OFFICIAL REPORTS ON PHARMACOVIGILANCE PROGRAMS - 20 December 2021

20/12/2021

ARGENTINA (Special report on vaccine safety surveillance in children and adolescents)

From 28 July 2021 when the adolescent vaccination campaign began, through 12 October 2021 when the vaccination campaign for 3- to 11-year-olds started, and until 31 October 2021, a total of 4,728,885 doses of COVID-19 vaccines were administered in this population group.
Among the 2,796,720 doses of vaccine administered to adolescents, there were 484 reports of AEFI (17.3 reports per 100,000 doses administered); and among the 1,932,165 doses of vaccine administered to children ages 3 to 11, 153 AEFI were reported (7.9 reports per 100,000 doses administered). For children under the age of 11, the Sinopharm vaccine was used.

The rate of reports of serious AEFI was 1.2 per 100,000 doses administered for the Sinopharm vaccine, 2.7/100,000 for the Moderna vaccine, and 1.1/100,000 for the Pfizer vaccine.
The most common adverse events reported for the Sinopharm vaccine were mild and moderate allergic reactions, local reactions without fever, and flu-like symptoms. For the Moderna vaccine, the most common events reported were local reactions without fever, and flu-like symptoms followed by one or more of the following: headache, myalgia, arthralgia, asthenia, and chills. For the Pfizer vaccine, the most frequent adverse events reported were local reactions without fever, followed by one or more of the following: headache, myalgia, arthralgia, asthenia, and chills.
One reported case of myocarditis following vaccination with the Pfizer vaccine, from which the patient recovered fully, is currently under investigation.

Source: Argentina Ministry of Health. Special report on vaccine safety surveillance in children and adolescents. Argentina, November 2021, available at: https://www.argentina.gob.ar/coronavirus/vacuna/equipos-salud/informesseguridad

BRAZIL (State of Santa Catarina)

Between 18 January and 30 September 2021, 8,790,520 doses of COVID-19 vaccines were administered in the state of Santa Catarina, consisting of 3,852,286 doses of the AstraZeneca vaccine, 2,397,194 doses of Sinovac/Butantan, 2,284,348 doses of Pfizer-BioNTech, and 256,692 doses of the Janssen vaccine.
In the same period, there were 10,251 reports of AEFI, representing 0.1% of total doses administered. According to the classification of severity, 9,638 (94%) were non-serious events and 613 (6%) were serious events. Of total events reported, 6,373 were associated with the AstraZeneca/Fiocruz vaccine, 2,528 with the Sinovac/Butantan vaccine, 1,093 with the Pfizer vaccine, and 257 with the Janssen vaccine.
Most non-serious events involved symptoms such as fever, myalgia, injection-site pain, redness, and edema.
A total of 242 suspected AEFI-related deaths that occurred within 30 days following vaccination were identified. Of these, the majority (75.2%) occurred in the over-65-year-old population; 227 of the deaths (93.8%) were determined to have no causal relation to the vaccine, two (0.8%) were considered to be causally related to COVID19 vaccines, and 13 (5.4%) are still under investigation.
The two deaths that were determined to be causally related to the vaccine were associated with the AstraZeneca vaccine, and were classified as thrombosis with thrombocytopenia syndrome (TTS).

Source: Secretary of State of Santa Catarina, Brazil. Boletim de Monitoramento de Eventos Adversos Pós-Vacinação contra a Covid-19 em Santa Catarina. Published 10 November 2021. Available at: https://www.saude.sc.gov.br/index.php/noticias-geral/13079-nota-secretaria-de-estado-da-saude-divulga-boletim-demonitoramento-de-eventos-adversos-pos-vacinacao-contra-a-covid-19-em-santa-catarina

CANADA

As of 26 November 2021, 42,033,351 doses of the Pfizer-BioNTech COVID-19 vaccine, 14,709,597 doses of the Moderna vaccine, and 2,798,295 doses of the AstraZeneca/Covishield vaccine (AstraZeneca vaccine manufactured by the Serum Institute of India) had been administered.
There were 27,798 individual reports of one or more AEFI (0.046% of doses administered). Of these, 6,492 reports involved serious events (0.011% of doses administered).
Considering all reports, there were 72,292 reported adverse events following immunization (AEFI), with 27,798 reports involving one or more events. The majority of non-serious adverse events consisted of paresthesia, injection-site pain, headache, pruritis, dyspnea, fatigue, urticaria, nausea, etc.

