U.S. drugmaker Pfizer and its German partner BioNTech said on Wednesday that the related documents for COVID-19 vaccine development had been "unlawfully accessed" in a cyberattack on Europe's medicines regulator.
Without further details, the European Medicines Agency (EMA), the agency tasked to assess medicines and vaccines for European countries said it was targeted by cyberattacks.
Pfizer and BioNTech said they did not believe any personal data of trial participants had been compromised and EMA “has assured us that the cyber attack will have no impact on the timeline for its review.”
It wasn't clear when or how the attack took place, who responsible or what other information may have been compromised.
The two companies said they had been informed by the EMA “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” had been viewed.
Such documents could be extremely valuable to other countries and companies rushing to develop vaccines, experts said.
“When it comes to the data submitted to these kinds of regulatory bodies, we are talking confidential information about the vaccine and its mechanism of action, its efficiency, its risks & known possible side effects and any unique aspects such as handling guidelines,” said Marc Rogers, founder of a volunteer group fighting Covid-related breaches, CTI-League told Reuters.
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