Treatments and vaccines for COVID-19
The European Medicines Agency's (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.
Remdesivir is a ‘viral RNA polymerase inhibitor’ (a medicine that interferes with the production of viral genetic material, preventing the virus from multiplying) given by infusion (drip) into a vein.
It has a conditional marketing authorisation for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen.
Rapid assessment of remdesivir
EMA's CHMP assessed the application under a short timeframe, while still allowing for a thorough evaluation of the medicine’s benefits and risks. The evaluation began on 8 June 2020.
Prior to this, the CHMP had assessed some data on the medicine as part of a rolling review, between 30 April and 15 May 2020. This covered data on quality and manufacturing, preliminary data from clinical studies and supporting data from compassionate use programmes.
In parallel with the rolling review, EMA's Pharmacovigilance Risk Assessment Committee (PRAC) completed an initial assessment of the preliminary risk management plan (RMP) for the medicine, and the Paediatric Committee (PDCO) rapidly evaluated the company’s paediatric investigation plan (PIP).
For more information on how EMA fast-tracks the evaluation of promising potential COVID-19 treatments, see Guidance for medicine developers and companies on COVID-19: Accelerated procedures for COVID-19 treatments and vaccines.
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:
Summary on compassionate use for Remdesivir Gilead (PDF/3 MB) (updated)Adopted
First published: 03/04/2020
Last updated: 31/07/2020
Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring adressed to member states for Remdesivir Gilead available for compassionate use (PDF/279.87 KB) (updated)Adopted
First published: 03/04/2020
Last updated: 31/07/2020
EMA/178636/2020 Rev. 1
EMA is liaising closely with developers of potential COVID-19 medicines.
EMA has been in discussion with the developers of 38 potential COVID-19 vaccines and 154 potential COVID-19 treatments*. These include immunomodulators, antivirals and hyperimmune serums.
EMA has also finalised 17 scientific advice procedures* to provide developers with direction on the most appropriate methods and study designs for potential COVID-19 medicines. A further 15 such procedures* are ongoing.
*Figures correct as of 30 July 2020
EMA welcomes the launch of large clinical trials to test promising treatments and generate conclusive evidence on which of them work, in line with the advice of its human medicines committee (CHMP).
Potential COVID-19 treatments currently undergoing clinical trials include:
- 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.
Vaccine development timelines are difficult to predict. Based on past experience, EMA estimates that it might take at least until the beginning of 2021 before a vaccine against COVID-19 is ready for approval and available in sufficient quantities to enable widespread use.
Update: Dexamethasone is a corticosteroid with anti-inflammatory and immunosuppressant effects. It is authorised at national level in the EU and is used in a wide range of conditions, including rheumatic problems, skin diseases, severe allergies, asthma and chronic obstructive lung disease.
Review of dexamethasone
On 24 July 2020, EMA's human medicines committee (CHMP) started a review under Article 5(3) of Regulation 726/2004 of the results from the RECOVERY study arm that involved the use of dexamethasone in patients with COVID-19 admitted to hospital.
CHMP will provide an opinion on the results of the RECOVERY study and on the potential use of dexamethasone to treat adults with COVID-19.
Update: During the COVID-19 pandemic, EMA is implementing exceptional measures to maximise the transparency of its regulatory activities on treatments and vaccines for COVID-19 that are approved or are under evaluation.
EMA is achieving this by shortening its standard publishing timeframes and publishing information it does not normally publish for other medicines.
|Regulatory procedure||Standard practice||COVID-19 medicines|
|Compassionate use opinion||Published in Compassionate use after CHMP opinion||News announcement published within 1 day of CHMP opinion|
|Start of rolling review||Not applicable||News announcement published within 1 day of start of review|
|Marketing authorisation application||Active substance and therapeutic area listed in Medicines under evaluation||News announcement published within 1 day of application|
|Application for extension of indication||Not announced||News announcement published within 1 day of application|
|Publication of European public assessment report (EPAR)||Published at least 2 weeks after marketing authorisation||Published within 3 days of marketing authorisation|
|Product information||Published in all EU languages with EPAR||Published (in English) within 1 day of positive CHMP opinion; published in other EU languages with EPAR|
|Risk management plan (RMP)||Summary of RMP published||Full RMP published|
|Clinical trial data||Publication suspended until further notice||Published on Clinical data website after marketing authorisation|
EMA may increase transparency of other regulatory procedures.
These measures aim to address the high interest for information and to support global research on COVID-19 medicines. They are in addition to the information EMA normally publishes on human medicines.
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.
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.
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.