FDA/USA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals
05/05/2022
05/05/2022
| 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 New | 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 New | 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 |
*Vaccines that have different authorizations, but with the same developer.
It is suggested to use the filters to select the variables with more information
| 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 |
It is suggested to use the filters to select the variables with more information
| 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**** |
It is suggested to use the filters to select the variables with more information
| COVID-19 vaccines | Other Names | Platform | SAGE/WHO Indication | Dosage | 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 | Vial contains a monodose of 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 | The vial presentation can be: multidose of 5 doses (2,5 mL), 10 doses (5 mL), or 20 doses (10 mL) and a monodose vial of 0.5 mL | 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) | Has not been authorized | IM | The vial presentation can be: multidose 10 doses of 0.5 mL each (vial volume: 5 mL), or monodose vial of 0.5 mL | No | No | No | 12 months | No | No | 12 months | Maximum 6 hours (2 to 8°C) | |
| AstraZeneca/Oxford (AO); 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 | Vial contains 2, 8 or 10 doses of 0.5 mL each (vial volume: 1, 4 or 5 mL; respectively) | No | No | No | AO: 6 months SII: 9 months | No | No | AO: 6 months SII: 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: vial contains 1 of 0.5 mL or 5 doses of 0.5 mL each (vial volume: 3 mL). Sputnik Light: vial contains 5 doses of 0.5 mL each (vial volume: 3 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: vial contains 10 doses of 0.5 mL each (vial volume: 5 mL). Every 10-dose vial contains thiomersal; Soberana 02 ST and Soberana plus ST: vial contains a 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 | The vial contains 5 doses of 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 | The vial contains 10 or 15 doses of 0.5 mL each (vial volume: 5 mL) | 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 | The vial contains 1 or 10 doses of 0.5 mL each | 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, children aged between 5-17 years with comorbidities, pregnancy and breastfeeding | IM | Concentrate for dispersion for injection: vial contains 6 doses of vaccine after dilution, of 0.3 mL each (vial volume: 0.45 mL). 'Ready to use' formulation: multi-dose vial. One dose (0.3 mL) contains 30 mg of Pfizer-BioNTech COVID-19 vaccine | 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 (2 or 5 doses) | 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 | The vial contains 1 or 2 doses of 0.5 mL each (vial volume: 0.5 or 5 mL) or as a single-dose vial 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 | The vial contains 10 doses of 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) |
It is suggested to use the filters to select the variables with more information
| 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 |
It is suggested to use the filters to select the variables with more information
| Individuals 5 to 11 years old | Individuals 12 to 17 years old | Individuals 18 years old and more | Pregnant and breastfeeding women | Immunocompromised persons (moderate and severe) | |||
|---|---|---|---|---|---|---|---|
| 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 with an interval of 8 to 12 weeks between doses, or a third dose within an interval of 28 or 56 days apart. | - | - | - | - |
| Bharat Biotech COVID-19 vaccine | Not recommended yet | Not recommended yet | Two doses - 0.5 mL each with an interval of 4 weeks apart. | SAGE: Two doses - 0.5 mL each with an interval of 4 weeks between doses. WHO recommends the use of COVID-19 vaccine in pregnant women only if the benefits of vaccination to the pregnant woman outweigh the potential risks. | Not recommended yet | Not recommended yet | SAGE: Two doses - 0.5 mL each with an interval of 4 weeks between doses; an additional (third) dose 1-3 months after the second dose, and a booster (fourth) dose administered 3-6 months after the additional dose. |
| CanSino COVID-19 vaccine | - | - | One dose - 0.5 mL. | - | - | - | - |
| AstraZeneca/Oxford; AstraZeneca/SK BIO; Serum Institute of India COVID-19 vaccine | Not recommended yet | Not recommended yet | Two doses - 0,5mL each, with an interval 4-12 weeks. WHO recommends an interval of 8-12 weeks between the 2 doses. | SAGE: Two doses - 0.5 mL each with an interval of 8-12 weeks between doses. WHO recommends the use of COVID-19 vaccine in pregnant women only if the benefits of vaccination to the pregnant woman outweigh the potential risks. | Not recommended yet | Not recommended yet | SAGE: Two doses - 0.5 mL each with an interval of 8-12 weeks between doses; an additional (third) dose 1-3 months after the second dose, and a booster (fourth) dose administered 3-6 months after the additional (third) dose should be considered. |