Source: Public Health Agency of Canada. Canadian COVID-19 vaccine safety report. Source: Public Health Agency of Canada; 3 December 2021. Available at: https://health-infobase.canada.ca/covid-19/vaccine-safety/. Data reproduced by PAHO/WHO.

MEXICO

Vaccination against COVID-19 began in Mexico on 24 December 2020, and as of 29 October 2021, 81,842,426 doses of vaccines had been administered.
As of 29 October 2021, 31,095 AEFI had been reported by the states’ health services; of these, 97.38% (30,279) were non-serious events and 2.62% (816) were serious events.
The highest proportion of AEFI, both serious (59.80%) and non-serious (72.50%), occurred in women. The nonserious AEFI occurred primarily in the 30- to 39-year-old age group, while the serious AEFI were mostly in the over-60-year-old age group.
The most frequently reported non-serious AEFI signs and symptoms were headache, 64.78% (19,616), pain or tenderness at the injection site, 45.71% (13,841), and myalgia, 40.11% (12,145); while the most common serious AEFI were headache, 46.32% (378), asthenia and fatigue, 37.87% (309), and dyspnea, 31.50% (257).

Source: Reporte ESAVI COVID-19 octubre 2021, Dirección de Vigilancia Epidemiológica de Enfermedades Transmisibles. Mexico City. Available at:

https://www.gob.mx/cms/uploads/attachment/file/682464/REPORTE_ESAVI_2021_10.pdf

PARAGUAY

According to the 37th AEFI surveillance report of Paraguay’s Ministry of Health, 6,060,060 doses of COVID-19 vaccines were administered to 3,344,594 people between 22 February and 26 November.
In that same period, a total of 2,534 AEFI were reported, representing 0.04% of doses administered. A total of 413 reported cases were considered serious, representing 0.007% of doses administered.
Among reported AEFI, 71.6% (1,815) occurred in women; 68.4% (1,734) were in the 25- to 49-year-old age group.
Among the reported AEFI, 48.2% (1,221) were in people who received the AstraZeneca vaccine, 14.7% (372) the Sputnik V vaccine, 17.3% (437) the Pfizer/BioNTech vaccine, 7.2% (182) the CoronaVac vaccine, 6.2% (157) the Covaxin vaccine, 4.5% (113) the Moderna vaccine, and 2.1% (52) the Sinopharm vaccine.

Source: 37º Boletín informativo – Vigilancia de ESAVI relacionada a la vacunación contra COVID-19, 26 de noviembre de 2021. Available at: https://pai.mspbs.gov.py/esavis-2021/.

Consolidated reports of adverse events, by vaccine, in countries of the Region of the Americas, December 2021

As of 10 December 2021, 1.378.223.759 doses of COVID-19 vaccines had been administered in the Region of the Americas. The following table presents information provided by the countries regarding number of doses of vaccines administered, by manufacturer and number of associated AEFI:

Consolidated reports of adverse events, by vaccine, in countries of the Region of the Americas, December 2021

Source: Doses obtained from the Dashboard of COVID-19 Vaccination in the Americas.

(https://ais.paho.org/imm/IM_DosisAdmin-Vacunacion.asp. Accessed 10 December 2021.)

Cases: VigiBase data as of 8 December 2021 and public sources from the countries (Argentina epidemiological bulletin, 31 August; Brazil, as of 25 October, from the epidemiological bulletin, not including the state of São Paulo; Canada country website, 3 December 2021; Colombia, doses per vaccine reported by the country; Mexico, data as of 29 October 2021).
Countries using the indicated vaccines (countries included in the data presented in the table are in bold):
AstraZeneca: Anguilla, Antigua and Barbuda, Argentina, Bahamas, Barbados, Belize, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Dominica, Dominican Republic, Ecuador, El Salvador, Grenada, Guadalupe, Guatemala, Guyana, Honduras, Jamaica, Montserrat, Mexico, Nicaragua, Panama, Paraguay, Peru, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Suriname, Virgin Islands, Trinidad and Tobago, and Uruguay.
Bharat Biotech: Paraguay
CanSino: Chile, Mexico
Gamaleya: Argentina, Bolivia, Guatemala, Guyana, Honduras, Mexico, Nicaragua, Panama, Paraguay, Saint Vincent and the Grenadines, Venezuela
Janssen: Bolivia, Brazil, Colombia, Haiti, Mexico, USA
Moderna: Argentina, Canada, Colombia, Guadeloupe, Guatemala, Haiti, Honduras, Mexico, Panama, Paraguay, USA

