.5 mL, respectively.	No	Lipid nanoparticle (LNP)	No
Novavax/Serum Institute of India (SII) COVID-19 vaccine	NUVAXOVID; COVOVAX; NVX-CoV2373	Protein subunit	Individuals aged 12 years and over, pregnancy, and breastfeeding	IM	Multidose vial of 10 doses (0.5 mL each). Vial volume: 5 mL.	No	Matrix-M1	No
Pfizer-BioNTech COVID-19 vaccine (EUL)	Comirnaty; tozinameran; BNT162b2	RNA-based vaccine	Individuals aged 6 months and over, pregnancy and breastfeeding.	IM	Concentrate for dispersion for injection: multidose vial of 6 doses after dilution (0.3 mL each). 'Ready to use' formulation: multi-dose vial (0.3 mL each). Pediatric formulation (5-11 years): concentrate for dispersion for injection: multidose vial of 10 doses after dilution (0.2 mL each).	Concentrate for dispersion for injection: Sodium Chloride. 'Ready to use' formulation: No	Lipid nanoparticle (LNP)	No
Sinopharm/BIBP (Beijing Institute of Biological Products) COVID-19 vaccine (EUL)	Covilo; Inactivated SARS-CoV-2-vaccine (Vero cell); BBIBP-CorV; adsorbed COVID-19 vaccine	Inactivated virus	Individuals aged 18 years and over, pregnancy (if the benefits of vaccination to the pregnant person outweigh the potential risks) and breastfeeding	IM	Monodose (0.5 mL) or multidose vial of 2 or 5 doses (1, or 2.5 mL).	No	Aluminium hydroxide-based adjuvant	No
Sinopharm/WIBP (Wuhan Institute of Biological Products) COVID-19 vaccine	Inactivated SARS-CoV-2-vaccine (Vero cell); WIBP-CorV; adsorbed COVID-19 vaccine	Inactivated virus	Has not been recommended	IM	Monodose vial (0.5 mL)	No	Aluminium hydroxide-based adjuvant	No
Sinovac COVID-19 vaccine (EUL)	CoronaVac; adsorbed COVID-19 vaccine	Inactivated virus	Individuals aged 18 years and over, pregnancy (if the benefits of vaccination to the pregnant person outweigh the potential risks) and breastfeeding	IM	(a) Monodose (0.5 mL) or multidose vial of 2 doses (vial volume: 1 mL), or (b) monodose in a prefilled syringe.	No	Aluminium hydroxide-based adjuvant	No
Vector Institute COVID-19 vaccine	EpiVacCorona; EpiVakKorona	Protein subunit	Has not been recommended	IM	Not yet available	No	No	No
Valneva COVID-19 vaccine	COVID-19 vaccine (inactivated, adjuvanted, adsorbed); VLA2001	Inactivated virus	Individuals aged 18-50 years, pregnancy (if the benefits of vaccination to the pregnant person outweigh the potential risks) and breastfeeding	IM	Multidose vial of 10 doses (0.5 mL each). Vial volume: 5 mL.	No	Aluminium hydroxide-based adjuvant	No

	Myocarditis/pericarditis	Guillain-Barré Syndrome (GBS)	Thrombosis with thrombocytopenia syndrome (TTS)	Capillary leak syndrome (CLS)	Cerebral venous sinus thrombosis (CVST) without thrombocytopenia	Menstrual disorders	Multisystem inflammatory syndrome (MIS)	Small vessel vasculitis with cutaneous manifestations	Autoimmune Hepatitis (AIH)
AstraZeneca/Oxford; SK BIO; Serum Institute of India COVID-19 vaccine: Vaxzevria; Covishield	NA	Guillain-Barré syndrome (GBS) have been reported very rarely following vaccination with Vaxzevria [21]. The benefits of the vaccine outweigh the risks of GBS [2]; [3].	TTS in some cases accompanied by bleeding, has been observed very rarely following vaccination with Vaxzevria. This includes severe cases ans unusual sites such as cerebral venous sinus thrombosis, splanchnic vein thrombosis, as well as arterial thrombosis. Some cases had a fatal outcome. The majority of these cases occurred within the first three weeks following vaccination. The reporting rates after the second dose are lower compared to after the first dose [21]. Vaxzevria is contraindicated in persons who have experienced TTS with previous doses of the vaccine [2].	Very rare cases of capillary leak syndrome (CLS) were reported in the first days after vaccination with Vaxzevria, with fatal outcomes in some people with prior experience of CLS. EMA recommends that persons with a known history of CLS should not be vaccinated with Vaxzevria [5] [21].	Events of cerebrovascular venous and sinus thrombosis (CVST) without thrombocytopenia have been observed very rarely following vaccination with Vaxzevria, mostly within the first four weeks following vaccination. This information should be considered for individuals at increased risk for CVST [3].	NA	NA	NA	NA
Bharat Biotech COVID-19 vaccine: Covaxin (suspended supply)	NA	NA	NA	NA	NA	NA	NA	NA	NA
CanSino COVID-19 vaccine: Convidecia	NA	NA	Very rare cases of thrombosis with thrombocytopenia syndrome (TTS) were reported globally (0.081 cases per 100.000 vaccinees as of December 2021) around 3-30 days following vaccination with CanSino [1].	NA	NA	NA	NA	NA	NA
Janssen COVID-19 vaccine: Jcovden	Reporting of advers events probably increased risks of myocarditis and pericarditis, particularly within the period 0 to 7 days after vaccination [cb18ffd03bac048bbab5482a4784537781c67a3f]	GBS has been reported very rarely following vaccination with Janssen COVID-19 vaccine. As of April 2022, 535 cases were reported globally (1.5 cases per million vaccinees) [6], [18] The benefits of the vaccine outweigh the risks of GBS [6].	Very rare cases of thrombosis with thrombocytopenia syndrome (TTS) were reported following the first dose of Janssen COVID-19 vaccine. As of April 2022, 109 cases were reported globally (2 cases per million vaccinees) [6]. The benefits of vaccination outweigh the risks, especially in older age groups [4]. Janssen COVID-19 vaccine is contraindicated in persons who have experienced TTS with previous doses of the vaccine [4]; [6].	Very rare cases of capillary leak syndrome (CLS) were reported in the first days after vaccination with Janssen COVID-19 vaccine, with fatal outcomes in some people with prior experience of CLS. EMA recommends that persons with a known history of CLS should not be vaccinated with Janssen COVID-19 vaccine [7] [18]	Venous thromboembolism (VTE) has been observed rarely following vaccination with Janssen COVID-19 vaccine. This should be considered for individuals at increased risk for VTE [8].	NA	NA	PRAC/EMA recommends that small vessel vasculitis with cutaneous manifestations should be added to the product information of the Janssen COVID-19 vaccine as a possible side effect with unknown frequency [9].	NA
Moderna COVID-19 vaccine: Spikevax	These conditions can develop within just a few days after vaccination, and have primarily occurred within 14 days. They have been observed more often after the second dose compared to the first dose, and more often in younger males [19]. The benefits of Spikevax continue to outweigh its risks in all age groups [10].	NA	NA	A few cases of capillary leak syndrome (CLS) flare-ups have been reported in the first days after vaccination with Spikevax [19].	NA	The PRAC-EMA has concluded that heavy menstrual bleeding is a side effect of unknown frequency of Spikevax. Most of cases are non-serious and temporaty in nature. There is no evidence to suggest the menstrual disorders experienced have any impact on reproduction and fertility [12].	NA	NA	According to PRAC/EMA, the available evidence does not support a causal link between Moderna COVID-19 vaccine and very rare cases of autoimmune hepatitis (AIH) [13].
Novavax COVID-19 vaccine: Nuvaxovid; Covovax	There is an increased risk of myocarditis and pericarditis following vaccination with Nuvaxovid. These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days. [16].	NA	NA	NA	NA	NA	NA	NA	NA
Pfizer-BioNTech COVID-19 vaccine: Comirnaty	There is an increased risk of myocarditis and pericarditis following vaccination with Comirnaty. These conditions can develop within just a few days after vaccination, and have primarily occurred within 14 days. They have been observed more often after the second vaccination, and more often in younger males; [14], [17]. The benefits of Comirnaty continue to outweigh its risks in all age groups [14].	NA	NA	NA	NA	The PRAC-EMA has concluded that heavy menstrual bleeding is a side effect of unknown frequency of Comirnaty. Most of cases are non-serious and temporaty in nature. There is no evidence to suggest the menstrual disorders experienced have any impact on reproduction and fertility [17].	According to PRAC/EMA, there is currently insufficient evidence of a possible link between Comirnaty and very rare cases of multisystem inflammatory syndrome (MIS) [15].	NA	According to PRAC-EMA, the available evidence does not support a causal link between Comirnaty and very rare cases of autoimmune hepatitis (AIH) [13].
Sinopharm/BIBP COVID-19 vaccine: Covilo	NA	NA	NA	NA	NA	NA	NA	NA	NA
Sinovac COVID-19 vaccine: CoronaVac	NA	NA	NA	NA	NA	NA	NA	NA	NA

