EU strategy for COVID-19 therapeutics
Vaccination against COVID-19 offers the best preventive protection against infection, severe disease, loss of life, and long-term consequences of illness. While vaccination was the best way to end the pandemic and get back to normal life, in parallel, the Commission remains committed to ensuring that COVID-19 therapeutics are available to treat those who are infected.
The European Commission’s strategy on COVID-19 therapeutics supports the development and availability of medicines, including for the treatment of ‘long COVID’, thus complementing the EU Vaccines Strategy, as part of the European Health Union.
Since the launch of the Strategy, several ‘rolling reviews’ by the European Medicines Agency (EMA) and joint procurement contracts for COVID-19 medicines have been launched. By the end of 2021, five new therapeutics had already been authorised. More than 75 COVID-19 treatments in development have since received scientific advice from the European Medicines Agency, including small molecules and monoclonal antibodies, antivirals, and immunomodulators. The European Medicines Agency is also evaluating several marketing authorisation applications for the treatment of COVID-19.
In October 2021, the Commission established a portfolio of 10 potential COVID-19 therapeutics. The list was based on independent scientific advice and focused on COVID-19 treatment candidates that were likely to be authorised and therefore available on the European market rapidly. Out of these ten therapeutics, six soon brought treatment to patients across the EU once their safety and effectiveness had been confirmed by the European Medicines Agency. These six therapeutics are:
- Antiviral monoclonal antibodies that are most efficacious in the earliest stages of infection:
- Ronapreve, a combination of two monoclonal antibodies casirivimab and imdevimab, from Regeneron Pharmaceuticals and Roche
- Xevudy (sotrovimab) from Vir Biotechnology and GlaxoSmithKline
- Evusheld, a combination of two monoclonal antibodies tixagevimab and cilgavimab, from AstraZeneca
- Oral antivirals for use as quickly as possible after the infection:
- PF-07321332 from Pfizer
- Immunomodulators to treat hospitalised patients:
- Actemra (tocilizumab) from Roche Holding
- Kineret (anakinra) from Swedish Orphan Biovitrum
Questions and answers about the list of 10 candidate COVID-19 therapeutics
An initial list of 5 promising candidate COVID-19 therapeutics was already published on 29 June 2021. The five products were each in an advanced stage of development and with a high potential to receive authorisation, provided that the final data demonstrate their safety, quality, and efficacy under the European Medicines Agency’s rolling review - a regulatory tool to speed up the assessment of a promising medicine during a public health emergency. Out of the list, three newly developed monoclonal antibodies had been approved for use by the end of the year:
- Ronapreve, combination of casirivimab and imdevimab from Regeneron Pharmaceuticals, Inc. and F. Hoffman-La Roche, Ltd: 22 EU Member States signed up to the joint procurement to buy 55 000 treatments
- Regdanvimab from Celltrion
- Sotrovimab from GlaxoSmithKline and Vir Biotechnology, Inc.: 16 EU Member States are participating in the procurement for the purchase of up to 220 000 treatments
Questions and answers about the first 5 candidate COVID-19 therapeutics
The European Medicines Agency - COVID-19 treatments
The Commission also hosted pan-European matchmaking events to accelerate and scale up the development and production of therapeutics for COVID-19 in the EU. Following a first matchmaking event on COVID-19 medicines in July 2021, a second matchmaking event was held on 29-30 November 2021.
On 23 May 2022, the Commission presented the Therapeutics Innovation Booster to facilitate the identification of promising research projects and technologies in different stages of development in order to accelerate innovation. This report was an essential element in the efforts to bring safe and effective treatments to patients across the EU as fast as possible, helping to identify the most promising candidates for the EU portfolio of COVID-19 treatments.
In November 2022, the Commission organised a multidisciplinary workshop on the development and availability of broad-spectrum antivirals as high priority medical countermeasures for better pandemic preparedness, bringing together participants from 25 countries across the globe.
Joint procurements
On 8 October 2020, the Commission signed a joint procurement framework contract with the pharmaceutical company Gilead for the supply of up to 500 000 treatment courses of Veklury, the brand name for Remdesivir. It is the only medicine with a conditional marketing authorisation in the EU for the treatment of COVID-19 patients who needing oxygen supply. All participating countries place their orders directly.
The Commission also purchased and distributed €70 million worth of doses of Remdesivir to Member States and the UK under the Emergency Support Instrument.
On 23 November 2022, the Commission's Health Preparedness and Response Authority (HERA) signed a joint procurement Framework Contract for the supply of Paxlovid, a SARS-CoV-2 protease inhibitor oral treatment for patients with COVID-19 at risk of developing severe disease. The contract was signed with the pharmaceutical company Pfizer and ran for an initial period of 12 months, allowing for the purchase of up to 3 427 514 five-day treatment courses of the orally-administrated Paxlovid.
13 EU and EEA Member States and EU candidate countries participated in the procurement.