Human regulatory

COVID-19

COVID-19 medicines that received EMA advice

Table of contents

During the COVID-19 pandemic, the European Medicines Agency (EMA) interacted with developers of potential COVID-19 vaccines and treatments to enable their distribution in the European Union (EU) as soon as possible.

The outcome of any consultation or advice from EMA was not binding on developers.

EMA published the information on this page for use during the COVID-19 public health emergency. EMA is no longer updating this page.

COVID-19 vaccines that have received EMA advice

ProductDeveloperDevelopment stage at time of guidance
Ad26.COV2.SJanssen-Cilag International N.V.Non-clinical phase
Ad5-nCoV vaccineCansino BiotechClinical phase
Adjuvanted whole virion inactivated vaccineSinovac Life Sciences CoNon-clinical phase
ChAdOx1-SARS-CoV-2Vaccitech/AstraZenecaClinical phase
Coronavirus-like particle (COVLP)MedicagoNon-clinical phase
CVnCoV, CV07050101 vaccineCurevacNon-clinical phase
Herpes simplex virus vector tetravalent SARS-CoV-2 vaccine Krystal BioNon-clinical phase
LNP-saRNA CoVid19 vaccineVacEquity Global Health/Imperial College LondonClinical phase
LUNAR-COV19 mRNA vaccineArcturus TherapeuticsClinical phase
mRNA SARS-CoV-2 vaccineBiontechNon-clinical phase
mRNA-1273 SARS-CoV-2 vaccineModernaNon-clinical phase
MV-SARS-CoV-2 vaccineThemis Bioscience GmbH/Merck Sharp & Dohme (MSD)Non-clinical phase
NVX-CoV-2 rSNovavaxNon-clinical phase
Protein nanoparticle vaccineEmergex Vaccines Holding LtdNon-clinical phase
rVSVΔG-SARS-CoV-2 live attenuatedMerck Sharp & Dohme (MSD)/IAVINon-clinical phase
SARS-CoV-2 DNA vaccineInovioNon-clinical phase
SARS-Cov-2 vaccineQueensland University/Seqirus/CSLNon-clinical phase
SARS-CoV-2 vaccine recombinant, adjuvantedSanofi PasteurNon-clinical phase
S-trimer subunit vaccineClover BiopharmaClinical phase
Subunit vaccine adjuvanted MVC-COV1901MedigenNon-clinical phase
VLA 2001 vaccineValnevaNon-clinical phase
Protein vaccine adjuvantedKentucky Bioprocessing, IncNon-clinical phase
DNA Plasmid vaccineTakis S.r.l., Rottapham BiotechNon-clinical phase
Gam-COVID-VacThe Gamaleya National Centre of Epidemiology and MicrobiologyClinical phase
MRT5500 mRNA vaccineSanofi / Translate BioNon-clinical phase
PB-206HIPRANon-clinical phase
UB-612Vaxxinity (Covaxx) / UBI (United Biomedical, Inc.)Clinical phase
MVA-SARS-2-S and MVA-SARS-2-STIDT-Biologika / German Center for Infection Research (DZIF)Clinical phase
GBP510Sk Bioscience Co. LtdClinical phase
FINCoVac 2.0 vaccineRokote Laboratories Finland OyNon-clinical phase
GRAd-COV2Reithera S.r.l.Clinical phase
GSK&CV SARS-COV-2 vaccine (2nd generation)GSK and CureVacClinical phase
Prime‐2‐CoVSperansa TherapeuticsClinical phase
Vaxzevria-AZD-2816AstraZenecaClinical phase
RVX-13RocketVax AGNon-clinical phase
ABNCoV2Bavarian Nordic ASClinical phase
VB10.2210Nykode TherapeuticsClinical phase
PHH-1VLaboratorios HIPRA S.A.Clinical phase
ISR52ISR Vaccine ABNon-clinical phase
INO-4800InovioClinical phase
ARCT-154Arcturus Therapeutics Europe B.V.Clinical phase
Ad5-nCoV-IHCansino BiotechClinical phase
MVC-COV1901Medigen Vaccine Biologics Corp.Clinical phase
Dellera, mRNA vaccineFondo Ricerca Medica S.r.l.Clinical phase
CV0501CureVac and GSKClinical phase
COVI-LivBilthoven Biologicals B.V.Clinical phase
CD40.RBDv,
CD40.Pan.CoV		LinKinVaxNon-clinical phase
MVA-CoV2-S(3P)Biofabri S.L.Non-clinical phase
 
