On 20 January 2021, French Member of the European Parliament (MEP) Jean-Paul Garraud of the Identity and Democracy Group, posed a written parliamentary question to the European Commission:
“According to press reports, the European Medicines Agency (EMA) has been hacked, resulting in stolen documents being published on the dark web.
The documents in question, which relate to the assessment of Pfizer‑BioNTech’s COVID-19 vaccine, include emails suggesting that the EMA was put under pressure by the Commission to approve the first vaccine quickly.
Moreover, in an exchange with the Danish Medicines Agency, a senior EMA official expressed surprise that the Commission President had identified two vaccines (Pfizer‑BioNTech and Moderna) that could be approved before the end the year, even though some problems persisted.
In November, the EMA raised three major objections in connection with the Pfizer-BioNTech vaccine: the failure to inspect sites where the vaccine was manufactured, a lack of data on commercial vaccine batches and qualitative differences between commercial batches and those used in clinical trials.
Can the Commission:
1. Explain how Ursula von der Leyen was able to prejudge the licensing of the two vaccines in question?
2. Confirm that she did not seek to accelerate the process to authorise COVID-19 vaccines?
3. Explain how the EMA could be hacked?”
On 27 April 2021, Health and Food Safety Commissioner Stella Kyriakides responded on behalf of the European Commission stating: “In December 2020, the European Medicines Agency (EMA) was the subject of a cyberattack. Some of the unlawfully accessed documents including email correspondence were made public through the Internet and were subsequently picked up by some media outlets. EMA swiftly launched a full investigation, in close cooperation with law enforcement and other relevant entities.
EMA continues to fully support the criminal investigation related to the cyberattack led by law enforcement authorities, in cooperation with other entities and will continue to provide information in due course, to the extent possible, given its duty towards the ongoing investigations.
EMA and the European medicines regulatory network remained fully functional and timelines related to the evaluation and approval of COVID-19 medicines and vaccines have not been affected by the cyberattack. EMA is transparent about the start of their COVID-19 related assessments and the expected timelines for their completion.
The Commission, as the authorising body for all centrally authorised products, takes the legally binding decision based on EMA’s recommendation. Thus, the Commission follows closely the work of EMA and its Committees but does not exert any pressure or otherwise influence their independent scientific role.
EMA’s human medicines committee (CHMP) assessed the BioNTech/Pfizer and Moderna vaccines on the basis of robust data on their quality, safety and efficacy. The Commission authorised both vaccines for the European Union market based on EMA’s independent scientific evaluation.”
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