In December 2020, confidential documents were hacked at the European Medicines Agency (EMA), the European medicines regulatory body. These documents have since resurfaced on the Dark Web. The world was able to consult some of this confidential information. The twenty elements published mainly concern the evaluation process of the vaccine against Covid-19 developed by the Pfizer and BioNTech laboratories. The file also includes about twenty emails, some of which would have been “manipulated“by hackers, as the European Medicines Agency indicates in a press release dated January 15, 2021.
The pirated documents relate mainly to the approval of Pfizer’s vaccine in Europe, where the process took three weeks longer than in the United Kingdom. “In November, the European Agency formulated three ‘major objections’ to this vaccine: some manufacturing sites had not yet been inspected; data on commercial vaccine batches was still missing; but, above all , the available data revealed qualitative differences between the commercial batches and those used in clinical trials ” explain our colleagues from World.
Less active substance in commercial vials
According to the leaked documents, the European Medicines Agency had observed a poorer quality of doses intended for commerce compared to those used in clinical trials. The composition of these two types of products differed too greatly. Like the vaccine developed by Moderna, the one from Pfizer and BioNTech works using RNA technology, a temporary copy of part of the virus’s genome. But the concentration of RNA in the two types of doses would have turned out to be very different. While vials intended for clinical trials contained between 69% and 81% RNA, commercial vials contained only 59%.
Some batches even went up to 51% RNA concentration. The danger: a vaccine whose effectiveness would not be guaranteed, for lack of active substance. “Data provided by the manufacturer to the EMA indicate that with a complete RNA level of 62%, the protein is still produced in comparable quantities.“, explains the evening daily. After these exchanges, the factories would then have managed to find a way to guarantee an average rate of 75% (the same as for clinical trials). According to the leaked documents, Pfizer and BioNTech first proposed to raise the minimum level of RNA to 60% to avoid falling below 50% in the final product. Finally, the rate of 75% seems to have been retained.
Two new supply chains implemented by Pfizer
The reason for this difference in product quality would be a change in method to increase production from a clinical stage to a commercial stage. “We have adapted our production chains and have taken a number of steps to accelerate the scale-up and manufacture of our vaccine candidate such as the in place rapid plans for the design of installations, equipment and processes“, explains Pfizer France in an interview given to Science and the Future. The laboratory explains having started “to be manufactured in parallel with the first clinical trials“, put in place “two parallel supply chains to produce the vaccine as quickly as possible – one in the United States and one in Europe“and hired staff, as at the Puurs site in Belgium, where 150 new employees have been recruited.
The doses of vaccines for France are manufactured in the Belgian factory in Puurs. “In terms of production, Pfizer has the following sites, involved in the manufacture of the vaccine: in the United States, the one in Saint-Louis is dedicated to the manufacture of raw materials, that of Andover deals with the drug substance, and that of from Kalamazoo manages formulation, filling and finishing. In Europe, the Belgian site of Puurs also deals with formulation, filling and finishing“, details the firm in an interview published in The gallery. Pfizer states that the doses are shipped from Kalamazoo sites in the United States and Puurs directly to points of use.
Delivery delays are to be expected. “Our goal is to go from 1.3 billion doses of vaccine initially planned for 2021 to 2 billion doses. To do this, certain modifications to the production processes are currently in progress on our European site in Puurs (Belgium)“Pfizer explains to Science and the Future. The number of doses delivered in France and in the Member States of the European Union will be temporarily reduced the week of January 18. “We will return to the original schedule of deliveries from the week of January 25, with an increase in deliveries from the week of February 15. This will allow us to deliver the total amount of vaccine doses expected in the first trimester and a much larger amount. from the second trimester. “
The European Medicines Agency under pressure?
It appears according to the documents peeled by The world that the European Medicines Agency was put under pressure to deliver its opinion. “On November 19, a senior EMA official also referred to a conference call with the European Commission allegedly held in “ a rather tense atmosphere, sometimes even a bit unpleasant, which gives an idea of what the EMA can expect if expectations are not met, whether those expectations are realistic or not. ““
Some emails appear to have been tampered with by cyber hackers. But among the dated emails which do not seem to have been modified, five would illustrate the tensions that the Medicines Agency has been subjected to to approve a first vaccine against Covid-19. “In an exchange dated November 12, an Agency official reported, for example, a discussion with the European Commissioner for Health, Stella Kyriakides. The latter having undertaken “that all the member states receive the vaccine at the same time”, she would then have insisted on the importance of not “forcing” them to use national procedures because of delays in the process. official authorization. According to an EU directive, states can indeed use drugs not authorized by the EMA in the event of an epidemic. “
For the moment, neither the identity of the hackers nor their intentions have been revealed. Suspicions are on the Russian track. Indeed, some files were retrieved from RuTOR, a site on the dark web dedicated to Russian-speaking users (“Ru“for Russia and”TOR“, like the browser allowing anonymous surfing on the Internet.)