	Individuals 6 months to 4 years old	Individuals 5 to 11 years old	Individuals 12 to 17 years old	Individuals 18 years old and older	Pregnant and breastfeeding women	Immunocompromised persons (moderate and severe)				Heterologous scheme	Booster doses
	Individuals 6 months to 4 years old	Individuals 5 to 11 years old	Individuals 12 to 17 years old	Individuals 18 years old and older	Pregnant and breastfeeding women	6 months to 4 years old	5 to 11 years old	12 to 17 years old	18 years and older	Heterologous scheme	Booster doses
Anhui Zhifei Longcom COVID-19 vaccine: Zifivax (Authorized) [1]	Not recommended yet	Not recommended yet	Not recommended yet	INVIMA/Colombia: Three doses (0.5 mL each) 4 and 8 weeks apart.	INVIMA/Colombia: contraindicated in pregnant women.	Not recommended yet	Not recommended yet	Not recommended yet	INVIMA/Colombia: primary series of three doses (0.5 mL each) 4 and 8 weeks apart.	There is no available data on interchangeability.	There is no available data on booster doses beyond the third dose.
AstraZeneca/Oxford; AstraZeneca/SK BIO; Serum Institute of India COVID-19 vaccine: Vaxzevria; Covishield (EUL/WHO authorization) [2]	Not recommended yet	Not recommended yet	Not recommended yet	SAGE/WHO: Two doses (0.5 mL each) 4 to 12 weeks apart. WHO recommends an interval of 8 to 12 weeks between doses.	SAGE/WHO: Two doses (0.5 mL each) 8 to 12 weeks apart. WHO recommends using the Vaxzevria/Covishield COVID-19 vaccine in pregnant women only if the benefits of vaccination outweigh the potential risks.	Not recommended yet	Not recommended yet	Not recommended yet	SAGE/WHO: Extended primary series with an additional (third) dose of 0.5 mL 1-3 months after the second dose, followed by a booster (fourth) dose provided 3-6 months after.	SAGE/WHO: Vaxzevria/Covishield combined with any other EUL COVID-19 vaccine is considered a complete primary series.	SAGE/WHO: A booster dose should be given 4-6 months after the primary series* using any other EUL vaccine (preferably an mRNA-based or Novavax vaccine).
Bharat Biotech COVID-19 vaccine: Covaxin (EUL/WHO authorization, suspended supply) [3]	Not recommended yet	Not recommended yet	Not recommended yet	SAGE/WHO: Two doses (0.5 mL each) 4 weeks apart.	SAGE/WHO: Two doses (0.5 mL each) 4 weeks apart. WHO recommends using the Bharat Biotech COVID-19 vaccine in pregnant women only if the benefits of vaccination outweigh the potential risks.	Not recommended yet	Not recommended yet	Not recommended yet	SAGE/WHO: Extended primary series with an additional (third) dose of 0.5 mL 1-3 months after the second dose, followed by a booster (fourth) dose provided 3-6 months after.	SAGE/WHO: Bharat Biotech COVID-19 vaccine combined with any other EUL COVID-19 vaccine is considered a complete primary series.	SAGE/WHO: A booster dose should be given 4-6 months after the primary series*.
CanSino COVID-19 vaccine: Convidecia (EUL/WHO authorization) [4]	Not recommended yet	Not recommended yet	Not recommended yet	SAGE/WHO: One dose of 0.5 mL.	SAGE/WHO: One dose of 0.5 mL. WHO recommends using the CanSino COVID-19 vaccine in pregnant women only if the benefits of vaccination outweigh the potential risks.	Not recommended yet	Not recommended yet	Not recommended yet	SAGE/WHO: Extended primary series with an additional (second) dose administered 1-3 months after the first dose.	SAGE/WHO: CanSino COVID-19 vaccine may be used as a booster dose following a primary series using any other EUL COVID-19 vaccine.	SAGE/WHO: A booster dose should be given 4-6 months after the primary series*.
CIGB COVID-19 vaccine: Abdala (Authorized) [5]	CECMED/Cuba: 2 years of age and older. Three doses (0.5 mL) 2 weeks apart.	CECMED/Cuba: Three doses (0.5 mL) 2 weeks apart.	CECMED/Cuba: Three doses (0.5 mL) 2 weeks apart.	CECMED/Cuba: Three doses (50 µg, 0.5 mL) 2 weeks apart.	CECMED/Cuba: if the benefits of the vaccination outweigh the potential risks.	CECMED/Cuba: 2 years of age and older. Three doses (0.5 mL) 2 weeks apart.	CECMED/Cuba: Three doses (0.5 mL) 2 weeks apart.	CECMED/Cuba: Three doses (0.5 mL) 2 weeks apart.	CECMED/Cuba: Three doses (50 µg, 0.5 mL) 2 weeks apart.	There is no available data on interchangeability.	There is no available data on booster doses.
Finlay Institute of Vaccines COVID-19 vaccine: Soberana 02; Soberana Plus (Authorized) [6]	CECMED/Cuba: SOBERANA 02 and SOBERANA 02 ST: 2 years of age and older. Two doses (0.5 mL) 4 weeks apart. SOBERANA PLUS and SOBERANA PLUS as a booster dose 4 weeks after.	CECMED/Cuba: SOBERANA 02 and SOBERANA 02 ST: Two doses (0.5 mL) 4 weeks apart. SOBERANA PLUS and SOBERANA PLUS as a booster dose 4 weeks after.	CECMED/Cuba: SOBERANA 02 and SOBERANA 02 ST: Two doses (0.5 mL) 4 weeks apart. SOBERANA PLUS and SOBERANA PLUS as a booster dose 4 weeks after.	CECMED/Cuba: SOBERANA® 02 and SOBERANA® 02 ST: Two doses (0.5 mL each) 4 weeks apart. Soberana Plus and Soberana Plus ST: Single dose (0.5 mL) as a booster vaccine 4 weeks after a primary schedule with SOBERANA® 02 or SOBERANA® 02 ST.	CECMED/Cuba: if the benefits of the vaccination outweigh the potential risks.	CECMED/Cuba: SOBERANA 02 and SOBERANA 02 ST: 2 years of age and older. Two doses (0.5 mL) 4 weeks apart. SOBERANA PLUS and SOBERANA PLUS as a booster dose 4 weeks after.	CECMED/Cuba: SOBERANA 02 and SOBERANA 02 ST: Two doses (0.5 mL) 4 weeks apart. SOBERANA PLUS and SOBERANA PLUS as a booster dose 4 weeks after.	CECMED/Cuba: SOBERANA 02 and SOBERANA 02 ST: Two doses (0.5 mL) 4 weeks apart. SOBERANA PLUS and SOBERANA PLUS as a booster dose 4 weeks after.	CECMED/Cuba: SOBERANA® 02 and SOBERANA® 02 ST: Two doses (0.5 mL each) 4 weeks apart. Soberana Plus and Soberana Plus ST: Single dose (0.5 mL) as a booster vaccine 4 weeks after a primary schedule with SOBERANA® 02 or SOBERANA® 02 ST.	There is no available data on interchangeability.	CECMED/Cuba: SOBERANA Plus and SOBERANA Plus ST may be used as a booster dose 4 weeks after a primary schedule with SOBERANA 02 or SOBERANA 02 ST.
