Pfizer Confirms EMA Cyberattack Accessed COVID-19 Vaccine Documents
Pfizer and BioNTech were informed of a data breach at the European Medicines Agency (EMA) where documents related to their COVID-19 vaccine candidate were accessed. No Pfizer or BioNTech systems were breached in the incident.
Pfizer Inc. confirmed on December 9, 2020, that the European Medicines Agency (EMA) had been the target of a cyberattack. This attack resulted in the unlawful access of some documents concerning the regulatory submission for Pfizer and BioNTech's COVID-19 vaccine candidate, BNT162b2, which were stored on an EMA server.
The company stated that no Pfizer or BioNTech systems were breached in connection with the incident. Pfizer is also unaware that any study participants have been identified through the accessed data. The pharmaceutical company is awaiting further information from the EMA's investigation and will respond appropriately as per EU law.
EMA has assured Pfizer that the cyberattack will not impact the timeline for its regulatory review process. Pfizer and BioNTech continue their efforts to bring a vaccine to market to combat the ongoing pandemic.
Pfizer and BioNTech have been developing an mRNA-based vaccine against COVID-19. The vaccine candidate, BNT162b2, has shown high efficacy in late-stage clinical trials and is under review by multiple regulatory agencies worldwide.