Confidential documents stolen from the European Medicines Agency (EMA) on December 9, 2020 are resurfacing in the Dark Web. The world was able to recover some of them, and a European team of journalists peeled them. The set includes about twenty elements, mainly around the evaluation file of the Pfizer-BioNTech vaccine. It also includes 19 emails, exchanged between November 10 and November 25 by various agency officials, some of which are said to have been “Manipulated” by hackers, warned the EMA, Friday, January 15, in a statement. However, in an exchange with The world, the agency recognizes that “Leaked emails reflect issues and discussions that have taken place”.
Among the e-mails, which appear duly dated, with the various recipients visible, so a priori less likely to have been the subject of manipulation, five allow us to point out the pressure the agency was facing to approve the a first vaccine against Covid-19 faster. In an exchange dated November 12, an EMA official reports, for example, a discussion with the European Commissioner for Health, Stella Kyriakides. This one having committed “That all member states receive the vaccine at the same time”, she would then have insisted on the importance of not “To force” to use national procedures because of delays in the official authorization process. According to an EU directive, states can indeed use drugs not authorized by the EMA in the event of an epidemic.
On November 19, a senior EMA official also referred to a conference call with the European Commission that was 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”. The next day, in an exchange with the Danish Medicines Agency, the same official said he was surprised that Ursula von der Leyen, President of the European Commission, had “Clearly identified the two vaccines that could be approved before the end of the year [Pfizer-BioNTech et Moderna]. There are still problems with both ”, underlines the agent.
It’s on some of these ” problems “ that carry the other documents stolen in December 2020, not suspected of manipulation by the EMA. And more particularly, the problems regarding the Pfizer-BioNTech vaccine. We thus discover that in November the European agency formulated three “Major objections” with respect to this vaccine: some manufacturing sites had not yet been inspected; data on commercial vaccine lots was still missing; more importantly, the available data revealed qualitative differences between the commercial batches and those used in clinical trials. It is on this last point that the evaluators seem most concerned.
” Blocking point “
Indeed, to move from a clinical stage to a commercial stage, manufacturers have had to change their manufacturing processes, they have also invested in new production lines and new factories. These modifications could explain the differences in the exact composition of vaccines, in particular a decrease in the degree of RNA integrity. This is the crucial element of this vaccine which, once injected into cells, makes it possible to manufacture the virus’s Spike protein and thus teach the immune system to recognize this pathogen and neutralize it. The vaccines used in clinical trials had between 69% and 81% “intact” RNA, that is, the entire sequence used to make the Spike protein. In contrast, data on the batches produced in these new production lines revealed lower percentages, 59% on average. Some lots even went down to 51% and 52%. A ” blocking point “, says the EMA on Nov. 23.
The question arises as to whether this lower RNA level could not only impact the effectiveness of the vaccination but also its safety, because who says less RNA integrates, says more impurities, especially RNA. truncated. “We often have a little shorter or a little longer RNA in these products. We filter according to the size of the molecule, but this filtration is difficult on a large scale ”, comments Steve Pascolo, researcher at the University Hospital of Zurich, who has worked for twenty years on RNA vaccines (co-founder of CureVac in 2000, he left this company, and now has joint projects with BioNTech). These truncated RNAs can obviously no longer be translated into Spike protein. However, 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. “In the early trials of BioNTech, they had immune responses with just one microgram of RNA, pointe Steve Pascolo. There the vaccine is supposed to have 30 micrograms of it, so they have room. “
This is also the point of view of the American Food and Drug Administration (FDA), with which the EMA was in contact. “The issue of the messenger RNA content is not perceived as major” for the FDA, explains an EMA official in an email dated November 23. It actually appears in this post that these manufacturing and quality control issues do not affect Emergency Use Clearances (implemented by the US, Canada, or UK). These do not in fact constitute an authorization of the vaccine itself, but an authorization for its temporary use. Conversely, the temporary marketing authorization, aimed at by the EMA, seems more restrictive on this point. Hence this need to “Align with common specifications” to the EMA, the FDA and the Canadian Agency, “In order to prevent a region from getting all the sub-optimal material”, can we read a few days later in an e-mail.
