Posted on 07/24/2023 9:31:24 AM PDT by george76
Conservative public interest advocacy group Defending the Republic (DTR) has obtained almost 15,000 pages of Moderna’s COVID-19 vaccine clinical trial data, claiming the data show an “utter lack of thoroughness” of the trials and calls the vaccine’s safety into “serious doubt.”
As a result of successful Freedom of Information Act (FOIA) litigation against the U.S. Food and Drug Administration (FDA), the group recently announced it had obtained—and is releasing—nearly 15,000 pages of documents relating to testing and adverse events associated with “Spikevax,” Moderna’s COVID-19 vaccine.
Since 2022, the group has been involved in litigation against the FDA relating to the production of data submitted by Moderna in support of its application to federal regulators for approval of its vaccine.
As a result, the FDA agreed to produce around 24,000 pages of the Moderna records by the end of this year, with the 15,000 pages being the first instalment.
The records, some of which relate to adverse events related to the vaccine, include important information related to the safety profile of Spikevax, which was first authorized for emergency use in the United States in December 2020 and in January 2022 received full approval for adults.
“The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement earlier this year.
But the new data call this view into question. The advocacy group says that the tens of thousands of pages of clinical trial data released by the FDA supports the conclusion that there is “serious doubt” about both the safety of Spikevax and the FDA’s standards for approval.
Neither Moderna nor the FDA immediately responded to a request for comment.
More Details..
DTR filed its FOIA lawsuit after the FDA rejected requests to produce the Moderna COVID-19 records, justifying its decision by claiming there was no pressing need for the public to review the information.
The documents obtained as part of the group’s litigation against the FDA are the first significant release of data from Moderna’s COVID-19 clinical trials.
The studies reveal the causes of deaths, serious adverse events, and instances of neurological disorders potentially associated with Spikevax.
...
One of the key takeaways from the documents is that many of those who died after receiving the Moderna vaccine were not given an autopsy.
“According to one study, 16 individuals died after being administered the Moderna vaccine. The study’s authors indicated that out of those 16 deaths, only two autopsies were performed, five of the dead were not autopsied, and the autopsy status of nine of the dead was ‘unknown,’” DTR said in a statement.
“Yet this did not stop those running these ‘studies’ from concluding, despite the absence of evidence, that the Moderna vaccine was not related to these deaths,” the group added.
As an example, the group gave the case of a 56-year-old woman who experienced ‘sudden death’ 182 days after receiving the second dose of the Moderna vaccine.
“The cause of death was unknown, and no autopsy was conducted. It seems they purposely decided not to investigate suspicious deaths in case the Moderna vaccine might be the cause,” the group stated.
There were also numerous examples in the clinical trial data of participants diagnosed with post-vaccination Bell’s Palsy and Shingles, with numerous vaccinated trial participants seeing the onset of Shingles less than 10 days after getting the shot.
The studies also showed that there were a number of serious adverse events noted in the vaccinated groups, with a number of participants experiencing heart attacks, pulmonary embolisms, and spontaneous miscarriages.
Overall, the group concludes that the 15,000 pages of data create “serious doubt concerning the safety of the Moderna vaccine and the FDA’s standards and approval of the Moderna vaccine.”
The 15,000 pages or so of data released by DTR, all of which can be found here, add to the growing body of evidence suggesting that the COVID-19 vaccines may not be as safe as advertised.
FDA Ordered to Speed Up Release of COVID-19 Data..
Elsewhere, a federal judge in Texas ordered the FDA to make public data it relied on to license COVID-19 vaccines at an accelerated rate, requiring all documents to be made public by mid-2025 rather than, as the FDA wanted, over the course of about 23.5 years.
In a May 9 decision hailed as a win for transparency by the lawyer representing the plaintiffs (the parents of a child injured by a COVID-19 vaccine) in a lawsuit (pdf) against the FDA, the agency was ordered to produce the data on Moderna’s vaccine for adults and Pfizer’s for children about 10 times faster than the agency wanted.
“Democracy dies behind closed doors,” is how U.S. District Judge Mark Pittman opened his order (pdf), which requires the FDA to produce the data on Moderna’s and Pfizer’s COVID-19 vaccines at an average rate of at least 180,000 pages per month. The FDA had argued it would be “impractical” to release the estimated 4.8 million pages at more than between 1,000 and 16,000 pages per month, which would have taken at least 23.5 years.
The January 2022 order (pdf), also issued by Pittman, forced the FDA to produce all its data on Pfizer’s COVID-19 vaccine for those aged 16 and older at a rate of 55,000 pages per month, or much faster than the 75 years the agency had sought.
