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.
Sorry. I need Captain Kirk or Picard to do a sling shot around the sun while
Not altering the time line according to the prime directive to verify your conclusions
Your statements are at best academic philosophical examples worthy of a seminar instead of rooted in reality.
Btw I appreciate the explanation of the random deaths, but should be disregarded as the same factors would be in any random sample.
As the sample gets larger, we will be able to be more accurate. I want that data too.
“The vaccine is supposed to PREVENT you from getting Covid-19.”
NO.
It. Is . Not.
It is supposed to create antibodies to the virus and is supposed to be about 90-94% effective in doing so. It is not a panacea, no one that had any idea of how it works ever claimed it would be!
The idea here is that if you become exposed your immune system knows what to do and it would then kill off or fight the virus. You may still become ill, but *should* have less severe symptoms and a shortened length of illness. This is a lot like the FLU vaccine.
Not seeing those studies? CAN you be specific?
one study found ‘Reactivation of HSV-1 or VZV was observed in 34% of the patients with Bell’s palsy’
But reactivation was defined as testing positive for these viri.
Interestingly i have heard about clusters occurring in hospital staff (mostly female nurses) Cdc comes takes reports but then nothing
“It is supposed to create antibodies to the virus and is supposed to be about 90-94% effective in doing so. It is not a panacea”
I offer Panacea for everyone
https://m.youtube.com/watch?v=Ljyn7hYJ6O8
Once you have a Zoster, you always have it.
Herpes, Chicken Pox, Shingles, are all Zoster viruses.
There are various types of herpes of course, Bell’s Palsy is one.
Just like with Chicken Pox, there is a window of when you’re contagious, the same with Bell’s Palsy. Once you’re past that window, and past the symptom stage, you are a carrier, but not contagious.
So what they’re saying is in some people, the vaccine “wakes up” the Bell’s Palsy Zoster virus.
My guess is, those people were likely carriers already. I mean Reactivation means, reactivation, not contracted, or newly infected.
A CNN medical correspondent was commenting about how we shouldn’t be surprised if people die after taking the vaccine, though I think he was trying to say “vaccinating the elderly, some of the old will die”.
The really F-ed up thing was arguing you still have to wear a mask and stay home despite having the vaccine, because you might spread it. Uh, if you can still get it and still have to abide by restrictions, what’s the point?
So no need to list the other underlying conditions when someone dies with covid, but when it comes to the vaccine then we need to clearly show the underlying conditions.
Got it....
Bell's Palsy is not contagious.
Cause/effect are indeed rooted in reality. And my explanation is not academic. It gives a probability of outcome in making a ‘choice’ which occurs when a random element is introduced that causes that ‘choice’ to be made.
No different then leaving for work every day at 7AM, drive the highway and safely arriving at work. But then one morning you are getting into your car to leave for work and your neighbor waves at you to hold up. He needs a jump, his battery is dead. Instead of leaving for work, you help your neighbor jump his car which delays you 15 minutes.
Perfect example of random element and choice.
So... then you get into your car and drive off not realizing that those 15 minutes have now sealed your fate on the highway. You enter the highway and not more than 15 minutes later a random car blows out a tire, careens into you and you are killed.
This proves that the causation of ‘choice’ to help the neighbor a 7AM to jump his car effected an outcome different from arriving safely at work for past 10 years.
~~~~
My example is no different involving the vaccine as if it were the neighbor. A routine life and familiar choices made by those people for years and then an object(event) is introduced that if it had not existed(the vaccine trial), would not have caused a not-so-typical ‘choice’ to be made.
So then, like the choice that altered the drivers time he would normally have left for work... now we have several people who altered their lives choosing to participate in a vaccine trial.
That choice put them on a path that would effect a collision with another kind of ‘blown tire’, the vaccine trial, which would then be the catalyst that would end their lives.
It just sounds like a Star Trek episode, but indeed it is rooted in reality.
Interesting. But I still think this is a rudimentary chaos theory and it works the opposite way as well. The neighbor who held the subject up for 15 minutes could have also caused a miss in an accident that would have happened at 7 AM. It is not a cause and effect. It is two independent events.
In this construct you are perhaps introducing the element of predestination. It’s a very teleological and philosophical question. But causation? It’s a stretch in my opinion
Caress of Steel, great album!
interesting article at your link, especially the part
“A team in the United Kingdom is conducting a trial of a new COVID-19 vaccine (charmingly called ChAdOx1 nCOV-19) and they are comparing it not to a saline injection but to a vaccine against meningitis.”
If you compare the potential side effects of a meningitis vaccine with some of the reported symptoms, it starts to make sense why the ‘placebo’ group may have had issues, depending on which menengitis vaccine version was used, that is, if Moderna used the same meningitis placebo:
https://www.md-health.com/Meningitis-Vaccine-Side-Effects.html
Only one died from COVID-19, and that one had received the placebo.
FDA advisory panel endorses Moderna’s Covid-19 vaccine, clearing way for authorization
By STAT STAFF
DECEMBER 17, 2020
https://www.statnews.com/2020/12/17/moderna-vaccine-fda-panel/
” Jacqueline Miller, a Moderna senior vice president, said...She also said that one patient, who received placebo, had died from severe Covid-19.”
“while the last committed suicide ‘21 days’ after the first dose.”
Mask hysteria?
So they are using a meningitis vaccine as the placebo with the most twisted and convoluted of reasoning.
Mmr shots were a seventies and 80s thing weren’t they?
While looking for motives, I found the following and thought it was interesting. Not much about motives beyond allusions to the usual neuroses, though (article).
Anti-vaxxers Are Anti-vaxxers for One of These Four Reasons
Newsweek
BY KASHMIRA GANDER
3/21/19
https://www.newsweek.com/anti-vaxxers-are-anti-vaxxers-one-these-four-reasons-1369344
[Excerpt:]
“...people spanning demographics and the political spectrum...
By looking at the information the Facebook users shared about themselves, the team were able to collect demographic data...
Most of the subjects were female, at 89 percent; 78 percent were parents, 29 percent were employed, and 24 percent had a post-secondary education. Of the total, 56 percent supported Donald Trump, and 11 percent supported Bernie Sanders. Although not all users shared their location, of those who did 24 were in California, nine Texas, eight Australia, and eight from Canada.”
Somewhat interesting in re. motives. “Crunchy moms:” neo-hippies. That’s why most of them are in California.
I Used to Be An Anti-Vaxxer. Here’s What Changed My Mind.
https://www.self.com/story/from-anti-to-pro-vaccine
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