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LONDON: US pharmaceutical company Pfizer and its German partner BioNTech said on Wednesday (December 9) that documents related to the development of its COVID-19 vaccine had been “illegally accessed” in a cyberattack on the European drug regulator.
The European Medicines Agency (EMA), which evaluates medicines and vaccines for the European Union, said hours earlier that it had been the target of a cyberattack. He did not elaborate.
Pfizer and BioNTech said they did not believe that any personal data of the trial participants had been compromised and the EMA “has assured us that the cyberattack will have no impact on the timing of their review.”
It was not immediately clear when or how the attack took place, who was 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 the target of a cyberattack and that some documents related to Pfizer’s regulatory filing and BioNTech’s COVID-19 vaccine candidate have been seen.”
Such documents could be extremely valuable to other countries and companies rushing to develop vaccines, experts said.
“When it comes to the data sent to these types of regulatory bodies, we are talking about confidential information about the vaccine and its mechanism of action, its efficiency, its risks and possible known side effects and any unique aspects such as management guidelines,” he said . Marc Rogers, founder of a volunteer group fighting COVID-related breaches, CTI-League.
“It also provides detailed information on other parties involved in the supply and distribution of the vaccine and potentially significantly increases the attack surface of the vaccine,” adding more ways that formulas or production could be pirated or stolen.
The companies said that “no BioNTech or Pfizer systems have been breached in connection with this incident and we do not know that the study participants were identified through the data accessed.”
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A BioNTech spokeswoman declined to comment further. Pfizer did not respond to a request for additional comment.
The Pfizer-BioNTech vaccine is one of the main competitors in the global race to defeat COVID-19. It is already being administered in Great Britain.
The EMA has said it will complete its review before December 29, although its schedule may change.
The EMA statement gave few details about the attack, saying it was only investigating with the help of law enforcement agencies.
“The EMA cannot provide additional details while the investigation is ongoing,” it said in a statement.
US law enforcement and cybersecurity officials did not respond to requests for comment.
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Hacking attempts against medical and healthcare organizations have intensified during the COVID-19 pandemic as attackers ranging from state-backed spies to cybercriminals seek information.
Reuters has previously reported allegations that hackers linked to North Korea, South Korea, Iran, Vietnam, China and Russia have tried on separate occasions to steal information about the virus and possible treatments.
Reuters has documented that the spy campaigns targeted a large number of pharmaceutical and vaccine development companies, including Gilead, Johnson & Johnson, Novavax and Moderna. Regulators and international organizations like the World Health Organization have also come under repeated attacks.
“Vaccine candidates represent liquid gold for many parties, both in terms of opportunity and pure market value,” said Rogers, who is also a vice president of security firm Okta. “Information about the vaccine and access to any link in the supply chain has significantly increased the value.”
The respiratory virus, which emerged in China in late 2019, has infected more than 68 million people worldwide, according to a Reuters tally. More than 1.5 million people have died.
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