U.S. pharmaceutical company Pfizer and its German partner BioNTech applied last week to the European Medicines Agency for the marketing authorization of their coronavirus vaccine - and it now appears that some of their documents relating to the regulatory submission were leaked as Pfizer blames the European computer system for the breach. Here's Pfizer's statement:
Today, we were informed by the European Medicines Agency (ENIA) that the agency has been subject to a cyberattack and that some documents relating to the regulatory submission for Pfizer and BioNTech's COVID-19 vaccine candidate, BNT162b2, which has been stored on an EMA server, had been unlawfully accessed.
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 cyberattack will have no impact on the timeline for in review.
Given the critical public health considerations and the importance of transparency, we continue to provide clarity around all aspects of the vaccine development and regulatory processes. Our focus remains steadfast on working in close partnership with Governments and regulators to bring our COVID-19 vaccine to people around the globe as safely and as efficiently as possible to help bring an end to this devastating pandemic.
Pfizer shares are down more than 2% in the afternoon session.