Coronavirus disease (COVID-19)
The European Medicines Agency (EMA) contributes to the global response to the novel coronavirus outbreak, which began in December 2019 in Wuhan, China. Under its plan for managing emerging health threats, EMA supports the development and approval of vaccines and treatments for novel coronavirus, together with other regulators in the European Union (EU) and worldwide.
The novel coronavirus (2019-nCoV) is a new strain of coronavirus that had not previously been identified in humans. The coronavirus family is known to cause illness in humans, from common cold to more severe or even fatal diseases such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS).
The Wuhan-centred outbreak is expected to continue to spread widely within China and globally. Cases have been detected in several countries in Asia, North America, Europe and in Australia.
On 30 January 2020, The World Health Organization (WHO) declared the outbreak a public health emergency of international concern.
There are currently no authorised vaccines or treatments in the EU to prevent or treat novel coronavirus disease (COVID-19) specifically or any other coronaviruses.
EMA has activated its plan for managing emerging health threats , which determines how EMA responds to and communicates on serious public health threats. For more information, see Public health threats.
EMA encourages developers of potential vaccines or treatments for novel coronavirus infection to contact EMA as soon as possible to discuss their strategy for evidence-generation, by emailing email@example.com.
EMA has regulatory mechanisms to speed up development and approval, including:
- scientific advice;
- the PRIME scheme;
- the accelerated assessment and conditional marketing authorisation procedures.
Scientific advice can be fast-tracked for potential novel coronavirus treatments or vaccines.
EMA analyses all available information on medicine development pipelines in order to map potential treatments and vaccines.
During an emerging public health threat, EMA works closely with other European bodies, including the European Commission, the Health Security Committee and the European Centre for Disease Prevention and Control (ECDC), and with international partners such as the WHO and regulators from affected countries.
ECDC and WHO produce a series of risk assessments, epidemiological updates and other information:
EU authorities monitor the outbreak closely and provide updates as information becomes available.