OFFICIAL REPORTS ON PHARMACOVIGILANCE PROGRAMS - 8 November 2021

08/11/2021

BRAZIL (State of Rio Grande do Sul)

In the period from 18 January to 18 September 2021, a total of 13,053,922 doses of COVID-19 vaccines were administered in the State of Rio Grande do Sul: 6,126,758 doses of Covishield (Oxford/AstraZeneca/Fiocruz), 4,125,951 doses of CoronaVac (Sinovac/Butantan), 2,500,115 doses of Comirnaty (Pfizer/Wyeth), and 301,098 doses of the Janssen-Cilag (Ad26.COV2-S [recombinant]) vaccine.
From 18 January to 18 September 2021, there were 13,020 reports of suspected adverse events following immunization (AEFI) (0.1% of doses administered). Of these, 2,016 involved immunization errors, 1,074 reported a diagnosis of COVID-19, and 9,930 were confirmed AEFI.
The number of reports, by producing laboratory, were: 7,009 for Covishield (Oxford/AstraZeneca/Fiocruz), 2,222 for CoronaVac (Sinovac/Butantan), 542 for Comirnaty (Pfizer/Wyeth), and 157 for the Janssen-Cilag vaccine. Incidence per 100,000 doses administered was as follows: 114.4 for Covishield, 53.9 for CoronaVac, 21.7 for Comirnaty, and 52.1 for Janssen-Cilag.
A higher number of reported adverse events were in women (7,358) than in men (2,572).
Among the 9,930 individuals who reported at least one adverse event, a total of 27,762 events (signs and symptoms) were reported.

In terms of the severity of the adverse events, 27,058 (97.5%) were classified as non-serious, and 704 (2.5%) as serious.
Among the non-serious adverse events, the most common ones associated with the Covishield (AstraZeneca/Fiocruz) vaccine were fever, headache, myalgia, chills, and nausea; for CoronaVac (Sinovac/Butantan), headache, myalgia, diarrhea, fever, and sore throat; for Comirnaty (Pfizer/Wyeth), headache, myalgia, fever, cough, and nausea; and for the Janssen-Cilag vaccine, the most common adverse events were fever, headache, myalgia, fatigue, and chills.
The highest incidence of reported serious events temporally associated with vaccination for the Covishield (AstraZeneca/Fiocruz) vaccine were headache, fever, dyspnea, death, and Guillain-Barré syndrome; for CoronaVac (Sinovac/Butantan), death, dyspnea, cerebrovascular accidents (CVA), acute myocardial infarction (AMI), and fever; for Comirnaty (Pfizer/Wyeth), headache, vomiting, myelitis, and fever; and for the Janssen-Cilag vaccine, headache, neurological disorders, dysarthria, dysphagia, and acute disseminated encephalomyelitis.
A total of 120 thromboembolic events were reported. These included 83 cases (1.35/100,000 doses administered) after vaccination with the Covishield (AstraZeneca/Fiocruz) vaccine, 28 (0.28/100,000 doses) with CoronaVac (Sinovac/Butantan), 6 (0.24/100,000 doses) with Comirnaty (Pfizer/Wyeth), and 3 (1.00/100,000 doses) after vaccination with the Janssen-Cilag vaccine. Among the cases clinically classified as thromboembolic events were 45 cases of cerebrovascular accidents, 3 cases of acute myocardial infarction, 2 cases of pulmonary thromboembolism, 9 cases of thrombophlebitis, and 61 cases of thrombosis, including deep vein thrombosis, limb arterial thrombosis, mesenteric venous thrombosis, cerebral thrombosis, embolism and thrombosis of unspecified veins, embolism and other aortic thrombosis, and unspecified thrombosis.
There were 190 reported deaths, of which 186 are still under investigation. Of the four deaths investigated for which causality was determined, one remains unclassifiable due to lack of supplementary data, one was temporally associated with vaccination, and two, which were inconsistent or coincident with vaccination, were determined not have a causal relationship with the vaccines, due to pre-existing or emerging conditions.

Source: https://coronavirus.rs.gov.br/upload/arquivos/202110/18094756-boletim-eapv-04-2021.pdf.

CANADA

As of 5 November 2021, 40,654,538 doses of the Pfizer-BioNTech COVID-19 vaccine, 14,254,199 doses of the Moderna vaccine, and 2,787,374 doses of the AstraZeneca/Covishield vaccine (AstraZeneca vaccine manufactured by the Serum Institute of India) had been administered.

A total of 22,280 individual reports of one or more AEFI (0.038% of doses administered) were received. Of these, 5,699 reports involved serious AEFI (0.010% of doses administered).

