Pharmacovigilance for COVID-19 vaccines
Disclaimer: It is important to note that the data on spontaneous reports of adverse events after vaccination are just suspicious adverse events. The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. Causal associations cannot (and should not) be made using data from spontaneous reports.
Moreover, this data is not valid for estimating the frequency of occurrence of adverse reactions in patients receiving the vaccine, nor do they allow comparisons between different vaccines. However, this data coming from spontaneous report can be useful to provide hypothesis, requiring additional epidemiological and clinical investigations to be confirmed or refuted. Further confirmation in controlled studies is usually required.
Moreover, this data is not valid for estimating the frequency of occurrence of adverse reactions in patients receiving the vaccine, nor do they allow comparisons between different vaccines. However, this data coming from spontaneous report can be useful to provide hypothesis, requiring additional epidemiological and clinical investigations to be confirmed or refuted. Further confirmation in controlled studies is usually required.
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The vaccines detailed below have been prioritized based on their use in the Region of the Americas
In Progress
CanSino
COVID-19 vaccine
Convidecia; PakVac; Ad5-nCoV
EUL
Phase 4
| Authorization status: EUL (WHO) |
| Developer: Cansino Biological inc; Beijing Institute of Biotechnology |
| Manufacturer: CanSino Biologics Inc |
| Platform: Viral Vector (non-replicating) |
| Pharmaceutical form: Solution for intramuscular injection |
Dosification:
+
5°C (41°F)
In Progress
EU Nodes-AstraZeneca/ Oxford; AstraZeneca/SK BIO; Serum Institute of India
COVID-19 vaccine
Vaxzevria in Europe (formerly AZD1222 and ChAdOx1); Covishield in India; ChAdOx1-S [recombinant]
EUL
Phase 4
| Authorization status: EUL (WHO) |
| Developer: AstraZeneca; Oxford University |
| Manufacturer: AstraZeneca/SK Bioscience Co. Ltd, Republic of Korea; Serum Institute of India Pvt. Ltd, India; AstraZeneca AB, Sweden |
| Platform: Viral Vector (non-replicating) |
| Pharmaceutical form: Suspension for intramuscular injection |
Dosification:
+
5°C (41°F)
In Progress
Janssen
COVID-19 vaccine
Jcovden; JNJ-78436735; Ad26.COV2-S (recombinant)
EUL
Phase 4
| Authorization status: EUL (WHO) |
| Developer: Janssen Pharmaceutical |
| Manufacturer: Janssen–Cilag International NV, Belgium |
| Platform: Viral Vector (non-replicating) |
| Pharmaceutical form: Suspension for intramuscular injection |
Dosification:
-20°C (-4°F)
In Progress
Moderna
COVID-19 vaccines
Spikevax (original); elasomeran; mRNA-1273; TAK-919
Original
EUL
Phase 4
| Authorization status: EUL (WHO) |
| Developer: Moderna - National Institute of Allergy and Infectious Diseases (NIAID) |
| Manufacturer: Moderna TX, Inc., USA; Rovi Pharma Industrial Services S.A, Spain. |
| Platform: RNA-based vaccine |
| Pharmaceutical form: Suspension for intramuscular injection |
Dosification:
+
-20°C (-4°F)
Spikevax bivalent (Original/Omicron)
In Progress
Pfizer-BioNTech
COVID-19 vaccines
Comirnaty (original); tozinameran; BNT162b2
Original
EUL
Phase 4
| Authorization status: EUL (WHO) |
| Developer: Pfizer/BioNTech |
| Manufacturer: Pfizer Europe MA EEIG |
| Platform: RNA-based vaccine |
| Pharmaceutical form: Concentrated dispersion /dispersion for intramuscular injection |
Dosification:
+
-75°C (-103°F)
Comirnaty bivalent (Original/Omicron)
EULIn Progress
Sinopharm/BIBP
COVID-19 vaccine
Covilo; Inactivated SARS-CoV-2-vaccine (Vero cell); BBIBP-CorV; adsorbed COVID-19 vaccine
EUL
Phase 4
| Authorization status: EUL (WHO) |
| Developer: Sinopharm; China National Biotec Group Co; Beijing Institute of Biological Products |
| Manufacturer: Beijing Institute of Biological Products Co. Ltd. |
| Platform: Inactivated virus |
