AstraZeneca Admits Vaxzevria COVID Vaccine Can Cause Fatal Side Effects
- by Carolyn Hendler, JD
- Published
- Risk & Failure Reports
AstraZeneca plc, the largest and most profitable pharmaceutical company in the United Kindgdom1 has admitted in court documents that its COVID-19 vaccine, Vaxzevria, which was developed in partnership with the University of Oxford, can cause the blood disorder thrombosis with thrombocytopenia syndrome (TTS) in “very rare cases.” TTS is an immune disorder specifically associated with Vaxzevria and sometimes referred to as VITT (vaccine-induced immune thrombotic thrombocytopenia),2 3 which causes blood clots and low platelet counts that have led to the injury and death of recipients of the vaccine.4 5
The AstraZeneca/Oxford University Vaxzevria COVID vaccine was never approved by the U.S. Food and Drug Administration (FDA) to be distributed in the U.S., although the company did conduct clinical trials in the U.S.
While TTS has been listed as a warning since Vaxzevria was approved for public use by government health officials in the U.K. and other countries, this is the first time that AstraZeneca has admitted in court that the vaccine can cause the very serious and often deadly blood disorder. The pending class action lawsuit alleges that Vaxzevria caused serious injury to and the death of certain individuals.6
The stakes are high for the pharmaceutical giant as 51 cases have been filed in London’s High Court with potentially $125 million in damages on the line.7 There have been 445 confirmed cases of TTS and 81 deaths in the United Kingdom post vaccination.8 AstraZeneca protests that Vaxzevria is not the cause of all these cases of TTS and argues that the condition can occur in people who have not received the vaccine. Spokespersons for the pharmaceutical giant said that the company will rely on expert testimony to determine causation in every single case.9
Vaxzevria a Chimpanzee Adenovirus-Vectored Vaccine
In contrast to mRNA COVID biologicals developed by Pfizer/BioNTech and Moderna/NIAID, Vaxzevria is a chimpanzee adenovirus-vectored vaccine. To make the inactivated vaccine, AstraZeneca/Oxford University researchers used a genetically modified adenovirus that infects chimpanzees as a vector to deliver coronavirus synthetic spike protein into cells of the human body to provoke an immune response.10
Plaintiff’s attorneys for Vaxzevria reaction victims are alleging the shot causes “vaccine-induced immune thrombocytopenia and thrombosis” that can cause brain injury and death, while in court documents defense attorneys admit that “the AstraZeneca vaccine can, in very rare cases, cause TTS. The causal mechanism is not known.”11 The risk of VITT is greater in women and individuals under 60 years old, with cases typically appearing between five and 30 days post vaccination.12
Jamie Scott, an IT engineer and father of two children in the U.K., who suffered a permanent brain injury from a blood clot and bleeding in his brain post vaccination, filed the initial case in a multi-pound lawsuit against AstraZeneca in the U.K.’s High Court in August 2023.13 14 In May 2023, in response to the lawsuit, AstraZeneca stated:
We do not accept that TTS is caused by the vaccine at a generic level.15
Mr. Scott’s wife, Kate Scott, countered:
The medical world has acknowledged for a long time that VITT was caused by the vaccine. It’s only AstraZeneca who have questioned whether Jamie’s condition was caused by the jab.16
U.S Lawsuit Filed by Vaxzevria Clinical Trial Victim Against AstraZeneca
Brianne Dressen was a participant in AstraZeneca’s early clinical trials for Vaxzevria in the Salt Lake City area of the U.S. and was eventually diagnosed with “post-vaccine neuropathy” by neurologists at the National Institutes of Health (NIH). When she entered the clinical trial, the 39-year-old mother of two children said she was “the picture of health.” Dressen began feeling adverse effects from the vaccine a few hours after she was given the vaccine. At first, she experienced tingling in her arm that spread to her shoulder, other arm and legs. Her symptoms soon included a headache, ringing in her ears, blurred vision and vomiting.17 18
The lawsuit alleges that Dressen developed a severe neurological condition including paresthesia and “post-vaccine neuropathy” due to her participation in Vaxzevria trials.19 Dressen is no longer able to work as a pre-school teacher.20 Dressen said:
I walked into the clinic fine, and walked out the beginning of a nightmare I wouldn’t wish on my worst enemy.21
The lawsuit accuses AstraZeneca of not following through with its contractual obligation to cover any medical costs incurred due to side-effects affects from it COVID vaccine. The complaint states that the pharmaceutical giant, “refused to honor their contractual obligations to provide medical care/referrals and cover the costs of the injury.”22
By asserting that AstraZeneca breached their contractual obligation, Dressen is able to get around the federal Countermeasures Injury Compensation Program (CICP) prohibition against filing COVID vaccine injury lawsuits against manufacturers of vaccines used during declared public health emergencies in accordance with the 2005 PREP Act.23
AstraZeneca defended Vaxzevria…
From the body of evidence in clinical trials and real-world data, the AstraZeneca/Oxford vaccine has continuously been shown to have an acceptable safety profile and regulators around the world consistently state that the benefits of vaccination outweigh the risks of extremely rare potential side effects.24
Vaxzevria Withdrawn from the European Union Market in March 2024
AstraZeneca has voluntarily withdrawn Vaxzevria from the European Union market effective Mar. 7, 2024, with plans to withdraw it from other countries that had previously approved the two-dose vaccine. Vaxzevria was approved for adults aged 18 and older only.25 The FDA never approved Vaxzevria for use in the U.S.26
AstraZeneca claims that Vaxzevria is being withdrawn due to commercial reasons because updated shots better matched new variants of the virus.27 Despite AstraZeneca’s admission in court that the vaccine can cause TTS, the company said the decision to withdraw the vaccine now was pure coincidence and had nothing to do with the lawsuits.28
AstraZeneca released the following statement:
We are incredibly proud of the role Vaxzevria played in ending the global pandemic. According to independent estimates, over 6.5 million lives were saved in the first year of use alone and over three billion doses were supplied globally. “Our efforts have been recognized by governments around the world and are widely regarded as being a critical component of ending the global pandemic.29
Sarah Moore, plaintiff attorney for the Vaxzevria victims suing AstraZeneca, said:
To those who we represent, all of whom have suffered bereavement or serious injury as a result of the AstraZeneca vaccine, this decision to withdraw marketing authorization, ending the usage of the AstraZeneca vaccine in the E.U., will be welcomed.
It will be seen as a decision linked with AstraZeneca’s recent admission that the vaccine can cause TTS, and the fact that regulators across the world suspended or stopped usage of the vaccine following concerns regarding TTS.30
AstraZeneca has been criticized since Vaxzevria first went on the market for omitting important information from public statements, for making mistakes during the vaccine’s clinical trials, and for production delays that reportedly strained relations with leaders of E.U. countries. The majority of the vaccine was distributed in the E.U., as well as in poor countries through a United Nations program.31
In April 2021, labeling information about Vaxzevria was updated by E.U. and U.K. regulators to include mention of the deadly blood clotting/bleeding disorder as a possible, though rare, side-effect. While U.K. regulators, who reviewed the details of 18 fatalities among 62 reported cases of clotting in the sinuses that drain blood from the brain and 24 cases of clotting in the abdomen, suggested that people under age 30 should use other types of COVID vaccines, they still recommended that those, who had already received the first AstraZeneca shot, be offered the second dose. However, German regulators went further and suspended use of Vaxzevria vaccine in people under 60 years old.32
Despite these problems, AstraZeneca managed to earn close to $4 billion in revenue from sales of the vaccine.33
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