COVID-19

Treatments and vaccines for COVID-19

Research and development
Medicines undergoing evaluation
Authorised medicines
Post-authorisation

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The European Medicines Agency (EMA) is interacting with developers of potential COVID-19 treatments and vaccines to enable promising medicines to reach patients as soon as possible. It is also making use of real-world data to monitor the safety and effectiveness of medicines used in patients with COVID-19.

Research and development

EMA is providing guidance to assist developers of potential COVID-19 medicines, to prepare for eventual applications for marketing authorisation.

This includes scientific advice, as well as informal consultation with the COVID-19 EMA pandemic Task Force (COVID-ETF).

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

COVID-19 medicines that have received EMA advice

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	Immunomodulator	Clinical phase
Ad26.COV2.S	Janssen-Cilag International N.V.	Vaccine	Non-clinical phase
Ad5-nCoV vaccine	Cansino Biotech	Vaccine	Clinical phase
Adjuvanted whole virion inactivated vaccine	Sinovac Biotech Ltd	Vaccine	Non-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
ChAdOx1-SARS-CoV-2	Vaccitech/AstraZeneca	Vaccine	Clinical phase
CHAG-COVID19-CA	ChimAgents	Challenge agent for human infection models	Non-clinical phase
Chloroquine	Oxford University	Other therapeutics	Clinical phase
Chloroquine and hydroxychloroquine cyclops DPI	PureIMS	Other therapeutics	Clinical phase
Copper chloride	ACOM srl	Antiviral	Clinical phase
Coronavirus-like particle (COVLP)	Medicago	Vaccine	Non-clinical phase
CT-P59	Celltrion	Antiviral (monoclonal antibody)	Non-clinical phase
CVnCoV, CV07050101 vaccine	Curevac	Vaccine	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
Herpes simplex virus vector tetravalent SARS-CoV-2 vaccine	Krystal Bio	Vaccine	Non-clinical phase
Kamada Anti-SARS-CoV-2	Kamada Ireland Ltd	Immunoglobulin	Non-clinical phase
Larifan Plus	Auramed Ltd	Antiviral	Non-clinical phase
LNP-saRNA CoVid19 vaccine	VacEquity Global Health/Imperial College London	Vaccine	Clinical phase
LUNAR-COV19 mRNA vaccine	Arcturus Therapeutics	Vaccine	Clinical phase
LY-CoV555 (LY3819253) and LY-CoV016 (LY3832479)	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
mRNA SARS-CoV-2 vaccine	Biontech	Vaccine	Non-clinical phase
mRNA-1273 SARS-CoV-2 vaccine	Moderna	Vaccine	Non-clinical phase
MV-SARS-CoV-2 vaccine	Themis Bioscience GmbH/MSD	Vaccine	Non-clinical phase
NVX-CoV-2 rS	Novavax	Vaccine	Non-clinical phase
Otilimab	GSK	Immunomodulator	Clinical phase
PF-07304814	Pfizer	Antiviral	Non-clinical phase
Protein nanoparticle vaccine	Emergex Vaccines Holding Ltd	Vaccine	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
RGB-22	Gedeon Richter Plc Hungary	Antiviral	Non-clinical phase
rVSVΔG-SARS-CoV-2 live attenuated	MSD/IAVI	Vaccine	Non-clinical phase
Sarilumab	Sanofi Aventis	Immunomodulator	Clinical phase
SARS-CoV-2 DNA vaccine	Inovio	Vaccine	Non-clinical phase
SARS-Cov-2 vaccine	Queensland University/Seqirus	Vaccine	Non-clinical phase
SARS-CoV-2 vaccine recombinant, adjuvanted	Sanofi Pasteur	Vaccine	Non-clinical phase
Siltuximab	EUSApharma	Immunomodulator	Clinical phase
SNG-001	Synargein	Immunomodulator	Clinical phase
S-trimer subunit vaccine	Clover Biopharma	Vaccine	Clinical phase
Subunit vaccine adjuvanted	Medigen	Vaccine	Non-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
VLA 2001 vaccine	Valneva	Vaccine	Non-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 (Bmab 600)	Biocon Biologics Limited	Immunomodulator (monoclonal antibody)	Clinical phase
TAP-COVID-19	Kentucky Bioprocessing, Inc	Vaccine	Non-clinical phase
BI 764198	Boehringer Ingelheim International GmbH	Other therapeutic	Clinical phase
COVID-eVax	Takis S.r.l., Rottapham Biotech	Vaccine	Non-clinical phase
Nitric Oxide (RESP301)	Thirty Respiratory Limited (30 Technology)	Antiviral	Clinical phase
4P021	4P-Pharma	Antiviral	Non-clinical phase

Last updated 26 November 2020.

