The European Medicines Agency has ordered the deletion of country-by-country data on adverse reactions to the Covid vaccine. The letter from the EMA is dated 9 October 2025 and sent by Alexandra Nikol, Head of the Medicinal Products for Human Use Division.
She asked Emmanuelle Darles, a doctor in computer science and teacher-researcher, and Vincent Pavan, a mathematician and teacher-researcher, to permanently delete all the data extracted from the Eudravigilance system, in particular the country of occurrence of adverse reactions linked to Covid-19 vaccines, within eight days.
Researchers must also destroy the source code used to analyse the data by country, as well as all calculations, reports submitted to institutions such as the European Parliament, communications and derivative legal actions.
In other words, it becomes impossible to analyse reports by country, which is essential if we are to understand the differences in the profile and frequency of effects in different national contexts.
The EMA justifies this request on the grounds of personal data protection, believing that mention of the country of occurrence could create a direct identifier. This is an official order to delete this information, on pain of violating the European Data Protection Regulation.
Emmanuelle Darles refutes this interpretation, as identifiers such as “EV58875” associated with a country such as Spain are not sufficient to trace an identity. Pseudonymisation is recognised as not violating personal data.
Why prevent data from being read differently from one country to another?
Why is the writer of this letter not on the EMA’s organisation chart? And yet the letter was signed by one of EMA’s directors?
Why is this request being made 3 years later?
Is a ban on all analysis looming?
Emanuelle and Vincent have confirmed that they will not give in to intimidation, which is as ridiculous as it is blatantly illegal, and that they will get back to work on the statistical study of adverse events based on EUDRAVIGILANCE data. They are considering taking action with the European Commission, which oversees the EMA, to question its transparency and legitimacy.
