According to information acquired by Le Monde from reliable sources, the European Medicines Agency (EMA) has recently been under extraordinary pressure. The agency was told bluntly to speed up the authorization process of the coronavirus vaccine produced by the pharmaceutical company, Pfizer. The most curious fact in this story is that the newspaper has received the documents about this incident from a reliable source.
After a careful study of the documents, the reporters found out that despite the strong disapproval of the European Medicines Agency, Pfizer's coronavirus vaccine was issued the emergency use authorization. Curiously enough, it was done in the shortest period of time. In the fall of 2020, EMA pointed out several fundamental flaws that would hinder the authorization of the vaccine. First and foremost, not all laboratories met the appropriate requirements. Those laboratories where the vaccines had already been produced were not inspected. Data on commercial batches of vaccines was not specified in any source. It means that there was not even an overall accounting. Finally, there was a significant difference between the drugs that were used for clinical trials and the production of commercial batches.
According to the data obtained by the journalists, EMA sharply criticized Pfizer's vaccine developed specifically for mass use since its quality was at an extremely low level. The agency assumed that with the introduction of new laboratories for the production of the vaccine, the methods of its manufacturing were violated, which led to a change in the properties of the vaccine. Therefore, its quality has suffered due to the hasty development. However, the pharmaceutical giant has assured more than once that this will not happen.
Last year, an anonymous employee at EMA, said that the President of the European Commission, Ursula von der Leyen, also called for quicker approval of the Pfizer and Moderna vaccines. After a few weeks when the vaccine was authorized for an emergency use, experts had started finding out problems with the vaccine. The EU government and other regulatory bodies voiced concerns over the possible side effects of the vaccine. Suspiciously enough, prior to its introduction, none discovered anything wrong with the vaccine.
