FDA Refuses to Release Key COVID Vaccine Safety Data

[munkle]

And yet people like RFK Jr. are censored when they say the vaxxes are not safe.

Epoch Times: FDA Refuses to Provide Key COVID-19 Vaccine Safety Analyses:
“U.S. drug regulators are refusing to provide key analyses of a COVID-19 vaccine safety database, claiming that the factual findings cannot be separated by internal discussions protected by law.

The Epoch Times asked the Food and Drug Administration (FDA) in July for all analyses performed by the agency for the COVID-19 vaccines using a method called Empirical Bayesian data mining, which involves comparing the adverse events recorded after a specific COVID-19 vaccine with those recorded after vaccination with non-COVID-19 vaccines.

According to operating procedures laid out by the agency and its partner in January 2021 and February 2022, the FDA would perform data mining “at least biweekly” to identify adverse events “reported more frequently than expected following vaccination with COVID-19 vaccines.” The agency would perform the mining on data from the Vaccine Adverse Event Reporting System (VAERS).

In a recent response, the FDA records office told The Epoch Times that it would not provide any of the analyses, even in redacted form.

The agency cited an exemption to the Freedom of Information Act that lets the government withhold inter-agency and intra-agency memorandums and letters “that would not be available by law to a party other than an agency in litigation with the agency.”

The agency also pointed to the Code of Federal Regulations, which says that “all communications within the Executive Branch of the Federal government which are in written form or which are subsequently reduced to writing may be withheld from public disclosure except that factual information which is reasonably segregable in accordance with the rule established in § 20.22 is available for public disclosure.”

It’s not clear why the FDA could not produce copies of the analyses with non-factual information redacted. The Epoch Times has appealed the determination by the records office. The FDA declined to comment, citing the appeal.”

 

[Manonthestreet]

Vax on secure in the knowledge the govt would never experiment on you......

 

[HereWeGoAgain]

Vax on secure in the knowledge the govt would never experiment on you......

Or kill you intentionally.

 

[munkle]

Or kill you intentionally.

Hiding this data is the most clear ringing admission possible that the vaxxes kill.

 

[munkle]

Vax on secure in the knowledge the govt would never experiment on you......

 

[munkle]

FDA Withholding Autopsy Results on People Who Died After Getting COVID-19 Vaccines

The Epoch Times reported on September 29, 2022:

“The U.S. Food and Drug Administration (FDA) is refusing to release the results of autopsies conducted on people who died after getting COVID-19 vaccines.

The FDA says it is barred from releasing medical files, but a drug safety advocate says that it could release the autopsies with personal information redacted.

The refusal was issued to The Epoch Times, which submitted a Freedom of Information Act for all autopsy reports obtained by the FDA concerning any deaths reported to the Vaccine Adverse Event Reporting System following COVID-19 vaccination.“

Kim Witczak told the Times via email:

“The personal information could easily be redacted without losing the potential learnings from [the] autopsy….Autopsies can be an important part of postmortem analysis and should be done especially with increased deaths following COVID-19 vaccination,”

The FDA refusal takes place after a number of pathologists in different countries have concluded firmly that the COVID vaccines, which are still in phase III adult clinical trials, are the direct cause of many of the unexpected deaths being reported post-vaccination, to databases such as the CDC’s Vaccine Adverse Event Reporting System (VAERS,) which was set up as an “early warning system that monitors the safety of vaccines after they are authorized or licensed for use by the U.S. Food and Drug Administration (FDA).“

The VAERS “early warning system,” the CDC’s words, was set up to indicate when the distribution of a drug must be terminated so that it can be studied further for safety issues.

 

[john doe 101]

And yet people like RFK Jr. are censored when they say the vaxxes are not safe.

Epoch Times: FDA Refuses to Provide Key COVID-19 Vaccine Safety Analyses:
“U.S. drug regulators are refusing to provide key analyses of a COVID-19 vaccine safety database, claiming that the factual findings cannot be separated by internal discussions protected by law.

The Epoch Times asked the Food and Drug Administration (FDA) in July for all analyses performed by the agency for the COVID-19 vaccines using a method called Empirical Bayesian data mining, which involves comparing the adverse events recorded after a specific COVID-19 vaccine with those recorded after vaccination with non-COVID-19 vaccines.

According to operating procedures laid out by the agency and its partner in January 2021 and February 2022, the FDA would perform data mining “at least biweekly” to identify adverse events “reported more frequently than expected following vaccination with COVID-19 vaccines.” The agency would perform the mining on data from the Vaccine Adverse Event Reporting System (VAERS).

In a recent response, the FDA records office told The Epoch Times that it would not provide any of the analyses, even in redacted form.

The agency cited an exemption to the Freedom of Information Act that lets the government withhold inter-agency and intra-agency memorandums and letters “that would not be available by law to a party other than an agency in litigation with the agency.”