Gamaleya COVID-19 vaccine: Sputnik V; Gam-COVID-Vac; Spuntik Light (Authorized) [7],[8]	Not recommended yet	Not recommended yet	Not recommended yet	ANMAT/Argentina: Sputnik V: Two doses of different components (0,5ml each) 3 weeks apart. Sputnik Light: One dose (0.5 mL).	ISP/Chile: if the benefits of the vaccination outweigh the potential risks.	Not recommended yet	Not recommended yet	Not recommended yet	ANMAT/Argentina: primary schedule with Sputnik V, followed by an additional (third) dose 4 months after with Sputnik V.	ANMAT/Argentina: a heterologous scheme using Sputnik V component 1 followed by a second dose of any authorized mRNA-based or viral vector vaccine may be used.	ANMAT/Argentina: A booster dose should be given at least 4 months after the primary scheme using an mRNA-based or viral vector vaccine.
Janssen COVID-19 vaccine: Jcovden (EUL/WHO authorization) [9]	Not recommended yet	Not recommended yet	Not recommended yet	SAGE/WHO: One or two doses (0.5 mL each). WHO recommends providing two doses with an interval of 2 to 6 months.	SAGE/WHO: One or two doses (0.5 mL each) 2-6 months apart. WHO recommends using the Janssen COVID-19 vaccine in pregnant women only if the benefits of vaccination outweigh the potential risks.	Not recommended yet	Not recommended yet	Not recommended yet	SAGE/WHO: Two doses (0.5 mL each) 1-3 months apart.	SAGE/WHO: the homologous two-dose schedule is the standard practice. However, a heterologous scheme using a second dose of an mRNA vaccine may be more immunogenic and effective.	SAGE/WHO: the need and timing of booster doses beyond the second dose are under assessment.
Moderna COVID-19 vaccine: Spikevax (EUL/WHO authorization) [10]	SAGE/WHO: for ages 6 months-5 years: Two doses (25 µg, 0.25 ml each) 4-8 weeks apart.	SAGE/WHO: ages 6-11 years: Two doses (50 µg each) 4-8 weeks apart.	SAGE/WHO: Two doses (100 µg, 0.5 ml each) 4 to 8 weeks apart.	SAGE/WHO: Two doses (100 µg, 0.5 ml each) 4 to 8 weeks apart.	SAGE/WHO: Two doses (100 µg, 0.5 mL each) 8 weeks apart.	SAGE/WHO: Extended primary series with an additional (third) dose 1-3 months after the second dose, and two boosters (fourth and fifth doses) given 4-6 months after the previous dose.	SAGE/WHO: Extended primary series with an additional (third) dose 1-3 months after the second dose, and two boosters (fourth and fifth doses) given 4-6 months after the previous dose.	SAGE/WHO: Extended primary series with an additional (third) dose 1-3 months after the second dose, and two boosters (fourth and fifth doses) given 4-6 months after the previous dose.	SAGE/WHO: Extended primary series with an additional (third) dose 1-3 months after the second dose, and two boosters (fourth and fifth doses) given 4-6 months after the previous dose.	SAGE/WHO: Moderna COVID-19 vaccine combined with any other EUL COVID-19 vaccine is considered a complete primary series.	SAGE/WHO: A booster dose should be given 4-6 months after the primary series* and a second booster after 4-6 months for specific population groups**. WHO recommends Moderna COVID-19 vaccine as a heterologous booster.
Novavax/ Serum Institute of India COVID-19 vaccine: Nuvaxovid; Covovax (EUL/WHO authorization) [11], [12]	Not recommended yet	Not recommended yet	SAGE/WHO: Two doses (0.5 mL each) 3-4 weeks apart.	SAGE/WHO: Two doses (0.5 mL each) 3-4 weeks apart.	SAGE/WHO: Two doses (0.5 mL each) 3-4 weeks apart.	Not recommended yet	Not recommended yet	SAGE/WHO: Extended primary series with an additional (third) dose 1-3 months after the second dose, and two boosters (fourth and fifth doses) given 4-6 months after the previous dose.	SAGE/WHO: Extended primary series with an additional (third) dose 1-3 months after the second dose, and two boosters (fourth and fifth doses) given 4-6 months after the previous dose.	SAGE/WHO: Novavax COVID-19 vaccine combined with any other EUL COVID-19 vaccine is considered a complete primary series.	SAGE/WHO: A booster dose should be given 4-6 months after the primary series* and a second booster after 4-6 months for specific population groups**.
