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Law360 (December 9, 2020, 2:14 PM EST ) Regulatory documents related to a COVID-19 vaccine candidate produced by Pfizer and BioNTech were "unlawfully accessed" during a cyberattack at the European Union's top authority for approving medicines, the companies said Wednesday.
In a joint statement, the U.S. pharmaceutical giant and German biotechnology company said the European Medicines Agency had told them that hackers gained access to a government server and viewed documents filed by the companies as part of their bid for regulatory approval of their COVID-19 vaccine candidate, known as BNT162b2.
The EMA confirmed that it had been hit with a cyberattack, saying in a statement that it was working with law enforcement and "other relevant entities" to investigate the matter. The agency provided no further details.
The identities of the hackers, their motives, and the specific information they accessed remained unknown Wednesday. But government officials from the U.S., U.K. and Canada have warned in recent months that cyberattackers backed by the Chinese and Russian governments were targeting COVID-19 vaccine research.
EU regulators have told Pfizer and BioNTech that the incident will have "no impact" on their timeline for reviewing the vaccine candidate, the companies said.
BioNTech and Pfizer said the cyberattack did not affect their own systems. They added that they were "unaware of any personal data of study participants being accessed" as part of the incident.
News of the cyberattack came on the same day that Canada's government authorized use of the Pfizer-BioNTech vaccine, becoming the third country in the world to do so, after the U.K. and Bahrain.
Britain's National Health Service began inoculating patients with the vaccine Tuesday, starting with nursing home residents and their caretakers, as well as health care workers and people over 80 years old.
The U.S. Food and Drug Administration is scheduled to meet Thursday to consider a request by Pfizer and BioNTech for emergency approval of the shot.
--Editing by Alyssa Miller and Aaron Pelc.
Update: This story has been updated with additional information on the cyberattack and the vaccine.
For a reprint of this article, please contact reprints@law360.com.
