Pfizer and BioNTech’s jointly-developed COVID-19 vaccine, which this week began to rolled out to elderly patients in the UK after securing emergency approval from the MHRA, has been targeted through the EMA by hackers, it has been reported.
BioNTech confirmed that it had heard of the attack via the EMA. The hackers managed to access regulatory submission documents relating to the vaccine that were stored on an EMA server. The European regulator is currently reviewing the regulatory submission for the drug, with a decision expected later this month.
Both BioNTech and Pfizer were left untouched by the attackers, but the former company said it could not confirm whether or not confidential trial participant data had been breached.
“At this time, we await further information about EMA’s investigation and will respond appropriately and in accordance with EU law. EMA has assured us that the cyberattack will have no impact on the timeline for its review,” BioNTech said in a statement. “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 said that it could not reveal any further information while an investigation is still underway, so it is still unclear at this stage if data for any of the other COVID-19 vaccines currently under review were compromised.
This isn’t the first case of a cyber security breach in relation to COVID-19 research; AstraZeneca reported that it had suffered an attack from North Korean hackers targeting its COVID-19 research at the end of November.
Matt Fellows
This is a syndicated feed from Pharmafile
