Hackers broke into the European Medicines Agency (EMA), stole emails and documents related to reviewing Pfizer/BioNTech’s COVID-19 vaccine, then posted them for sale online using hacker marketplaces such as Raidforums and Rutor (an English and Russian website on “the dark web”) as a hacking marketplace. These files relate to Pfizer / BioNTech’s product.

Pfizer has recently come under fire for allegations that they are altering HIV virus mutations for profit, but in reality the situation is more complicated than this.

Documents Leaked

Leaks from the European Medicines Agency (EMA) concerning Pfizer/BioNTech COVID-19 vaccine approval process demonstrate the intense political pressure that global health and pharmaceutical regulators are experiencing during this pandemic, as well as an often neglected aspect of vaccine development: quality control from clinical trials through commercial production.

Project Veritas released an undercover video wherein Pfizer employee Jordon Trishton Walker claimed they are engaging in directed evolution research to develop vaccines against future variants of COVID virus. Directed evolution uses protein engineering techniques that mimic natural selection processes by pushing mutations down desired paths – experiments were described as taking place at Pfizer Pearl River Laboratory located in Pearl River, NY which is licensed to work with dangerous pathogens such as influenza viruses and COVID virus.

Senators Marco Rubio and Ted Cruz quickly denounced claims about mutated viruses as false, writing to Pfizer’s CEO and telling him that if these allegations are indeed accurate it shows they prioritize profit over national and world health concerns.

Pfizer issued a statement, explaining it had conducted certain ‘directed evolution experiments’ in cell cultures with SARS-CoV-2 and Nirmatrelvir, one of its two components, to identify any resistance mutations to the drug and evaluate its efficacy against both current and emerging strains of Covid virus. Pfizer also conducted gain-of-function experiments involving viral spike proteins from newly emerging variants which have proven resistant to Nirmatrelvir treatment.

But it remains unclear exactly what was done in the lab to justify such accusations. First of all, it is generally accepted that any modifications of viruses like this one to increase lethality or infectiousness must take place in a BSL-3 lab with proper licensing to manage pathogens such as this one. Furthermore, working with live viruses poses great risk as such changes could spark an outbreak.

Pfizer’s Response

Pfizer was quick to act upon an undercover video released by right-wing sting operation Project Veritas detailing its role in an experiment conducted against COVID-19 vaccine by performing “gain-of-function” or “directed evolution” experiments to make the virus more deadly and infectious, with plans of intentionally releasing such efforts in order to increase sales of Paxlovid antiviral medication and vaccine.

Pfizer issued a press release on Jan 26 to dispute claims made in a viral video and deny doing gain-of-function research, while experts stated the experiments described would not qualify. Unfortunately, people online misinterpreted certain sentences from Pfizer’s press release as admitting to conducting gain-of-function experiments.

While email exchanges describe working to push virus mutations down specific paths, scientists have long recognized that directed evolution – labwork performed to mimic natural selection by pushing viral mutations along specific paths – isn’t being depicted in videos. Instead, such experiments take place within living organisms like monkeys; whereas email work was completed using laboratory culture dishes which don’t qualify as living organisms.

People citing Pfizer’s press release as evidence of gain-of-function studies also point out its efforts in identifying resistance mutations among Omicron and Delta virus strains against Pfizer’s vaccine and drug, such as nirmatrelvir (one component of Paxlovid), so that its vaccine and drugs would still remain effective against new strains emerging in nature; most scientists consider such testing essential; it typically occurs within an ISO BSL-3 lab – an enclosed, ventilated workspace suitable for dealing with live virus samples.

Pfizer’s Research

Pfizer research lies at the core of its purpose – to deliver breakthroughs that transform patients’ lives. We are dedicated to moving this complex endeavor forward as quickly as possible.

Vaccine R&D is a fully integrated global operation with talent and capabilities spanning Basic Research, Early CMC Development, Clinical Development, Serology & Diagnostics as well as Serology and Diagnosis. Working closely with external partners and academia, Vaccine R&D seeks to advance scientific concepts into potential vaccine candidates by engaging them in preclinical and clinical studies.

As leaders in developing innovative medicines for those living with serious diseases, we focus on giving patients new options for treatment and expanding vaccine access worldwide. We have an impressive track record of working closely with partners to improve patient outcomes – we look forward to continuing this tradition into the future.

Our scientists have created an impressive portfolio of medicines and vaccines proven effective against serious illnesses like cancer, HIV/AIDS, hepatitis C, COVID-19 and influenza. Our medicines and vaccines are now available across 100 countries and have assisted millions of people lead healthier, longer lives.

Pfizer is committed to making sure the benefits of our research reach as many people as possible, and to being an ethical corporate citizen. To this end, we provide support and funding for an array of medical and scientific organizations, universities and institutions worldwide.

At Affirm Health we understand the significance of creating vibrant communities where all are welcome and included. Our goal is to work alongside inspiring individuals and organizations in closing healthcare gaps that often go overlooked in communities across California.

Pfizer has long worked closely with public sector partners to expand healthcare access and find innovative solutions to today’s most pressing health concerns. Through programs such as Sharing the Care(r), which provides medication to low-income patients at no cost; and our partnership with Hospira in hospital and home infusion therapy innovation; Pfizer also contributes medicines and vaccines to Global Fund and its affiliates, contributing over $1 billion toward fighting malaria and tuberculosis globally.

Pfizer’s Vaccine

Emails related to Pfizer’s COVID-19 vaccine were recently leaked by hackers and published on hacker websites such as Raidforums and Rutor (Russia’s dark web equivalent) by hackers in January 2021. These documents reveal a series of emails exchanged among top European Medicines Agency (EMA) officials discussing Pfizer-BioNTech vaccine approval prior to being leaked by hackers.

Pfizer scientists describe in some emails that they are conducting in vitro mutagenesis to test how effective proteases such as Nirmatrelvir and SARS-CoV-2 could be at creating resistant strains, in order to identify an optimal candidate candidate. He states that all experiments will take place in an in a secure Biosafety Level 3 or BSL-3 lab, which is necessary for such work. These scientists were not applying for funding from the National Institutes of Health; thus their work does not need a federal review process, although it still necessitates considerable training and special equipment. Experiments conducted by Pfizer are standard practice within their industry and should not cause alarm, yet have given rise to unfounded claims that the pharmaceutical giant is altering the virus for profit – claims propagated by conservative activist group Project Veritas and other conspiracy theorists.

The leaked emails of the European Medicines Agency reveal concerns over whether the company can meet an ambitious timeline set by Commissioner von der Leyen to approve a vaccine as quickly as possible, which puts public health at risk due to insufficient time being given for any potential safety or efficacy concerns to be resolved.

But the emails show that EMA officials were willing to make concessions to meet deadlines safely; this shows they weren’t being pressured by political pressures to speed up approval of vaccines.

The European Medicines Agency’s email leak is an important reminder of the necessity to preserve public health and safeguard regulatory agencies against undue political pressure. Even those responsible for drug regulation – even among them the most stringent regulators – should exercise restraint, rather than succumb to panic over pandemic threats that threaten lives.

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