In all, 59,370 adverse events following immunization were reported (22,280 reports involving one or more events). Most of the adverse events were non-serious, and included paresthesia, injection-site reactions, headache, pruritus, fatigue, dyspnia, urticaria, erythema, etc.

Source: Public Health Agency of Canada. Canadian COVID-19 vaccine safety report. Ottawa: Public Health Agency of Canada. November 5, 2021. https://health-infobase.canada.ca/covid-19/vaccine-safety/. Data reproduced by PAHO/WHO.

COLOMBIA

In the October bulletin of INVIMA, which covers the reporting period for adverse events following immunization (AEFI) from 17 February to 15 October 2021, there were 23,625 reports of AEFI, out of a total 44,350,661 doses of vaccines administered, representing a reporting rate of 53 per 100,000 doses administered.
The distribution of reports, by vaccine manufacturer, as of 15 October 2021 was: 13,284 reports for the Pfizer vaccine (95.3 per 100,000 doses administered), 5,223 for SinoVac (33.4 per 100,000 doses administered), 2,385 for AstraZeneca (36.2 per 100,000 doses administered), 1,648 for Janssen (18.7 per 100,000 doses administered), 1,041 for Moderna (5.5 per 100,000 doses administered), and 44 reports for which the vaccine manufacturer was not identified.
The distribution of events, by sex, was 71% in women and 29% in men. Of reported events, 22,675 (96%) were classified as non-serious and 950 (4%) as serious.
The most frequently reported signs and symptoms were headache (25.1%), injection-site pain (11.1%), dizziness (9.2%), muscle pain (9.0%), fever (8.4%), and malaise (8%).

Source: https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/VS/ED/boletin6-farmacovigilanciavacunas-oct2021.pdf.

UNITED STATES

As of 10 November 2021, following the administration of more than 401 million doses of mRNA vaccines (PfizerBioNTech and Moderna) in the United States, only two cases of thrombosis with thrombocytopenia syndrome (TTS), associated with the Moderna vaccine, had been reported to VAERS. Given the available information, there does not appear to be an increased risk of TTS following vaccination with mRNA COVID-19 vaccines.
As of 27 October, more than 15.5 million doses of the J&J/Janssen COVID-19 vaccine had been administered. The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have identified 48 confirmed reports of people who received the J&J/Janssen vaccine and subsequently developed TTS. Women under the age of 50 should be alerted to the rare but increased risk of this adverse event. There are other COVID-19 vaccine options available for which this risk has not been seen.
Following the administration of more than 15.5 million doses of the Janssen vaccine, approximately 244 preliminary reports of Guillain-Barré syndrome had been identified, as of 27 October 2021. These cases have mostly been reported approximately two weeks after vaccination and primarily in men, many ages 50 and older.
As of 27 October, VAERS had received 1,784 reports of myocarditis or pericarditis among people 30 years of age or younger who had received a COVID-19 vaccine. Most cases have been reported after mRNA COVID-19 vaccination (Pfizer-BioNTech or Moderna), particularly in male adolescents and young adults.
Reports of deaths following vaccination with COVID-19 vaccines are rare. More than 423 million doses of COVID19 vaccines were administered in the United States between 14 December 2020 and 1 November 2021. During this time, VAERS received 9,367 reports of death (0.0022%) among people who received a COVID-19 vaccine.

Source: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html.

PARAGUAY

On 29 October, the thirty-fourth AEFI surveillance report of the Paraguayan Ministry of Health indicated that, during the period from 22 March to 29 October, 5,289,784 doses of COVID-19 vaccines had been administered to 2,919,120 people.
Between 22 February 29 October 2021, there were 2,325 reports of AEFI (0.05% of total doses administered). Of these, 379 cases were considered serious.
Among the AEFI reported, 71.7% (1,667) were in women; 68.7% (1,610) were in people between the ages of 25 and 49. Additionally, among all AEFI reported, 49.3% (1,149) were for people who received the AstraZeneca vaccine, followed by 15.1% (352) for the Sputnik V vaccine, 14.1% (330) for the Pfizer/BioNTech vaccine, 7.8% (182) for CoronaVac, 6.7% (156) for COVAXIN, 4.6% (108) for Moderna, and 2.1% (49) for the Sinopharm vaccine.

Source: https://pai.mspbs.gov.py/esavis-2021/.

