A cyberattack on servers belonging to the European Medicines Agency — the EU regulatory body responsible COVID-19 vaccine approval — has resulted in the “unlawful access” of internal documents detailing the development of a potential COVID-19 vaccine.
While the EMA’s own statement on the attacks doesn’t disclose much, simply confirming that the breach happened. However, pharma giant Pfizer and its German partner, BioNTech, issued their own joint statement explaining that some of their own documents related to the “regulatory submission” for their vaccine candidate, BNT162b2, was held on one of the agency’s servers that were caught up in the breach. The companies said that neither of their own internal systems were affected by the attack and that they were “unaware” of any trial participants being identified as a result.
“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 Pfizer–BioNTech statement reads. “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 Associated Press first reported news of the breach after the companies disclosed it.
The attack came at a pretty inopportune time for the EMA; the agency was at the centre of a pretty tight race after both Pfizer–BioNTech and Moderna submitted their vaccines for EU regulatory review, which were both expected to collectively wrap up by early January. There’s a chance that this latest attack might push that timeline back a bit.
Three countries — Bahrain, the UK, and Canada — have so far approved the Pfizer–BioNTech vaccine. The U.S. Food and Drug Administration is scheduled to hold a hearing on the companies’ vaccine on Thursday, a crucial step for it to receive approval for use in the U.S. The FDA is set to have a similar hearing regarding Moderna’s vaccine on Dec. 17.