Meeting highlights from the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency, from 27 to 30 September 2021
04/10/2021
Assessment of rare cases of venous thromboembolism with the Janssen COVID-19 vaccine
The Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that there is a possible link between rare cases of venous thromboembolism (VTE) and the Janssen COVID-19 vaccine.
VTE is a condition in which a blood clot forms in a deep vein, usually in a leg, arm, or groin, and may travel to the lungs causing a blockage of the blood supply, with possible life-threatening consequences. This safety issue is distinct from the very rare side effect of thrombosis with thrombocytopenia syndrome (TTS) (i.e. blood clots with low blood platelets).
VTE was included in the risk management plan for the Janssen COVID-19 vaccine, as a safety concern to be investigated, based on a higher proportion of cases of VTE observed within the vaccinated group versus the placebo group, in the large clinical study that was used to authorize this vaccine. The issue has been closely monitored.
The PRAC also reviewed evidence from the post-marketing setting – that is, data gathered while the vaccine is being used in vaccination campaigns. When taking all evidence into account, the committee concluded that there is a reasonable possibility that rare cases of VTE are linked to vaccination with the Janssen COVID-19 vaccine.
The committee is therefore recommending that VTE be listed in the product information as a rare side effect of the Jansen COVID-19 vaccine, together with a warning to raise awareness among healthcare professionals and people receiving the vaccine, especially those who may have an increased risk of VTE.
PRAC assessment of cases of immune thrombocytopenia with the Vaxzevria and Janssen COVID-19 vaccines The PRAC assessed cases of immune thrombocytopenia (ITP) reported following vaccination with the Vaxzevria vaccine (formerly AstraZeneca COVID-19 vaccine), as well as with the Janssen COVID-19 vaccine.
ITP is a condition in which the immune system mistakenly targets blood cells called platelets, which are needed for normal blood clotting. Very low levels of blood platelets can be associated with bleeding, and have serious health consequences.
The committee assessed all of the available data, and recommended updating the product information of both vaccines to include ITP as an adverse reaction with unknown frequency.
Furthermore, a warning statement has been agreed upon to highlight the fact that cases of very low levels of blood platelets have been reported very rarely, usually within the first four weeks following vaccination with the Janssen or Vaxzevria COVID-19 vaccine.
If an individual has a history of ITP, the risk of developing low platelet levels should be considered before vaccination, and platelet monitoring is recommended after vaccination with either of these vaccines.
The PRAC will continue to monitor new information, and will take any further actions that may be necessary.
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 12 years and over, pregnancy, and breastfeeding
IM
Multidose vial of 10 doses (0.5 mL each). Vial volume: 5 mL.
No
Matrix-M1
No
Pfizer-BioNTech COVID-19 vaccine (EUL)
Comirnaty; tozinameran; BNT162b2
RNA-based vaccine
Individuals aged 6 months and over, pregnancy and breastfeeding.
IM
Concentrate for dispersion for injection: multidose vial of 6 doses after dilution (0.3 mL each).
'Ready to use' formulation: multi-dose vial (0.3 mL each).
Pediatric formulation (5-11 years): concentrate for dispersion for injection: multidose vial of 10 doses after dilution (0.2 mL each).
Concentrate for dispersion for injection: Sodium Chloride.
'Ready to use' formulation: No
Lipid nanoparticle (LNP)
No
Sinopharm/BIBP (Beijing Institute of Biological Products) COVID-19 vaccine (EUL)
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: Vaxzevria; Covishield
NA
Guillain-Barré syndrome (GBS) have been reported very rarely following vaccination with Vaxzevria [21].
The benefits of the vaccine outweigh the risks of GBS [2]; [3].
TTS in some cases accompanied by bleeding, has been observed very rarely following vaccination with Vaxzevria. This includes severe cases ans unusual sites such as cerebral venous sinus thrombosis, splanchnic vein thrombosis, as well as arterial thrombosis. Some cases had a fatal outcome. The majority of these cases occurred within the first three weeks following vaccination. The reporting rates after the second dose are lower compared to after the first dose [21].
Vaxzevria is contraindicated in persons who have experienced TTS with previous doses of the vaccine [2].
Very rare cases of capillary leak syndrome (CLS) were reported in the first days after vaccination with Vaxzevria, with fatal outcomes in some people with prior experience of CLS. EMA recommends that persons with a known history of CLS should not be vaccinated with Vaxzevria [5] [21].