Pfizer-BioNTech COVID-19 vaccine: Comirnaty (EUL/WHO authorization) [13]	SAGE/WHO: Three doses (3 µg, 0.2 each). The first two doses administered 3 weeks apart, followed by a third dose 8 weeks after.	SAGE/WHO: Two doses (10 µg, 0.2 mL each) 4 to 8 weeks apart.	SAGE/WHO: Two doses (30 µg, 0.3 mL each) 4 to 8 weeks apart.	SAGE/WHO: Two doses (30 µg, 0.3 mL each) 4 to 8 weeks apart. WHO recommends an interval of 8 weeks.	SAGE/WHO: Two doses (30 µg, 0.3 mL each) 8 weeks apart.	SAGE/WHO: Three doses (3 µg, 0.2 each), and two boosters (fourth and fifth doses) given 4-6 months after the previous dose.	SAGE/WHO: Extended primary series with an additional (third) 10 µg dose 1-3 months after the second dose, and two boosters (fourth and fifth doses) given 4-6 months after the previous dose.	SAGE/WHO: Extended primary series with an additional (third) 30 µg dose 1-3 months after the second dose, and two boosters (fourth and fifth doses) given 4-6 months after the previous dose.	SAGE/WHO: Extended primary series with an additional (third) 30 µg dose 1-3 months after the second dose, and two boosters (fourth and fifth doses) given 4-6 months after the previous dose.	SAGE/WHO: Comirnaty (Pfizer-BioNTech) combined with any other EUL COVID-19 vaccine is considered a complete primary series.	SAGE/WHO: A booster dose should be given 4-6 months after the primary series* and a second booster after 4-6 months for specific population groups**. WHO recommends Comirnaty vaccine as a heterologous booster.
Sinopharm/BIBP COVID-19 vaccine: Covilo (EUL/WHO authorization) [7], [14]	ANMAT/Argentina: 3 years of age and older. Two doses (0.5 mL each) 3 weeks apart.	ANMAT/Argentina: Two doses (0.5 mL each) 3 weeks apart.	ANMAT/Argentina: Two doses (0.5 mL each) 3 weeks apart.	SAGE/WHO: Two doses (0.5mL each) 3 weeks apart. WHO recommends an interval of 3-4 weeks.	SAGE/WHO: Two doses (0.5 mL each) 3 to 4 weeks apart. WHO recommends using the Sinopharm/BIBP COVID-19 vaccine in pregnant women only if the benefits of vaccination outweigh the potential risks.	ANMAT/Argentina: 3 years of age and older. Two doses (0.5 mL) 3 weeks apart, followed by an additional (third) dose provided 4 weeks after.	ANMAT/Argentina: Two doses (0.5 mL) 3 weeks apart, followed by an additional (third) dose provided 4 weeks after.	ANMAT/Argentina: Two doses (0.5 mL) 3 weeks apart, followed by an additional (third) dose provided 4 weeks after.	SAGE/WHO: Extended primary series with an additional (third) dose of 0.5 mL 1-3 months after the second dose, followed by a booster (fourth) dose provided 3-6 months after.	SAGE/WHO: Sinopharm/BIBP COVID-19 vaccine combined with any other EUL COVID-19 vaccine is considered a complete primary series.	SAGE/WHO: A booster dose should be given 4-6 months after the primary series* using any other EUL vaccine (preferably an mRNA-based or viral vector vaccine).
Sinopharm/WIBP COVID-19 vaccine (Authorized) [15], [16]	Not recommended yet	Not recommended yet	Not recommended yet	NMPA/China: Two doses (0.5mL each) 3-4 weeks apart.	NMPA/China: There is insufficient data on using the Sinopharm/WIBP COVID-19 vaccine during pregnancy.	Not recommended yet	Not recommended yet	Not recommended yet	NMPA/China: Two doses (0.5mL each) 3-4 weeks apart.	NMPA/China: a heterologous booster schedule is recommended.	NMPA/China: A booster dose should be given 6 months after the primary series using a protein subunit vaccine (Anhui Zhifei vaccine) or a viral vector-based one (CanSino vaccine).
Sinovac COVID-19 vaccine: CoronaVac (EUL/WHO authorization) [8], [17]	ISP/Chile: Two doses 2-4 weeks apart (dosage recommendation not yet available)	ISP/Chile: Two doses (0.5 mL) 2-4 weeks apart.	ISP/Chile: Two doses (0.5 mL) 2-4 weeks apart.	SAGE/WHO: Two doses (0.5 mL each) 2-4 weeks apart. WHO recommends an interval of 4 weeks.	SAGE/WHO: Two doses (0.5 mL each) 2-4 weeks apart. WHO recommends using the Sinovac COVID-19 vaccine in pregnant women only if the benefits of vaccination outweigh the potential risks.	ISP/Chile: recommendation not yet available	ISP/Chile: 3 years of age and older. Two doses (0.5 mL) 2-4 weeks apart and a booster (third) dose provided 2 months after.	ISP/Chile: Two doses (0.5 mL) 2-4 weeks apart and a booster (third) dose provided 2 months after.	SAGE/WHO: Extended primary series with an additional (third) dose of 0.5 mL 1-3 months after the second dose, followed by a booster (fourth) dose provided 3-6 months after.	SAGE/WHO: CoronaVac (Sinovac) combined with any other EUL COVID-19 vaccine is considered a complete primary series.	SAGE/WHO: A booster dose should be given 4-6 months after the primary series* using any other EUL vaccine (preferably an mRNA-based or viral vector vaccine).
Valneva COVID-19 vaccine (Authorized) [18]	Not recommended yet	Not recommended yet	Not recommended yet	SAGE/WHO: Two doses (0.5 mL each) 4 weeks apart.	SAGE/WHO: Two doses (0.5 mL each) 4 weeks apart. WHO recommends using the Valneva COVID-19 vaccine in pregnant women only if the benefits of vaccination outweigh the potential risks.	Not recommended yet	Not recommended yet	Not recommended yet	SAGE/WHO: Extended primary series with an additional (third) dose of 0.5 mL 1-3 months after the second dose, followed by a booster (fourth) dose provided 4-6 months after.	SAGE/WHO: Valneva COVID-19 vaccine may be used as a booster dose following a primary series using Vaxzevria or Covishield.	SAGE/WHO: A booster dose should be given 4-6 months after the primary series* using any other EUL vaccine.
Vector Institute COVID-19 vaccine: EpiVacCorona (Authorized) [19]	Not recommended yet	Not recommended yet	Not recommended yet	Ministry of Health/Russian Federation: Two doses (0.5 mL) 3 weeks apart.	Ministry of Health/Russian Federation: contraindicated in pregnant women.	Not recommended yet	Not recommended yet	Not recommended yet	Ministry of Health/Russian Federation: Two doses (0.5 mL) 3 weeks apart.	There is no available data on interchangeability.	There is no available data on booster doses.

