United States drugmaker Pfizer and its German partner BioNTech said that documents related to the regulatory submission of its COVID-19 vaccine were “unlawfully accessed” in a cyberattack on Europe’s medicines regulators.
No impact on the timeline for its review
The European Medicines Agency (EMA), responsible for assessing and approving medicines and vaccines for the European Union (EU), confirmed on Wednesday that it had been subjected to a cyberattack but did not provide any details beyond saying a full investigation had been launched.
BioNTech published a statement, saying,
“It is important to note that no BioNTech or Pfizer systems have been breached in connection with this incident and we are unaware that any study participants have been identified through the data being accessed. At this time, we await further information about EMA’s investigation and will respond appropriately and in accordance with EU law. EMA has assured us that the cyber attack will have no impact on the timeline for its review.”
The agency is due to complete its review by 29 December. NCSC is supporting vital vaccine research and manufacture to defend against cyber threats. They are working with international partners to understand the impact of this incident affecting the EU’s medicine regulator.