Posted on 12/21/2020 7:12:28 PM PST by SeekAndFind
Official documents from the U.S Food and Drug Administration (FDA) record that 13 people died during trials of the Moderna vaccine, while the FDA has also issued a new warning regarding Bell’s Palsy as a potential effect of the vaccine.
A sponsor briefing document prepared for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) recorded the various outcomes on participants in the Moderna vaccine trial, listing the effects of those who had received the vaccine and those who had taken the placebo.
The evidence presented listed 13 deaths in the trials, with 6 deaths being people who had taken the vaccine, and 7 those who had received the placebo. Results were correct up until December 3.
An FDA briefing presentation provided a breakdown of those who died. Of those in the vaccine group who had died, one was a 78-year-old who suffered “cardiac arrest 21 days after dose 1”; a 77-year-old died of “[m]yocardial infarction 45 days after dose 2.” Two participants were found dead at home, and their deaths are declared to be of “uncertain” cause: a 70-year-old was found dead at home “57 days after dose 2,” and a 56-year-old was found likewise “37 days after dose 1.” However, the FDA document continues by saying that for the 56-year-old person, head trauma was given as the official cause of death.
Two more participants died from the vaccine recipient group, a 72-year-old having “multiorgan failure” 59 days after the second dose, while the last committed suicide “21 days” after the first dose. The person who had multi-organ failure was “hospitalized for thrombocytopenia and acute kidney failure due to obstructive nephrolithiasis” prior to developing “complications” that resulted in organ failure.
Out of the 7 participants who took the placebo, three died from “myocardial infarction,” one from “intra-abdominal perforation,” and another from “systemic inflammatory response syndrome in the setting of known malignancy.” Another died from “COVID-19,” and the cause of death for the last person was not known.
Moderna does not connect any of the 13 deaths to either the vaccine or the placebo, saying instead that “[t]hese deaths represent events and rates that occur in the general population of individuals in these age groups.”
The document comes in addition to the news of a Ukranian Greek Catholic priest who died suddenly in his home after previously being a volunteer in the testing of Moderna’s vaccine. Fr. John Fields apparently suffered a heart attack just under two months after his second jab, although it is still unclear if the 70-year-old’s death is related to the vaccine.
ActivistPost.com showed an image of a version of the FDA briefing document, which contained interesting information not found in current versions. The old version of the document stated that during “data cleaning,” one participant who received the vaccine was updated from “death” to “SAE” or severe adverse event. In contrast, a participant who received the placebo was updated from “SAE” to “death” on his record. ActivistPost also referenced an as yet unpublished document by Dr. James Lyons-Weiler, president and CEO of The Institute for Pure and Applied Knowledge (IPAK), who has analyzed the FDA Moderna document, finding worrying and false evidence in the text.
Despite the 13 deaths in the trial, the FDA gave emergency use authorization (EUA) to the Moderna vaccine on December 19, after the VRBPAC voted 18-0 in recommending the vaccine.
An FDA press statement on the issuing of the EUA read: “Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA.”
However, the FDA previously released its own warning for any potential COVID-19 vaccine, including strokes, encephalitis, auto-immune disease, birth defects, and Kawasaki disease among the potential side-effects to be monitored. First on the list of 22 possible conditions is “Guillain-Barré syndrome,” described as “a rare disorder in which your body's immune system attacks your nerves.” The syndrome has “no known cure,” and its mortality rate is “4% to 7%.”
“There may be limited information available at licensure on level and duration of effectiveness,” the text reads. This might prompt manufacturers to “conduct certain COVID-19 vaccine effectiveness post-licensure studies.”
Since then, the FDA has also issued a staff report, warning of “facial paralysis,” or Bell’s Palsy, as a possible condition to be looked for in those who take the Moderna vaccine. Four out of the 30,000 original participants in the trial developed the condition, with 3 in the vaccine group and 1 in the placebo group.
The report notes a “small imbalance” in participants reporting Bell’s Palsy, adding that one lady in the vaccine group had to be hospitalized “for stroke due to new facial paralysis 32 days after vaccination.” Two other cases of the condition in the vaccine group reported the effects 28 days and 22 days after vaccination.
