Farmacovigilancia de vacunas para COVID-19

COVID-19 vaccines	Country
Abdala of Center for Genetic Engineering and Biotechnology (CIGB)	Click to see the list
Ad26.COV2.S of Janssen (Johnson & Johnson)	Click to see the list
AstraZeneca of SK BIO	Click to see the list
Aurora-CoV of Vector State Research Center of Virology and Biotechnology	Russia
BBIBP-CorV of Beijing Institute of Biological Products; China National Pharmaceutical Group (Sinopharm)	Click to see the list
Comirnaty (BNT162b2) of Pfizer-BioNTech	Click to see the list
Convidicea of CanSino Biologics	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
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
Inactivated vaccine of Chinese Academy of Medical Sciences	China
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
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
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-919 (Moderna formulation) of Takeda	Japan
Turkovac of Health Institutes of Turkey	Turkey
Vaxzevria of AstraZeneca/Oxford	Click to see the list
VLA2001 of Valneva	Bahrain
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

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
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	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]) New	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

*Vaccines that have different authorizations, but with the same developer.

	Pfizer-BioNTech COVID-19 vaccine	AstraZeneca/ Oxford; SK BIO; Serum Institute of India COVID-19 vaccine	Janssen COVID-19 vaccine	Moderna COVID-19 vaccine	Sinovac COVID-19 vaccine	Gamaleya COVID-19 vaccine	Sinopharm/BIBP COVID-19 vaccine	Sinopharm/WIBP COVID-19 vaccine	CanSino COVID-19 vaccine	Novavax COVID-19 vaccine	Anhui Zhifei Longcom COVID-19 vaccine	Bharat Biotech COVID-19 vaccine [8]	Vector Institute COVID-19 vaccine	Instituto Finlay COVID-19 vaccine	CIGB COVID-19 vaccine
Alpha B.1.1.7	Has not been measured or reported	70% (44% to 84%) [2]	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	Has not been measured or reported	Has not been measured or reported	86% (71% to 83%) [6]	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
Beta B.1.351	100% (54% to 100%) [1]	10% (0% to 55%) [10]	52% (30% to 67%) [5]	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	Has not been measured or reported	43% (0% to 70%) [7]	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
Gamma P.1	Has not been measured or reported	63.6% (0.00% to 87.00%) [9]	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	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	Has not been measured or reported	Has not been measured or reported	Has not been measured or reported
Delta B.1.617.2	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	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	Has not been measured or reported	65% (33% to 83%) [11]	Has not been measured or reported	Has not been measured or reported	Has not been measured or reported

1 [Thomas SJ, 2021 ]
2 [Emary KRW, 2021 ]
3 [Sadoff J, 2021 ]
4 [Clemens SAC, 2021 ]
5 [Sadoff J, 2021 ]
6 [Heath PT, 2021 ]
7 [Shinde V, 2021 ]
8 [Logunov, Denis Y, 2021 ]
9 [Clemens SAC, 2021 ]
10[Madhi SA, 2021 ]
11[Ella R, 2021 ]