Publications on potential signs of problems with the safety of COVID-19 vaccines

Myocarditis following administration of COVID-19 mRNA vaccines: A case series and incidence rate determination

A cohort study was published on 3 November, its purpose was to analyze the incidence rate of myocarditis and pericarditis in the vaccinated population compared to the incidence rate in the general population. A series of retrospective cases was conducted using the COVID-19 vaccine registry of the Mayo Clinic in the United States. The myocarditis incidence rate and temporal relation to the COVID-19 mRNA vaccine were calculated, compared to the occurrence of myocarditis in a comparable population between 2016 and 2020. Clinical characteristics and outcomes of affected patients were collected. While 21 people were identified, only 7 patients ultimately met the inclusion criteria for vaccine-associated myocarditis. The overall incidence rate ratio (IRR) of COVID-19-related myocarditis was 4.18 (95% CI 1.63, 8.98), which was solely attributable to an increase in IRR among adult men (IRR 6.69, 95% CI 2.35, 15.52) compared to women (IRR 1.41, 95% CI 0.03, 8.45). All cases occurred within two weeks of administration of one dose of a COVID-19 mRNA vaccine, and most occurred within 3 days (range 1–13 days) following the second dose (6/7 patients, 86%). Overall, cases were mild, and all patients survived. The authors conclude that myocarditis is a rare adverse event associated with COVID-19 mRNA vaccines, and that its incidence rate in adult men is significantly higher than in the base population. At present, recurrence of myocarditis following subsequent doses of mRNA vaccines is unknown.

Source: Perez Y, Levy ER, Joshi AY, et al. Myocarditis Following COVID-19 mRNA Vaccine: A Case Series and Incidence Rate Determination. Clin Infect Dis. 3 November 2021 Nov 3;ciab926. doi: 10.1093/cid/ciab926. Online ahead of print, available at: https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciab926/6420408

A systematic review of cases of central nervous system (CNS) demyelination following COVID-19 vaccination

A systematic review was published on 9 November with the aim of reviewing published cases of CNS demyelination associated with COVID-19 vaccination. The review was conducted in the PubMed, SCOPUS, EMBASE, Google Scholar, Ovid, and medRxiv databases, as of 30 September 2021, of published articles and preprints of cases of CNS demyelination associated with COVID-19 vaccines. Descriptive findings of reported cases were reviewed and stratified by demographic and clinical characteristics, diagnostic assessment, management, and overall outcome. Thirty-two cases were identified, with women accounting for the majority of cases (68.8%), and with a median age of 44 years. Eleven reported cases were in individuals who had received the Pfizer vaccine, eight who received the AstraZeneca vaccine, six the Moderna, five the Sinovac/Sinopharm, and one who received the Sputnik vaccine followed by the Johnson & Johnson vaccine. Most cases (71.8%) occurred after the first dose of vaccine, with neurological symptoms manifesting after a median of nine days. The most common presentations were transverse myelitis (12/32), and multiple sclerosis-like imaging (initial diagnosis or relapse) in another 12/32 cases, followed by disorders similar to acute disseminated encephalomyelitis (5/32) and to neuromyelitis optica spectrum disorder (3/32). In 17/32 (53.1%) of cases, a history of immune-mediated disease was reported. Demyelinating syndromes were most often reported in association with mRNA vaccines (17/32), followed by viral vector vaccines (10/32) and inactivated vaccines (5/32). Most multiple sclerosis-like episodes reported (9/12) were triggered by mRNA-based vaccines, while transverse myelitis occurred following vaccination with viral-vector and mRNA vaccines. Treatment included high doses of methylprednisolone, plasma exchange, intravenous immunoglobulin, or a combination of these, with favorable outcomes in most cases and marked or complete improvement (25/32), with stabilization or partial recovery in the remaining cases. The authors, through this systematic review, identified few cases of CNS demyelination following any of the currently approved COVID-19 vaccines. The clinical presentation was heterogeneous, mainly after the first dose; however, half of the published cases included a history of immune-mediated disease. Most cases had a favorable outcome. Long-term post-marketing surveillance is suggested for these cases, in order to assess causation and ensure the safety of COVID19 vaccines.