Events of cerebrovascular venous and sinus thrombosis (CVST) without thrombocytopenia have been observed very rarely following vaccination with Vaxzevria, mostly within the first four weeks following vaccination. This information should be considered for individuals at increased risk for CVST [3].
Very rare cases of thrombosis with thrombocytopenia syndrome (TTS) were reported globally (0.081 cases per 100.000 vaccinees as of December 2021) around 3-30 days following vaccination with CanSino [1].
NA
NA
NA
NA
NA
NA
Janssen COVID-19 vaccine: Jcovden
Reporting of advers events probably increased risks of myocarditis and pericarditis, particularly within the period 0 to 7 days after vaccination [cb18ffd03bac048bbab5482a4784537781c67a3f]
GBS has been reported very rarely following vaccination with Janssen COVID-19 vaccine. As of April 2022, 535 cases were reported globally (1.5 cases per million vaccinees) [6], [18]
The benefits of the vaccine outweigh the risks of GBS [6].
Very rare cases of thrombosis with thrombocytopenia syndrome (TTS) were reported following the first dose of Janssen COVID-19 vaccine. As of April 2022, 109 cases were reported globally (2 cases per million vaccinees) [6]. The benefits of vaccination outweigh the risks, especially in older age groups [4].
Janssen COVID-19 vaccine is contraindicated in persons who have experienced TTS with previous doses of the vaccine [4]; [6].
Very rare cases of capillary leak syndrome (CLS) were reported in the first days after vaccination with Janssen COVID-19 vaccine, with fatal outcomes in some people with prior experience of CLS. EMA recommends that persons with a known history of CLS should not be vaccinated with Janssen COVID-19 vaccine [7] [18]
Venous thromboembolism (VTE) has been observed rarely following vaccination with Janssen COVID-19 vaccine. This should be considered for individuals at increased risk for VTE [8].
NA
NA
PRAC/EMA recommends that small vessel vasculitis with cutaneous manifestations should be added to the product information of the Janssen COVID-19 vaccine as a possible side effect with unknown frequency [9].
NA
Moderna COVID-19 vaccine: Spikevax
These conditions can develop within just a few days after vaccination, and have primarily occurred within 14 days. They have been observed more often after the second dose compared to the first dose,
and more often in younger males [19].
The benefits of Spikevax continue to outweigh its risks in all age groups [10].
NA
NA
A few cases of capillary leak syndrome (CLS) flare-ups have been reported in the first days after vaccination with Spikevax [19].
NA
The PRAC-EMA has concluded that heavy menstrual bleeding is a side effect of unknown frequency of Spikevax. Most of cases are non-serious and temporaty in nature. There is no evidence to suggest the menstrual disorders experienced have any impact on reproduction and fertility [12].
NA
NA
According to PRAC/EMA, the available evidence does not support a causal link between Moderna COVID-19 vaccine and very rare cases of autoimmune hepatitis (AIH) [13].
Novavax COVID-19 vaccine: Nuvaxovid; Covovax
There is an increased risk of myocarditis and pericarditis following vaccination with Nuvaxovid.
These conditions can develop within just a few days after vaccination and have primarily occurred
within 14 days. [16].
NA
NA
NA
NA
NA
NA
NA
NA
Pfizer-BioNTech COVID-19 vaccine: Comirnaty
There is an increased risk of myocarditis and pericarditis following vaccination with Comirnaty. These conditions can develop within just a few days after vaccination, and have primarily occurred within 14 days. They have been observed more often after the second vaccination, and more often in younger males; [14], [17].
The benefits of Comirnaty continue to outweigh its risks in all age groups [14].
NA
NA
NA
NA
The PRAC-EMA has concluded that heavy menstrual bleeding is a side effect of unknown frequency of Comirnaty. Most of cases are non-serious and temporaty in nature. There is no evidence to suggest the menstrual disorders experienced have any impact on reproduction and fertility [17].
According to PRAC/EMA, there is currently insufficient evidence of a possible link between Comirnaty and very rare cases of multisystem inflammatory syndrome (MIS) [15].
NA
According to PRAC-EMA, the available evidence does not support a causal link between Comirnaty and very rare cases of autoimmune hepatitis (AIH) [13].
Sinopharm/BIBP COVID-19 vaccine: Covilo
NA
NA
NA
NA
NA
NA
NA
NA
NA
Sinovac COVID-19 vaccine: CoronaVac
NA
NA
NA
NA
NA
NA
NA
NA
NA
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: Vaxzevria; Covishield (EUL/WHO authorization) [2]
Not recommended yet
Not recommended yet
Not recommended yet
SAGE/WHO: Two doses (0.5 mL each) 4 to 12 weeks apart. WHO recommends an interval of 8 to 12 weeks between doses.
