On 1 February 2016, the World Health Organization (WHO) declared the Zika outbreak a public health emergency of international concern. The European Medicines Agency (EMA) is supporting the global response to the Zika outbreak with the creation of a group of specialised European scientific experts.
Currently, there are no vaccines to protect people from Zika virus infection or medicines to treat any related symptoms approved in any region of the world or undergoing clinical studies.
Ad-hoc task force
The Agency has established a group of European experts who have specialised knowledge in vaccines, infectious diseases and clinical trial design to contribute to the global response to the threat of the Zika virus infection. The task force will be available to give advice on any scientific and regulatory matters for research and development of medicines or vaccines against the virus.
Mechanisms to support medicines' developers
EMA's existing mechanisms and tools which can be used to help speed up the development of medicines and vaccines to combat the Zika virus include:
- providing scientific advice on the tests and studies needed to develop a medicine or vaccine, including clinical trial design, manufacturing-related issues such as scaling-up production or batch release, and post-authorisation safety monitoring;
- issuing opinions on medicines intended for use outside the European Union (EU) to prevent or treat diseases of major public health interest, in cooperation with WHO and experts from the countries concerned, under the 'Article 58' procedure.
The Agency is encouraging medicines developers to contact EMA if they have any promising projects in this area.
EMA will also proactively reach out to companies already planning to work on investigational vaccines and offer scientific and regulatory advice. EMA will review any new information as soon as it becomes available to support the response to this widening public health crisis.
Safety assessment of human-derived substances
It concluded that manufacturing processes for these products successfully inactivate or remove virus and recommended no additional safety measures such as testing or exclusion of certain donors.
EMA published the results of this assessment in September 2016:
- Biologics Working Party report on viral safety of plasma-derived and urine-derived medicinal products with respect to Zika virus
The BWP recommendation on plasma-derived products is in line with the European Centre for Disease Prevention and Control's (ECDC) preparedness guide on Zika and substances of human origin, published in July 2016.
As per standard practice during an international health emergency, EMA will seek to work closely together with European bodies, including the European Commission and the ECDC, and with international partners such as WHO and international regulators from affected countries.
The European Commission has mobilised €10 million for research on the Zika virus. If the suspected link between the virus and the severe congenital brain malformations across Latin America is proven, this fund could be used to combat the Zika virus by developing diagnostics and testing potential treatments or vaccines.
In addition, Horizon 2020 already offers a number of opportunities to finance projects that can help in the fight against Zika. For more information, see:
The ECDC produces risk assessments, epidemiological updates and other updates on the Zika virus. For more information, see:
- EMA sets up task force on Zika virus (08/02/2016)