Unknown hackers have broken into the computers of the European Medicines Agency. While the EMA is largely silent, two companies have reported whose data was also likely targeted by the hackers.
Amsterdam (dpa) – During a cyber attack on the European Medicines Agency EMA in Amsterdam, data from pharmaceutical companies Pfizer and Biontech, among others, was tapped. The companies announced this in a statement after they had been informed by the EMA about the attack.
Accordingly, “some documents” related to the two companies’ applications for approval of their coronavirus vaccine were under 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 the EMA that the attack had “no effect” on the vaccine approval process.
The EMA itself has not provided further details about the cyber attack, nor about the size of the attacked files, nor about 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. While the investigation is underway, no details can be released.
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 have been made” to security. The EMA also assesses the vaccine from, among others, the pharmaceutical company Moderna. A decision on approval is expected on January 12.
The vaccine from Pfizer and Biontech already has emergency approval in the UK. According to Cooke, this is only valid for a limited time. The EMA strives for a fully valid approval. The EMA boss was also positive about possible side effects of the vaccine. “No significant side effects were found, and certainly none serious.” The vaccine works in both older and younger people.