COVID-19 medicines that received EMA advice

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.
Human COVID-19
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 received EMA advice

Last updated 6 October 2022 
This information should not be read as an endorsement of any medicine
Product Developer Development stage at time of guidance
Ad26.COV2.S Janssen-Cilag International N.V. Non-clinical phase
Ad5-nCoV vaccine Cansino Biotech Clinical phase
Adjuvanted whole virion inactivated vaccine Sinovac Life Sciences Co Non-clinical phase
ChAdOx1-SARS-CoV-2 Vaccitech/AstraZeneca Clinical phase
Coronavirus-like particle (COVLP) Medicago Non-clinical phase
CVnCoV, CV07050101 vaccine Curevac Non-clinical phase
Herpes simplex virus vector tetravalent SARS-CoV-2 vaccine  Krystal Bio Non-clinical phase
LNP-saRNA CoVid19 vaccine VacEquity Global Health/Imperial College London Clinical phase
LUNAR-COV19 mRNA vaccine Arcturus Therapeutics Clinical phase
mRNA SARS-CoV-2 vaccine Biontech Non-clinical phase
mRNA-1273 SARS-CoV-2 vaccine Moderna Non-clinical phase
MV-SARS-CoV-2 vaccine Themis Bioscience GmbH/Merck Sharp & Dohme (MSD) Non-clinical phase
NVX-CoV-2 rS Novavax Non-clinical phase
Protein nanoparticle vaccine Emergex Vaccines Holding Ltd Non-clinical phase
rVSVΔG-SARS-CoV-2 live attenuated Merck Sharp & Dohme (MSD)/IAVI Non-clinical phase
SARS-CoV-2 DNA vaccine Inovio Non-clinical phase
SARS-Cov-2 vaccine Queensland University/Seqirus/CSL Non-clinical phase
SARS-CoV-2 vaccine recombinant, adjuvanted Sanofi Pasteur Non-clinical phase
S-trimer subunit vaccine Clover Biopharma Clinical phase
Subunit vaccine adjuvanted MVC-COV1901 Medigen Non-clinical phase
VLA 2001 vaccine Valneva Non-clinical phase
Protein vaccine adjuvanted Kentucky Bioprocessing, Inc Non-clinical phase
DNA Plasmid vaccine Takis S.r.l., Rottapham Biotech Non-clinical phase
Gam-COVID-Vac The Gamaleya National Centre of Epidemiology and Microbiology Clinical phase
MRT5500 mRNA vaccine Sanofi / Translate Bio Non-clinical phase
PB-206 HIPRA Non-clinical phase
UB-612 Vaxxinity (Covaxx) / UBI (United Biomedical, Inc.) Clinical phase
MVA-SARS-2-S and MVA-SARS-2-ST IDT-Biologika / German Center for Infection Research (DZIF) Clinical phase
GBP510 Sk Bioscience Co. Ltd Clinical phase
FINCoVac 2.0 vaccine Rokote Laboratories Finland Oy Non-clinical phase
GRAd-COV2 Reithera S.r.l. Clinical phase
GSK&CV SARS-COV-2 vaccine (2nd generation) GSK and CureVac Clinical phase
Prime‐2‐CoV Speransa Therapeutics Clinical phase
Vaxzevria-AZD-2816 AstraZeneca Clinical phase
RVX-13 RocketVax AG Non-clinical phase
ABNCoV2 Bavarian Nordic AS Clinical phase
VB10.2210 Nykode Therapeutics Clinical phase
PHH-1V Laboratorios HIPRA S.A. Clinical phase
ISR52 ISR Vaccine AB Non-clinical phase
INO-4800 Inovio Clinical phase
ARCT-154 Arcturus Therapeutics Europe B.V. Clinical phase
Ad5-nCoV-IH Cansino Biotech Clinical phase
MVC-COV1901 Medigen Vaccine Biologics Corp. Clinical phase
Dellera, mRNA vaccine Fondo Ricerca Medica S.r.l. Clinical phase
CV0501 CureVac and GSK Clinical phase
COVI-Liv Bilthoven Biologicals B.V. Clinical phase
CD40.RBDv,
CD40.Pan.CoV
LinKinVax Non-clinical phase
MVA-CoV2-S(3P) Biofabri S.L. Non-clinical phase

