Treatments and vaccines for COVID-19

EMA has been in discussion with the developers of around 125 potential COVID-19 treatments (figure correct as of 26 May 2020).

EMA welcomes the launch of large clinical trials to test promising treatments and generate conclusive evidence on which of them work, in line the advice of its human medicines committee (CHMP).

Potential COVID-19 treatments currently undergoing clinical trials include:

• remdesivir (an investigational medicine);
• lopinavir/ritonavir (currently authorised as an anti-HIV medicine);
• chloroquine and hydroxychloroquine (currently authorised at national level as treatments against malaria and certain autoimmune diseases such as rheumatoid arthritis).
• systemic interferons, in particular interferon beta (currently authorised to treat diseases such as multiple sclerosis);
• monoclonal antibodies with activity against components of the immune system.

Remdesivir is a ‘viral RNA polymerase inhibitor’ (a medicine that interferes with the production of viral genetic material, preventing the virus from multiplying). It has shown broad in vitro activity against different RNA viruses, including SARS-CoV-2 and was originally developed for the treatment of Ebola virus disease. 

Remdesivir is being developed by Gilead Sciences Ireland CU and is given by infusion (drip) into a vein. 

Assessment of remdesivir

Update: EMA's Committee for Medicinal Products for Human Use (CHMP) cuncluded its rolling review of data on the use of remdesevir to treat COVID-19 on 15 May 2020.

The next step in for the company to submit an application for a conditional marketing authorisation, together with the data requested by the CHMP upon completion of the rolling review.

The CHMP will assess the conditional marketing authorisation application under the minimum timeframe necessary to allow for a thorough evaluation of the medicine’s benefits and risks. The exact timeframe will depend on the robustness of the data submitted by the company.

The CHMP initiated the rolling review of data on remdesivir on 30 April 2020, based on preliminary results from a study that suggested a beneficial effect of remdesivir in the treatment of hospitalised patients with mild-to-moderate or severe COVID-19. 

Rolling review procedure is one of EMA's regulatory tools to speed up the evaluation of a promising potential COVID-19 treatments. It allows the CHMP to assess data on a rolling basis while development of a medicine is still ongoing.

Compassionate use

Recommendations are available from EMA’s CHMP on how remdesivir should be used in compassionate use programmes across Europe when treating COVID-19 patients who are not eligible for inclusion in clinical trials.

These recommendations aim to ensure a harmonised approach across EU Member States.

They also explain which group of patients may benefit from treatment and provide preliminary information on the medicine’s safety:

EMA has been in discussion with developers of a 33 potential COVID-19 vaccines (figure correct as of 26 May 2020).

Vaccine development timelines are difficult to predict. Based on past experience, EMA estimates that it might take at least a year before a vaccine against COVID-19 is ready for approval and available in sufficient quantities to enable widespread use.

Update: EMA has contracted Utrecht University to conduct research into data sources and methods that can be used to monitor the safety, effectiveness and coverage of COVID-19 vaccines in clinical practice. This aims to ensure that an infrastructure for monitoring COVID-19 vaccines in the real world is in place when these vaccines reach the European market.

The ACCESS (vACcine Covid-19 monitoring readinESS) project is identifying and examining the utility of a Europe-wide network of data sources. These include health insurance records and health records from general practitioners and hospitals. The project is also identifying possible adverse events requiring extra consideration. 

University Medical Center Utrecht (UMCU) and Utrecht University are leading the project. Utrecht University coordinates a public-academic partnership of 22 European research centres.

Final delivery of the project is planned by the end of 2020, with first deliverables due in August 2020.

Real-world monitoring of vaccines on the market complements EMA's regular safety-monitoring activities. These include the spontaneous reporting of suspected side effects by patients and healthcare professionals.

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.