Last updated 6 October 2022

This information should not be read as an endorsement of any medicine

COVID-19 treatments that have received EMA advice

ProductDeveloperTherapeutic class/drug typeDevelopment stage at time of guidance
A64-DPBCN Peptides SAImmunomodulatorNon-clinical phase
AcalabrutinibAcerta Pharma BV / AstraZenecaImmunomodulatorClinical phase
Anti-SARS-CoV-2 polyclonal hyperimmune immunoglobulinAlliance hyperimmune project (Biotest AG, Bio Products Laboratory, LFB, Octapharma, CSL Behring and Takeda)AntiviralClinical phase
APN01Apeiron BiologicsImmunomodulatorClinical phase
ApremilastAmgen Europe BVImmunomodulatorClinical phase
AZD7442AstraZenecaAntiviral (monoclonal antibody)Non-clinical phase
BaricitinibEli LillyImmunomodulatorClinical phase
CD24FcOncoimmune IncImmunomodulatorClinical phase
CHAG-COVID19-CAChimAgentsChallenge agent for human infection modelsNon-clinical phase
ChloroquineOxford UniversityOther therapeuticClinical phase
Chloroquine and hydroxychloroquine cyclops DPIPureIMSOther therapeuticClinical phase
Copper chlorideACOMAntiviralClinical phase
CT-P59CelltrionAntiviral (monoclonal antibody)Non-clinical phase
DanoprevirAscletis Pharmaceuticals Co LtdAntiviralClinical phase
EculizumabAlexion

Immunomodulator

Clinical phase
Emapalumab and anakinraSwedish Orphan Biovitrum AB (SOBI)ImmunomodulatorClinical phase
FAV00BFarmak International Holding GmbHAntiviralNon-clinical phase
FavipiravirGlenmark Pharmaceuticals LtdAntiviralClinical phase
GimsilumabRoivantImmunomodulatorClinical phase
Kamada Anti-SARS-CoV-2Kamada Ireland LtdImmunoglobulinNon-clinical phase
Larifan Plus

Auramed Ltd

AntiviralNon-clinical phase
LY-CoV555 (LY3819253) and LY-CoV016 (LY3832479)Eli LillyAntiviral (monoclonal antibody)Non-clinical phase
M5049Merck HealthcareImmunomodulatorNon-clinical phase
MavrilimumabKiniksa PharmaceuticalsImmunomodulatorClinical phase
MeplazumabJiangsu Pacific Meinuoke Biopharmaceutical Co LtdAntiviral (monoclonal antibody)Clinical phase
MK-4482Ridgeback Biotherapeutics LP/Merck Sharp & Dohme (Europe) IncAntiviralNon-clinical phase
OtilimabGSKImmunomodulatorClinical phase
PF-07304814PfizerAntiviralNon-clinical phase
RaloxifeneDompéAntiviralNon-clinical phase
RavulizumabAlexionOther therapeuticsClinical phase
RBT-9Renibus Therapeutics IncAntiviralClinical phase
REGN10933, REGN10987, REGN10989Regeneron UKAntiviral (monoclonal antibody)Non-clinical phase
RemdesivirGileadAntiviralClinical phase
RESP301Thirty Respiratory Limited (30 Technology)AntiviralNon-clinical phase
SarilumabSanofi AventisImmunomodulatorClinical phase
SiltuximabEUSApharmaImmunomodulatorClinical phase
TocilizumabRocheImmunomodulatorClinical phase
UNI911Union TherapeuticsAntiviralClinical phase

VIR-7831, VIR-7832

Vir Biotechnology/GSKAntiviral (monoclonal antibody)Clinical phase
SNG001

Synairgen Research Limited

ImmunomodulatorClinical phase
VRP-033Venus Pharma GmbHImmunomodulatorNon-clinical phase
BRII-196, BRII-198Brii BiosciencesAntiviral (monoclonal antibody)Non-clinical phase
SCTA01Sinocelltech Ltd.Antiviral (monoclonal antibody)Clinical phase
ItolizumabBiocon Biologics LimitedImmunomodulatorClinical phase
BI 764198Boehringer Ingelheim International GmbHOther therapeuticClinical phase
4P0214P-PharmaAntiviralNon-clinical phase
Masitinib mesylateAB ScienceAntiviralNon-clinical phase
EX-14870Boehringer Ingelheim International BmBHAntiviralNon-clinical phase
2-DEOXY-D-GLUCOSEDermin Sp. Z.0.0Other therapeutic

