EMA mails hacked: BionaTech and Pfizer corona vaccine had quality issues Documents from the European Medicines Agency (EMA) prove that the corona vaccine from Pfizer and BioNTech had quality problems shortly before the approval. The amounts of intact mRNA were too low. The quality of the corona vaccine from Pfizer and BioNTech had raised serious concerns at the European Medicines Agency (EMA) shortly before its approval. In November 2020, the authorities found that the proportion of intact mRNA in the vaccine was significantly lower than expected. This is from EMA emails leaked by strangers. One month later, the vaccine was approved The e-mails were published on the Darknet and targeted several journalists, including the British Medical Journal (BMJ). The magazine analyzed the writing traffic. The EMA then confirmed the authenticity of the emails and conducted a criminal investigation against the unknown hackers. According to the specialist journal, the documents show that the supervisory authorities had major concerns about unexpectedly small amounts of intact messenger RNA in batches of the vaccine developed for commercial production. In one of the leaked emails of November 23, a high-ranking EMA official described a whole series of problems with the vaccine. The EMA raised "important objections" with Pfizer, along with a series of questions it wanted answered. The email points out that there are too few intact mRNAs in the vaccine. In the vaccine used in the clinical trials, the proportion of intact mRNA was around 78 percent, while in the batches produced for commercial use, the proportion was only 55 percent. “The cause is not known and the effects of this loss of RNA integrity on the safety and efficacy of the vaccine have not yet been defined" the EMA official said in an email. An e-mail in December stated: The vaccine now contains 70 to 75 percent intact mRNA. The EMA votes "cautiously optimistic". As a result of the traffic, Pfizer allegedly improved the manufacturer's quality. Exactly how Pfizer was able to allay the concerns of the EMA is not known. Vaccine approved Finally, on December 21, the EMA approved the vaccine from Pfizer and BioNTech. The authorities' public assessment report - a technical document published on their website - stated: "The quality of this drug, which was submitted in the emergency context of the current (Covid-19) pandemic, is considered sufficiently consistent and" sufficient. The EMA stated in relation to "BMJ" that the effectiveness of the vaccine depends on the amount of suitable amounts intact mRNA. However, EU authorities did not comment on how low mRNAs can affect the effectiveness of the vaccine. The question of how Pfizer was able to clear the authorities' concerns in such a short time also remained unanswered. The specialist journal asked the pharmaceutical manufacturers Pfizer, Moderna and CureVac, as well as several supervisory authorities, what percentage of mRNA integrity they consider acceptable for vaccines against Covid-19. None of the companies gave the magazine information. Pfizer only said: "Every batch of vaccines is tested before the final product release by the official drug control laboratory - the Paul-Ehrlich-Institut in Germany. "This has doubled the quality of all vaccine cans that come on the market in Europe to ensure compliance with the specifications agreed with the licensing authorities." Both the US Food and Drug Administration (FDA) and the EMA, as well as the Canadian Ministry of Health Health Canada, have "cleared out" their initial concerns about the corona vaccine. Exactly how the concerns were cleared is not known here either. At the request of "BMJ", the authorities informed that the specific criteria related to the approval were confidential, and referred to the manufacturer. The specialist journal speculates that the lack of information provided may possibly reflect the lack of certainty among regulatory authorities as to how the evidence for this new technology can be fully assessed. Sensitive vaccine It is known that mRNA instability is one of the biggest hurdles for scientists to develop nucleic acid-based vaccines. It is the main reason for the strict requirements of the cooling chain of this technology. "The complete, intact mRNA molecule is essential for the effectiveness of the vaccine," wrote Professor of Biopharmacy Daan J.A. Crommelin and his colleagues in the " Journal of Pharmaceutical Sciences" at the end of last year. "Even a slight degradation reaction, somewhere along an mRNA strand, can greatly slow or stop the proper translation performance of this strand and thus lead to an incomplete expression of the target antigen."