SAGE/WHO: Two doses (0.5 mL each) 8 to 12 weeks apart. WHO recommends using the Vaxzevria/Covishield COVID-19 vaccine in pregnant women only if the benefits of vaccination outweigh the potential risks.
Not recommended yet
Not recommended yet
Not recommended yet
SAGE/WHO: Extended primary series with an additional (third) dose of 0.5 mL 1-3 months after the second dose, followed by a booster (fourth) dose provided 3-6 months after.
SAGE/WHO: Vaxzevria/Covishield combined with any other EUL COVID-19 vaccine is considered a complete primary series.
SAGE/WHO: A booster dose should be given 4-6 months after the primary series* using any other EUL vaccine (preferably an mRNA-based or Novavax vaccine).
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 COVID-19 vaccine: Abdala (Authorized) [5]
CECMED/Cuba: 2 years of age and older. Three doses (0.5 mL) 2 weeks apart.
CECMED/Cuba: Three doses (0.5 mL) 2 weeks apart.
CECMED/Cuba: Three doses (0.5 mL) 2 weeks apart.
CECMED/Cuba: Three doses (50 µg, 0.5 mL) 2 weeks apart.
CECMED/Cuba: if the benefits of the vaccination outweigh the potential risks.
CECMED/Cuba: 2 years of age and older. Three doses (0.5 mL) 2 weeks apart.
CECMED/Cuba: Three doses (0.5 mL) 2 weeks apart.
CECMED/Cuba: Three doses (0.5 mL) 2 weeks apart.
CECMED/Cuba: Three doses (50 µg, 0.5 mL) 2 weeks apart.
There is no available data on interchangeability.
There is no available data on booster doses.
Finlay Institute of Vaccines COVID-19 vaccine: Soberana 02; Soberana Plus (Authorized) [6]
CECMED/Cuba: SOBERANA 02 and SOBERANA 02 ST: 2 years of age and older. Two doses (0.5 mL) 4 weeks apart. SOBERANA PLUS and SOBERANA PLUS as a booster dose 4 weeks after.
CECMED/Cuba: SOBERANA 02 and SOBERANA 02 ST: Two doses (0.5 mL) 4 weeks apart. SOBERANA PLUS and SOBERANA PLUS as a booster dose 4 weeks after.
CECMED/Cuba: SOBERANA 02 and SOBERANA 02 ST: Two doses (0.5 mL) 4 weeks apart. SOBERANA PLUS and SOBERANA PLUS as a booster dose 4 weeks after.
CECMED/Cuba: SOBERANA® 02 and SOBERANA® 02 ST: Two doses (0.5 mL each) 4 weeks apart.
Soberana Plus and Soberana Plus ST: Single dose (0.5 mL) as a booster vaccine 4 weeks after a primary schedule with SOBERANA® 02 or SOBERANA® 02 ST.
CECMED/Cuba: if the benefits of the vaccination outweigh the potential risks.
CECMED/Cuba: SOBERANA 02 and SOBERANA 02 ST: 2 years of age and older. Two doses (0.5 mL) 4 weeks apart. SOBERANA PLUS and SOBERANA PLUS as a booster dose 4 weeks after.
CECMED/Cuba: SOBERANA 02 and SOBERANA 02 ST: Two doses (0.5 mL) 4 weeks apart. SOBERANA PLUS and SOBERANA PLUS as a booster dose 4 weeks after.
CECMED/Cuba: SOBERANA 02 and SOBERANA 02 ST: Two doses (0.5 mL) 4 weeks apart. SOBERANA PLUS and SOBERANA PLUS as a booster dose 4 weeks after.
CECMED/Cuba: SOBERANA® 02 and SOBERANA® 02 ST: Two doses (0.5 mL each) 4 weeks apart.
Soberana Plus and Soberana Plus ST: Single dose (0.5 mL) as a booster vaccine 4 weeks after a primary schedule with SOBERANA® 02 or SOBERANA® 02 ST.
There is no available data on interchangeability.
CECMED/Cuba: SOBERANA Plus and SOBERANA Plus ST may be used as a booster dose 4 weeks after a primary schedule with SOBERANA 02 or SOBERANA 02 ST.