Source: Ismail II, Salama S. A systematic review of cases of CNS demyelination following COVID-19 vaccination. J Neuroimmunol. 2021 Nov 9;362:577765. doi: 10.1016/j.jneuroim.2021.577765. Online ahead of print. PMID: 34839149; PMCID: PMC 8577051. Available at: https://www.jamda.com/article/S1525-8610(20)30371-6/fulltext

Immunogenicity and Risk of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection after Coronavirus Disease 2019 (COVID-19) vaccination in patients with cancer: a systematic review and meta-analysis

On 26 October, a systematic review and meta-analysis was published, with the aim of assessing the immune response after vaccination against COVID-19 of the population with cancer compared to the population without cancer. A search was conducted of the PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science databases from 1 March 2020 to 12 August 2021. Primary end-points were anti-SARS-CoV-2 spike protein (S) immunoglobulin G (IgG) seroconversion rates, T cell response, and documented SARS-CoV-2 infection after COVID19 immunization. Overall effects were pooled using random-effects models. This systematic review and meta-analysis included 35 original studies. Overall, 51% (95% confidence interval, 41–62) and 73% (95% CI, 64–81) of patients with cancer developed anti-S IgG above the threshold level after partial and complete immunization, respectively. Patients with hematologic malignancies had a significantly lower seroconversion rate than those with solid tumors after complete immunization (65% vs. 94%; P < 0.0001). Compared with controls, patients with cancer with an incomplete vaccination schedule had a 55% reduced likelihood of achieving anti-S IgG titers above the threshold level (RR 0.45; 95% CI 0.35– 0.58), whereas a 31% reduced likelihood of seroconversion was documented among those with a complete vaccination schedule (RR 0.69, 95% CI 0.56–0.84). Moreover, when compared with non-cancer controls, oncological patients had a tendency towards increased documented SARS-CoV-2 infection after partial (RR 3.21; 95% CI 0.35–29.04) and complete COVID-19 immunization (RR 2.04; 95% CI 0.38–11.10). Patients with cancer had an impaired immune response to COVID-19 vaccination compared with controls. Strategies that endorse the completion of vaccination schedules are warranted. Future studies should aim to evaluate different approaches that enhance oncological patients’ immune response.

Source: Becerril-Gaitan A, Vaca-Cartagena BF, Ferrigno AS, et al. Immunogenicity and risk of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection after Coronavirus Disease 2019 (COVID-19) vaccination in patients with cancer: a systematic review and meta-analysis. Eur J Cancer. 2021 Oct 26:S0959– 8049(21)01168–0. doi:10.1016/j.jinf.2020.02.028. Online ahead of print. PMID: 34794855; PMCID: PMC8548030. Available at: https://www.ejcancer.com/article/S0959-8049(21)01168-0/fulltext

Association between vaccination with the BNT162b2 mRNA COVID-19 vaccine and Bell's palsy: a population-based study

On 4 November, a cohort study was published examining the association between the BNT162b2 mRNA COVID-19 vaccine and Bell's palsy. Using the database of the largest healthcare provider in Israel, the authors retrieved data from different periods in 2018-2021. Observed cases of Bell's palsy occurring within 21 days after the first vaccine dose and within 30 days after the second vaccine dose were compared to the expected cases, based on the experience of the population in 2019. Standardized incidence ratios (SIRs) and attributable risks (ARs) were computed.

Overall, 132 cases of Bell's palsy were reported among 2,594,990 individuals after vaccination with a first dose, and

152 cases among 2,434,674 individuals after receiving a second dose. The age and sex weighted SIRs were 1.36 (1.14-1.61) and 1.16 (0.99-1.36) after the first and second vaccine dose, respectively. SIRs tended to be higher in older age groups after the first and second vaccine doses. The estimates were more pronounced in older females after the first vaccine dose; SIR=1.71 (1.10-2.54) at ages 45-64, and 2.51 (1.65-3.68) at age ≥65 years. The highest AR was 4.46 per 100,000 individuals vaccinated, detected in females aged ≥65 years. In patients with a previous history of Bell's palsy, only 4 cases of Bell's palsy were reported in 7,567 individuals vaccinated and 10 cases in 7,045 individuals vaccinated after the first and the second dose, respectively. The age- and sex-weighted SIRs were 1.15 (0.36-2.76) and 2.15 (1.09-3.83) after the first and second vaccine dose, respectively. The authors conclude that this study suggests that the BNT162b2 mRNA COVID-19 vaccine might be associated with increased risk of Bell's palsy. The small estimated attributable risks suggest that the impact on public health is relatively minor. The benefits of vaccinations explicitly outweigh the possible link to Bell's palsy, which has high recovery rate if timely treated with corticosteroids.