“[C]onsidering the temporal association and biological plausibility, a potential contribution of the vaccine to the manifestations of these events of facial palsy cannot be ruled out,” the FDA writes.
It is worth noting that in trials for the Pfizer vaccination, 4 out of the 43,000 participants developed Bell’s Palsy, all of whom had received the vaccine.
Dr. Paul Offi, a member of the VRBPAC, spoke to CNBC about the importance of monitoring the condition, saying, “I’m not dismissing that yet.” CNBC mentioned how five cases of Kawasaki disease found in the vaccine recipients of Merck’s rotavirus vaccine were “statistically significant,” resulting in the company having to alter its label to mention the disease.
13 people died during Moderna’s COVID-19 vaccine trial
Few of them had anything to do with the trials, but they died during them.
It gets posted because of its sensationalism and breathlessness. It is sad that people (not seekandfind, but in this case life site) commits a lie of omission by not pointing out that the death rate is ~1/5000 over the time period. Given the demographics of the patients — this is about would you would expect.
More fear and loathing so that we may remain locked down.
Day #7 here and I am still alive.
‘placebo’, or ‘control’?
Bells paralysis is interesting also
The FDA said that there were four reported cases of Bell’s palsy among Moderna’s 30,000 trial participants, including three who got the vaccine.
However, “currently available information is insufficient to determine a causal relationship with the vaccine,” the FDA wrote in briefing documents.
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so it is interesting one of the “placebo “ people got it, or is it ?
https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Bells-Palsy-Fact-Sheet
looks like 1 in 8000 people get every year so we see en extremely high number of extra cases that would not be expected statistically
There was a lot of information that I could not find when looking into this
Exactly!
What? You mean the vaccine does NOT PREVENT ALL DEATHS FROM ALL CAUSES? You’re just as likely to die of a heart attack if you get the vaccine as you are by not getting the vaccine?
This is STUNNING NEWS! Next thing you know they’ll be showing that the vaccine doesn’t prevent car accident fatalities! How disappointing! /sarc
With that number of wicked side effects I know for sure now that I’ll take my chances with nothing.
So for both vaccines, Bell’s Palsy occurred in about 1 in 10,000 people.
100 million doses means 10,000 cases...for a disease with well over a 99.5% survival rate for those under 70. I don’t see that as worth the risk. Perhaps confine use to those at high risk, of whatever age?
The only mention of the total number in the trial was of ‘30,000 original participants in the trial’ - and that when the article was discussing incidence of Bells’ Palsy (which is usually temporary.)
This article lacks a lot in terms of actual information.
Bells paralysis is normally 1 in 8000 per year.
In the vaccine and control trials it was 3 in 5000
But if everyone wears masks, what does it matter?
I am confused by the attempts to frighten people away from the vaccine.
What is the endgame here?
Just on the off chance it is, I’ll pass on taking the vaccine.
It’s a matter of cause and effect. Introducing an element of chance that then leads to changes by subsequent events/decisions ultimately leads to their fate/death along another time-line, then if they hadn’t had the vaccine as a choice/influence in making decisions that would have led them to a different outcome in fate which most ‘likely’ they would still be alive today.
Of course that’s assuming their decision making path having not been influenced by the existence of the vaccine into their lives, continued without an accidental unintended death.
So yes, having no vaccine as a choice, they ‘likely’ would be alive today.
Speaking only for myself, I don’t care if people take drugs or not. I just get upset when people lie with statistics, use extremely misleading language, and get well paid to mislead people
Thank you. Most kind of you to point that out.
You are aware of course that the wicked side effects are about the same as for many other medications taken each day?
Ummmmm just to run the math:
Bell’s palsy is a brief self limited facial nerve paralysis. It is judged to be very benign. Risk 1/10000
Using your statement of Covid mortality is 0.5% which is 5/1000 or 1/200 (again the statement you use)
Therefore the relative risk of death is 50x higher than contracting a benign and self limited nerve palsy
So do you perhaps what to rethink your statement in lieu of the statistical analysis you present?
can you explain a litte more please
is having mmr good or bad
what a bout those born 1957 or before assumed to have had measles and never had mmr
My pleasure.
So out of 30,000 people in the vaccine trials, 13 died. If none of the 30,000 had ever participated in the trials, the same 13 would most likely have died of the same causes. People die every day.
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