COVID-19 treatments that received EMA advice

Last updated 6 October 2022
This information should not be read as an endorsement of any medicine
Product Developer Therapeutic class/drug type Development stage at time of guidance
A64-DP BCN Peptides SA Immunomodulator Non-clinical phase
Acalabrutinib Acerta Pharma BV / AstraZeneca Immunomodulator Clinical phase
Anti-SARS-CoV-2 polyclonal hyperimmune immunoglobulin Alliance hyperimmune project (Biotest AG, Bio Products Laboratory, LFB, Octapharma, CSL Behring and Takeda) Antiviral Clinical phase
APN01 Apeiron Biologics Immunomodulator Clinical phase
Apremilast Amgen Europe BV Immunomodulator Clinical phase
AZD7442 AstraZeneca Antiviral (monoclonal antibody) Non-clinical phase
Baricitinib Eli Lilly Immunomodulator Clinical phase
CD24Fc Oncoimmune Inc Immunomodulator Clinical phase
CHAG-COVID19-CA ChimAgents Challenge agent for human infection models Non-clinical phase
Chloroquine Oxford University Other therapeutic Clinical phase
Chloroquine and hydroxychloroquine cyclops DPI PureIMS Other therapeutic Clinical phase
Copper chloride ACOM Antiviral Clinical phase
CT-P59 Celltrion Antiviral (monoclonal antibody) Non-clinical phase
Danoprevir Ascletis Pharmaceuticals Co Ltd Antiviral Clinical phase
Eculizumab Alexion Immunomodulator Clinical phase
Emapalumab and anakinra Swedish Orphan Biovitrum AB (SOBI) Immunomodulator Clinical phase
FAV00B Farmak International Holding GmbH Antiviral Non-clinical phase
Favipiravir Glenmark Pharmaceuticals Ltd Antiviral Clinical phase
Gimsilumab Roivant Immunomodulator Clinical phase
Kamada Anti-SARS-CoV-2 Kamada Ireland Ltd Immunoglobulin Non-clinical phase
Larifan Plus Auramed Ltd Antiviral Non-clinical phase
LY-CoV555 (LY3819253) and LY-CoV016 (LY3832479) Eli Lilly Antiviral (monoclonal antibody) Non-clinical phase
M5049 Merck Healthcare Immunomodulator Non-clinical phase
Mavrilimumab Kiniksa Pharmaceuticals Immunomodulator Clinical phase
Meplazumab Jiangsu Pacific Meinuoke Biopharmaceutical Co Ltd Antiviral (monoclonal antibody) Clinical phase
MK-4482 Ridgeback Biotherapeutics LP/Merck Sharp & Dohme (Europe) Inc Antiviral Non-clinical phase
Otilimab GSK Immunomodulator Clinical phase
PF-07304814 Pfizer Antiviral Non-clinical phase
Raloxifene Dompé Antiviral Non-clinical phase
Ravulizumab Alexion Other therapeutics Clinical phase
RBT-9 Renibus Therapeutics Inc Antiviral Clinical phase
REGN10933, REGN10987, REGN10989 Regeneron UK Antiviral (monoclonal antibody) Non-clinical phase
Remdesivir Gilead Antiviral Clinical phase
RESP301 Thirty Respiratory Limited (30 Technology) Antiviral Non-clinical phase
Sarilumab Sanofi Aventis Immunomodulator Clinical phase
Siltuximab EUSApharma Immunomodulator Clinical phase
Tocilizumab Roche Immunomodulator Clinical phase
UNI911 Union Therapeutics Antiviral Clinical phase
VIR-7831, VIR-7832 Vir Biotechnology/GSK Antiviral (monoclonal antibody) Clinical phase
SNG001
Synairgen Research Limited Immunomodulator Clinical phase
VRP-033 Venus Pharma GmbH Immunomodulator Non-clinical phase
BRII-196, BRII-198 Brii Biosciences Antiviral (monoclonal antibody) Non-clinical phase
SCTA01 Sinocelltech Ltd. Antiviral (monoclonal antibody) Clinical phase
Itolizumab Biocon Biologics Limited Immunomodulator Clinical phase
BI 764198 Boehringer Ingelheim International GmbH Other therapeutic Clinical phase
4P021 4P-Pharma Antiviral Non-clinical phase
Masitinib mesylate AB Science Antiviral Non-clinical phase
EX-14870 Boehringer Ingelheim International BmBH Antiviral Non-clinical phase
2-DEOXY-D-GLUCOSE Dermin Sp. Z.0.0 Other therapeutic

