Two previous reports:
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Astra Zeneca Covid Vaccine Study Paused After One Serious Illness- Transverse Myelitis
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Astra Zeneca Definitely Expedited The Covid Vaccine Review Process As Trials Resume
The latest
AstraZeneca, Under Fire for Vaccine Safety, Releases Trial Blueprints
Experts are concerned that the company has not been more forthcoming about two participants who became seriously ill after getting its experimental vaccine.Experts have been particularly concerned about AstraZeneca’s vaccine trials, which began in April in Britain, because of the company’s refusal to provide details about serious neurological illnesses in two participants, both women, who received its experimental vaccine in Britain. AstraZeneca’s 111-page trial blueprint, known as a protocol, states that its goal is a vaccine with 50 percent effectiveness
To determine with statistical confidence (statistical confidence is not the same as the real world - due to the FACT that AZ will have cherry picked their test subjects, etc.,) whether the company has met that target, there will have to be 150 people ill with confirmed coronavirus among participants who were vaccinated or received placebo shots.
However, the plan anticipates that a safety board will perform an early analysis after there have been just 75 cases. If the vaccine is 50 percent effective at that point, it might be possible for the company to stop the trial early and apply for authorization from the government to release the vaccine for emergency use.
The problem with looking at the data too many times, after a relatively small number of cases, is that it increases the odds of finding an appearance of safety and efficacy that might not hold up. Stopping trials early can also increase the risk of missing rare side effects that could be significant once the vaccine is given to millions of people.
Or billions of people? Making the "side effects" not so rare.
Dr. Topol said AstraZeneca’s plan, like those of Moderna and Pfizer, had a problematic feature: All count relatively mild cases of Covid-19 when measuring efficacy, which may hamper efforts to determine whether the vaccine prevents moderate or severe illness.
Cherry picking test subjects and data...
The company has released few details about the two cases of serious illness in its trial. The first participant received one dose of the vaccine before developing inflammation of the spinal cord, known as transverse myelitis, according to a participant information sheet for AstraZeneca’s vaccine from July. The condition can cause weakness in the arms and legs, paralysis, pain and bowel and bladder problems.
AZ said the first vaccine victim had "multiple sclerosis"- This serves their interest to make such a claim and shouldn't be accepted as accurate. The second vaccine victim, another women, whatever happened to her seems to have gone down the memory hole.
Transverse myelitis can sometimes be the first sign of multiple sclerosis, which involves more complex symptoms. But the myelitis alone can also occur after the body encounters an infectious agent like a virus.
The condition is rare, but serious, and experts said that finding even one case among thousands of trial participants could be a red flag. Multiple confirmed cases, they said, could be enough to halt AstraZeneca’s vaccine bid entirely.“If there are two cases, then this starts to look like a dangerous pattern,” said Mark Slifka, a vaccine expert at Oregon Health and Science University. “If a third case of neurological disease pops up in the vaccine group, then this vaccine may be done.”
Would Astra Zeneca acknowledge a third case? Seems doubtful.
Dr. Mark Goldberger, an infectious disease expert at the Global Antibiotic Research and Development Partnership and a former F.D.A. official, said he found the rapid restarting of trials abroad to be “a little disturbing,” especially given the lack of details around the patients’ symptoms and the ambiguity around their connection to the vaccine.
The company did not immediately inform the public about the neurological problems of either participant. Nor did it promptly alert the F.D.A. that it was again pausing its trials after the second U.K. volunteer developed illness and an independent safety board called for a temporary halt, according to multiple people familiar with the situation. The company’s chief executive told investors about the problems but did not discuss them publicly until the information was leaked and reported by STAT.
The vaccine being developed by AstraZeneca, which formed a partnership with Oxford University scientists, uses a virus meant to carry coronavirus genes into human cells and trigger an immune response that will protect people from the coronavirus. This so-called vector is a modified form of an adenovirus that causes common colds in chimpanzees but is considered safe for people. Several other companies, including Johnson & Johnson and CanSino, are pursuing similar adenovirus-based approaches, although there are multiple types of adenoviruses, and specific ingredients differ from vaccine to vaccine.While other adenovirus-based products have seen some success in the past, they have also been linked to serious adverse events. The most famous was the case of 18-year-old Jesse Gelsinger, who died in 1999 after receiving gene therapy through an adenovirus that sparked a lethal inflammatory response from his immune system.