The European Medicines Agency (EMA), which authorises the use of medicines across the European Union, has announced it has been hit by a cyber-attack and vital documents relating to a Covid-19 vaccine have been accessed by the hackers.
BioNTech, which makes one of the vaccines in partnership with Pfizer, said its regulatory Vaccine submission was accessed during the attack.
The EMA is working on approval of two Covid-19 vaccines, which it expects to conclude within weeks but says the hack will not affect that timeline.
The EMA did not provide any details on the nature of the cyber-attack, or who was responsible, but in a brief statement published on its website, said a full investigation had been launched.
A spokesperson for the agency said it was still “functional”.
BioNTech, in a statement published on its website on Wednesday, December 9, said ;
“Today, we were informed… 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,” it said.
“EMA has assured us that the cyber-attack will have no impact on the timeline for its review,” it added.
It said it had made the details of the hack public “given the critical public health considerations and the importance of transparency”.
And it also said it was “unaware” of any personal data of participants in its medical studies being compromised.
The EMA is trying to decide if the Pfizer/BioNTech vaccine which is being rolled out in the UK – and another made by Moderna are safe for use in EU countries.
The cyber-attack comes the day before the EMA is due to update the European Parliament on the progress of the vaccine assessments.