ANMAT/Argentina: Sputnik V: Two doses of different components (0,5ml each) 3 weeks apart. Sputnik Light: One dose (0.5 mL).
ISP/Chile: if the benefits of the vaccination outweigh the potential risks.
Not recommended yet
Not recommended yet
Not recommended yet
ANMAT/Argentina: primary schedule with Sputnik V, followed by an additional (third) dose 4 months after with Sputnik V.
ANMAT/Argentina: a heterologous scheme using Sputnik V component 1 followed by a second dose of any authorized mRNA-based or viral vector vaccine may be used.
ANMAT/Argentina: A booster dose should be given at least 4 months after the primary scheme using an mRNA-based or viral vector vaccine.
SAGE/WHO: One or two doses (0.5 mL each). WHO recommends providing two doses with an interval of 2 to 6 months.
SAGE/WHO: One or two doses (0.5 mL each) 2-6 months apart. WHO recommends using the Janssen COVID-19 vaccine in pregnant women only if the benefits of vaccination outweigh the potential risks.
Not recommended yet
Not recommended yet
Not recommended yet
SAGE/WHO: Two doses (0.5 mL each) 1-3 months apart.
SAGE/WHO: the homologous two-dose schedule is the standard practice. However, a heterologous scheme using a second dose of an mRNA vaccine may be more immunogenic and effective.
SAGE/WHO: the need and timing of booster doses beyond the second dose are under assessment.
Moderna COVID-19 vaccine: Spikevax (EUL/WHO authorization) [10]
SAGE/WHO: for ages 6 months-5 years: Two doses (25 µg, 0.25 ml each) 4-8 weeks apart.
SAGE/WHO: Two doses (100 µg, 0.5 ml each) 4 to 8 weeks apart.
SAGE/WHO: Two doses (100 µg, 0.5 ml each) 4 to 8 weeks apart.
SAGE/WHO: Two doses (100 µg, 0.5 mL each) 8 weeks apart.
SAGE/WHO: Extended primary series with an additional (third) dose 1-3 months after the second dose, and two boosters (fourth and fifth doses) given 4-6 months after the previous dose.
SAGE/WHO: Extended primary series with an additional (third) dose 1-3 months after the second dose, and two boosters (fourth and fifth doses) given 4-6 months after the previous dose.
SAGE/WHO: Extended primary series with an additional (third) dose 1-3 months after the second dose, and two boosters (fourth and fifth doses) given 4-6 months after the previous dose.
SAGE/WHO: Extended primary series with an additional (third) dose 1-3 months after the second dose, and two boosters (fourth and fifth doses) given 4-6 months after the previous dose.
SAGE/WHO: Moderna COVID-19 vaccine combined with any other EUL COVID-19 vaccine is considered a complete primary series.
SAGE/WHO: A booster dose should be given 4-6 months after the primary series* and a second booster after 4-6 months for specific population groups**.
WHO recommends Moderna COVID-19 vaccine as a heterologous booster.
Novavax/ Serum Institute of India COVID-19 vaccine: Nuvaxovid; Covovax (EUL/WHO authorization) [11], [12]
Not recommended yet
Not recommended yet
SAGE/WHO: Two doses (0.5 mL each) 3-4 weeks apart.
SAGE/WHO: Two doses (0.5 mL each) 3-4 weeks apart.
SAGE/WHO: Two doses (0.5 mL each) 3-4 weeks apart.
Not recommended yet
Not recommended yet
SAGE/WHO: Extended primary series with an additional (third) dose 1-3 months after the second dose, and two boosters (fourth and fifth doses) given 4-6 months after the previous dose.
SAGE/WHO: Extended primary series with an additional (third) dose 1-3 months after the second dose, and two boosters (fourth and fifth doses) given 4-6 months after the previous dose.
SAGE/WHO: Novavax COVID-19 vaccine combined with any other EUL COVID-19 vaccine is considered a complete primary series.
SAGE/WHO: A booster dose should be given 4-6 months after the primary series* and a second booster after 4-6 months for specific population groups**.
SAGE/WHO: Three doses (3 µg, 0.2 each). The first two doses administered 3 weeks apart, followed by a third dose 8 weeks after.
SAGE/WHO: Two doses (10 µg, 0.2 mL each) 4 to 8 weeks apart.
SAGE/WHO: Two doses (30 µg, 0.3 mL each) 4 to 8 weeks apart.
