Regulators were concerned about the effectiveness of Pfizer's new corona vaccine
The EMA covid-19 data leak, and what it tells us about mRNA instability | The BMJ
https://www.bmj.com/content/372/bmj.n627
In December 2020, the European Medicines Agency (EMA), which regulates pharmaceuticals in the European Union, analyzed the new coronavirus vaccine 'BNT162b2 ' developed by Pfizer , a major American pharmaceutical company, and BioNTech SE, a biotechnology company. Was there. However, at this timing, EMA was attacked by a cyber attack from a hacker, and some information about 'BNT162b2' was leaked.
Drug regulators leak information on Pfizer's new corona vaccine after a cyberattack-GIGAZINE
The data stolen from the EMA by hackers was as large as 40GB, which was published on the dark web. After that, data about the vaccine leaked by hackers was sent to the media, journalists, and scholars around the world via anonymous email addresses. Since the email address used to send the data was anonymous, it seems that it was not possible to exchange messages with the sender, as it remained unknown who sent the data.
BMJ, who investigated the leak data of 'BNT162b2' sent from an anonymous person, said that EMA scientists said that 'the amount of complete (non-defective) mRNA contained in the commercial version of the mRNA vaccine BNT162b2' I discover that I was worried that it was unexpectedly low.
According to the BMJ, EMA scientists reviewing Pfizer's information about the BNT162b2 cited some of the vaccine's problems in an email sent on November 23, 2020. It seems that it was. Specifically, 'BNT162b2' had a different complete mRNA content between the one used in the clinical trial and the commercial version. The clinical trial version contained 78% complete mRNA, while the commercial version contained only 55%.
EMA scientists write that they are 'uncertain' about how the reduced mRNA content will change the vaccine's effectiveness. As a result, the EMA has submitted to Pfizer two 'major objections' and a document summarizing multiple questions.
The EMA finally approved 'BNT162b2' on December 21, 2020. In an evaluation report published by EMA, 'BNT162b2' states that 'the data on vaccines submitted during the pandemic of coronavirus infection (COVID-19) is sufficiently consistent and acceptable.' However, it seems impossible to read from the leak information how the concerns that EMA originally had were resolved.
However, according to information that the BMJ obtained from an anonymous source in the United States, it seems that the EMA had received an email from Pfizer saying 'to deal with the problem.'
The EMA argues that the data leaked by the hacker's cyberattack has been 'partially corrected', admitting that it is genuine.
In addition, the BMJ said, 'The leaked data has spread concerns about quality assurance of mRNA vaccines to the medical community. Of particular concern is'RNA instability'.' RNA instability. Is one of the most important variables related to mRNA vaccines, which have received little attention in the clinical community, and RNA instability is not only Physer's vaccine, but also Moderna's vaccine and Imperial. It's also a problem related to the vaccine developed by College London, 'he said, pointing out that the leak once again put the spotlight on RNA instability.
RNA is much more responsive than DNA, that is, it is unstable. However, if the RNA contained in the densely constructed mRNA vaccine reacts even a little during transportation, the efficacy of the vaccine may be significantly reduced. Therefore, mRNA vaccines must be stored below minus 70 degrees Celsius, which is a major problem delaying vaccine distribution.
It was reported as of 2020 that special equipment would be required to supply the mRNA vaccine, and some media even pointed out that it would be a 'nightmare for logistics.'
Pfizer's new corona vaccine is reported to be a 'logistics nightmare,' and why? --GIGAZINE
The BMJ has asked pharmaceutical companies and regulators questions about their mRNA content, but most pharmaceutical companies and regulators have refused to respond, saying that the details of the acceptance criteria are confidential.
However, the EMA acknowledged that the efficacy of the vaccine 'depends on the appropriate amount of intact mRNA,' and the commercial version of 'BNT162b2,' which was of concern in the leak information, was 'safe. The amount of complete mRNA was too low to build risk. ' However, working with Pfizer since the leak, the issue has been 'well addressed,' the EMA emphasizes.
Health Canada has also revealed to BMJ that it has conducted a survey on the commercial version of Pfizer's BNT162b2, saying that 'the integrity of the vaccine has been improved and is consistent with what was seen in the clinical trial version. Changes have been made to the process. ' In short, it became clear that regulators such as EMA and Health Canada worked together to work with Pfizer to improve the mRNA content of Pfizer vaccines. However, no agency refuses to share any other details with the BMJ because it is commercially confidential.
Related Posts:
in Science, Posted by logu_ii