Source: Shibli R, Barnett O, Abu-Full Z, et al. Association between vaccination with the BNT162b2 mRNA COVID-19 vaccine and Bell's palsy: a population-based study. Lancet Reg Health Eur. 2021 Dec;11:100236. doi: 10.1016/j.lanepe.2021.100236. Epub 2021 November 4. PMID: 34751262; PMCID: PMC8566165. Available at: https://www.sciencedirect.com/science/article/pii/S2666776221002222?via%3Dihub

Thrombotic Events after COVID-19 Vaccination in the Over-50s: Results from a Population-Based Study in Italy

On 10 November, a cohort study was published to evaluate post-vaccination thrombotic events in patients over 50 years of age. The study mentions that several European countries suspended or changed recommendations for the use of Vaxzevria (AstraZeneca) for suspected adverse effects due to atypical blood-clotting. This research aimed to identify the number of expected thrombotic events in the Italian population over the age of 50 that received the Vaxzevria vaccine between 22 January and 12 April 2021. The venous thromboembolism (VT) and immune thrombocytopenia (IT) event rates were estimated from a population-based cohort. The overall VT rate was 1.15 (95% CI 0.93–1.42) per 1,000 person-years, and the ITP rate was 2.7 (95% CI 0.7–11) per 100,000 person-years. These figures translate into 83 VT events and 2 ITP events, in the 15 days following the first administration of Vaxzevria. The number of thrombotic events reported from the Italian Medicines Agency does not appear to have increased beyond that expected in individuals over 50 years of age. The authors conclude that these findings contribute to the ongoing discussion about vaccine safety, particularly for adenovirus-based vaccines, where the occurrence of coagulationrelated disorder constitutes a significant concern.

Source: Baldi I, Azzolina D, Francavilla A, et al. Thrombotic Events after COVID-19 Vaccination in the Over-50s:

Results from a Population-Based Study in Italy Vaccines (Basel). 2021 Nov 10;9(11):1307. doi:

10.3390/vaccines9111307. PMID: 34835237; PMCID: PMC8620372. Available at: https://www.mdpi.com/2076393X/9/11/1307

Risk-benefit analysis of the AstraZeneca COVID-19 vaccine in Australia using a Bayesian network modelling framework

On 4 November, a study was conducted using a Bayesian model, which provided a risk-benefit analysis of the AstraZeneca vaccine. This study was based on the fact that thrombosis with thrombocytopenia syndrome (TTS) has been associated with the AstraZeneca (AZ) COVID-19 vaccine (Vaxzevria). Australia has reported low TTS incidence of < 3/100,000 after the first dose, with a case fatality rate (CFR) of 5%–6%. Risk-benefit analysis of vaccination has been challenging because of rapidly evolving data, changing levels of transmission, and variation in rates of TTS, COVID-19, and CFR between different age groups. The aim of the authors was to optimize risk–benefit analysis by developing a model that enables inputs to be updated rapidly as evidence evolves. A Bayesian network was used to integrate local and international data, government reports, published literature, and expert opinion. The model estimates probabilities of outcomes under different scenarios of age, sex, low/medium/high transmission (0.05%/0.45%/5.76% of population infected over 6 months), SARS-CoV-2 variant, vaccine dose, and vaccine effectiveness. The authors used the model to compare estimated deaths from AZ vaccine-associated TTS with (i) COVID-19 deaths prevented under different scenarios; and (ii) deaths from COVID-19-related atypical severe blood clots (cerebral venous sinus thrombosis and portal vein thrombosis). For a million people aged ≥ 70 years where 70% received a first dose and 35% received two doses, the model estimated < 1 death from TTS, 25 deaths prevented under low transmission, and > 3,000 deaths prevented under high transmission. Risks versus benefits varied significantly between age groups and transmission levels. Under high transmission, deaths prevented by AZ vaccine far exceed deaths from TTS (by 8 to > 4,500 times depending on age). Probability of dying from COVIDrelated atypical severe blood clots was 58–126 times higher (depending on age and sex) than dying from TTS. The authors mention that this is the first example of the use of Bayesian networks for risk–benefit analysis for a COVID19 vaccine. The model can be rapidly updated to incorporate new data, adapted for other countries, extended to other outcomes (e.g., severe disease), or used for other vaccines.