SAGE/WHO: Two doses (30 µg, 0.3 mL each) 4 to 8 weeks apart. WHO recommends an interval of 8 weeks.
SAGE/WHO: Two doses (30 µg, 0.3 mL each) 8 weeks apart.
SAGE/WHO: Three doses (3 µg, 0.2 each), and two boosters (fourth and fifth doses) given 4-6 months after the previous dose.
SAGE/WHO: Extended primary series with an additional (third) 10 µg dose 1-3 months after the second dose, and two boosters (fourth and fifth doses) given 4-6 months after the previous dose.
SAGE/WHO: Extended primary series with an additional (third) 30 µg dose 1-3 months after the second dose, and two boosters (fourth and fifth doses) given 4-6 months after the previous dose.
SAGE/WHO: Extended primary series with an additional (third) 30 µg dose 1-3 months after the second dose, and two boosters (fourth and fifth doses) given 4-6 months after the previous dose.
SAGE/WHO: Comirnaty (Pfizer-BioNTech) combined with any other EUL COVID-19 vaccine is considered a complete primary series.
SAGE/WHO: A booster dose should be given 4-6 months after the primary series* and a second booster after 4-6 months for specific population groups**.
WHO recommends Comirnaty vaccine as a heterologous booster.
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: EpiVacCorona (Authorized) [19]
Not recommended yet
Not recommended yet
Not recommended yet
Ministry of Health/Russian Federation: Two doses (0.5 mL) 3 weeks apart.
Ministry of Health/Russian Federation: contraindicated in pregnant women.
Not recommended yet
Not recommended yet
Not recommended yet
Ministry of Health/Russian Federation: Two doses (0.5 mL) 3 weeks apart.
Beta variant (South Africa, vaccine efficacy -VE-): 52.0%.
Gamma variant (Brazil, VE): 68.1%.
Omicron variant (South Africa, healthcare workers): effectiveness against COVID-19-related hospitalizations was 55% (95% CI: 22-74) [WHO, 2022].
Delta variant (USA, effectiveness): 79.8% (95% CI: 67.4-87.5%), and 94.0% (95% CI: 92.3-95.4%) after a booster dose.
Omicron variant (USA, effectiveness): 42.8% (95% CI: 33.8- 50.7%) and 67.9% (95% CI: 65.8-69.9%) after a booster dose [WHO, 2022].
Alpha variant (UK, vaccine efficacy -VE-): 86% (95% CI: 71-94); and 94% (95% CI: 82-98) in USA.
Beta variant (South Africa, VE): 49% (95% CI: 28-63) during circulation of Beta [WHO, 2022].
Omicron variant: effectiveness is lower compared to Delta [WHO, 2022].
NA
Gamma and Alpha variants (Chile, effectiveness): 65.9% (95% CI: 65-66%).
Delta variant (Chile, effectiveness): 79% (95% CI: 77-81%) for a 3-dose schedule with CoronaVac (Sinovac) [WHO, 2022].
SARS-CoV-2 variants
Global Advisory Committee on Vaccine Safety (GACVS)
NA
NA
NA
NA
NA
NA
NA
NA
NA
SARS-CoV-2 variants
Technical Advisory Group (TAG)
Vaccine effectiveness against COVID-19 declines as for six months after a primary series in the context of variants of concern (including Delta and Omicron variants)[TAG, 2022].
Vaccine effectiveness against COVID-19 declines as for six months after a primary series in the context of variants of concern (including Delta and Omicron variants)[TAG, 2022].
NA
Vaccine effectiveness against COVID-19 declines as for six months after a primary series in the context of variants of concern (including Delta and Omicron variants)[TAG, 2022].
Vaccine effectiveness against COVID-19 declines as for six months after a primary series in the context of variants of concern (including Delta and Omicron variants)[TAG, 2022].
Vaccine effectiveness against COVID-19 declines as for six months after a primary series in the context of variants of concern (including Delta and Omicron variants [TAG, 2022].
Vaccine effectiveness against COVID-19 declines as for six months after a primary series in the context of variants of concern (including Delta and Omicron variants)[TAG, 2022].
Vaccine effectiveness against COVID-19 declines as for six months after a primary series in the context of variants of concern (including Delta and Omicron variants)[TAG, 2022].
Vaccine effectiveness against COVID-19 declines as for six months after a primary series in the context of variants of concern (including Delta and Omicron variants)[TAG, 2022].