	Pfizer-BioNTech COVID-19 vaccine [1]	AstraZeneca/ Oxford; SK BIO; Serum Institute of India COVID-19 vaccine [2], [9]	Janssen COVID-19 vaccine [3]	Moderna COVID-19 vaccine [4]	Sinovac COVID-19 vaccine [5],[6]	Gamaleya COVID-19 vaccine [7]	Sinopharm/BIBP COVID-19 vaccine [8]	Sinopharm/WIBP COVID-19 vaccine [8]	CanSino COVID-19 vaccine [14]	Novavax COVID-19 vaccine [10],[11]	Anhui Zhifei Longcom COVID-19 vaccine	Bharat Biotech COVID-19 vaccine [12]	Vector Institute COVID-19 vaccine	Instituto Finlay COVID-19 vaccine [13]	CIGB COVID-19 vaccine
Contracting COVID-19*	91% (89% to 93%)	64% (39% to 79%)	67% (59% to 73%)	93% (90% to 94%)	71% (7% to 91%)	91% (83% to 95%)	74% (61% to 82%)	64% (49% to 75%)	57% (40% to 70%)	90% (84% to 93%)	Has not been measured or reported	77% (65% to 85%)	Has not been measured or reported	72% (61% to 80%)	Has not been measured or reported
Symptomatic COVID-19 infection**	91% (89% to 93%)	67% (57% to 74%)	67% (59% to 73%)	93% (90% to 94%)	71% (7% to 91%)	91% (83% to 95%)	78% (65% to 86%)	73% (58% to 82%)	64% (53% to 72%)	90% (80% to 95%)	Has not been measured or reported	68% (47% to 83%)	Has not been measured or reported	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	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	64% (29% to 82%)	Has not been measured or reported	Has not been measured or reported	Has not been measured or reported
Contracting severe COVID-19	96% (68% to 99%)	91% (7% to 99%)	76% (61% to 86%)	98% (92% to 100%)	94% (58% to 99%)	99% (87% to 100%)	Has not been measured or reported	Has not been measured or reported	96% (70% to 99%)	93% ( 46% to 99%)	Has not been measured or reported	93% (49% to 99%)	Has not been measured or reported	67% (-64% to 93%)	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****	Has not been measured or reported	Not estimated****	Not estimated****	Not estimated****	Not estimated****

* Virologically confirmed COVID-19 with positive test for SARS-CoV-2 infection
** Symptomatic COVID-19 infection confirmed with positive SARS-CoV-2 test
*** Asymptomatic COVID-19 infection confirmed with positive SARS-CoV-2 test
****The existing evidence does not allow to assess the impact of COVID-19 vaccine on the risk of this outcome attributable to COVID-19
1 [Thomas SJ, 2021 ]
2 [Voysey M, 2021 ]
3 [Sadoff J, 2021 ]
4 [El Sahly HM, 2021 ]
5 [Palacios R, 2021 ]
6 [Tanriover MD, 2021 ]
7 [Logunov, Denis Y, 2021 ]
8 [Al Kaabi N, 2021 ]
9 [Falsey AR, 2021 ]
10[Heath PT, 2021 ]
11[Dunkle LM, 2021 ]
12[Raches Ella MBBS, MS, 2021 ]
13[Maria Eugenia Toledo-Romani, 2021 ]
14[Halperin SA, 2021 ]