“Major objection”
On November 26, BioNTech and Pfizer have the opportunity to respond to EMA’s objections. Inspections of the various sites are underway, can we read in their presentation. They also propose to raise the minimum integrity rate of RNA to 60% in the first stages of manufacture to avoid falling below 50% in the final product, which appears to be the acceptance criterion in all documents consulted. In their presentation, the manufacturers of this vaccine called Comirnaty claim that these differences in the amount of RNA “Should not affect” neither the effectiveness nor the safety of their product. Some of these lots have been used in clinical trials.
But the EMA does not yet seem convinced, since the latest documents or exchanges available do not yet allow this “Major objection”. A screenshot of an email exchanged on November 30 between the EMA and the manufacturers confirms this: “These issues are considered critical, especially in the context of the novelty of this type of product and the limited experience, a stricter control strategy is therefore expected”. In one of the last available reports, however, we learn that an adjustment of the manufacturing processes makes it possible to regain integrity levels around 75%, comparable to batches in clinical trials.
Three days later, on December 3, the Wall Street Journal published an article reporting a problem with the production of the Pfizer vaccine. “Some of the first batches of raw materials did not meet standards. We fixed the problem, but ran out of time to respond to this year’s scheduled shipments ”, explains a “Person directly involved in the development of the Pfizer vaccine”. Should there be a link? Pfizer declined to comment, only mentioning the EMA’s ongoing investigation into the cyberattack. On Friday January 15, BioNTech and Pfizer again announced delivery delays, citing necessary work at the Belgian plant in Puurs.
Asked, the EMA confirmed that this quality problem was subsequently resolved: “The company was able to resolve these issues and provide the information and data necessary to enable the EMA to move towards a positive recommendation for this vaccine.” The agency also ensures that the current specifications on the level of RNA “Are considered scientifically justified and acceptable “. For example, it is unlikely, the agency points out, that these truncated RNA molecules could be translated into protein or peptide, and thus cause undesirable effects.. “Despite the urgency, there has always been a consensus across the EU not to compromise high quality standards and to base any recommendations on the strength of scientific evidence, safety, quality and efficacy of ‘a vaccine, and nothing else », Insists the EMA. The European Commission has also responded to our request: it affirms that these discussions “Never interfered with the independence of the agency and never interfered in any way with the integrity of the EMA’s mission with respect to the assessment of vaccine candidates or ‘other drugs’.
The Russian or Russophile track
It remains to be seen who could be behind this attack. The files were retrieved from Rutor: “Ru” for Russia and “tor” as the web browser for anonymously browsing the web. Which could give credence to the idea of a Russian or Russophile state hacker. “This kind of hacking tactic with data theft, followed by leaks, has already been practiced by Russian agents (Guccifer 2.0, or the case of the World Anti-Doping Agency)”, explains Jean-Michel Doan, specialist in cybercrime at Sekoia, an IT security company. It is difficult to exclude industrial cyber espionage as well, especially since there seems to have been a selection of documents specifically targeting Pfizer. The way this folder was named also suggests this: “Evidence of the big Pfizer vaccine data scam (…) ! » What about an antivax group that would seek to discredit vaccines? “It is unlikely that an antivax hacker will then publish his data on a rather obscure site, specialized in hacking”, comments Jean-Michel Doan.
Regardless of the reading of these documents, the facts are as follows: Pfizer-BioNTech’s vaccine will finally be approved on December 21, 2020 by the EMA, three weeks after the UK and two weeks after the US, which shows that the European Agency has nevertheless taken some time to resolve this quality problem before giving the green light. A delay that was nevertheless judged “Hardly acceptable by the European Commission”, according to an email exchange between EMA colleagues dated November 19: “Whatever we do, speed up the process to align [sur les autres agences] or take the time necessary to have a robust warranty (…), the EMA will have to face questions and criticisms from various parties (European Commission, Member States, European Parliament, media, general public) ”, wrote a senior official of the agency. He hadn’t foreseen that a cyberattack would also interfere.
This survey is part of the European #behindthepledge project, funded by Journalismfund and IJ4EU. Ludovica Jona (Italy), Hristo Boytchev (Germany), Lucien Hordijk (Netherlands) and Priti Patnaik (Switzerland) also contributed.
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