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Tue Sep 15, 2020, 11:53 AM

AstraZeneca vaccine trial: NIH 'very concerned' about serious side effect in vaccine trial

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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Reply AstraZeneca vaccine trial: NIH 'very concerned' about serious side effect in vaccine trial (Original post)
TomCADem Sep 15 OP
LovingA2andMI Sep 15 #1
NoRoadUntravelled Sep 15 #2
appalachiablue Sep 15 #3
TomCADem Sep 15 #4
LisaL Sep 15 #12
samsingh Sep 15 #5
gab13by13 Sep 15 #6
pandr32 Sep 15 #7
Yo_Mama_Been_Loggin Sep 15 #8
scipan Sep 15 #9
LisaL Sep 15 #11
DeminPennswoods Sep 15 #10
LisaL Sep 15 #13
DeminPennswoods Wednesday #17
NickB79 Sep 15 #14
DesertRat Sep 15 #15
BlueWavePsych Sep 15 #16

Response to TomCADem (Original post)

Tue Sep 15, 2020, 11:56 AM

1. Rush Vaccine Ensuring One Possibly Does Not Walk Again???

Will be skipping all parts of that rushed vaccine at "Warp Speed" - Thank You Very Much!

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Response to LovingA2andMI (Reply #1)

Tue Sep 15, 2020, 12:03 PM

2. Ditto

At this point there's no assurance that the current administration won't "doctor" the trial results and further endanger lives.
No way I would take a vaccine that has been rushed in this way.

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Response to LovingA2andMI (Reply #1)

Tue Sep 15, 2020, 12:04 PM

3. You know it. After coming down flat out sick

for two days from the (rushed) 1976 Swine Flu Shot it took me a while to warm up to vaccines. I didn't learn about the full story until decades later and met a man in 1985 who had who come down with Guillain Barre. The H1N1 in 2009 went fine so things are better.

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Response to LovingA2andMI (Reply #1)

Tue Sep 15, 2020, 12:11 PM

4. Trump appointees pushing to review, change CDC materials before publication: report

I am sure the Trump administration will dismiss any setback as fake news and the result of the deep state. Heck, I am sure that Trump will brag that he personally took 20 doses of the vaccine that he will announce next month and it not only kept him from getting COVID, but enabled him to read minds and see through walls.

https://thehill.com/homenews/coronavirus-report/516141-trump-appointees-pushing-to-review-change-cdc-materials-before

The health department’s politically-appointed communications aides have demanded the right to review and seek changes to the Centers for Disease Control and Prevention’s (CDC) weekly scientific reports on the status of the coronavirus pandemic, Politico reported Saturday.

Emails reviewed by Politico and three people reportedly familiar with the situation indicated that communications aides openly complained in emails to CDC Director Robert Redfield and other senior officials that the agency’s reports would undermine President Trump's optimistic messaging about COVID-19.

Politico reported that its three sources said CDC officials have resisted most of the changes proposed by the Department of Health and Human Services (HHS) but that the CDC has increasingly agreed to allow politically-appointed officials to review reports and, in a few cases, alter the wording in the documents.

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Response to LovingA2andMI (Reply #1)

Tue Sep 15, 2020, 02:02 PM

12. Add to that, vaccine is given to people who are healthy.

Drugs have side effects, sure, but people who take drugs suffer from some sort of conditions. Vaccine is given to someone who is healthy at the moment, and I don't know that people would be willing to risk a very serious side effect.

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Response to TomCADem (Original post)

Tue Sep 15, 2020, 12:27 PM

5. holy crap - can you imagine if this had been given to millions of people?

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Response to TomCADem (Original post)

Tue Sep 15, 2020, 12:36 PM

6. I could be wrong

but I believe that Trump gave 1 billion dollars to AstraZeneca.
He also ordered millions of the Abbott quick tests that have yet been proven to be effective.

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Response to TomCADem (Original post)

Tue Sep 15, 2020, 12:40 PM

7. We need to be able to trust the Scientific process

Political interference isn't much different from religious interference. This is unAmerican. This is against reason.

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Response to TomCADem (Original post)

Tue Sep 15, 2020, 12:42 PM

8. "Warp Speed!!!!" cries Trump

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Response to TomCADem (Original post)

Tue Sep 15, 2020, 12:47 PM

9. Don't forget the one who got MS

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Response to scipan (Reply #9)

Tue Sep 15, 2020, 02:00 PM

11. I believe they concluded that person had MS already and that's why he had a reaction.

NT

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Response to TomCADem (Original post)

Tue Sep 15, 2020, 12:58 PM

10. Watch one of the ubiquitous drug ads on TV

and listen to the potential side effects, up to and including death. These aren't drugs for life-threatening diseases either.

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Response to DeminPennswoods (Reply #10)

Tue Sep 15, 2020, 02:03 PM

13. What drugs have side effects including death and are not for life threatening diseases?

And frankly, if a possible side effect of vaccine is paralysis, I wouldn't want to take it.

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Response to LisaL (Reply #13)

Wed Sep 16, 2020, 05:28 AM

17. Then don't get a vaccine,

but don't pretent other approved drugs don't have serious side effects just as rare as this one appears to be. Go to drugs.com and check out the known side effects of any drug.

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Response to TomCADem (Original post)

Tue Sep 15, 2020, 04:51 PM

14. The first to be immunized will be our doctors and nurses

If this goes sideways, we'll take out a chunk of the very people we need now more than ever.

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Response to TomCADem (Original post)

Tue Sep 15, 2020, 04:52 PM

15. Financial motivation

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Response to TomCADem (Original post)

Tue Sep 15, 2020, 05:02 PM

16. Good job!



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