Credit: Photo by Flip Franssen

Brussels pressured drug regulator to approve Pfizer vaccine

By Lucien Hordijk, | 22 January, 2021

Leaked documents show that the European Commission put pressure on the European Medicines Agency to approve the first Covid-19 vaccines simultaneously with the American FDA. This happened when the regulator still had serious questions about the purity of the vaccine.

According to the European Medicines Agency, in a press release issued on 15 January, confidential documents about the approval process were stolen by malicious hackers, who then manipulated them and distributed them online. EMA said the hack “could undermine trust in the vaccines”.

Despite repeated requests, the EMA has not provided any evidence to support the claim that the leaked documents were indeed manipulated.

The leak contains about twenty documents, which together amount to almost 900 pages. This includes traceable email traffic (including names, dates, time) from EMA’s executive management, confidential reports from scientific staff and presentations from Pfizer/BioNTech. All documents contain information about the authorization of the corona vaccine and are dated between mid and late November. During that time, EMA’s rolling review of the first vaccine was in full swing.

The documents show roughly two things. First, the EMA still had questions before it could approve the Pfizer/BioNTech vaccine: a number of factories had not yet been inspected, some data on the vaccine were not available yet and the drug regulator had observed differences in quality of the active pharmaceutical ingredient between different batches of the vaccine. Second, the agency experienced strong political pressure from the European Commission to approve the vaccine as soon as possible.

Given the timeline, the EMA does not appear to have succumbed to this pressure. The British government approved the vaccine on 5 December and the American FDA on 11 December. The EMA issued a “conditional authorization” on 21 December, a week earlier than originally planned.

A spokesperson initially did not want to confirm or deny the authenticity. On Friday 15 January, the EMA issued a press release claiming the documents may have been tampered with. However, on Monday, 18 January, the spokesperson did not contest any citations from the leaked documents that we submitted for the purpose of this article.

Read the full article on FTM (in Dutch).

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