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On 16 April 2021, the World Health Organization (WHO) published conclusions from the Global Advisory Committee
on Vaccine Safety (GACVS) review of the latest evidence related to reports of rare adverse events following
immunization with the AstraZeneca COVID-19 vaccine (Vaxzevria and Covishield).
On 21 April 2021, the World Health Organization (WHO) published an update to the document “Interim
recommendations for use of the ChAdOx1-S [recombinant] vaccine against COVID-19 (AstraZeneca COVID-19
vaccine AZD1222, SII Covishield, SK Bioscience),” based on the recommendations issued by the Strategic Advisory
Group of Experts on Immunization (SAGE) at its extraordinary meeting on 8 February 2021 (1), updated on 21 April
2021.
An electronic population study of Denmark's hospital patient registry (Danish National Patient Registry, or DNPR) of
4.9 million adults estimated the number of thromboembolic events and the incidence of such events in the Danish
population between 2010 and November 2018.
On Wednesday, 4 April 2021, ANVISA reported that it had requested modification of the insert for the Oxford-
AstraZeneca-Fiocruz vaccine, to include in the warnings and precautions section the possibility of very rare cases of
blood clots associated with thrombocytopenia.
There are press releases and communiqués, though no published studies, stating the following: In response to
reports that emerged after a few recipients of the AstraZeneca COVID-19 vaccine...
The COVID-19 subcommittee of the Global Advisory Committee on Vaccine Safety (GACVS) met in March 2021 to
review available data on cases of thromboembolism and thrombocytopenia reported following administration of the
AstraZeneca COVID-19 vaccine.
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*
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.
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 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
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)
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)
AstraZeneca/Oxford; SK BIO; Serum Institute of India COVID-19 vaccine
NA
GBS has been reported very rarely (i.e. less than 1 in 10.000 vaccinees) following vaccination with Vaxzevria/Covishield. A causal relationship has neither confirmed, nor ruled out [2].
The benefits of the vaccine outweigh the risks of GBS [2]; [3].
Very rare cases of thrombosis with thrombocytopenia syndrome (TTS) were reported 3-21 days following vaccination with Vaxzevria/Covishield, mainly after the first dose. The benefits of vaccination outweigh the risks, especially in older age groups [2]; [4].
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].
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].
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
NA
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]
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].
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
Myocarditis is a very rare adverse event (up to 1 in 10.000 vaccinated people) reported after receipt a mRNA COVID-19 vaccine. Available data suggest that the course of myocarditis/pericarditis following vaccination is generally mild and responds to treatment. The observed risk is highest in young males (aged 18-24 years) and within a few days after the second dose of Moderna COVID-19 vaccine [10]; [11].
The benefits of Spikevax continue to outweigh its risks in all age groups [10].
NA
NA
In persons with history of this extremely rare condition, there is a potential occurrence of CLS flare-up following vaccination with Moderna COVID-19 vaccine [9].
NA
The currently available evidence does not support a causal relationship between Moderna COVID-19 vaccine and amenorrhea. As of June 2022, PRAC/EMA is still assessing reported cases about heavy menstrual bleeding [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
As for August 2022, based on a small number of reported cases, the PRAC/EMA has concluded that myocarditis and pericarditis can occur after vaccination with Novavax [13].
NA
NA
NA
NA
NA
NA
NA
NA
Pfizer-BioNTech COVID-19 vaccine
Myocarditis is a very rare adverse event (up to 1 in 10.000 vaccinated people) reported after receipt a mRNA COVID-19 vaccine. Available data suggest that the course of myocarditis and pericarditis following vaccination is generally mild and responds to treatment. The observed risk is highest in young males (aged 12-29 years) and higher after the second dose of Comirnaty [11]; [14].
The benefits of Comirnaty continue to outweigh its risks in all age groups [14].
NA
NA
NA
NA
The currently available evidence does not support a causal relationship between Comirnaty and amenorrhea. As of June 2022, PRAC/EMA is still assessing reported cases about heavy menstrual bleeding [12].
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
NA
NA
NA
NA
NA
NA
NA
NA
NA
Sinovac COVID-19 vaccine
NA
NA
NA
NA
NA
NA
NA
NA
NA
Main safety recommendations about EUL/WHO authorized vaccines are presented above.
More information about vaccines authorized by countries or regions is available in the extended version of the dashboard.
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)
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 (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).
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*.
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 (Abdala) COVID-19 vaccine (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 (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 (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 weeks after with Sputnik V (Component 1).
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.
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 (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: 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*. A second booster given 4-6 months after the previous should be considered for specific population groups**.
WHO recommends Moderna COVID-19 vaccine as a heterologous booster fo
Novavax/ Serum Institute of India COVID-19 vaccine (EUL/WHO authorization) [11], [12]
Not recommended yet
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 to 4 weeks apart. WHO recommends using the Novavax 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 1-3 months after the second dose.
SAGE/WHO: Novavax COVID-19 vaccine combined with any other EUL COVID-19 vaccine is considered a complete primary series.
EMA: A booster dose should be given 6 months after the primary series.
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*. A second booster given 4-6 months after the previous should be considered for specific population groups**.
WHO recommends Comirnaty as a heterologous booster following a prima
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).
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).
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 (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.
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, 2021].
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
Main advisory stakeholders' recommendations about EUL/WHO authorized vaccines are presented above.
More information about vaccines authorized by countries or regions is available in the extended version of the dashboard.
*NA: Not Available (there is currently no information or data).
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Primary schedule and booster dose for persons 6 months of age and older
EMA: Booster dose for persons from 12 years of age [2], MHRA: booster dose for persons ≥18 years [3].
FDA: Booster dose for persons from 18 years of age [4].
Primary schedule and booster dose for persons 6 months of age and older.
EMA: Booster dose for persons from 12 years of age [6].
EMA,FDA: Booster dose for persons from 12 years of age [6],[7].
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*
Single booster dose (0.5 mL) for persons ≥12 [2] or ≥18 years [3] after three months of the primary series or monovalent booster.
Single booster dose (0.5 mL) for persons ≥18 years after two months of the primary series or monovalent booster [4].
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*
Single booster dose (0.3 mL) for persons ≥12 years after three months of the primary series or monovalent booster [6].
Single booster dose (0.3 mL) for persons ≥12 years after two months of the primary series or monovalent booster [7]. 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
30 µg each dose of 0.3 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
Adapted COVID-19 vaccines authorized by regulatory agencies are presented above.
According to the targeted variant or subvariant under monitoring, authorization and recommended use between countries may differ.
*WHO recommends an interval between the first and second dose of 4 to 8 weeks, preferably extending it up to 8 weeks.
1. [WHO, 2022]
2. [EMA, 2022]
3. [MHRA, 2022]
4. [FDA, 2022]
5. [WHO, 2022]
6. [EMA, 2022]
7. [FDA, 2022]
Vaccines
Vaccine platform description
Candidate vaccine
Developers
Last update: 13 september, 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