A cyber attack gave unknown persons “unlawful” access to Biontech’s vaccination records. D.i.e European Medicines Agency EMA confirmed the attack.

In a cyber attack on the European Medicines Agency (EMA) in Amsterdam, data was tapped from the pharmaceutical companies Pfizer and Biontech. The two companies announced this in a joint statement on Thursday evening after they were informed of the attack by the EMA. Accordingly, “some documents” related to the two companies’ applications for approval of their coronavirus vaccine were caught in the attack.

Pfizer and Biontech also stressed that their respective systems had not been attacked in this context. Also, to the best of their knowledge, no data on the subjects has been made available. The drug companies were also informed by EMA that the attack had “no effect” on the vaccine approval process.

The EMA itself has not provided details on the cyber attack, nor on the size of the attacked files, nor on any assumptions about the attackers. A spokesman for the authority did not confirm the attack until Wednesday afternoon and nothing else was disclosed in a later announcement from the EMA. The agency only announced that a full investigation had been opened. No details can be released while the investigation is ongoing.

Especially during the corona crisis, the drug authority is currently in the spotlight. In the EU, she is responsible for the approval process for medicines, including corona vaccines.

Admission at the end of December

EMA director Emer Cooke, meanwhile, responded positively to the possible approval of the corona vaccine by Biontech and Pfizer on Wednesday evening. “We are increasingly convinced of the test results we have,” she said in an interview with Nieuwsuur. A decision will be made at the end of December. The vaccine shows a high effectiveness of almost 95 percent in 30,000 subjects and has hardly any side effects.

A meeting is scheduled for December 29 between the EMA and all drug authorities in the 27 EU Member States. Then the decision on the approval of the first corona vaccine in the EU must be taken, according to the director. Until then, the experts checked the test results day and night. The director stressed that “no concessions” are made to safety. The EMA also assesses the vaccine from, among others, the pharmaceutical company Moderna. A decision on approval is expected on January 12. People in the UK have been vaccinated en masse since Tuesday.

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