Non-clinical Phase

Clinical phase

Emiplacel Biopharma Excellence GmbH Other therapeutic Clinical phase
AT-527 Roche Antiviral Clinical phase
ABBV-47D11 AbbVie Antiviral Clinical phase
Aviptadil Relief Therapeutics Holding S.A Other therapeutic Clinical phase
AR-711 Aridis Pharmaceuticals, Inc. Antiviral (monoclonal antibody) Non-clinical phase
Colchicine Pharmascience Inc. (PMS) / Montreal Health Institute (MHI) Immunomodulator Clinical phase
CoviFab Inmunova S.A. / mAbxience Antiviral Clinical phase
Trimodulin (human IgM, IgA, IgG solution) Biotest AG Immunomodulator Clinical phase
MK-7110 Merck Sharp & Dohme (MSD) / Merck & Co. Immunomodulator Clinical phase
Camostat Daewoong Antiviral Clinical phase
Bemcentinib BergenBio Antiviral Clinical phase
Vidofludimus calcium (IMU–838) Immunic AG Immunomodulator / Antiviral Clinical phase
Vilobelimab InflaRx GmbH Immunomodulator Clinical phase
FBR-002 Fab'entech Antiviral (monoclonal antibody) Clinical phase
BMS986414 and BMS986413 Rockefeller University and Bristol Myers Squibb Antiviral (monoclonal antibody) Clinical phase
Proxalutamide Suzhou Kintor Pharmaceuticals / Applied Biology Other therapeutic Clinical phase
Calcifediol Vifor Fresenius Medical Care Renal Pharma France Other therapeutic Clinical phase
Lenzilumab Humanigen Immunomodulator Clinical phase
Azelastine Ursapharm Immunomodulator Clinical phase
Opaganib hydrochloride RedHill Biopharma Other therapeutic Clinical phase
MAD0004J08 Menarini Ricerche S.p.A. Antiviral (monoclonal antibody) Clinical phase
C21 Vicore Pharma Immunomodulator Clinical phase
nezulcitinib Theraevance Biopharma Immunomodulator Clinical phase
Imlifidase (Idefirix) Hansa Biopharma AB Immunomodulator Clinical phase
WP 1122 Wpd Pharmaceuticals Sp z o.o Other therapeutic Non clinical phase
RGB-22 Chemical Works Of Gedeon Richter PLC Antiviral Non-clinical phase
XAV-19 Xenothera Antiviral Clinical phase
Imatinib Mesilate Exvastat Immunomodulator Clinical phase
PF-07321332 Pfizer Antiviral Clinical phase
Fostamatinib Rigel Immunomodulator Clinical phase
ADG20 Adagio Therapeutics Immunomodulator Clinical phase
Interferon alfa (INF-alpha), chimeric  Genova Inc Other therapeutic Non-clinical phase
XVR011 Exevir Bio Antiviral Clinical phase
N,N’-bis[2-(1H-imidazol-2-yl)ethyl]pentanediamide Treamid GmbH Immunomodulator Clinical phase
S-217622B Shionogi B.V. Antiviral Clinical phase
CYCLOBENZAPRINE HYDROCHLORIDE M-Squared Consulting S.r.l. Other therapeutic Clinical phase
F004 HWI Analytik GmbH Antiviral Non-clinical phase
XC221GI Valenta Pharmaceuticals JSC Antiviral Clinical phase
RMD-101 Remedy Biologics Limited Antiviral Non-clinical phase
PRO75 Evotec International GmbH Antiviral (monoclonal antibody) Non-clinical phase
Reparixin Dompé farmaceutici s.p.a  Immunomodulator Clinical phase
Ensovibep Novartis Antiviral Clinical phase
Ivermectin Hwi Pharma Services GmbH Antiviral Clinical phase
HH-120 Huahui Health Ltd. Antiviral Clinical phase
ASUNERCEPT Apogenix AG Immunomodulator Clinical phase
Regdanvimab Celltrion Healthcare Hungary Kft. Antiviral (monoclonal antibody) Clinical phase
Plitidepsin Pharma Mar, S.A. Antiviral Clinical phase
Ronapreve Regeneron Antiviral (monoclonal antibody) Clinical phase
Cetylpyridinium chloride Veristat Spain S.L. Antiviral Clinical phase
Olokizumab R-Pharm CJSC Antiviral (monoclonal antibody) Clinical phase
Aprotinin Gerencia De Atención Integrada De Ciudad Real Antiviral Clinical phase
Niclosamide nasal spray Union Therapeuthics Antiviral Clinical phase
AZD7518 (AZD3152, AZD3959) AstraZeneca AB Antiviral (monoclonal antibody) Clinical phase
Sabizabulin Veru Inc. Antiviral Clinical phase
TATX-03 (21-F2, 22-F7, 23-H7, 2-A6) Talem Therapeutics LLC Antiviral (monoclonal antibody) Clinical phase
GS-5245 Gilead Sciences Ireland Unlimited Company Antiviral Clinical phase
SPK001 SpikImm Antiviral (monoclonal antibody) Clinical phase
BC 007 (GS 522 or ARC183) Berlin Cures Immunomodulator Clinical phase
Arylacenamide Meletios Therapeutics Antiviral
and immunomodulator
Clinical phase
MK-7845 Merck Antiviral Non-clinical phase
Bemnifosbuvir hemisulfate Atea Pharmaceuticals Inc Antiviral Clinical phase
ALG-097558 Aligos Belgium BV Antiviral Non-clinical phase

Share this page