COVID-19 vaccines	Other Names	Platform	SAGE/WHO Indication	Administration	Presentation	Diluent	Adjuvant	Preservatives	Shelf-life	Ultra-low temperature -90ºC to -60ºC (-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	ZF2001; ZIFIVAX; ZF-UZ-VAC 2001	Protein subunit	Has not been authorized	IM	Monodose vial (0.5 mL)	No	Aluminium hydroxide-based adjuvant	Not yet available	Not yet available	Not yet available	Not yet available	Not yet available	Not yet available
Bharat Biotech COVID-19 vaccine (EUL)	BBV152; Covaxin	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	9 months	No	No	9 months	Maximum 6 hours (2 to 8°C)
CanSino COVID-19 vaccine	Ad5-nCoV; Convidecia; PakVac	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	12 months	No	No	12 months	Maximum 6 hours (2 to 8°C)
AstraZeneca/Oxford; SK BIO; Serum Institute of India (SII) COVID-19 vaccine (EUL)	ChAdOx1-S [recombinant]; Vaxzevria in Europe (formerly AZD1222 and ChAdOx1); Covishield in India	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	Vaxzevria: 6 months Covishield: 9 months	No	No	Vaxzevria: 6 months Covishield: 9 months	Maximum 6 hours (2 to 8°C)
Gamaleya COVID-19 vaccine	Sputnik V; Gam-COVID-Vac; Adeno-based (rAd26-S+rAd5-S)/ Sputnik light	Viral Vector (non-replicating)	Has not been authorized	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	3 months	No	6 months (-18°C or below)	No	Maximum 2 hours (15 °C to 25 °C)
Instituto Finlay COVID-19 vaccine	FINLAY-FR-2, SOBERANA 02; SOBERANA 02 ST; SOBERANA PLUS; SOBERANA PLUS ST	Protein subunit	Has not been authorized	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	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
Janssen COVID-19 vaccine (EUL)	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	24 months	No	24 months	WHO: 4.5 months. EMA: 11 months.	WHO: Maximum 6 hours (2 to 8°C) EMA: 3 hours (maximally 25°C)
Moderna COVID-19 vaccine (EUL)	mRNA-1273; Elasomeran; Spikevax, TAK-919	RNA-based vaccine	Individuals aged 12 years 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	7-9 months	No	7-9 months (-20 ± 5°C)	1 month	Maximum 6 hours (2 to 25 °C)
Novavax/Serum Institute of India (SII) COVID-19 vaccine	NVX-CoV2373; COVOVAX; NUVAXOVID	Protein subunit	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 10 doses (0.5 mL each). Vial volume: 5 mL.	No	Matrix-M1	No	9 months	No	No	9 months	Monodose: Use immediately** Multidose: Maximum 6 hours (2 to 8°C)
Pfizer-BioNTech COVID-19 vaccine (EUL)	2BNT162b2; Tozinameran; Comirnaty	RNA-based vaccine	Individuals aged 5 years and over, pregnancy and breastfeeding.	IM	Concentrate for dispersion for injection: multidose vial of 6 doses after dilution (0.3 or 0.2 mL each). 'Ready to use' formulation: multi-dose vial. One dose (0.3 mL).	Concentrate for dispersion for injection: Sodium Chloride. 'Ready to use' formulation: No	Lipid nanoparticle (LNP)	No	9 months	9 months	2 weeks	31 days (undiluted)	Maximum 6 hours (2 to 8°C)
Sinopharm/BIBP (Beijing Institute of Biological Products) COVID-19 vaccine (EUL)	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	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	Inactivated SARS-CoV-2-vaccine (Vero cell); WIBP-CorV; adsorbed COVID-19 vaccine	Inactivated virus	Has not been authorized	IM	Monodose vial (0.5 mL)	No	Aluminium hydroxide-based adjuvant	No	6 months	No	No	6 months	Monodose: Use immediately**
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	12 months	No	No	12 months	Monodose: Use immediately** Multidose: Maximum 6 hours (2 to 8°C)
Vector Institute COVID-19 vaccine	EpiVacCorona; EpiVakKorona	Protein subunit	Has not been authorized	IM	Not yet available	No	No	No	Not yet available	Not yet available	Not yet available	Not yet available	Not yet available
CIGB (Centro de Ingeniería Genética y Biotecnología) COVID-19 vaccine	Abdala; CIGB-66	Protein subunit	Has not been authorized	IM	Multidose vial of 10 doses (0.5 mL each). Vial volume: 5 mL.	No	Aluminium hydroxide-based adjuvant	Thiomersal	6 months	No	No	6 months	Maximum 6 hours (2 to 8°C)

* The maximum time starts from the moment that the vial is thawed
** After the first puncture of the vial, preferably use immediately