SARS-CoV-2 variants
Centers for Disease Control and Prevention (CDC)
NA
NA
NA
NA
Omicron variant (USA): vaccine effectiveness during the BA.2/BA.2.12.2 period was lower than that during the BA.1 period [CDC, 2022].
NA
Omicron variant (USA): vaccine effectiveness during the BA.2/BA.2.12.2 period was lower than that during the BA.1 period [CDC, 2022].
NA
NA
SARS-CoV-2 variants
Food and Drug Administration (FDA)
NA
NA
NA
NA
Vaccine efficacy among ages 6 months through 5 years was evaluated during the Omicron-predominant period [FDA, 2022].
NA
NA
NA
NA
SARS-CoV-2 variants
European Medicines Agency (EMA)
NA
NA
NA
Alpha variant (efficacy): 71.6% (95% CI: 43.2; 86.9) after the first dose, and 94.2% (95% CI: 62.9; 99.9) after a second dose [EMA, 2022].
NA
The vaccine efficacy in adults was assessed while Alpha, Beta, and Gamma was circulating; in ages 12 to 17, during the Delta variant-predominant period [EMA, 2022].
NA
NA
NA
SARS-CoV-2 variants
Regulatory Authority MHRA/UK
NA
NA
NA
NA
NA
NA
NA
NA
NA
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 6 years of age [2].
EMA: Booster dose for persons from 12 years of age [2], FDA: Booster dose for persons from 6 months of age [3].
Primary schedule and booster dose for persons 6 months of age and older.
WHO: Booster dose for persons from 12 years of age [5].
WHO: Booster dose for persons from 12 years of age [7], FDA: for persons from 6 months of age [8].
Dosing and schedule
According to age:
- 6 months to 5 years: two doses (25 µg /0.25 mL each) 4 weeks apart.
- 6 to 11 years: two doses (50 µg /0.5 mL each) 4 weeks apart.
- 12 years and above: two doses (100 µg /0.5 mL each) 4 weeks apart*
According to age:
- 6-11 years: EMA: single booster dose (0.25 mL) after three months of the primary series or monovalent booster [2].
- ≥12 years: EMA: single booster dose (0.5 mL) after three months of the primary series or monovalent booster [2].
According to age:
- 6 months-5 years: FDA: single booster dose (0.2 mL) after two months of the primary series [3].
6-11 years: FDA: single booster dose (0.25 mL) after two months of the primary series or monovalent booster [3].
- ≥12 years: FDA: single booster dose (0.5 mL) after two months of the primary series or monovalent booster [3]. EMA recommends an interval of three months [2].
According to age:
- 6 months to 4 years: three doses (3 µg /0.2 mL each). The first two doses 3 weeks apart followed by a third dose 8 weeks after.
- 5 to 11 years: two doses (10 µg /0.2 mL each) 4 weeks apart.
- 12 years and above: two doses (30 µg /0.3 mL each) 4 weeks apart*
EMA: Single booster dose (0.3 mL) for persons ≥12 years after three months of the primary series or monovalent booster [6].
According to age:
- 6 months-4 years: FDA: third primary series dose (0.2 mL) after 8 weeks of two monovalent doses [8], and single booster dose (0.2 mL) after two months [9].
- 5-11 years: FDA: single booster dose (0.2 mL) after two months of the primary series or monovalent booster [8].
- ≥12 years: FDA: single booster dose (0.3 mL) after two months of the primary series or monovalent booster [8]. EMA recommends an interval of three months [6].
Presentation of the vial
Light blue border label: 100 µg / 0.5 mL
Purple border label: 50 µg / 0.5 mL
Magenta border label: 25 µg / 0.25 mL
25 µg elasomeran and 25 µg imelasomeran each dose of 0.5 mL
25 µg elasomeran and 25 µg davesomeran each dose of 0.5 mL
Purple cap: 30 µg / 0.3 mL, after dilution.
Grey cap: 30 µg / 0.3 mL
Orange cap: 10 µg / 0.2 mL, after dilution.
Maroon cap: 3 µg / 0.2 mL, after dilution.
15 µg tozinameran and 15 µg riltozinameran each dose of 0.3 mL
15 µg tozinameran and 15 µg famtozinameran each dose of 0.3 mL
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. [FDA, 2022]
4. [WHO, 2022]
5. [WHO, 2022]
6. [EMA, 2022]
7. [WHO, 2022]
8. [FDA, 2022]
9. [FDA, 2023]
Vaccines
Vaccine platform description
Candidate vaccine
Developers
Last update: 3 March 2023
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