BioNTech and Pfizer Vaccine Docs Hacked in EMA Cyberattack
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“The Agency has swiftly launched a full investigation, in close cooperation with law enforcement and other relevant entities,” the EMA said in a brief statement.
The European Medicines Agency is the agency responsible for evaluating and approving medicines for European Union countries. EMA is based in the Netherlands.
Typically, EMA evaluates clinical trial data at the conclusion of the studies. To speed up the process, EMA has been evaluating COVID-19 vaccine candidates with rolling reviews. This means the agency is evaluating data as it becomes available rather than waiting until data is collection has ended.
EMA is evaluating a COVID-19 vaccine candidate developed in a joint effort by BioNTech and Pfizer. The agency is also evaluating vaccine candidates developed by U.S. biotech Moderna (MRNA) and another from a partnership between AstraZeneca (AZN) and the University of Oxford.
“Some documents relating to the regulatory submission for Pfizer and BioNTech’s COVID-19 vaccine candidate, BNT162b2, which has been stored on an EMA server, had been unlawfully accessed,” said pharmaceutical manufacturers BioNTech and Pfizer in a joint statement.
German biotechnology company BioNTech is partnered with American pharmaceutical corporation Pfizer to develop and test a coronavirus vaccine. The companies concluded their phase 3 studies in November. Their COVID-19 vaccine is known as BNT162b2.
“It is important to note that no BioNTech or Pfizer systems have been breached in connection with this incident and we are unaware that any study participants have been identified through the data being accessed,” BioNTech said in a statement on its website.
CISA and NCSC Warned of Cyberattacks
In October, the United States Department of Homeland Security (DHS) Cybersecurity and Infrastructure Security Agency (CISA) and the United Kingdom’s National Cyber Security Centre (NCSC) issued a joint alert warning about COVID-19 themed phishing campaigns. The agencies warned governments and organizations about the increasing number of malware attacks and phishing email campaigns. Threat actors from advanced persistent threat groups (APT) are exploiting the increased use of video conferencing apps to steal information related to COVID-19 19 vaccine development.
In March, a Chinese APT group was sending phishing emails disguised as fake World Health Organization (WHO) press briefings to spread RAT malware.
Russia COVID-19 Data Vaccine Hacked
In October Russia’s vaccine maker Dr. Reddy’s Laboratories was impacted by a cyberattack. Drug manufacturer was temporarily crippled but resumed operations within a few days.