Source: Lau CL, Mayfield HJ, Sinclair JE, et al. Risk-benefit analysis of the AstraZeneca COVID-19 vaccine in Australia using a Bayesian network modelling framework. Vaccine. 2021 Nov 4:S0264–410X(21)01428–6. doi: 10.1016/j.vaccine.2021.10.079. Online ahead of print. PMID: 34810000; PMCID: PMC8566665. Available at: https://www.sciencedirect.com/science/article/pii/S0264410X21014286?via%3Dihub

COVID-19 vaccines	Country
Abdala of Center for Genetic Engineering and Biotechnology (CIGB)	Click to see the list
Ad5-nCoV-IH of CanSino Biologics New	Click to see the list
Aurora-CoV of Vector State Research Center of Virology and Biotechnology	Russia
Comirnaty (BNT162b2) of Pfizer-BioNTech	Click to see the list
Comirnaty bivalente Original/Ómicron BA.1 of Pfizer-BioNTech	Click to see the list
Comirnaty bivalente Original/Ómicron BA.4/BA.5 of Pfizer-BioNTech New	Click to see the list
Convidecia; PackVac of CanSino	Click to see the list
Corbevax of Biological E Limited	India
CoronaVac of Sinovac Research and Development	Click to see the list
Covaxin (BBV152) of Bharat Biotech	Click to see the list
Covifenz of Medicago	Canada
Covilo of Beijing Institute of Biological Products; China National Pharmaceutical Group (Sinopharm)	Click to see the list
CovIran Barekat of Shifa Pharmed Industrial Group	Iran
Covishield of Serum Institute of India	Click to see the list
Covovax (Novavax formulation) of Serum Institute of India	Click to see the list
EpiVacCorona of Vector State Research Center of Virology and Biotechnology	Click to see the list
Fakhravac (MIVAC) of Organization of Defensive Innovation and Research	Iran
Gam-COVID-Vac of Gamaleya	Russia
Gemcovac-19 of Gennova Biopharmaceuticals	India
Inactivated vaccine of Chinese Academy of Medical Sciences	China
Incovacc of Bharat Biotech	Click to see the list
Jcovden (Ad26.COV2.S) of Janssen (Johnson & Johnson)	Click to see the list
Kconvac of Minhai Biotechnology Co	China; Indonesia
KoviVac of Chumakov Center	Russia; Belarus; Cambodia
Mvc-cov1901 of Medigen	Paraguay; Somaliland; Taiwan
Noora of Baqiyatallah University of Medical Sciences	Iran
Nuvaxovid of Novavax	Click to see the list
QazVac of Research Institute for Biological Safety Problems (RIBSP)	Kazakhstan; Kyrgyzstan
Razi Cov Pars of Razi Vaccine and Serum Research Institute	Iran
Recombinant SARS-CoV-2 Vaccine (CHO Cell) of National Vaccine and Serum Institute	United Arab Emirates
Skycovione of SK Bioscience	Corea del sur
Soberana 02 of Finlay Institute of Vaccines	Click to see the list
Soberana Plus of Finlay Institute of Vaccines	Click to see the list
Spikevax (mRNA-1273) of Moderna	Click to see the list
Spikevax bivalente Original/Ómicrom BA.1 of Moderna	Click to see the list
Spikevax Original/Ómicrom BA.4/BA.5 of Moderna	Click to see the list
SpikoGen of Vaxine/CinnaGen Co	Iran
Sputnik Light of Gamaleya/	Click to see the list
Sputnik V of Gamaleya	Click to see the list
Tak-019 (Novavax formulation) of Takeda	Japan
Tak-919 (Moderna formulation) of Takeda	Japan
Turkovac of Health Institutes of Turkey	Turkey
V-01 of Livson Mabpharm Inc	China
Valneva Vla2001 of Valneva	Click to see the list
Vaxzevria of AstraZeneca AB	Click to see the list
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