“That production should be completed in a few more months,” Siri said in a statement, referring to the earlier Pfizer data for those aged 16 and up.
The latest order requires the FDA to produce all of its data on Pfizer’s COVID-19 vaccine for 12- to 15-year-olds (and Moderna’s product for adults) by June 31, 2025.
Even the phrase “serious doubt” operates as a mind-numbing euphemism with respect to the recent wordwide vexxationation war crime.
Much stronger language is warranted. And—of course—action.
Prove that the vaccines were dangerous and risky, and by extension give President Trump a black eye?
“The study’s authors indicated that out of those 16 deaths, only two autopsies were performed, five of the dead were not autopsied, and the autopsy status of nine of the dead was ‘unknown,”
One wonders why the authors didn’t report the results of the two autopsies that were performed? That casts serious doubts on whether the autopsies confirmed the role of vaccines in their deaths.
EUA authorization is limited to very specific circumstances according to the CFRs. So he can speak up and inform we the people or let his continued silence speak for him. I am disappointed that Tucker does not ask him hard questions. Independents don’t like this.
“...who still to this day touts his facilitating the rapid development of the COVID vaccines?”
It was fast! He did the right thing! Was Trump supposed to get a medical degree to have a better understanding? He acted swiftly and properly. Too bad the in-situ so-called expert medical people were charlatans. Not his fault.
From the lack of effort to even perform just 16 autopsies, I'm betting the 2 that were done showed a massive invasive 'spike' infection like they saw in the rats maternity testing, and didn't want to see any more 'bad news' and decided not to do autopsies.
Calcified placentas sez it all ...
We zipped way past “serious doubt” thousands of needless deaths and disabilities long ago.
RideForever wrote: “From the lack of effort to even perform just 16 autopsies, I’m betting the 2 that were done showed a massive invasive ‘spike’ infection like they saw in the rats maternity testing, and didn’t want to see any more ‘bad news’ and decided not to do autopsies.”
I would bet the reason the authors didn’t provide the results fo the two autopsies is because the two autopsies didn’t suppor their narrative that the vaccines caused their deaths.
Remember it took a court order to get these documents published, which is crazy if the trial results were as glowing as DugwayDuke surmises.
100’s of millions of lives disrupted, people lost their savings, homes everything. People murdered by the non working vaccine, people crippled, people waiting for the heart attack or stroke because the vaccines clog up the arteries.
The pharma people making billions and millions for the CDC people.
RideForever wrote: “If they were getting such great results, as DugwayDuke suggests, why wouldn’t they be encouraged to do more autopsies instead of fewer? Especially after the rat testing, which he fails to rationalize with a possible ‘clean’ mandatory autopsy report. They had the bodies.”
No, they did not have the bodies. The bodies belonged to the next-of-kin which may not have wanted the autopsies. Then again, in some cases, there may have been no reason to do the autopsies. For example, where the cause of death was clear, ie, accidents, suicides, homicides, etc.
DugwayDuke wrote - a bunch of nonsense to waste readers’ time. The article stated the body count and body availability, and DugWayDuke decided to change the numbers, apparently, and give bogus reasons for the change. He has no clue if any of the bodies actually had a next-of-kin, for example.
RideForever wrote: “DugwayDuke wrote - a bunch of nonsense to waste readers’ time. The article stated the body count and body availability, and DugWayDuke decided to change the numbers, apparently, and give bogus reasons for the change. He has no clue if any of the bodies actually had a next-of-kin, for example.”
The article says nothing about the availability of the bodies. I quoted the numbers exactly as they’re shown in the article. You’re the one posting ‘bogus reasons’. You have no idea why there were only two autopsies. You have no idea of what these autopsies found. Yet, you’re willing to jump to conclusions that only two were performed because these two autopsies showed the vaccines were the cause. There are multiple plausible reasons for not doing the reamining autopsies, yet you insist upon implausible conspiracy theories as the reason.
This allows an 'inconclusive' determination of the autopsy portion of the trials that won't halt the project. Clever, right? But it's better if buried from the public by a court order. Nothing suspicious there, right DugwayDuke?
DougwayDuke stated yet you insist upon implausible conspiracy theories
I, at least, have science shown in the Excess Deaths Reports and the lack of a report from the 2 autopsies that were performed. This, after the disastrous trial rat maternity testing, which DougwayDuke wants you to ignore in order for you to be 'fully informed' about CoVID treatments.
RideForever wrote: “This allows an ‘inconclusive’ determination of the autopsy portion of the trials that won’t halt the project. Clever, right? But it’s better if buried from the public by a court order. Nothing suspicious there, right DugwayDuke?”