Publications on potential safety signals identified with the use of COVID-19 vaccines

Anaphylactic and nonanaphylactic reactions to SARS-CoV-2 vaccines: a systematic review and meta-analysis

A systematic review and meta-analysis of anaphylactic and nonanaphylactic reactions following SARS-CoV-2 vaccines in the general adult population was published on 16 October. Its objective was to estimate the incidence rates of anaphylactic and nonanaphylactic reactions after COVID-19 vaccines and to describe the demographic and clinical characteristics, triggers, presenting signs and symptoms, treatment, and clinical course of confirmed cases. The authors searched electronic databases (Proquest, Medline, Embase, Pubmed, CINAHL, Wiley online library, and Nature) for English-language entries from 1 December 2020 to 31 May 2021. Of the 1,734 articles identified, 26 were included in the systematic review (8 case reports, 5 cohort studies, 4 case series, 2 randomized controlled trials, and one randomized cross-sectional study), while 14 articles were included in the meta-analysis (one cohort study, 2 case series, one randomized controlled trial, and one randomized cross-sectional study). Studies involving 26,337,421 vaccine recipients (Pfizer-BioNTech [n = 14,505,399] and Moderna [n = 11,831,488]) were analyzed. The overall pooled prevalence estimate of anaphylactic reactions to both vaccines was 5.0 (95% CI 2.9 to 7.2, I² = 81%, p = < 0.0001), while the overall pooled prevalence estimate of nonanaphylactic reactions to both vaccines was 53.9 (95% CI 0.0 to 116.1, I² = 99%, p = < 0.0001). Vaccination with Pfizer-BioNTech resulted in higher anaphylactic reactions compared to Moderna (8.0, 95% CI 0.0 to 11.3, I² = 85% versus 2.8, 95% CI 0.0 to 5.7, I² = 59%). However, lower incidence of nonanaphylactic reactions was associated with Pfizer-BioNTech compared to Moderna (43.9, 95% CI 0.0 to 131.9, I² = 99% versus 63.8, 95% CI 0.0 to 151.8, I² = 98%). Across the included studies, the most commonly identified risk factors for anaphylactic and nonanaphylactic reactions to SARS-CoV-2 vaccines were female sex and personal history of atopy. Previous history of anaphylaxis and comorbidities such as asthma, allergic rhinitis, atopic and contact eczema/dermatitis and psoriasis, and cholinergic urticaria were also found to be important. The authors conclude that the prevalence of COVID-19 mRNA vaccine-associated anaphylaxis is very low, while nonanaphylactic reactions occur at a higher rate; cutaneous reactions, however, are largely self-limited. Neither anaphylactic nor nonanaphylactic reactions should discourage vaccination.

Source: Alhumaid S, Al Mutair A, Al Alawi Z, et al. Anaphylactic and nonanaphylactic reactions to SARS-CoV-2 vaccines: a systematic review and meta-analysis. Allergy Asthma Clin Immunol. 2021 Oct 16;17(1):109. doi: 10.1186/s13223–021-00613–7. PMID: 34656181; PMCID: PMC8520206. Available at: https://aacijournal.biomedcentral.com/articles/10.1186/s13223-021-00613-7.

Systemic autoimmune myopathies: A prospective phase 4 controlled trial of an inactivated virus vaccine against SARS-CoV-2

On 19 October, an online pre-print cohort study, with a control group, was published, with the objective of evaluating immunogenicity and safety of an inactivated SARS-CoV-2 vaccine in systemic autoimmune myopathies (SAMs) and the possible influence of baseline disease parameters, comorbidities, and therapy on immune response. This prospective controlled study included 53 patients with SAMs and 106 non-immunocompromised individuals as a control group (CTRL). All participants received two doses of the CoronaVac-Sinovac vaccine (28-day interval). Immunogenicity was assessed by anti-SARS-CoV-2 S1/S2 IgG seroconversion (SC), anti-S1/S2 IgG geometric mean titer (GMT), factor increase GMT (FI-GMT), neutralizing antibodies (NAb) positivity, and median neutralizing activity after each vaccine dose (D0 and D28) and six weeks after the second dose (D69). Participants with pre-vaccination positive IgG serology and/or NAb and those with RT-PCR-confirmed COVID-19 during the protocol were excluded from immunogenicity analysis. Patients and CTRL were of comparable sex (P>0.99) and age (P=0.90). Immunogenicity of 37 patients and 79 CTRL-naïve participants revealed, at D69, a moderate but significantly lower SC (64.9% vs 91.1%, P<0.001), GMT (7.9 [95%CI 4.7–13.2] vs 24.7 [95%CI 30.0–30.5] UA/ml, P<0.001) and frequency of NAb (51.4% vs 77.2%, P<0.001). Median neutralizing activity was comparable in both groups (57.2% [interquartile range (IQR) 43.4–83.4] vs 63.0% [IQR 40.3–80.7], P=0.808). Immunosuppressives were less frequently used among NAb+ patients vs NAb- patients (73.7% vs 100%, P=0.046). Type of SAMs, disease status, other drugs, or comorbidities did not influence immunogenicity. Vaccine-related adverse events were mild, with similar frequencies in patients and CTRL (P>0.05). The authors conclude that, based on this study, CoronaVac-Sinovac is safe and has a moderate short-term immunogenicity in SAMs, but reduced compared with CTRL. They further identified that immunosuppression is associated with diminished NAb positivity.

