Filenews 21 September 2020
The trials of astraZeneca's coronavirus vaccine have been "frozen" again. According to a New York Times report, according to a report released by the company, a second participant who received a dose of the experimental vaccine developed a serious neurological disease. It is a transverse myelitis, a rare inflammatory disease that affects the spinal cord, causing weakness, sensory lesions and dysfunction of the autonomic nervous system.
The company did not confirm the diagnosis in the second case, however, a man from the close environment of the second participant who spoke to the Times said the disease had been labeled as transverse myelitis.
According to the report, this side effect is rare but serious, and experts said that even finding a hypothesis, among thousands of test participants, could be a "red flag" and completely stop AstraZeneca's vaccine trials.
"Experts were particularly concerned about AstraZeneca's vaccine trials, which began in April in Britain, due to the company's refusal to provide details of serious neurological diseases to two participants, both women, who received the experimental vaccine in Britain. These cases prompted the company to stop its own testing twice, the second time earlier this month," the report notes. It adds that studies are continuing in Britain, Brazil, India and South Africa, but have stopped in the US, noting that around 18,000 people worldwide have received the AstraZeneca vaccine so far.
The New York Times notes that polls show that Americans are increasingly wary of accepting a vaccine for coronavirus. And scientists inside and outside the government are concerned that regulators, pressured by the president for results before election day on November 3, may release an unproven or unsafe vaccine.
"The release of these protocols seems to reflect some public pressure to do so," said Natalie Dean, a biostatistician and expert in vaccine clinical trial design at the University of Florida.
The 111-page publication of AstraZeneca, known as the protocol, states that its goal is a vaccine with 50% efficacy, the limit set by the US FDA agency. "In order to determine with statistical accuracy whether the company achieves this goal, 150 confirmed patients with coronavirus should participate in the trials. However, an early analysis of the data will also be carried out when there are 75 patient participants. If then the vaccine is 50% effective, the company can stop testing earlier and seek permission from the U.S. government to dispose of its vaccine for emergency use," concludes the New York Times
Source:skies/skai/NYT
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