Topics	Main advisory stakeholders	AstraZeneca/ Oxford; SK BIO; Serum Institute of India COVID-19 vaccine: Vaxzevria; Covishield	Bharat Biotech COVID-19 vaccine: Covaxin (suspended supply)	CanSino COVID-19 vaccine: Convidecia	Janssen COVID-19 vaccine: Jcovden	Moderna COVID-19 vaccine: Spikevax	Novavax COVID-19 vaccine: Nuvaxovid; Covovax	Pfizer-BioNTech COVID-19 vaccine: Comirnaty	Sinopharm/BIBP COVID-19 vaccine: Covilo	Sinovac COVID-19 vaccine: CoronaVac
Efficacy against symptomatic COVID-19 in adults (95% CI)	Strategic Advisory Group of Experts on Immunization (SAGE)	72% (63-79%) *against confirmed COVID-19 [WHO, 2022 ].	78% (65-86%) *against confirmed COVID-19 [WHO, 2022 ].	58% (40-70%) *against confirmed COVID-19 [WHO, 2022 ].	Single dose: 67% (59-73%). Two doses: 75% (55-87%) [WHO, 2022 ].	93% (91-95%) *against confirmed COVID-19 [WHO, 2022 ].	90% (80-95%) *against confirmed COVID-19 [WHO, 2022 ].	91% (89-93%) **persons >16 years [WHO, 2022 ].	79% (66-87%) *against confirmed COVID-19 [WHO, 2022 ].	51% (36-62%) [WHO, 2022 ].
Efficacy against symptomatic COVID-19 in adults (95% CI)	Global Advisory Committee on Vaccine Safety (GACVS)	NA	NA	NA	NA	NA	NA	NA	NA	NA
Efficacy against symptomatic COVID-19 in adults (95% CI)	Technical Advisory Group (TAG)	>76% [TAG, 2022 ].	>64% [TAG, 2022 ].	NA	>67% [TAG, 2022 ].	>93% [TAG, 2022 ].	>90% [TAG, 2022 ].	>95% [TAG, 2022 ].	>79% [TAG, 2022 ].	>67% [TAG, 2022 ].
Efficacy against symptomatic COVID-19 in adults (95% CI)	Centers for Disease Control and Prevention (CDC)	NA	NA	NA	66% (60-71%) [CDC, 2021 ].	94.1% (89.3-96.8%) [CDC, 2020 ].	89.6% (82.4-93.8%) [Twentyman E, 2022 ]	95.0% (90.3-97.6%) **persons >16 years [CDC, 2020 ].	NA	NA
Efficacy against symptomatic COVID-19 in adults (95% CI)	Food and Drug Administration (FDA)	NA	NA	NA	66.9% (59.0-73.4%) [FDA, 2021 ].	94.1% (89.3-96.8%) [FDA, 2022 ].	NA	95.0% (90.3-97.6%) **persons >16 years [FDA, 2022 ].	NA	NA
Efficacy against symptomatic COVID-19 in adults (95% CI)	European Medicines Agency (EMA)	74.0% (65.3-80.5%) [EMA, 2022 ].	NA	NA	66.9% (59.0-73.4%) [EMA, 2022 ].	94.1% (89.3-96.8%) [EMA, 2022 ].	90.4% (82.9-94.6%) [EMA, 2022 ].	95% **persons >16 years [EMA, 2022 ].	NA	NA
Efficacy against symptomatic COVID-19 in adults (95% CI)	Regulatory Authority MHRA/UK	66.7% (57.4-74.0%) [MHRA, 2022 ].	NA	NA	66.9% (59.0-73.4%) [MHRA, 2022 ].	94.1% (89.3-96.8%) [MHRA, 2022 ].	NA	95.0% (90.3-97.6%) [MHRA, 2022 ].	NA	NA
Efficacy against symptomatic COVID-19 in children and adolescents (95% CI)	Strategic Advisory Group of Experts on Immunization (SAGE)	Ongoing studies. Data not yet available [WHO, 2022 ].	Ongoing studies. Data not yet available [WHO, 2022 ].	Ongoing studies. Data not yet available [WHO, 2022 ].	Ongoing studies. Data not yet available [WHO, 2022 ].	Ages 12 to 17: 93% (48-100%) [WHO, 2022 ].	80% (95% CI: 47-92) [WHO, 2022 ].	Ages 5 to 11: 90.7% (67.7-98.3%). Ages 12 to 15: 100% (75-100%) [WHO, 2022 ].	Ongoing studies. Data not yet available [WHO, 2022 ].	Ongoing studies. Data not yet available [WHO, 2022 ].
Efficacy against symptomatic COVID-19 in children and adolescents (95% CI)	Global Advisory Committee on Vaccine Safety (GACVS)	NA	NA	NA	NA	NA	NA	NA	NA	NA
Efficacy against symptomatic COVID-19 in children and adolescents (95% CI)	Technical Advisory Group (TAG)	NA	NA	NA	NA	NA	NA	NA	NA	NA
Efficacy against symptomatic COVID-19 in children and adolescents (95% CI)	Centers for Disease Control and Prevention (CDC)	NA	NA	NA	NA	6 months to 5 years of age: 37.8% (20.9-51.1%) [CDC, 2022 ].	NA	6 months to 4 years of age: 80.0% (22.8-94.8%) [CDC, 2022 ].	NA	NA
Efficacy against symptomatic COVID-19 in children and adolescents (95% CI)	Food and Drug Administration (FDA)	NA	NA	NA	NA	6 to 23 months of age: 31.5% (27.7-62.0%). 2 to 5 years of age: 46.4%. (19.8-63.8%) [FDA, 2022 ].	NA	Ages 5 to 11: 90.7% (67.7-98.3%) Ages 12 to 15: 100% (78.1-100%) [FDA, 2022 ].	NA	NA
Efficacy against symptomatic COVID-19 in children and adolescents (95% CI)	European Medicines Agency (EMA)	Data not yet available [EMA, 2022 ].	NA	NA	Data not yet available [EMA, 2022 ].	In age groups from 6 to 17 years the efficacy is similar to that in adults [EMA, 2022 ].	Ages 12 to 17: 79.5% (46.8-92.1%) [EMA, 2022 ].	Ages 5 to 11: 90.7% (67.7-98.3%) Ages 12 to 15: 100% (75-100%) [EMA, 2022 ].	NA	NA
Efficacy against symptomatic COVID-19 in children and adolescents (95% CI)	Regulatory Authority MHRA/UK	Data not yet available [MHRA, 2022 ].	NA	NA	Data not yet available [MHRA, 2022 ].	Data not yet available [MHRA, 2022 ].	NA	Ages 5 to 11: 90.7% (67.7-98.3%) Ages 12 to 15: 100% (75.3-100.0%) [MHRA, 2022 ].	NA	NA
Vaccination during pregnancy	Strategic Advisory Group of Experts on Immunization (SAGE)	Recommended if the benefits of vaccination outweigh the potential risks [WHO, 2022 ].	Recommended if the benefits of vaccination outweigh the potential risks [WHO, 2022 ].	Recommended if the benefits of vaccination outweigh the potential risks [WHO, 2022 ].	Recommended if the benefits of vaccination outweigh the potential risks [WHO, 2022 ].	Recommended [WHO, 2022 ].	Recommended [WHO, 2022 ].	Recommended [WHO, 2022 ].	Recommended if the benefits of vaccination outweigh the potential risks [WHO, 2022 ].	Recommended if the benefits of vaccination outweigh the potential risks [WHO, 2022 ].
Vaccination during pregnancy	Global Advisory Committee on Vaccine Safety (GACVS)	NA	NA	NA	NA	NA	NA	NA	NA	NA
