However BioNTech, based in Mainz in Germany, issued a press release stating that “some documents relating to the regulatory submission for Pfizer and BioNTech’s COVID-19 vaccine candidate, BNT162b2, which had been stored on an EMA server, had been unlawfully accessed.”
“It is important to note that 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 company said.
The EMA is currently thought to be nearing the end of its deliberations on granting a licence for the Pfizer/BioNTech vaccine, which has been very much in the news this week as the UK – which has its own regulatory authority – starts vaccinating the public.
As well as the Pfizer/BioNTech vaccine, which is produced in Puurs in Antwerp province, the EMA is also considering approval of another vaccine, from US company Moderna.
The EMA said it is investigating the cyber-attack, and has assured the company the incident will have no effect on the timeline of its review.
Belgium has ordered 600,000 doses of the vaccine, and the government has said it should be possible to begin vaccinations in early January.
As an investigation is underway, the EMA has offered few details. It is not known how long the attack lasted, or whether documents were accessed or copied.
“The Agency quickly launched a full investigation, in close cooperation with law enforcement agencies and other relevant entities,” the agency said in a statement.
“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,” BioNTech said.
“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.”