February 26, 2021

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Hacked cache shows EU drug regulator’s ‘major issues’ with Pfizer/BioNTech jab

3 min read

An alleged hacked cache of information reportedly documents “unpleasant and uncomfortable” exchanges between EU officials and the European Medicines Agency (EMA), indicating that the EU drug regulator was uncomfortable about fast-tracking approval for the Pfizer and Moderna Covid jabs, French publication Le Monde has reported.

The EMA announced on Jan.4 that some data on the Pfizer/BioNTech COVID-19 vaccine, stolen during a cyber-attack in early December 2020, was released on the dark web shortly after the breach. 

At the time, it was concluded that only a small number of documents had been accessed, limited specifically to the Pfizer/BioNTech COVID-19 vaccine.

According to sources on technology and cybersecurity website BleepingComputer, however, the hackers accessed Word documents, PDFs, email screenshots, PowerPoint presentations, and EMA peer review comments.

The agency acknowledged to the French newspaper that the correspondences released online reflect “issues and discussions” that took place in the lead-up to the decision to grant approval to the vaccines.

On Jan. 16, Pfizer said it’s been forced to delay shipments of the Covid-19 shots in the next three to four weeks due to “works” at its key plant in Belgium.

Less than congenial discussions

Some of the “discussions” appear to have been less than congenial.

For example, in a document dated November 19, a senior EMA official described a “rather tense, sometimes even a little unpleasant” conference call with the European Commission regarding the review process for the drugs.

The official said he felt there was a clear “expectation” that the vaccines would be approved.

A day later, the same individual had an exchange with the Danish Medicines Agency in which he expressed surprise that European Commission President Ursula von der Leyen had announced that the Moderna and Pfizer jabs could receive the green light before the end of the year. 

“There are still problems with both,” the unnamed EMA official noted in the leaked correspondence. 

Proherbarium

3 ‘major issues’ withPfizer/BioNTech vaccine

According to Le Monde, the hacked documents primarily detail issues that the EMA had with the Pfizer/BioNTech drug.

The regulator apparently had three “major issues” with the vaccine:
Certain manufacturing sites used for its production had not yet been inspected; data on batches produced for commercial use were still missing; and, most importantly; available data revealed qualitative differences between the commercial batches and those used during clinical trials. 

The EMA expressed particular concern about the last point, noting that mass production had decreased the purity of the RNA contained in the vaccine.

The Pfizer jab uses a mRNA strand, a sequence of molecules that tell cells what to ‘build’ in order to produce a disease-specific antigen.   

The EU drug regulator signaled that it was worried that “less rigorous manufacturing methods” would make the vaccine less effective and safe.

Accelerate the process

Despite its hesitancy, it appears the EMA understood that it was under a clear deadline.

In an email exchange between colleagues at the agency, one employee said the EMA needs to “accelerate the process to align [with other agencies],” and risks facing “questions and criticisms” from Brussels, the media, and the general public if it did not fast-track approval. 

Stefan de Keersmaecker, the European Commission spokesperson for health, food safety, and transport, told Russian broadcaster RT that there was nothing unusual about the process that led to the approval of the two jabs. 

“Such discussions have never encroached on the independence of the agency nor have they ever interfered in any way with the integrity of EMA’s mission with regards to the assessment of vaccine candidates or other medicines…the Commission does not compromise on safety and has never exerted any political pressure on EMA to do so.”

The Pfizer jab was granted approval by the EU on December 21, while the Moderna variant was given the go-ahead earlier this month.

Since then, numerous reports have emerged of both drugs being linked to adverse effects in countries around the world, prompting investigations by health authorities.