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Parliamentary questions
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20 January 2021
E-000324/2021
Question for written answer  E-000324/2021
to the Commission
Rule 138
Jean-Paul Garraud (ID)
 Answer in writing 
 Subject: Pressure exerted on the European Medicines Agency in the process to authorise COVID‑19 vaccines

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?

Original language of question: FR
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