	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)
Anhui Zhifei Longcom COVID-19 vaccine	NA	NA	NA	NA	NA	NA	NA	NA	NA
Bharat Biotech COVID-19 vaccine	NA	NA	NA	NA	NA	NA	NA	NA	NA
CanSino COVID-19 vaccine	NA	NA	NA	NA	NA	NA	NA	NA	NA
AstraZeneca/ Oxford; SK BIO; Serum Institute of India COVID-19 vaccine	NA	Based on available data from the WHO until July 2021, GBS has been reported very rarely following vaccination with AstraZeneca/Oforxd COVID-19 vaccine. WHO and EMA state that the potential benefits of the AstraZeneca/Oxford vaccine continue to outweigh any potential risk of GBS, particularly after the emergence of more transmissible SARS-CoV-2 variants. Health workers should be alert to possible signs and symptoms of GBS to ensure timely and accurate diagnosis and management of potential cases. According to the EMA's COVID-19 vaccine safety update as of September 2021, PRAC concluded that a causal relationship between AstraZeneca/Oxford vaccine and GBS is considered at least a reasonable possibility and that GBS should therefore be added to the vaccine information as a very rare (i.e. occurring in less than 1 in 10,000 persons) side effect. Vaccinated people are advised to seek immediate medical attention if they develop signs and symptoms suggestive of GBS, such as weakness in the extremities, double vision or difficulty moving eyes [6] [7]	Vaccine information was updated on the very rare risk of TTS. As of July 2021 a total of 1,503 cases had been reported worldwide from around 592 million doses administered, with no large differences by sex. WHO and EMA reccommend that people who have had TTS following the first dose of AstraZeneca/Oxford COVID-19 vaccine should not receive a second dose of the same [6] [7]	In consideration of the identification of CLS as a side effect of AstraZeneca/Oxford COVID-19 vaccine, PRAC assessed a possible mechanism of action for the development of CLS following vaccination and no definitive mechanism could be identified. Data that emerges after September 2021 is under monitoring [7]	WHO recommends post-authorization monitoring activities and research on the background rates of adverse events of special interest such as CVST. On September 2021, PRAC requested the marketing authorisation holder to provide further data on CVST [6] [7]	NA	Until August 2021, no cases of MIS were reported in a child after vaccination with the AstraZeneca/Oxford COVID-19 vaccine in the European Economic Area [7]	NA	NA
Gamaleya Sputnik V; Sputnik Light COVID-19 vaccine	NA	NA	NA	NA	NA	NA	NA	NA	NA
Instituto Finlay COVID-19 vaccine	NA	NA	NA	NA	NA	NA	NA	NA	NA
Janssen COVID-19 vaccine	NA	As of July 2021, GBS will be listed as a very rare side effect of Janssen COVID-19 vaccine [1]. By the end of 2021, GBS was reported as 7-8 per million doses administered, with 64% of the cases reported from the USA. Healthcare professionals and vaccinated people should be alert to signs and symptoms suggestive of GBS, such as weakness in the extremities, double vision or difficulty moving eyes. In countries with ongoing SARS-CoV-2 transmission, EMA confirms that the benefit of vaccination in protecting against COVID-19 far outweighs the risks of GBS [5]	According to the WHO interim recommendations updated to december 2021 [1], the benefit-risk ratio of vaccination is greatest in older age groups including COVID-19 related thromboembolic events. WHO recommends that Janssen COVID-19 vaccine should be given with caution to individuals with thrombocytopenia, any coagulation disorder, or individuals on anticoagulation therapy. TTS was reported as approximately 2 per million doses administered, 69% of the cases were reported from the USA and 83% in age groups below 65 years. WHO recommends safety surveillance and monitoring of thromboembolic events and TTS after vaccination with Janssen COVID-19 vaccine [1]. According to Janssen's Report on the Risk for immune thrombocytopenia (ITP) and venous thromboembolism (VTE) [12], individuals who present with thrombosis within 3 weeks of vaccination should be evaluated for thrombocytopenia to assess a potential diagnosis of TTS that requires specialized clinical management. People should seek immediate medical attention if they experience severe or persistent headache, blurred vision, confusion, seizures, shortness of breath, chest pain, leg swelling, leg pain, persistent abdominal pain, unusual skin bruising or pinpoint round spots beyond the site of vaccination within three weeks of vaccination, as these could be signs of TTS	According to the WHO interim recommendations updated to december 2021 [1], in countries with ongoing SARS-CoV-2 transmission, the benefit of vaccination in protecting against COVID-19 far outweighs the risks of CLS. Very rare cases of CLS (0.21 per million doses administered) have been reported, some in persons with a prior history of CLS and some have had with fatal outcomes	According to Janssen's Report on the Risk for immune thrombocytopenia (ITP) and venous thromboembolism (VTE) [12], VTE has been observed rarely following vaccination with the Janssen COVID-19 vaccine. Healthcare professionals and vaccinated people should be alert to the signs and symptoms of VTE such as shortness of breath, chest pain, leg pain, leg swelling, or persistent abdominal pain. Individuals with increased risk for thromboembolism should consider higher risk of VTE	NA	NA	According to the PRAC - EMA, small vessel vasculitis with cutaneous manifestations (inflammation of blood vessels in the skin which may result in a rash, pointed or flat, red spots under the skin‘s surface and bruising) should be added to the product information of Janssen COVID-19 vaccine as a possible side effect of unknown frequency.	NA