The agency also pointed to the Code of Federal Regulations, which says that “all communications within the Executive Branch of the Federal government which are in written form or which are subsequently reduced to writing may be withheld from public disclosure except that factual information which is reasonably segregable in accordance with the rule established in § 20.22 is available for public disclosure.”

It’s not clear why the FDA could not produce copies of the analyses with non-factual information redacted. The Epoch Times has appealed the determination by the records office. The FDA declined to comment, citing the appeal.”

Epoch Times.....the go to source!

 

[TheGreatSatan]

Epoch Times.....the go to source!

^^^ supports hiding information from Americans AKA censorship.

 

[john doe 101]

^^^ supports hiding information from Americans AKA censorship.

Why do you choose conspiracies over the truth?

 

[TheGreatSatan]

Why do you choose conspiracies over the truth?

Why do you support censorship?

 

[john doe 101]

Why do you support censorship?

Why do you think spreading lies is a noble cause?

 

[jc456]

 

[TheGreatSatan]

Why do you think spreading lies is a noble cause?

Why do you support censorship?

 

[john doe 101]

Why do you support censorship?

So you admit you're being lied to.

 

[jc456]

Why do you think spreading lies is a noble cause?

who determines facts?

 

[billyerock123]

And yet people like RFK Jr. are censored when they say the vaxxes are not safe.

Epoch Times: FDA Refuses to Provide Key COVID-19 Vaccine Safety Analyses:
“U.S. drug regulators are refusing to provide key analyses of a COVID-19 vaccine safety database, claiming that the factual findings cannot be separated by internal discussions protected by law.

The Epoch Times asked the Food and Drug Administration (FDA) in July for all analyses performed by the agency for the COVID-19 vaccines using a method called Empirical Bayesian data mining, which involves comparing the adverse events recorded after a specific COVID-19 vaccine with those recorded after vaccination with non-COVID-19 vaccines.

According to operating procedures laid out by the agency and its partner in January 2021 and February 2022, the FDA would perform data mining “at least biweekly” to identify adverse events “reported more frequently than expected following vaccination with COVID-19 vaccines.” The agency would perform the mining on data from the Vaccine Adverse Event Reporting System (VAERS).

In a recent response, the FDA records office told The Epoch Times that it would not provide any of the analyses, even in redacted form.

The agency cited an exemption to the Freedom of Information Act that lets the government withhold inter-agency and intra-agency memorandums and letters “that would not be available by law to a party other than an agency in litigation with the agency.”

The agency also pointed to the Code of Federal Regulations, which says that “all communications within the Executive Branch of the Federal government which are in written form or which are subsequently reduced to writing may be withheld from public disclosure except that factual information which is reasonably segregable in accordance with the rule established in § 20.22 is available for public disclosure.”

It’s not clear why the FDA could not produce copies of the analyses with non-factual information redacted. The Epoch Times has appealed the determination by the records office. The FDA declined to comment, citing the appeal.”

the Epoch Times is a far-right international multi-language newspaper and media company affiliated with the Falun Gong new religious movement. The newspaper, based in New York City, is part of the Epoch Media Group, which also operates New Tang Dynasty (NTD) Television. it's a conspiracy theorist you moron ... you are so ignorant about the covid drug ... its scary that people buy this shit ...

 

[billyerock123]

FDA Withholding Autopsy Results on People Who Died After Getting COVID-19 Vaccines

The Epoch Times reported on September 29, 2022:

“The U.S. Food and Drug Administration (FDA) is refusing to release the results of autopsies conducted on people who died after getting COVID-19 vaccines.

The FDA says it is barred from releasing medical files, but a drug safety advocate says that it could release the autopsies with personal information redacted.

The refusal was issued to The Epoch Times, which submitted a Freedom of Information Act for all autopsy reports obtained by the FDA concerning any deaths reported to the Vaccine Adverse Event Reporting System following COVID-19 vaccination.“

Kim Witczak told the Times via email:

“The personal information could easily be redacted without losing the potential learnings from [the] autopsy….Autopsies can be an important part of postmortem analysis and should be done especially with increased deaths following COVID-19 vaccination,”

The FDA refusal takes place after a number of pathologists in different countries have concluded firmly that the COVID vaccines, which are still in phase III adult clinical trials, are the direct cause of many of the unexpected deaths being reported post-vaccination, to databases such as the CDC’s Vaccine Adverse Event Reporting System (VAERS,) which was set up as an “early warning system that monitors the safety of vaccines after they are authorized or licensed for use by the U.S. Food and Drug Administration (FDA).“

The VAERS “early warning system,” the CDC’s words, was set up to indicate when the distribution of a drug must be terminated so that it can be studied further for safety issues.

The Food and Drug Administration published an article in the journal Vaccine on Dec. 1 that described an early warning system for vaccine safety and noted that the system identified some potential safety signals for the COVID-19 vaccine from Pfizer/BioNTech that should be investigated further.


Among them were pulmonary embolisms, or blood clots in the lung, a condition that calls to mind one of the most commonly advanced claims made by anti-vaccination campaigners — the unfounded idea that COVID-19 vaccines are causing widespread death due to blood clots.