| Gamaleya COVID-19 vaccine | - | - | Sputnik V Two doses - 0,5ml each - with an interval 21 days apart. Sputnik Light, One dose of 0.5mL | - | - | - | - |
| Janssen COVID-19 vaccine | Not recommended yet | Not recommended yet | One dose - 0.5mL. WHO recommends an inter-dose interval of 2 - 6 months. | SAGE: One or two doses - 0.5 mL each with an inter-dose interval of 2 to 6 months. WHO recommends the use of COVID-19 vaccine in pregnant women only if the benefits of vaccination to the pregnant woman outweigh the potential risks. | Not recommended yet | Not recommended yet | SAGE: Two doses - 0.5 mL each with an inter-dose interval of 1 to 3 months. |
| Moderna COVID-19 vaccine | Not recommended yet | SAGE: Two doses - 100 µg, 0.5 ml each with an interval of 4 to 8 weeks between doses. | Two doses - 0.5 mL each, with an interval of 4-8 weeks apart. | SAGE: Two doses - 30 µg, 0.3 mL each with an interval of 8 weeks between doses. | Not recommended yet | SAGE: Two doses - 30 µg, 0.3 mL each with an interval of 8 weeks between doses; an additional (third) full 100 µg dose, and a booster (fourth) 50 µg dose 3-6 months after the additional (third) dose. | SAGE: Two doses - 30 µg, 0.3 mL each with an interval of 8 weeks between doses; an additional (third) full 100 µg dose, and a booster (fourth) 50 µg dose 3-6 months after the additional (third) dose. |
| Novavax/ Serum Institute of India COVID-19 vaccine | Not recommended yet | Not recommended yet | Two doses - 0.5 mL each, with an interval of 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) with an interval of 3 to 4 weeks between doses. WHO recommends the use of COVID-19 vaccine in pregnant women only if the benefits of vaccinatio | 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) with an interval of 3 to 4 weeks between doses. An additional (third) dose should be given between 1 and 3 months after the second dose. |
| Pfizer-BioNTech COVID-19 vaccine | SAGE: Two doses - 10 µg, 0.2 mL each with an interval of 8 weeks between doses. | SAGE: Two doses - 0.3 mL each with an interval of 8 weeks between doses. | Two doses - 0.3 mL each, 8 weeks apart. | SAGE: Two doses - 30 µg, 0.3 mL each with an interval of 8 weeks between doses. | SAGE: Two doses - 10 µg, 0.2 mL each with an interval of 8 weeks between doses; an additional (third) dose (10 µg) 1-3 months after the second dose. Booster dose has not yet been determined. | SAGE: Two doses - 30 µg, 0.3 mL each with an interval of 8 weeks between doses; an additional (third) dose (30 µg) 1-3 months after the second dose, and a booster (fourth) dose 4-6 months after the additional dose. | SAGE: Two doses - 30 µg, 0.3 mL each with an interval of 8 weeks between doses; an additional (third) dose (30 µg) 1-3 months after the second dose, and a booster (fourth) dose 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 dose with an interval of 3 to 4 weeks between doses. WHO recommends the use of COVID-19 vaccine in pregnant women only if the benefits of vaccination to the pregnant woman outweigh the potential risks. | Not recommended yet | Not recommended yet | SAGE: Two doses - 0.5 ml each dose with an interval of 3 to 4 weeks between doses. An additional (third) dose should be given at 1 to 3 months after the second dose, and a a booster (fourth) dose can be administered 3-6 months after the third dose. |
| Sinopharm/WIBP COVID-19 vaccine | - | - | Two doses - 0.5mL each, 21 to 28 days apart. | - | - | - | - |
| Sinovac COVID-19 vaccine | Not recommended yet | Not recommended yet | Two doses - 0.5mL each. WHO recommends an interval of 4 weeks. | SAGE: Two doses - 0.5 ml each dose with an interval of 2 to 4 weeks between doses. WHO recommends the use of COVID-19 vaccine in pregnant women only if the benefits of vaccination to the pregnant woman outweigh the potential risks. | Not recommended yet | Not recommended yet | SAGE: Two doses - 0.5 ml each dose with an interval of 2 to 4 weeks between doses. An additional (third) dose should be given at 1 to 3 months after the second dose. |
| Finlay Institute of Vaccines COVID-19 vaccine | - | - | Soberana 02: Two doses - 0.5mL each, 28 days apart. Soberana 02 ST: Two doses - 0.5mL each, 28 days apart. Soberana Plus: Single dose - 0.5 mL- as a booster vaccine 28 days after a two-dose vaccine schedule with SOBERANA® 02 or SOBERANA® 02 ST. | - | - | - | - |
| Vector Institute COVID-19 vaccine | - | - | Two doses - 0.5mL- 21 days apart. | - | - | - | - |
| CIGB (Abdala) COVID-19 vaccine | - | - | Three doses - 0.5mL each, 2 weeks apart. | - | - | - | - |
| Vaccine platform description | Type of candidate vaccine | Developers |
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Last update: 3 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