Vaccination during pregnancy	Technical Advisory Group (TAG)	Recommended [TAG, 2022 ].	Recommended if the benefits of vaccination outweigh the potential risks [TAG, 2022 ].	NA	Recommended [TAG, 2022 ].	Recommended [TAG, 2022 ].	Recommended if the benefits of vaccination outweigh the potential risks [TAG, 2022 ].	Recommended [TAG, 2022 ].	Recommended [TAG, 2022 ].	Recommended [TAG, 2022 ].
Vaccination during pregnancy	Centers for Disease Control and Prevention (CDC)	NA	NA	NA	Recommended [CDC, 2022 ].	Recommended [CDC, 2022 ].	NA	Recommended [CDC, 2022 ].	NA	NA
Vaccination during pregnancy	Food and Drug Administration (FDA)	NA	NA	NA	Available data are insufficient to inform vaccine-associated risks in pregnancy [FDA, 2021 ].	Available data are insufficient to assess the vaccine-associated risks in pregnancy [FDA, 2022 ].	NA	Available data are insufficient to inform vaccine-associated risks in pregnancy [FDA, 2022 ].	NA	NA
Vaccination during pregnancy	European Medicines Agency (EMA)	Recommended if the benefits of vaccination outweigh the potential risks [EMA, 2022 ].	NA	NA	Recommended if the benefits of vaccination outweigh the potential risks [EMA, 2022 ].	Recommended [EMA, 2022 ].	Recommended if the benefits of vaccination outweigh the potential risks [EMA, 2022 ].	Recommended [EMA, 2022 ].	NA	NA
Vaccination during pregnancy	Regulatory Authority MHRA/UK	Recommended if the benefits of vaccination outweigh the potential risks [MHRA, 2022 ].	NA	NA	Recommended if the benefits of vaccination outweigh the potential risks [MHRA, 2022 ].	Recommended [MHRA, 2022 ].	NA	Recommended [MHRA, 2022 ].	NA	NA
SARS-CoV-2 variants	Strategic Advisory Group of Experts on Immunization (SAGE)	Delta variant (effectiveness against hospitalization): 92% (95% CI: 75-97%) Alpha variant (effectiveness against hospitalization): 86% (95% CI: 53-96%) [WHO, 2022 ].	Delta variant (efficacy): 65% (95% CI: 33-83%) [WHO, 2022 ].	NA	Beta variant (South Africa, vaccine efficacy -VE-): 52.0%. Gamma variant (Brazil, VE): 68.1%. Omicron variant (South Africa, healthcare workers): effectiveness against COVID-19-related hospitalizations was 55% (95% CI: 22-74) [WHO, 2022 ].	Delta variant (USA, effectiveness): 79.8% (95% CI: 67.4-87.5%), and 94.0% (95% CI: 92.3-95.4%) after a booster dose. Omicron variant (USA, effectiveness): 42.8% (95% CI: 33.8- 50.7%) and 67.9% (95% CI: 65.8-69.9%) after a booster dose [WHO, 2022 ].	Alpha variant (UK, vaccine efficacy -VE-): 86% (95% CI: 71-94); and 94% (95% CI: 82-98) in USA. Beta variant (South Africa, VE): 49% (95% CI: 28-63) during circulation of Beta [WHO, 2022 ].	Omicron variant: effectiveness is lower compared to Delta [WHO, 2022 ].	NA	Gamma and Alpha variants (Chile, effectiveness): 65.9% (95% CI: 65-66%). Delta variant (Chile, effectiveness): 79% (95% CI: 77-81%) for a 3-dose schedule with CoronaVac (Sinovac) [WHO, 2022 ].
SARS-CoV-2 variants	Global Advisory Committee on Vaccine Safety (GACVS)	NA	NA	NA	NA	NA	NA	NA	NA	NA
SARS-CoV-2 variants	Technical Advisory Group (TAG)	Vaccine effectiveness against COVID-19 declines as for six months after a primary series in the context of variants of concern (including Delta and Omicron variants)[TAG, 2022 ].	Vaccine effectiveness against COVID-19 declines as for six months after a primary series in the context of variants of concern (including Delta and Omicron variants)[TAG, 2022 ].	NA	Vaccine effectiveness against COVID-19 declines as for six months after a primary series in the context of variants of concern (including Delta and Omicron variants)[TAG, 2022 ].	Vaccine effectiveness against COVID-19 declines as for six months after a primary series in the context of variants of concern (including Delta and Omicron variants)[TAG, 2022 ].	Vaccine effectiveness against COVID-19 declines as for six months after a primary series in the context of variants of concern (including Delta and Omicron variants [TAG, 2022 ].	Vaccine effectiveness against COVID-19 declines as for six months after a primary series in the context of variants of concern (including Delta and Omicron variants)[TAG, 2022 ].	Vaccine effectiveness against COVID-19 declines as for six months after a primary series in the context of variants of concern (including Delta and Omicron variants)[TAG, 2022 ].	Vaccine effectiveness against COVID-19 declines as for six months after a primary series in the context of variants of concern (including Delta and Omicron variants)[TAG, 2022 ].
SARS-CoV-2 variants	Centers for Disease Control and Prevention (CDC)	NA	NA	NA	NA	Omicron variant (USA): vaccine effectiveness during the BA.2/BA.2.12.2 period was lower than that during the BA.1 period [CDC, 2022 ].	NA	Omicron variant (USA): vaccine effectiveness during the BA.2/BA.2.12.2 period was lower than that during the BA.1 period [CDC, 2022 ].	NA	NA
SARS-CoV-2 variants	Food and Drug Administration (FDA)	NA	NA	NA	NA	Vaccine efficacy among ages 6 months through 5 years was evaluated during the Omicron-predominant period [FDA, 2022 ].	NA	NA	NA	NA
SARS-CoV-2 variants	European Medicines Agency (EMA)	NA	NA	NA	Alpha variant (efficacy): 71.6% (95% CI: 43.2; 86.9) after the first dose, and 94.2% (95% CI: 62.9; 99.9) after a second dose [EMA, 2022 ].	NA	The vaccine efficacy in adults was assessed while Alpha, Beta, and Gamma was circulating; in ages 12 to 17, during the Delta variant-predominant period [EMA, 2022 ].	NA	NA	NA
SARS-CoV-2 variants	Regulatory Authority MHRA/UK	NA	NA	NA	NA	NA	NA	NA	NA	NA

