Documents relating to the regulatory submission for Pfizer and BioNTech’s COVID-19 vaccine candidate were “unlawfully accessed” during a cyberattack on the European Medicines Agency (EMA), Pfizer said Wednesday.
“It is important to note that no BioNTech or Pfizer systems have been breached in connection with this incident and we are unaware of any personal data being accessed,” a statement said.
“We await further information about EMA’s investigation and will respond appropriately and in accordance with EU law.
“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.”
The Amsterdam-based EMA has said the incident was being investigated, but did not specify when it took place or whether its work on Covid-19 was targeted.
The Dutch national police high-tech crime team was involved in the probe into the cyberattack, but police gave no more information, the Dutch news agency ANP reported.
The EMA’s role as the drugs regulator for the 27-nation EU means it has access to data on the safety and quality of medicines from clinical trials and lab tests from companies that apply for authorization.
The agency has said it will give a decision on conditional approval for Pfizer-BioNTech’s Covid-19 vaccine at a meeting that will be held by December 29 at the latest, while a ruling on Moderna’s version should follow by January 12.
The Pfizer-BioNTech vaccine, BNT162b2, has received emergency approval in Great Britain and Canada.
The US Food and Drug Administration is holding a meeting on approval Thursday, with the green light expected in the days that follow.