Vaccine: Leaked emails show pressure on the drug agency EMA

The European Medicines Agency, based in Amsterdam, issues recommendations for the approval of medicines and vaccines. In the end, the approval comes from the European Commission.

picture alliance / ROBIN UTRECHT | ROBIN UTRECHT

The European Medicines Agency (EMA) is supposed to evaluate medicines according to their benefits and possible side effects and to approve them for market introduction, regardless of the policy But the political pressure the authority was exposed to when approving COVID-19 vaccines is now shown by emails that were stolen in a hack and evaluated by the international research team “Behind the Pledge” with The EMA reported a cyber attack on December 9th in which hackers stole internal mails and other documents.

According to one of the leaked emails, a senior EMA official reported a “tense” and “uncomfortable” conference call with an EU commissioner on November 19, a month before the first vaccine was approved. During the conference it became clear what the EMA will have to do if it does not meet expectations for rapid vaccine approval, regardless of whether these are “realistic or not”. The EMA coordinates the schedule, communication strategy and expectations for vaccine approval in close cooperation with the European Commission.

What apparently becomes clear in the conversation with the Commissioner: If the USA and Great Britain approve a vaccine, the EMA must not lag behind with its assessment for several weeks. Such a delay is “not easy to accept” for the commission, because the “political fall-out” would be too great, the official wrote according to the November 19 email.

In another conversation, the commissioner warned that it should not come to the point where member states are “forced” to bypass the EMA because of delays, another EMA official wrote to her colleagues on November 12th. According to an EU directive, member states can temporarily use unauthorized drugs in the event of an epidemic.

The European Commission is under pressure even from the Member States. The vaccine is said to come as soon as possible to alleviate the tremendous health and economic damage caused by the pandemic. According to the e-mails, the commission is passing on the pressure: it does not rely solely on the assessment of its competent authority, but sets goals for them based on the decisions and the schedule of the foreign institutions.

The EMA is confronted with these requirements and at the same time has to comply with its scientific and regulatory standards – which differ in detail from those of the foreign authorities and, according to the EMA, are sometimes stricter. But that is not understandable for the public, writes the EMA official.

No matter what the EMA does, it will have “a great challenge to ask questions and criticism” if there is a delay of several weeks, the EMA official writes in the internal email. Even if they accelerate the process as far as possible while ensuring safety and quality. “We have to be ready for the worst-case scenario,” writes the official. That appears to be the case if the EMA does not evaluate relatively simultaneously with the US and UK authorities – or comes to a different conclusion: “We will be overwhelmed on all fronts and in the middle of a storm. Whose support can we then rely on? “

The EMA is indirectly feeling the pressure at the highest level. On November 19, Commission President Ursula von der Leyen announced that the vaccines from Biontech / Pfizer and Moderna could be approved by the end of the year – “if everything goes without problems”. According to the documents, the EMA official writes that this wording is in line with the EMA. What is new for him, however, is that von der Leyen is naming the names of the vaccines that could be approved in 2020. “There are still problems with both of them,” the officer points out. One must see whether these can be cleared out in good time without compromising the “robustness of the review”.

According to an email dated November 22, the EMA official warned Commission staff: “We are speeding everything up as much as possible, but we also need to ensure that our scientific review is as robust as possible.”

When asked by about the leaks, the EMA replied: “Despite the urgency, there has always been a consensus in the EU not to jeopardize the high quality standards and each recommendation is based solely on the strength of scientific evidence for the safety, quality and effectiveness of one To support the vaccine. “

A spokesman for the Commission stated when asked: “The Commission does not compromise on security and has never put political pressure on the EMA to do so.” The discussions with the EMA never had the independence of the agency or its integrity in relation to interferes with the evaluation of vaccine candidates or other drugs.

The vaccine from Biontech and Pfizer was the first to receive an emergency approval in the USA on December 11th, shortly afterwards it received so-called conditional approval by the EU on December 21st. The Moderna vaccine followed on December 18 in the US and January 6, 2021 in the EU. There is no evidence that the EMA has not complied with scientific standards.

It is not known who is behind the hack of the EMA files; it is suspected, for example, that a secret service wants to damage the EMA and the trust in the vaccine approval. Screen recordings of emails and other files were shared on the dark web. According to the EMA, investigations are ongoing. First the Italian security company “Yarix” came across the data during an investigation into the Russian dark web and forwarded it to the Italian police. Company boss Mirko Gatto says he assumed that the files were real.

This article is part of #BehindThePledge research funded by and IJ4EU. Collaboration: Lise Barnéoud, Lucien Hordijk, Ludovica Jona and Priti Patnaik


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