Source: Shinjo SK, by Souza FHC, Borges IBP, et al. Systemic autoimmune myopathies: A prospective phase 4 controlled trial of an inactivated virus vaccine against SARS-CoV-2. Rheumatology (Oxford). 2021 Oct 19:keab773. doi: 10.1093/rheumatology/keab773. Pre-print e-pub. PMID: 34664616. Available at: https://academic.oup.com/rheumatology/advance-article/doi/10.1093/rheumatology/keab773/6402018.

Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine in a subgroup of healthy adults in Chile

On 19 September, an online pre-print article was published, reporting safety and immunogenicity results obtained for healthy Chilean adults aged ≥18 in a phase 3 clinical trial of the inactivated COVID-19 vaccine CoronaVac. Volunteers randomly received two doses of CoronaVac or placebo, separated by two weeks; 434 volunteers were enrolled, 397 aged 18-59 years, and 37 aged ≥60 years. Solicited and unsolicited adverse reactions were registered from all volunteers. Blood samples were obtained from a subset of volunteers and analyzed for humoral and cellular measures of immunogenicity. The primary adverse reaction in the 434 volunteers was pain at the injection site, with a higher incidence in the vaccine than in the placebo arm. Adverse reactions observed were mostly mild and local. No severe adverse events were reported. The humoral evaluation was performed on 81 volunteers. Seroconversion rates for specific anti-S1-RBD IgG were 86.67% in the 18-59 age group and 70.37% in the ≥60 age group, two and four weeks after the second dose. A significant increase in circulating neutralizing antibodies was detected two and four weeks after the second dose. The cellular evaluation was performed on 47 volunteers. The authors detected a significant induction of T-cell responses characterized by the secretion of IFN-gamma upon stimulation with Mega Pools of peptides from SARS-CoV-2. The authors conclude that immunization with CoronaVac in a 0-14 schedule in Chilean adults aged ≥18 is safe, induces anti-S1-RBD IgG with neutralizing capacity, activates T-cells, and promotes the secretion of IFN-gamma upon stimulation with SARS-CoV-2 antigens.

Source: Bueno SM, Abarca K, González PA, et al. Safety and Immunogenicity of an Inactivated SARS-CoV-2 Vaccine in a Subgroup of Healthy Adults in Chile. Clin Infect Dis. 2021 Sep 19:ciab823. doi: 10.1093/cid/ciab823. Pre-print epub. PMID: 34537835. Available at: https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciab823/6372423.

Reactogenicity to a third dose of mRNA vaccine (BNT162b2) in immunocompromised individuals and people over 60 years of age – a nationwide survey in Israel

On 24 September, an online pre-print retrospective cohort study, without a control group, was published. The objective of the study was to evaluate reactogenicity of the BNT162b2 vaccine, after administering a third dose to immunocompromised individuals and people 60 years old or older (approved in Israel on 13 July 2021). A retrospective cohort, using electronic surveys sent to booster vaccine recipients, between 20 July and 10 August 2021, was analyzed. A total of 17,820 people participated in the survey, with a response rate of 30.2%; 3,195 (17.9%) were immunocompromised. Fatigue, myalgia, and fever were the most frequent systemic side effects reported (19.6%, 9.2%, and 8.1%, respectively among immunocompromised; 21.3%, 9.9%, and 9.2%, respectively among seniors). 67.3% of immunocompromised and 62% of seniors reported experiencing a better or a similar response to the third dose, compared to the second. The authors conclude that local and systemic reactions after a third vaccination with SARSCoV-2 vaccine BNT162b, reported by immunocompromised and seniors, were similar to those observed following previous vaccines and mostly self-resolved. These findings may aid in promoting confidence among vaccine providers and recipients.

Source: Shapiro Ben David S, Shamir-Stein N, Baruch Gez S, et al. Reactogenicity of a third BNT162b2 mRNA COVID19 vaccine among immunocompromised individuals and seniors - A nationwide survey. Clin Immunol. 2021 Sep 24;232:108860. doi: 10.1016/j.clim.2021.108860. Pre-print e-pub. PMID: 34571262; PMCID: PMC8461972. Available at: https://www.sciencedirect.com/science/article/pii/S1521661621001972?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