"AstraZeneca didn't reveal any information about the possible side effect except to call it "a potentially unexplained illness." The health news site STAT first reported the pause in testing, saying the possible side effect occurred in the United Kingdom.When you read that sentence ask yourself, what's the real priority? The safety of the vaccine? Do no harm? Or keeping the timeline? According to the company statement the priority is on keeping the timeline. Hence the expediting of the review.
We are working to expedite (make (an action or process) happen sooner or be accomplished more quickly) the review of the single event to minimize any potential impact on the trial timeline," the company statement said.
It's likely the unexplained illness was serious enough to require hospitalization and not a mild side effect such as fever or muscle pain, said Deborah Fuller, a University of Washington researcher who is working on a different COVID-19 vaccine that has not yet started human testing. Serious enought to warrant hospitalizations "This is not something to be alarmed about," Fuller said. Instead, it's reassuring that the company is pausing the study to figure out what's happening and carefully monitoring the health of study participants.
Dr. Ashish Jha of Brown University said via Twitter that the significance of the interruption was unclear but that he was "still optimistic" that an effective vaccine will be found in the coming months.
"But optimism isn't evidence," he wrote. "Let's let science drive this process."
Will science drive this process? The company statement certainly suggests otherwise. And do understand that Astra Zeneca will exclude this hospitalized test subject from their results. The pharma companies, to my knowledge, always cherry pick their data.
Do we know what the illness is?
It is said to be transverse myelitis, although AstraZeneca has not confirmed that. That is inflammation of the sheath containing the nerves of the spinal cord. It can be treated by steroids to reduce the inflammation but the condition can be permanent.
Transverse myelitis has been associated with vaccination before (the Hepatitis B vaccine to be exact)More information on Transverse myelitis
In some people, transverse myelitis represents the first symptom of an autoimmune or immune-mediated disease such as multiple sclerosis or neuromyelitis optica. (Multiple sclerosis, or MS, is disease that causes distinctive lesions, or plaques, that primarily affect parts of the brain, spinal cord, and optic nerve—the nerve that carries information from the eye to the brain.
A very serious matter.
UPDATE # 2: Astra Zeneca is already manufacturing this vaccine for use:
"We are starting to manufacture this vaccine right now - and we have to have it ready to be used by the time we have the results," he said.
AstraZeneca says it will be able supply two billion doses of the vaccine.
Speaking to the BBC's Today programme, Mr Soriot said manufacturing was beginning already because, "we want to be as fast as possible".
"Of course, with this decision comes a risk but it's a financial risk and that financial risk is the vaccine doesn't work," he added.
You really think that Astra Zeneca is taking any financial risk? I don't. If they are manufacturing they are going to distribute
Clinical trial data on new drugs is systematically withheld from doctors and patients, bringing into question many of the premises of the pharmaceutical industry—and the medicine we use
Excerpt from Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients, by Ben Goldacre.
Published by Faber and Faber, Inc. © 2013 Ben Goldacre. Excerpted with permission from the publisher. All Rights Reserved.
Before we get going, we need to establish one thing beyond any doubt: industry-funded trials are more likely to produce a positive, flattering result than independently funded trials. This is our core premise, and you’re about to read a very short chapter, because this is one of the most well-documented phenomena in the growing field of “research about research”. It has also become much easier to study in recent years, because the rules on declaring industry funding have become a little clearer.