Moderna COVID-19 vaccine	Myocarditis is a very rare adverse event that has been reported after receipt of mRNA COVID-19 vaccines (Pfizer-BioNTech or Moderna). Available data suggest that the immediate course of myocarditis and pericarditis following vaccination is generally mild and responds to treatment. Reports of myocarditis after mRNA COVID-19 vaccination are often in male adolescents and young adults, more often after the second dose and usually within a week of vaccination. Higher risk of myocarditis and pericarditis after mRNA COVID-19 vaccination has been observed among males under 40 years of age, being the highest in males 18 through 24 years of age. Available evidence on the use of mRNA COVID-19 vaccines as booster doses suggests a lower myocarditis risk relative to the risk following the primary series second dose. Vaccinated individuals should be alert to symptoms such as chest pain, shortness of breath and feelings of having a fast-beating, fluttering, or pounding heart, to seek medical care [2] [3]	NA	There were no reports of thrombotic events that would suggest a causal relationship to Moderna COVID-19 Vaccine. WHO and EMA recommend that Moderna COVID-19 vaccine should be given with caution to individuals with thrombocytopenia, any coagulation disorder, or individuals on anticoagulation therapy. WHO also recommends safety surveillance and monitoring of thromboembolic events and TTS. People should seek immediate medical attention if they experience severe or persistent headache, blurred vision, confusion, seizures, shortness of breath, chest pain, leg swelling, leg pain, persistent abdominal pain, unusual skin bruising or pinpoint round spots beyond the site of vaccination within three weeks of vaccination, as these could be signs of TTS [2]	According to the PRAC-EMA, a warning for flare-ups of capillary leak syndrome (CLS) should be added to the product information for the Spikevax COVID-19 vaccine.	NA	According to the EMA, there is no evidence to suggest that COVID-19 vaccines affect fertility and cases of menstrual disorders have been reported following COVID-19 infection. This alterations are very common and can occur with a wide range of underlying medical conditions as well as from stress and tiredness. Nevertheless, as of February 2021, PRAC is assessing reported cases of heavy menstrual bleeding (heavy periods) and absence of menstruation (amenorrhea) following vaccination with the Moderna COVID-19 vaccine in view of spontaneous reports of menstrual disorders and of findings from the literature. At the time, evidence does not support a causal link between Moderna vaccine and menstrual disorders [13]	NA	NA	According to the PRAC-EMA, available evidence does not support a causal link between Spikevax COVID-19 vaccine and very rare cases of autoimmune hepatitis (AIH).
Novavax COVID-19 vaccine	NA	NA	NA	NA	NA	NA	NA	NA	NA
Pfizer-BioNTech COVID-19 vaccine	Myocarditis is a very rare adverse event that has been reported after receipt of mRNA COVID-19 vaccines (Pfizer-BioNTech or Moderna). Available data suggest that the immediate course of myocarditis and pericarditis following vaccination is generally mild and responds to treatment. Reports of myocarditis after mRNA COVID-19 vaccination are often in male adolescents and young adults, more often after the second dose and usually within a week of vaccination. Higher risk of myocarditis and pericarditis after mRNA COVID-19 vaccination has been observed among males under 40 years of age, being the highest in males 18 through 24 years of age. Available evidence on the use of mRNA COVID-19 vaccines as booster doses suggests a lower myocarditis risk relative to the risk following the primary series second dose. Vaccinated individuals should be alert to symptoms such as chest pain, shortness of breath and feelings of having a fast-beating, fluttering, or pounding heart, to seek medical care [3] [4]	NA	NA	NA	NA	According to the EMA, there is no evidence to suggest that COVID-19 vaccines affect fertility and cases of menstrual disorders have been reported following COVID-19 infection. This alterations are very common and can occur with a wide range of underlying medical conditions as well as from stress and tiredness. Nevertheless, as of February 2021, PRAC is assessing reported cases of heavy menstrual bleeding (heavy periods) and absence of menstruation (amenorrhea) following vaccination with the Pfizer-BioNTech COVID-19 vaccine in view of spontaneous reports of menstrual disorders and of findings from the literature. At the time, evidence does not support a causal link between Pfizer-BioNTech vaccine and menstrual disorders [13]	NA	NA	According to the PRAC-EMA, available evidence does not support a causal link between Pfizer-BioNTech COVID-19 vaccine and very rare cases of autoimmune hepatitis (AIH).
Sinopharm/BIBP COVID-19 vaccine	NA	NA	NA	NA	NA	NA	NA	NA	NA
Sinopharm/WIBP COVID-19 vaccine	NA	NA	NA	NA	NA	NA	NA	NA	NA
Sinovac COVID-19 vaccine	NA	NA	NA	NA	NA	NA	NA	NA	NA
Vector Institute COVID-19 vaccine	NA	NA	NA	NA	NA	NA	NA	NA	NA
	NA	NA	NA	NA	NA	NA	NA	NA	NA

