Documents related to the development of the Pfizer/BioNtech COVID-19 vaccine were accessed during a cyber-attack on Europe’s regulator, according to a statement by BioNTech on Wednesday.
“Today, we were informed by the European Medicines Agency (EMA) that the agency has been subject to a cyber-attack 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,” the German partner of the vaccine said.
The statement said: “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.”
The EMA confirmed that it had been subjected to a cyber-attack and said a “full investigation” had been launched. It also said the hacking “will have no impact on the timeline for its review,” which is due to be completed by Dec. 29.
BioNTech said they “await further information about the EMA’s investigation and will respond appropriately and in accordance with EU law.”
The firm said the EMA has “assured us that the cyber attack will have no impact on the timeline for its review.”
BioNTech also said: “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.”
The EMA is a European Union agency that authorizes the use of medicines across the member states.
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