Non-clinical Phase

Clinical phase

EmiplacelBiopharma Excellence GmbHOther therapeuticClinical phase
AT-527RocheAntiviralClinical phase
ABBV-47D11AbbVieAntiviralClinical phase
AviptadilRelief Therapeutics Holding S.AOther therapeuticClinical phase
AR-711Aridis Pharmaceuticals, Inc.Antiviral (monoclonal antibody)Non-clinical phase
ColchicinePharmascience Inc. (PMS) / Montreal Health Institute (MHI)ImmunomodulatorClinical phase
CoviFabInmunova S.A. / mAbxienceAntiviralClinical phase
Trimodulin (human IgM, IgA, IgG solution)Biotest AGImmunomodulatorClinical phase
MK-7110Merck Sharp & Dohme (MSD) / Merck & Co.ImmunomodulatorClinical phase
CamostatDaewoongAntiviralClinical phase
BemcentinibBergenBioAntiviralClinical phase
Vidofludimus calcium (IMU–838)Immunic AGImmunomodulator / AntiviralClinical phase
VilobelimabInflaRx GmbHImmunomodulatorClinical phase
FBR-002Fab'entechAntiviral (monoclonal antibody)Clinical phase
BMS986414 and BMS986413Rockefeller University and Bristol Myers SquibbAntiviral (monoclonal antibody)Clinical phase
ProxalutamideSuzhou Kintor Pharmaceuticals / Applied BiologyOther therapeuticClinical phase
CalcifediolVifor Fresenius Medical Care Renal Pharma FranceOther therapeuticClinical phase
LenzilumabHumanigenImmunomodulatorClinical phase
AzelastineUrsapharmImmunomodulatorClinical phase
Opaganib hydrochlorideRedHill BiopharmaOther therapeuticClinical phase
MAD0004J08Menarini Ricerche S.p.A.Antiviral (monoclonal antibody)Clinical phase
C21Vicore PharmaImmunomodulatorClinical phase
nezulcitinibTheraevance BiopharmaImmunomodulatorClinical phase
Imlifidase (Idefirix)Hansa Biopharma ABImmunomodulatorClinical phase
WP 1122Wpd Pharmaceuticals Sp z o.oOther therapeuticNon clinical phase
RGB-22Chemical Works Of Gedeon Richter PLCAntiviralNon-clinical phase
XAV-19XenotheraAntiviralClinical phase
Imatinib MesilateExvastatImmunomodulatorClinical phase
PF-07321332PfizerAntiviralClinical phase
FostamatinibRigelImmunomodulatorClinical phase
ADG20Adagio TherapeuticsImmunomodulatorClinical phase
Interferon alfa (INF-alpha), chimeric Genova IncOther therapeuticNon-clinical phase
XVR011Exevir BioAntiviralClinical phase
N,N’-bis[2-(1H-imidazol-2-yl)ethyl]pentanediamideTreamid GmbHImmunomodulatorClinical phase
S-217622BShionogi B.V.AntiviralClinical phase
CYCLOBENZAPRINE HYDROCHLORIDEM-Squared Consulting S.r.l.Other therapeuticClinical phase
F004HWI Analytik GmbHAntiviralNon-clinical phase
XC221GIValenta Pharmaceuticals JSCAntiviralClinical phase
RMD-101Remedy Biologics LimitedAntiviralNon-clinical phase
PRO75Evotec International GmbHAntiviral (monoclonal antibody)Non-clinical phase
ReparixinDompé farmaceutici s.p.a ImmunomodulatorClinical phase
EnsovibepNovartisAntiviralClinical phase
IvermectinHwi Pharma Services GmbHAntiviralClinical phase
HH-120Huahui Health Ltd.AntiviralClinical phase
ASUNERCEPTApogenix AGImmunomodulatorClinical phase
RegdanvimabCelltrion Healthcare Hungary Kft.Antiviral (monoclonal antibody)Clinical phase
PlitidepsinPharma Mar, S.A.AntiviralClinical phase
RonapreveRegeneronAntiviral (monoclonal antibody)Clinical phase
Cetylpyridinium chlorideVeristat Spain S.L.AntiviralClinical phase
OlokizumabR-Pharm CJSCAntiviral (monoclonal antibody)Clinical phase
AprotininGerencia De Atención Integrada De Ciudad RealAntiviralClinical phase
Niclosamide nasal sprayUnion TherapeuthicsAntiviralClinical phase
AZD7518 (AZD3152, AZD3959)AstraZeneca ABAntiviral (monoclonal antibody)Clinical phase
SabizabulinVeru Inc.AntiviralClinical phase
TATX-03 (21-F2, 22-F7, 23-H7, 2-A6)Talem Therapeutics LLCAntiviral (monoclonal antibody)Clinical phase
GS-5245Gilead Sciences Ireland Unlimited CompanyAntiviralClinical phase
SPK001SpikImmAntiviral (monoclonal antibody)Clinical phase
BC 007 (GS 522 or ARC183)Berlin CuresImmunomodulatorClinical phase
ArylacenamideMeletios TherapeuticsAntiviral
and immunomodulator		Clinical phase
MK-7845MerckAntiviralNon-clinical phase
Bemnifosbuvir hemisulfateAtea Pharmaceuticals IncAntiviralClinical phase
ALG-097558Aligos Belgium BVAntiviralNon-clinical phase
 
Last updated 6 October 2022

This information should not be read as an endorsement of any medicine

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