NA: Not Available (there is currently no information or data) or Not Associated (data found no association for the adverse event and the COVID-19 vaccine)

1. [WHO, 2022 ]
2. [FDA, 2021 ]
3. [CDC, 2021 ]
4. [World Health Organization, 2021 ]
5. [EMA, 2021 ]
6. [WHO, 2022 ]
7. [EMA, 2021 ]
8. [World Health Organization, 2022 ]
9. [WHO, 2022 ]
10. [CDC, 2021 ]
11. [CDC, 2021 ]
12. [EMA, 2021 ]
13. [European Medicines Agency (EMA), 2022 ]

	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)
	Individuals 5 to 11 years old	Individuals 12 to 17 years old	Individuals 18 years old and older	Pregnant and breastfeeding women	5 to 11 years old	12 to 17 years old	18 years and older
Anhui Zhifei Longcom COVID-19 vaccine	-	-	Two doses (0.5 mL each) 4 weeks apart, or three doses (0.5 mL each) 4 and 8 weeks apart.	-	-	-	-
Bharat Biotech COVID-19 vaccine	Not recommended yet	Not recommended yet	Two doses (0.5 mL each) 4 weeks apart.	SAGE: 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	SAGE: Two doses (0.5 mL each) 4 weeks apart, followed by an additional (third) dose 1-3 months after, and a booster (fourth) dose provided 3-6 months after the additional dose.
CanSino COVID-19 vaccine	Not recommended yet	Not recommended yet	One dose of 0.5 mL.	SAGE: 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	SAGE: One dose of 0.5 mL and an additional (second) dose administered 1-3 months after.
AstraZeneca/Oxford; AstraZeneca/SK BIO; Serum Institute of India COVID-19 vaccine	Not recommended yet	Not recommended yet	Two doses (0.5 mL each) 4 to 12 weeks apart. WHO recommends an interval of 8 to 12 weeks between doses.	SAGE: 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	SAGE: Two doses (0.5 mL each) 8-12 weeks apart, followed by an additional (third) dose 1-3 months after, and a booster (fourth) dose provided 3-6 months after the additional dose.
Gamaleya COVID-19 vaccine	-	-	Sputnik V: Two doses (0,5ml each) 3 weeks apart. Sputnik Light: One dose (0.5 mL).	-	-	-	-
Janssen COVID-19 vaccine	Not recommended yet	Not recommended yet	One or two doses (0.5 mL each). WHO recommends providing two doses with an interval of 2 to 6 months.	SAGE: 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	SAGE: Two doses (0.5 mL each) 1-3 months apart.
Moderna COVID-19 vaccine	Not recommended yet	SAGE: Two doses (100 µg, 0.5 ml each) 8 weeks apart.	Two doses (100 µg, 0.5 ml each) 4 to 8 weeks apart.	SAGE: Two doses (100 µg, 0.5 mL each) 8 weeks apart.	Not recommended yet	SAGE: Two doses (100 µg, 0.5 mL each) 8 weeks apart, followed by an additional (third) 100 µg dose. 1-3 months after, and a booster (fourth) 50 µg dose provided 3-6 months after the additional dose.	SAGE: Two doses (100 µg, 0.5 mL each) 8 weeks apart, followed by an additional (third) 100 µg dose 1-3 months after, and a booster (fourth) 50 µg dose provided 3-6 months after the additional dose.
Novavax/ Serum Institute of India COVID-19 vaccine	Not recommended yet	Not recommended yet	Two doses (0.5 mL each) 3-4 weeks apart.	SAGE: Two doses (5 µg of recombinant spike protein with 50 µg of Matrix-M adjuvant per 0.5 mL dose) 3 to 4 weeks apart. WHO recommends using the Novavax COVID-19 vaccine in pregnant women only if the benefits of vaccination outweigh the potent	Not recommended yet	Not recommended yet	SAGE: Two doses (5 µg of recombinant spike protein with 50 µg of Matrix-M adjuvant per 0.5 mL dose) 3 to 4 weeks apart, followed by an additional (third) dose 1-3 months after.