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

: Medicine regulatory authorities worldwide are also cooperating under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA) to expedite and streamline the development of COVID-19 vaccines and treatments.
For more information, see ICMRA: Supporting the development of COVID-19 vaccines and treatments.

Information on ongoing COVID-19 clinical trials in the European Economic Area (EEA) is available in the EU Clinical Trials Register (EU CTR):

EU CTR: COVID-19

Users can find information on:

phase II to phase IV adult clinical trials where the investigator sites are in the EEA;
any clinical trials in children with investigator sites in the EU and any trials that form part of a paediatric investigation plan, including those where the investigator sites are outside the EU.

Phase I clinical trials conducted solely in adults are not made publicly available in the EU CTR.

For more information on the EU CTR and how clinical trials are authorised and overseen in the EEA, see Clinical trials in human medicines.

: Information on ongoing COVID-19-related observational studies in the EU is available in the European Union electronic register of post-authorisation studies (EU PAS Register).
Users can find these studies by entering 'COVID-19' in the 'Title of Study' search filter.
EMA and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) are encouraging all researchers to register their pharmacoepidemiological studies related to the COVID-19 pandemic in the EU PAS Register.
They should also upload and make their study protocols public, with a description of the data collected or planned to be collected. Researchers should include ‘COVID-19’ in the study title to allow easy retrieval of their studies.

Medicines undergoing evaluation

EMA’s CHMP is assessing all the applications for COVID-19 medicines under the minimum timeframe necessary to allow for a thorough evaluation of the medicine’s benefits and risks.

EMA is assessing COVID-19 medicines in accordance with its usual standards for quality, safety and effectiveness.

COVID-19 vaccines

EMA's CHMP is evaluating the following COVID-19 vaccines:

Vaccine	Vaccine developer	Stage	Key milestones	More information
Ad26.COV2.S	Janssen-Cilag International N.V.	Rolling review ongoing	Start of rolling review: 01/12/2020	EMA starts rolling review of Janssen’s COVID-19 vaccine Ad26.COV2.S
mRNA-1273	Moderna Biotech Spain, S.L.	Conditional marketing authorisation application under evaluation	Start of evaluation of conditional marketing authorisation application: 01/12/2020 Start of rolling review: 16/11/2020	EMA receives application for conditional marketing authorisation of Moderna COVID-19 vaccine EMA starts rolling review of mRNA COVID-19 vaccine by Moderna Biotech Spain, S.L.
BNT162b2	BioNTech, in collaboration with Pfizer	Conditional marketing authorisation application under evaluation	Start of evaluation of conditional marketing authorisation application: 01/12/2020 Start of rolling review: 06/10/2020	EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2 EMA starts second rolling review of a COVID-19 vaccine
ChAdOx1-SARS-CoV-2	AstraZeneca, in collaboration with the University of Oxford	Rolling review ongoing	Start of rolling review: 01/10/2020	EMA starts first rolling review of a COVID-19 vaccine in the EU

For more information on the expedited evaluation procedure EMA is applying for COVID-19 vaccines, including the rolling review, see: COVID-19 vaccines: Scientific evaluation and approval: Accelerated evaluation.

COVID-19 treatments

EMA’s CHMP is evaluating the following COVID-19 treatments:

Treatment	Treatment developer	Stage	Start of evaluation	More information
Dexamethasone Taw	Taw Pharma	Marketing authorisation application under evaluation	31/08/2020	EMA receives application for marketing authorisation of Dexamethasone Taw for COVID-19

Authorised medicines

EMA's CHMP has assessed the use of the following medicines to treat COVID-19.

COVID-19 treatments

The following treatments can be used in the EU for the treatment of COVID-19, following assessment by the CHMP.

