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TomCADem

(17,837 posts)
Tue Sep 15, 2020, 11:53 AM Sep 2020

AstraZeneca vaccine trial: NIH 'very concerned' about serious side effect in vaccine trial [View all]

Source: MSN

The Food and Drug Administration is weighing whether to follow British regulators in resuming a coronavirus vaccine trial that was halted when a participant suffered spinal cord damage, even as the National Institutes of Health has launched an investigation of the case.

"The highest levels of NIH are very concerned," said Dr. Avindra Nath, intramural clinical director and a leader of viral research at the National Institute for Neurological Disorders and Stroke, an NIH division. "Everyone's hopes are on a vaccine, and if you have a major complication the whole thing could get derailed."

A great deal of uncertainty remains about what happened to the unnamed patient, to the frustration of those avidly following the progress of vaccine testing. AstraZeneca, which is running the global trial of the vaccine it produced with Oxford University, said the trial volunteer recovered from a severe inflammation of the spinal cord and is no longer hospitalized.

AstraZeneca has not confirmed that the patient was afflicted with transverse myelitis, but Nath and another neurologist said they understood this to be the case. Transverse myelitis produces a set of symptoms involving inflammation along the spinal cord that can cause pain, muscle weakness and paralysis. Britain's regulatory body, the Medicines and Healthcare Products Regulatory Agency, reviewed the case and has allowed the trial to resume in the United Kingdom.

Read more: https://www.msn.com/en-us/health/medical/astrazeneca-vaccine-trial-nih-very-concerned-about-serious-side-effect-in-vaccine-trial/ar-BB193RvH?li=BBnb7Kz&ocid=msnbcrd



This is why a lot of people are concerned about Trump political operatives making snake oil claims about a vaccine similar to Trump endorsements of hydroxychloroquine. Of course, Fox News will then attack anyone who questions Trump of being an anti-vaxxer when the whole issue that Trump and Republicans are repeatedly ignoring science.

https://nymag.com/intelligencer/2020/09/trump-hhs-aide-caputo-attacks-cdc-warns-of-insurrection.html

Trump HHS Aide Michael Caputo Launches Unhinged Attack on CDC, Warns of Insurrection

Michael Caputo, the former Trump campaign official and Roger Stone associate whom President Trump appointed to be spokesman of the Department of Health and Human Services, spent the weekend defending his efforts to alter the CDC’s weekly COVID-19 reports in order to protect the president politically — a defense that included baselessly claiming that scientists at the agency were deep-state agitators bent on taking down the president. The meddling and Caputo’s attacks prompted widespread outrage from infectious-disease and public-health experts. Then on Sunday, according to the New York Times, Caputo’s paranoid allegations went even further off the deep end.

In a video he posted to his personal Facebook page, Caputo decried the negative attention he was receiving; insisted, “I am not going anywhere”; and claimed that scientists “deep in the bowels of the CDC have given up science and become political animals” who “haven’t gotten out of their sweatpants except for meetings at coffee shops” to plot “how they’re going to attack Donald Trump.” The Times reports that Caputo said the agency “was riddled with anti-Trump researchers who ‘walk around like they are monks’ and ‘holy men’ but engage in ‘rotten science.’”

The political operative, who has no background in health care or science, accused the CDC scientists of “sedition” and made the outrageous allegation — again without any evidence, because there isn’t any — that the scientists were deliberately acting against the country’s public health as a “resistance unit” within the agency.

“There are scientists who work for this government who do not want America to get well, not until after Joe Biden is president,” Caputo reportedly warned, adding that, “to allow people to die so that you can replace the president is a grievous venial sin, venial sin. And these people are all going to hell.”
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