Autopsy results can only be released by the next of kin.
RideForever wrote: “I, at least, have science shown in the Excess Deaths Reports and the lack of a report from the 2 autopsies that were performed. This, after the disastrous trial rat maternity testing, which DougwayDuke wants you to ignore in order for you to be ‘fully informed’ about CoVID treatments.”
Gee, excess deaths increased during a pandemic. Who would have thought that?
The lack of those autopsy reports isn’t evidence of what caused the deaths.
If you want to discuss ‘rat maternity testing’ you’ll have to be more specific.
That is true some of the time, bot not in this case because they were donated to research.
Robert Kennedy Jr exposes the results of the Pfizer trial…
~ 22,000 were injected with the Pfizer vaccine and 22,000 took the placebo (saline)…
~ Results showed the NNTV (Number needed to vaccinate to save one life) was 1 in 22,000…
~ The vaccinated group were 21% more likely to die over the next 6 months from all cause mortality…
~ The vaccinated group was 400% more likely to suffer a cardiac arrest in the next 6 months.
Jun 17, 2023
https://twitter.com/matttttt187/status/1670139993019351040
Joe Biden Receives New COVID-19 Vaccine and Flu Shot
09/23/2023 4:31:41 PM PDT · by nickcarraway · 57 replies
New York Post ^ | Sep. 23, 2023 | Alyssa Guzman
President Joe Biden has been double jabbed, getting a COVID-19 shot and a flu shot, The White House confirmed. White House physician, Dr. Kevin O’Connor, confirmed in a memo that Biden, 80, received both shots on Friday. O’Connor also said Biden was vaccinated several weeks ago against the respiratory illness known as RSV. “As we enter the cold and flu season, the President encourages all Americans to follow his example and to check with their healthcare provider or pharmacist to assure that they are fully vaccinated,” the physician wrote in a memo.
People Looking to Get New COVID Vaccine Getting Hit With $190 Fees: Report
09/23/2023 4:29:10 PM PDT · by nickcarraway · 55 replies
New York Post ^ | Matthew Sedacca
People looking to get their new COVID-19 vaccine are feeling sore over hefty unexpected charges for the federally-recommended shot. Customers nationwide at pharmacies including Walgreens and CVS who landed appointments for the jab this week were shocked to learn they would feel the additional pinch of three-figure fees for their boosters. “Nightmare is the first word that comes to mind,” Acton, Massachusetts, resident Glen Cote told WBZ-TV after he learned his new booster would run him $190.99. It’s a complaint echoed by dozens of social media users after pharmacies dinged patients anywhere from between $125 to $200 for the latest...
Get Your Updated COVID-19 Vaccine With TRICARE
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TRICARE ^ | Sep 21, 2023 | TRICARE Communications
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Dr McCullough says research papers show COVID-19 vaccine myocarditis is common, serious, and fatal. Only hope until we know more is detoxification!
09/19/2023 5:16:32 AM PDT · by RandFan · 28 replies
Twitter/X ^ | Sep 19 | @P_McCulloughMD
@P_McCulloughMD Our research papers show COVID-19 vaccine myocarditis is common, serious, and fatal. Cannot be blamed on prior SARS-CoV-2 infection. Extremely concerned about cases if cardiac arrest 2+ years after ill-advised shots. Only hope until we know more is detoxification.
When to get the new Covid-19 vaccine to maximize your protection(OK… sarcasm and disgust)
09/14/2023 11:58:01 PM PDT · by Jayster · 17 replies
CNN ^ | September 14, 2023 | Deidre McPhillips
CNN — A new Covid-19 vaccine is available — and recommended — for everyone ages 6 months and older, and experts say it’s best to take advantage of the protection it provides sooner rather than later. The shot — greenlit by the US Food and Drug Administration and the US Centers for Disease Control and Prevention this week — is different than previous versions, with a formulation that’s been updated to target newer variants of the virus that are currently circulating.
CDC data shows COVID-19 vaccines can decrease the life expectancy of men by 24 YEARS
09/13/2023 8:13:17 AM PDT · by Paul46360 · 39 replies
NEWSTARGET ^ | 9-12-23 | Zoey Sky
Data from the U.S. Centers for Disease Control and Prevention (CDC) has revealed that Wuhan coronavirus (COVID-19) vaccines could reduce the lifespan of vaccinated men by at least 24 years.The CDC data also revealed that the damage to health caused by each vaccine dose does not lessen over time. Instead, it continues indefinitely.
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