Treatment	Status	More information
Veklury (remdesivir)	Conditional marketing authorisation granted	First COVID-19 treatment recommended for EU authorisation Clinical data Update on remdesivir - EMA will evaluate new data from Solidarity trial
Dexamethasone	Use endorsed following referral procedure	EMA endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation

Treatment

Status

More information

Veklury (remdesivir)

Conditional marketing authorisation granted

First COVID-19 treatment recommended for EU authorisation

Clinical data

Update on remdesivir - EMA will evaluate new data from Solidarity trial

Dexamethasone

Use endorsed following referral procedure

EMA endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation

For more information on how EMA fast-tracks the evaluation of promising potential COVID-19 medicines, see Guidance for medicine developers and companies on COVID-19: Accelerated procedures for COVID-19 treatments and vaccines.

Post-authorisation

EMA is taking steps to ensure that it can leverage real-world data from clinical practice to monitor the safety and effectiveness of medicines used in patients with COVID-19.

The real-world monitoring of medicines and vaccines on the market complements EMA's regular safety-monitoring activities, including spontaneous reporting of suspected side effects by patients and healthcare professionals.

EMA has contracted institutions specialising in observational research to conduct the research projects detailed below. Click on the research areas below to read more about each project.

Project title	CONSIGN (COVID-19 infectiOn aNd medicineS In preGNancy)
Objectives	Establish a multinational research network using existing data sources and cohorts of pregnant women Estimate the prevalence of medicines used in pregnant women with COVID-19 Describe the severity and clinical outcomes of COVID-19 according to treatments received during pregnancy Assess and compare the rate of pregnancy and neonatal outcomes of different treatments for COVID-19 in pregnant women
Timelines	Start of project: July 2020 First deliverables: October 2020 Final delivery: July 2021
Contractor	Utrecht University
Related information	COVID-19: EMA sets up infrastructure for real-world monitoring of treatments and vaccines (21/07/2020) Information on ongoing observational studies in the EU International Coalition of Medicines Regulatory Authorities (ICMRA): Supporting the development of COVID-19 vaccines and treatments

Project title	Multicentre collaboration for COVID-19 observational studies
Objectives	Identify large national cohorts of COVID-19 patients and appropriate comparator groups Develop a study protocol template for multinational studies Establish a collaborative framework for researchers together with the European Health Data & Evidence Network (EHDEN) consortium established under the EU's Innovative Medicines Initiative Conduct a multinational pilot study on a research question to be agreed with EMA
Timelines	Start of project: June 2020 First deliverables: September 2020 Final delivery: June 2021
Contractor	IQVIA Ltd.
Related information	Information on ongoing observational studies in the EU International Coalition of Medicines Regulatory Authorities (ICMRA): Supporting the development of COVID-19 vaccines and treatments

Project title	ACCESS (vACcine Covid-19 monitoring readinESS)
Objectives	Identify and examine the utility of a Europe-wide network of data sources (including health records from general practitioners and hospitals) Identify possible adverse events requiring extra consideration
Timelines	Start of project: May 2020 First deliverables: August 2020 Final delivery: end of 2020
Contractor	Utrecht University
Related information	EMA commissions independent research to prepare for real-world monitoring of COVID-19 vaccines (27/05/2020) International Coalition of Medicines Regulatory Authorities (ICMRA): Supporting the development of COVID-19 vaccines and treatments Information on ongoing observational studies in the EU

In June 2020, EMA extended its medical literature monitoring service to identify suspected adverse reactions by adding authorised active substances that could treat COVID-19.

Treatments and vaccines for COVID-19

Table of contents

Research and development

COVID-19 medicines that have received EMA advice

Medicines undergoing evaluation

COVID-19 vaccines

COVID-19 treatments

Authorised medicines

COVID-19 treatments

Post-authorisation

Related content

Visual guide: Fast-track procedures for treatments and vaccines for COVID-19

Publications

Related documents

EMA considerations on COVID-19 vaccine approval (PDF/205.33 KB) (new)

Reply to the European Ombudsman’s letter concerning transparency and independence of the work of the European Medicines Agency in supporting the development and evaluation of COVID-19 medicines (PDF/192.91 KB)

European Medicines Agency response to IQWIG on transparency of COVID-19 related activities (PDF/114.93 KB)

Press briefing - 14 May 2020

External links

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