Acute hepatitis

Subject: Acute hepatitis

On 23 April 2022 the WHO reported an increase in cases of acute hepatitis of unknown aetiology in children. Earlier, on 19 April 2022, the European Centre for Disease Prevention and Control reported further cases in children in Denmark, Ireland, the Netherlands and Spain, adding to the reports from the UK Health Security Agency about acute hepatitis cases in that country. At least 169 cases have been recorded so far: UK (114), Spain (13), Israel (12), USA (9), Denmark (6), Ireland (5), Netherlands (4), Italy (4), Norway (2), France (2), Romania (1), Belgium (1).

1. In connection with the ongoing toxicological and aetiological studies and with the research to establish the epidemiological picture and clinical characteristics of the recorded cases, how does the Commission intend to support the sharing of all available information with the Member States?

2. Despite claims that atypical hepatitis is unrelated to the COVID-19 vaccine, does the Commission plan to ask its agencies and networks, including the Hepatitis Network, the European Association for the Study of the Liver and the European Society of Clinical Microbiology and Infectious Diseases to look in detail at the possible factors – such as other infections (including COVID-19), environmental causes and genetic studies of the structure of changes in the adenovirus genome – that may be responsible for these cases of acute hepatitis?

Answer given by Ms Kyriakides on behalf of the European Commission

(19 July 2022)

1. The Commission’s activities in relation to the increase of severe acute hepatitis cases of unknown aetiology in children in the United Kingdom and several EU/European Economic Area (EEA) countries currently aim at preventing infections by knowing more about what causes them. The Commission is discussing the situation with EU Member States, EEA countries and partners in the Health Security Committee (1), and in a Risk Assessment of 28 April 2022 (2), the European Centre for Disease Prevention and Control (ECDC) called on EU/EEA countries to establish surveillance at national level, including appropriate testing, and quickly report cases to the European Surveillance System (3). Situation updates are also publicly available on a dedicated ECDC website (4).

Moreover, different European clinical research networks, several of which receive Horizon 2020 (5) funding (e.g. ECRAID (6), Penta (7)), swiftly reacted by setting up a rapid survey to assess the extent and geographical distribution of the outbreak (8), which is also being discussed and monitored at the level of the Global research collaboration for infectious disease preparedness (GloPID- R) (9).

2. ECDC, together with involved countries, the World Health Organisation and other stakeholders, is monitoring the situation and provides updates to the Commission. In addition, ECDC is working with research teams and Member States to plan aetiological studies for the hepatitis cases.

⋅1∙ An informal advisory group on health security at European level. For more information at https://health.ec.europa.eu/health-security-and-infectious-

diseases/preparedness-and-response/health-security-committee-hsc_en

⋅2∙ https://www.ecdc.europa.eu/en/publications-data/increase-severe-acute-hepatitis-cases-unknown-aetiology-children

⋅3∙ In accordance with Decision 1082/2013/EU on serious cross-border threats to health, which sets out the common rules for epidemiological surveillance of

communicable diseases and related special health issues (such as antimicrobial resistance), hepatitis is included in the list of notifiable diseases subject to epidemiological surveillance. This decision is currently under revision and should be adopted by the co-legislators soon, the new Cross-Border Health Threats Regulation will be a strengthened legal base including a Union preparedness plan, a system of regular assessments of national preparedness plans and improved, continued surveillance of communicable diseases.

⋅4∙ Increase in severe acute hepatitis cases of unknown aetiology in children (europa.eu)

⋅5∙ https://ec.europa.eu/info/research-and-innovation/funding/funding-opportunities/funding-programmes-and-open-calls/horizon-2020_en

⋅6∙ https://www.ecraid.eu/ projects ECRAID-Plan (Grant Agreement No 825715; https://cordis.europa.eu/project/id/825715), ECRAID-Base (Grant Agreement No

965313, https://cordis.europa.eu/project/id/965313), ECRAID-Prime (Grant Agreement No 101046109, https://www.ecraid.eu/ecraid-prime); total EU contribution EUR 42.9 million

⋅7∙ https://penta-id.org/ beneficiary of a total EU contribution of EUR 8.0 million in 8 Horizon 2020 projects (i.e. Grant Agreements No 734857, 777554, 825579,

825715, 965313, 965328, 101003589, 101016167) and 2 Horizon Europe projects (i.e. Grant Agreements No 101046118, 101057036). ⋅8∙ https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2022.27.19.2200370 ⋅9∙ https://www.glopid-r.org/