Update EMA on Treatments and Vaccines against COVID-19 under Development

EMA’s COVID-19 response team has been in contact with developers of around 40 therapeutic medicines, allowing better understanding of potential treatments. However, at this point, on the basis of the preliminary data presented to the Agency, no medicine has yet demonstrated efficacy in treating COVID-19.

Among the potential treatments for COVID-19 that are undergoing clinical trials to assess their safety and efficacy against the disease are:

• remdesivir (investigational)
• 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 and in particular interferon beta (currently authorised to treat diseases such as multiple sclerosis)
• monoclonal antibodies with activity against components of the immune system

The Agency has also had discussions with developers of a dozen potential COVID-19 vaccines. Two vaccines have already entered phase I clinical trials, which are the first trials needed and are carried out in healthy volunteers. In general, timelines for the development of medicinal products are difficult to predict. Based on the information currently available and past experience with vaccine development timeframes, EMA estimates that it might take at least one year before a vaccine against COVID-19 is ready for approval and available in sufficient quantities to enable widespread use. Adequate supply of doses to meet the needs of all EU countries has to be proactively forecast.

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