Documents relating to the regulatory submission for Pfizer-BioNTech's Covid-19 vaccine candidate were "unlawfully accessed" during a cyberattack on the European Medicines Agency (EMA), according to Pfizer.
The announcement of the cyberattack on the EMA comes just weeks before the EU medicines regulator is due to decide on special approval for two coronavirus vaccines.
"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 from Pfizer 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.
"EMA has been the subject of a cyberattack. The agency has swiftly launched a full investigation, in close cooperation with law enforcement and other relevant entities," the EMA said in a brief statement.
"EMA cannot provide additional details whilst the investigation is ongoing. Further information will be made available in due course."
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.
The regulator is also carrying out reviews of vaccines developed by Oxford University-AstraZeneca vaccine and Johnson & Johnson.
The EMA moved to Amsterdam from London after the UK decided to leave the European Union and oversees all medicines for the 27 member states.
Series of cyberattack warnings issued
The cyberattack on the EMA comes after a series of warnings about hacking related to the coronavirus pandemic.
The UK accused Russian-based, Kremlin-linked hackers in July of targeting laboratories conducting coronavirus vaccine research.
Cybercriminals have tried to attack several pharmaceutical companies developing vaccines including Johnson & Johnson, Novavax, AstraZeneca and South Korean laboratories, according to the Wall Street Journal.
Spanish laboratories also reportedly have been attacked by Chinese cybercriminals, the El Pais newspaper reported in September.
Microsoft urged a crackdown last month on cyberattacks perpetrated by states and "malign actors" after a spate of hacks disrupted healthcare organisations fighting the coronavirus.
IBM said last week that it too had uncovered a string of attacks, again potentially carried out by state actors, against companies involved in the effort to distribute the vaccine.
The European Commission's Directorate-General for Taxation and Customs Union was one target of the attacks, as well as European and Asian companies involved in the supply chain, IBM said.
It is not the first time a Netherlands-based international body has been targeted by hackers.
Dutch authorities expelled four suspected Russian intelligence agents in 2018 after an alleged bid to hack the Organisation for the Prohibition of Chemical Weapons in The Hague, using equipment in the back of a car parked in a neighbouring hotel.