Pfizer-BioNTech COVID-19 vaccine	SAGE: Two doses (10 µg, 0.2 mL each) 8 weeks apart.	SAGE: Two doses (30 µg, 0.3 mL each) 8 weeks apart.	Two doses (30 µg, 0.3 mL each) 4-8 weeks apart. WHO recommends an interval of 8 weeks.	SAGE: Two doses (30 µg, 0.3 mL each) 8 weeks apart.	SAGE: Two doses (10 µg, 0.2 mL each) 8 weeks apart, followed by an additional (third) 10 µg dose 1-3 months after the second dose. A booster dose has not yet been determined.	SAGE: Two doses (30 µg, 0.3 mL each) 8 weeks apart, followed by an additional (third) 30 µg dose 1-3 months after, and a booster (fourth) dose provided 4-6 months after the additional dose.	SAGE: Two doses (30 µg, 0.3 mL each) 8 weeks apart, followed by an additional (third) 30 µg dose 1-3 months after, and a booster (fourth) dose provided 4-6 months after the additional dose.
Sinopharm/BIBP COVID-19 vaccine	Not recommended yet	Not recommended yet	Two doses (0.5mL each) 3 weeks apart. WHO recommends an interval of 3-4 weeks.	SAGE: 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.	Not recommended yet	Not recommended yet	SAGE: Two doses (0.5 mL each) 3-4 weeks apart, followed by an additional (third) dose 1-3 months after, and a booster (fourth) dose provided 3-6 months after the additional dose.
Sinopharm/WIBP COVID-19 vaccine	-	-	Two doses (0.5mL each) 3-4 weeks apart.	-	-	-	-
Sinovac COVID-19 vaccine	Not recommended yet	Not recommended yet	Two doses (0.5 mL each) 2-4 weeks apart. WHO recommends an interval of 4 weeks.	SAGE: 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.	Not recommended yet	Not recommended yet	SAGE: Two doses (0.5 mL each) 3-4 weeks apart, followed by an additional (third) dose 1-3 months after, and a booster (fourth) dose provided 3-6 months after the additional dose.
Finlay Institute of Vaccines COVID-19 vaccine	-	-	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.	-	-	-	-
Vector Institute COVID-19 vaccine	-	-	Two doses (0.5 mL) 3 weeks apart.	-	-	-	-
CIGB (Abdala) COVID-19 vaccine	-	-	Three doses (50 µg, 0.5 mL) 2 weeks apart.	-	-	-	-

Vaccine platform description	Type of candidate vaccine	Developers

Last update: 20 may, 2022
Source: WHO. COVID-19 vaccine tracker and landscape

Phase vaccine not reported: COVID19 Oral Vaccine Consisting of Bacillus Subtilis Spores developed by DreamTec Research Limited

Updates

The European Commission authorised COVID-19 Vaccine Valneva

EMA recommends the authorization of the Valneva COVID-19 Vaccine (inactivated, adjuvanted) for primary immunization of people from 18 to 50 years of age)

EMA recommends authorization of Novavax

FDA authorizes Moderna and Pfizer-BioNTech COVID-19 vaccines for children down to 6 months of age

EMA published new safety updates for COVID-19 vaccines

SAGE/WHO published an interim statement on decision-making considerations for the use of variant updated COVID-19 vaccines

Progress in clinical trials of COVID-19 vaccines in Cuba