	Shelf-life	Ultra-low temperature -90°C to -60°C (-130ºF to -76ºF)	Freezing -25 °C to -15°C	Refrigeration 2ºC to 8ºC (36ºF to 46ºF)	Storage after first puncture
Anhui Zhifei Longcom COVID-19 vaccine: Zifivax	Not yet available	No	No	Not yet available	Not yet available
AstraZeneca/Oxford; SK BIO; Serum Institute of India COVID-19 vaccine: Vaxzevria; Covishield (EUL)	Vaxzevria: 6 months Covishield: 9 months	No	No	Vaxzevria: 6 months Covishield: 9 months	Maximum 6 hours (2 to 8°C)
Bharat Biotech COVID-19 vaccine: Covaxin (EUL, suspended supply)	9 months	No	No	9 months	Maximum 6 hours (2 to 8°C)
CanSino COVID-19 vaccine: Convidecia	12 months	No	No	12 months	Maximum 6 hours (2 to 8°C)
CIGB (Centro de Ingeniería Genética y Biotecnología) COVID-19 vaccine: Abdala	6 months	No	No	6 months	Maximum 6 hours (2 to 8°C)
Finlay Institute of vaccines COVID-19 vaccine: Soberana 02; Soberana Plus	Soberana 02 and Soberana 02 ST: 6 months Soberana Plus and Soberana Plus ST: 4 months	No	No	Soberana 02 and Soberana 02 ST: 6 months Soberana Plus and Soberana Plus ST: 4 months	Soberana 2 and Soberana Plus: Maximum 6 hours (2 to 8°C) Soberana 2 ST and Soberana Plus ST: Use immediately
Gamaleya COVID-19 vaccine: Sputnik V; Gam-COVID-Vac; Spuntik Light	3 months	No	6 months (-18°C or below)	No	Maximum 2 hours (15 °C to 25 °C)
Janssen COVID-19 vaccine: Jcovden (EUL)	24 months	No	24 months	11 months	Maximum 6 hours (2 to 8°C)
Moderna COVID-19 vaccine: Spikevax (EUL)	9 months	No	9 months	1 month	Maximum 6 hours (2 to 25 °C)
Vacuna de Moderna contra COVID-19: Spikevax bivalent (origina + omicron BA.1/BA.5) (EUL)	9 months	Yes (-50°C to -15°C)	No	19 hours	Maximun 19 hours (2 to 8 °C)
Novavax/Serum Institute of India (SII) COVID-19 vaccine: Nuvaxovid; Covovax	9 months	No	No	9 months	Monodose: Use immediately** Multidose: Maximum 6 hours (2 to 8°C)
Pfizer-BioNTech COVID-19 vaccine: Comirnaty (EUL)	18 months	18 months	Concentrate for dispersion for injection: 2 weeks * Do not store ready-to-use or pediatric formulations under freezer conditions (-25° to -15°C).	10 weeks	Maximum 6 hours (2 to 8°C)
Vacuna de Pfizer-BioNTech contra COVID-19: Comirnaty bivalent (original + omicron BA.1) (EUL)	12 months	Yes	No	10 Weeks	Maximun 6 hours (2 a 8°C)
Sinopharm/BIBP (Beijing Institute of Biological Products) COVID-19 vaccine: Covilo (EUL)	24 months	No	No	24 months	Monodose: Use immediately** Multidose: Maximum 6 hours (2 to 8°C)
Sinopharm/WIBP (Wuhan Institute of Biological Products) COVID-19 vaccine	6 months	No	No	6 months	Monodose: Use immediately**
Sinovac COVID-19 vaccine: CoronaVac (EUL)	12 months	No	No	12 months	Monodose: Use immediately** Multidose: Maximum 6 hours (2 to 8°C)
Vector Institute COVID-19 vaccine: EpiVacCorona	Not yet available	No	No	Not yet available	Not yet available
Valneva COVID-19 vaccine	21 months	No	No	21 months	Maximum 6 hours (2 to 8°C)