| Pharmaceutical form: Suspension for intramuscular injection |
Dosification:
+
5°C (41°F)
In Progress
Sinovac
COVID-19 vaccine
CoronaVac; adsorbed COVID-19 vaccine
EUL
Phase 4
| Authorization status: EUL (WHO) |
| Developer: Sinovac Research and Development Co, Ltd |
| Manufacturer: Sinovac Life Sciences., LTD. China |
| Platform: Inactivated virus |
| Pharmaceutical form: Suspension for intramuscular injection |
Dosification:
+
5°C (41°F)
In Progress
Anhui Zhifei Longcom
COVID-19 vaccine
Zifivax; ZF-UZ-VAC 2001; ZF2001
Phase 4
| Authorization status: Authorized |
| Developer: Anhui Zhifei Longcom Biopharmaceutical; Institute of Microbiology, Chinese Academy of Sciences |
| Manufacturer: Anhui Zhifei Longcom Biopharmaceutical Co. Ltd. |
| Platform: Protein subunit |
| Pharmaceutical form: Suspension for intramuscular injection |
Dosification:
5°C (41°F)
In Progress
Sinopharm/WIBP
COVID-19 vaccine
Inactivated SARS-CoV-2-vaccine (Vero cell); WIBP-CorV; adsorbed COVID-19 vaccine
Phase 4
| Authorization status: Authorized |
| Developer: Sinopharm; China National Biotec group Co; Wuhan Institute of Biological Products |
| Manufacturer: Wuhan Institute of Biological Products Co. Ltd. |
| Platform: Inactivated virus |
| Pharmaceutical form: Suspension for intramuscular injection |
Dosification:
+
5°C (41°F)
In Progress
Bharat Biotech
COVID-19 vaccine
Covaxin; BBV152
EUL
Phase 3
| Authorization status: EUL (WHO),Suspention of suppply |
| Developer: Bharat Biotech International Limited |
| Manufacturer: Bharat Biotech International Limited |
| Platform: Inactivated virus |
| Pharmaceutical form: Suspension for intramuscular injection |
Dosification:
+
5°C (41°F)
In Progress
Novavax/ Serum Institute of India (SII)
COVID-19 vaccine
Nuvaxovid; Covovax; NVX-CoV2373
EUL
Phase 3
| Authorization status: EUL (WHO) |
| Developer: Novavax |
| Manufacturer: Novavax, Serum Institute of India (SII) |
| Platform: Protein subunit |
| Pharmaceutical form: Dispersion for intramuscular injection |
Dosification:
+
5°C (41°F)
In Progress
CIGB
COVID-19 vaccine
Abdala; CIGB-66
Phase 3
| Authorization status: Authorized |
| Developer: Center for Genetic Engineering and Biotechnology (CIGB) |
| Manufacturer: Centro de Ingeniería Genética y Biotecnología (CIGB) |
| Platform: Protein subunit |
| Pharmaceutical form: Suspension for intramuscular injection |
Dosification:
5°C (41°F)
In Progress
Finlay Institute of Vaccines
COVID-19 vaccine
Soberana 02; Soberana 02 ST; Soberana Plus; Soberana Plus ST; FINLAY-FR-2
Phase 3
| Authorization status: Authorized |
| Developer: Finlay Institute de Vaccines |
| Manufacturer: Instituto Finlay de Vacunas |
| Platform: Protein subunit |
| Pharmaceutical form: Suspension for intramuscular injection |
Dosification:
/
5°C (41°F)
In Progress
Gamaleya
COVID-19 vaccine
Sputnik V; Gam-COVID-Vac; Adeno-based (rAd26-S+rAd5-S) / Sputnik light
Phase 3
| Authorization status: Authorized |
| Developer: Gamaleya Research Institute; Health Ministry of the Russian Federation |
| Manufacturer: N.F. Gamaleya Ministry of Health of Rusia |
| Platform: Viral Vector (non-replicating) |
| Pharmaceutical form: Solution for intramuscular injection |
Dosification:
/
-18°C (-0.4°F)
In Progress
Valneva
COVID-19 vaccine
Valneva; VLA2001
Phase 3
| Authorization status: Authorized |
| Developer: Valneva’s research |
| Manufacturer: Valneva Austria GmbH |
| Platform: Inactivated virus |
| Pharmaceutical form: Suspension for intramuscular injection |
Dosification:
+
5°C (41°F)
In Progress
Vector Institute
COVID-19 vaccine
EpiVacCorona; EpiVakKorona
Phase 3
| Authorization status: Authorized |
| Developer: Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "vector" (FBRI) |
| Manufacturer: Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "vector" (FBRI) |
| Platform: Protein subunit |
| Pharmaceutical form: Suspension for intramuscular injection |
Dosification: