The participant who triggered a global shutdown of AstraZeneca’s Phase 3 Covid-19 vaccine trials was a woman in the United Kingdom who experienced neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis, the drug maker’s chief executive, Pascal Soriot, said during a private conference call with investors on Wednesday morning. The woman’s diagnosis has not been confirmed yet, but she is improving and will likely be discharged from the hospital as early as Wednesday, Soriot said. The board tasked with overseeing the data and safety components of the AstraZeneca clinical trials confirmed that the participant was injected with the company’s Covid-19 vaccine and not a placebo, Soriot said on the conference call, which was set up by the investment bank J.P. Morgan. Soriot also confirmed that the clinical trial was halted once previously in July after a participant experienced neurological symptoms. Upon further examination, that participant was diagnosed with multiple sclerosis, deemed to be unrelated to the Covid-19 vaccine treatment, he said. The new disclosures made by Soriot were heard by three investors participating on the call and were shared with STAT.
To date, AstraZeneca’s public statements on the pause have been sparse with few details. For instance, the company has not publicly confirmed that this is the second time its trials have been stopped to investigate health events among participants.
AstraZeneca’s is the first Phase 3 Covid-19 vaccine trial known to have been put on hold. AstraZeneca only began its Phase 3 trial in the U.S. in late August. The vaccine — known as AZD1222 — uses an adenovirus that carries a gene for one of the proteins in SARS-CoV-2, the virus that causes Covid-19. The adenovirus is designed to induce the immune system to generate a protective response against SARS-2. The platform has not been used in an approved vaccine, but has been tested in experimental vaccines against other viruses, including the Ebola virus. Transverse myelitis is a serious condition involving inflammation of the spinal cord that can cause muscle weakness, paralysis, pain and bladder problems. In some instances, vaccines have triggered cases of transverse myelitis
The problem is this is a never been a proven RNA vaccine. The reason they went this rout is it is easy and cheap to manufacture. As with all vaccines, the idea is to trick our body into thinking it’s been infected. Those self-made spike proteins would train our bodies to detect and terminate any real SARS-CoV-2 infections before the virus wreaks havoc. The technique that has NEVER been successful and has been in development for more than 3 decades. This is known as an adenoviral vector vaccine using several unporven and untested technologies like messenger RNA (mRNA) vaccines. The first problem is as human bodies develop immune responses to most real viral infections, our bodies also develop immunity to adenoviral vectors. That makes booster shots of adenoviral vector vaccines problematic. Upon a second injection, our bodies will unleash an antibody attack on the vaccine itself. And since adenoviral vectors are based on natural viruses that some of us might already have been exposed to, the vaccines might not work for everyone. So far, no adenoviral vector vaccines have demonstrated they can prevent disease in humans. The way it works is that researchers take the genome of the adenovirus and cut out the section that allows it to reproduce. Then they splice in a section of (monkey) DNA that codes for the spike protein, turning the adenovirus into a recombinant vector. Because the adenovirus is a DNA virus, it has to get its genetic material not just into a cell but into the cell’s nucleus. Once in the nucleus, the DNA coding for the spike protein is transcribed into mRNA and then transported out of the nucleus into the cell’s cytoplasm, where it’s translated into protein. But it gets uglier. Because there are some drawbacks. Versions of the adenovirus spread in humans, there are many people who have immunity. To get around this, groups like the team at Oxford are using a chimpanzee adenovirus as a vector, which is different enough from human adenoviruses that most people’s immune systems won’t react to it right away. But once a vaccine is delivered using a chimpanzee adenovirus, it’s likely that many people would develop immunity to the new vector. That would make it difficult to use the same platform again for another dose of the vaccine. And here is the next problem they forget to tell you about. Since coronaviruses mutate so quickly immunity wears off… So the solution is a 2 shot regiment within thirty days and a booster show a month or two later. By that time the body is now building immunities to the coronal virus and the chimpanzee adenovirus. And an event sets up that could be deadly known as super sensitivity. And one of the diseases that is associated with super sensitivity to the monkey DNA is Transverse myelitis a deadly crippling neurological disease.