Vaccine characteristics	Moderna COVID-19 vaccine [1]	Moderna COVID-19 vaccine, bivalent (original + omicron BA.1)	Moderna COVID-19 vaccine, bivalent (original + omicron BA.4/BA.5)	Pfizer-BioNTech COVID-19 vaccine [4]	Pfizer-BioNTech COVID-19 vaccine, bivalent (original + omicron BA.1)	Pfizer-BioNTech COVID-19 vaccine, bivalent (original + omicron BA.4/BA.5)
Name	Spikevax (original)	Spikevax bivalent (original + omicron BA.1)	Spikevax bivalent (original + omicron BA.4/BA.5)	Comirnaty (original)	Comirnaty bivalent (original + omicron BA.1)	Comirnaty bivalent (original + omicron BA.4/BA.5)
International Nonproprietary Name (INN)	elasomeran	elasomeran + imelasomeran	elasomeran + davesomeran	tozinameran	tozinameran+riltozinameran	tozinameran+famtozinameran
Strain/lineage	SARS-CoV-2 Wuhan-Hu-1 strain (Original)	Original and omicron BA.1 [2]	Original and omicron BA.4/BA.5 [2],[3]	SARS-CoV-2 Wuhan-Hu-1 strain (Original)	Original and Omicron BA.1 [5]	Original and Omicron BA.4/BA.5 [7]
Indication	Primary schedule and booster dose for persons 6 months of age and older	EMA: Booster dose for persons from 6 years of age [2].	EMA: Booster dose for persons from 12 years of age [2], FDA: Booster dose for persons from 6 months of age [3].	Primary schedule and booster dose for persons 6 months of age and older.	WHO: Booster dose for persons from 12 years of age [5].	WHO: Booster dose for persons from 12 years of age [7], FDA: for persons from 6 months of age [8].
Dosing and schedule	According to age: - 6 months to 5 years: two doses (25 µg /0.25 mL each) 4 weeks apart. - 6 to 11 years: two doses (50 µg /0.5 mL each) 4 weeks apart. - 12 years and above: two doses (100 µg /0.5 mL each) 4 weeks apart*	According to age: - 6-11 years: EMA: single booster dose (0.25 mL) after three months of the primary series or monovalent booster [2]. - ≥12 years: EMA: single booster dose (0.5 mL) after three months of the primary series or monovalent booster [2].	According to age: - 6 months-5 years: FDA: single booster dose (0.2 mL) after two months of the primary series [3]. 6-11 years: FDA: single booster dose (0.25 mL) after two months of the primary series or monovalent booster [3]. - ≥12 years: FDA: single booster dose (0.5 mL) after two months of the primary series or monovalent booster [3]. EMA recommends an interval of three months [2].	According to age: - 6 months to 4 years: three doses (3 µg /0.2 mL each). The first two doses 3 weeks apart followed by a third dose 8 weeks after. - 5 to 11 years: two doses (10 µg /0.2 mL each) 4 weeks apart. - 12 years and above: two doses (30 µg /0.3 mL each) 4 weeks apart*	EMA: Single booster dose (0.3 mL) for persons ≥12 years after three months of the primary series or monovalent booster [6].	According to age: - 6 months-4 years: FDA: third primary series dose (0.2 mL) after 8 weeks of two monovalent doses [8], and single booster dose (0.2 mL) after two months [9]. - 5-11 years: FDA: single booster dose (0.2 mL) after two months of the primary series or monovalent booster [8]. - ≥12 years: FDA: single booster dose (0.3 mL) after two months of the primary series or monovalent booster [8]. EMA recommends an interval of three months [6].
Presentation of the vial	Light blue border label: 100 µg / 0.5 mL Purple border label: 50 µg / 0.5 mL Magenta border label: 25 µg / 0.25 mL	25 µg elasomeran and 25 µg imelasomeran each dose of 0.5 mL	25 µg elasomeran and 25 µg davesomeran each dose of 0.5 mL	Purple cap: 30 µg / 0.3 mL, after dilution. Grey cap: 30 µg / 0.3 mL Orange cap: 10 µg / 0.2 mL, after dilution. Maroon cap: 3 µg / 0.2 mL, after dilution.	15 µg tozinameran and 15 µg riltozinameran each dose of 0.3 mL	15 µg tozinameran and 15 µg famtozinameran each dose of 0.3 mL

Vector Institute COVID-19 vaccine

Vector Institute COVID-19 vaccine

Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "vector" (FBRI)

Authorization

Regulatory Authorities of Regional Reference in the Americas

Manufacturing

General characteristics

Risk considerations

Dosing and schedule

Indications and contraindications

Precautions

Storage and logistics

Clinical studies - general characteristics

Vaccine efficacy and effectiveness

Efficacy of preclinical studies on the vaccine

Efficacy of the vaccine in clinical trials

Main immunogenicity outcomes

Main efficacy outcomes of Vector Institute COVID-19 vaccine

Key messages

Contracting COVID-19

Contracting severe COVID-19

Efficacy and effectiveness of the vaccine in subgroups

Vaccine effectiveness (other comparative studies)

Efficacy and effectiveness against SARS-CoV-2 variants

Vaccine efficacy and effectiveness for booster dose

Vaccine efficacy and effectiveness for heterologous schedule

Vaccine efficacy and effectiveness for heterologous booster schedule

Safety of the vaccine

Safety of the vaccine in preclinical studies

Safety of the vaccine in clinical trials

Any adverse event

Serious adverse events

Non-serious adverse events

Safety of the vaccine in subgroups

Safety of the vaccine post-authorization

Monitoring

References