A couple of weeks after the article was published, the Epoch Times — a conservative outlet with a history of spreading dubious claims about the COVID-19 pandemic and vaccines — posted a misleading headline referencing that now-entrenched narrative, saying: “Pfizer’s COVID-19 Vaccine Linked to Blood Clotting: FDA.”


Then other outlets went even further. Conspiracy theorist Stew Peters, for example, posted a video that cited the Epoch Times story and claimed that “the FDA has finally admitted that Pfizer causes blood clots” and that this is “part of a mass genocide operation.”


One Facebook user shared the video with a message that said, “It’s why it’s called the ‘clot shot.'”


But all of these claims misrepresent the paper.


“The FDA has not found any new causal relationships between the Pfizer-BioNTech COVID-19 Vaccine and potential adverse events of special interest identified in 2021,” FDA spokeswoman Abby Capobianco said in an email to FactCheck.org.


“The FDA continues to find that the Pfizer-BioNTech COVID-19 Vaccine meets the FDA’s rigorous standards for safety and effectiveness and the agency strongly believes the potential benefits of COVID-19 vaccination outweigh the potential risks of COVID-19,” she said.


Here’s what the paper actually said: FDA researchers used a system drawing on data from the Centers for Medicare & Medicaid Services for more than 30 million elderly people — those who are 65 and older — to look at 14 ailments and track their incidence among recipients of the three available vaccines in the U.S. and then compare those numbers to a historical baseline for the incidence of those ailments.


The project didn’t investigate the cause of the potential safety signals, it only observed the frequency of certain health problems.


It found that four of the 14 ailments initially “met the threshold for a statistical signal” after COVID-19 vaccination with the Pfizer/BioNTech shot. None met the threshold following vaccination with the shots from either Moderna or Johnson & Johnson.


Then, after further evaluation, three of the initially flagged ailments — immune thrombocytopenia, disseminated intravascular coagulation and acute myocardial infarction — no longer met the statistical threshold, leaving only pulmonary embolism as a potential safety signal.


“Our new findings of statistical signals for four important outcomes for the [Pfizer] vaccine should be interpreted cautiously because the early warning system does not prove that vaccines cause the safety outcomes,” the researchers wrote. “FDA strongly believes the potential benefits of COVID-19 vaccination outweigh the potential risks of COVID-19 infection.”


Deeper epidemiological studies that account for factors such as age and nursing home residency are underway to further evaluate the potential safety signals, according to the paper.


As we’ve explained before, the mRNA vaccines — which include the shots from Pfizer and Moderna — have not been associated with any kind of clotting problem.


In March, Dr. John Su, a medical officer for the CDC’s Vaccine Safety Team, told us, “To date, CDC has detected no unusual or unexpected patterns of blood clots, such as deep venous thrombosis (DVT) and pulmonary embolism (PE) following immunization.”


The J&J vaccine, however, can cause a particular kind of clotting that also involves low levels of blood platelets. The condition is very rare, and the CDC has recommended the two mRNA vaccines over J&J’s, which has accounted for only a small minority of the vaccine doses administered in the U.S.


“There are very large population studies involving millions of people that show that there is no increase in risk with the Pfizer and the Moderna vaccines in terms of thrombosis,” Dr. Adam Cuker, a hematologist with expertise in blood clots at Penn Medicine told us in March. “So very, very clear evidence that those vaccines don’t cause clots.”


And that remains true now. A review published in November that looked at all the available research on the question of mRNA vaccines and clots, which included “six robust studies including analysis of over 27 million doses of mRNA vaccines,” found that “the consistent result is that mRNA vaccines are not statistically associated with [venous thromboembolism],” or clots that form in veins.


And, actually, vaccination against COVID-19 could help to prevent blood clots, since it can prevent infection with the virus that can cause clotting, as we’ve explained before.


A person is much more likely to get a blood clot after being infected with COVID-19 than they are to get a clot after being vaccinated, Allison Burnett, president of the Anticoagulation Forum — an organization that works with health care providers to improve patient care — told us in September.


“So the message is — get vaccinated to avoid blood clots,” since getting infected can increase the risk of clots, she said.


The FDA isn’t “taking any regulatory actions” based on the findings of the recent paper because the signals are still under investigation and “require more robust study,” the researchers wrote.


“The statistical signals of four serious outcomes are not necessarily causal and may be due to factors potentially unrelated to vaccination,” they wrote.


“For example, the elderly Medicare population that received the [Pfizer/BioNTech] vaccine differed from other elderly COVID-19 vaccinated populations, including a preponderance of nursing home residents and populations with a higher comorbidity burden,” they wrote.


When we asked Pfizer for comment on the claims circulating about the FDA’s paper, a spokesperson told us that the company takes seriously any adverse events reported after vaccination with its shots.


“It is important to understand, however, that the [adverse events] reported may not have any causal relationship to the vaccine. Rather, the event may be due to an underlying disease or some other factor such as past medical history or concomitant medication or the [adverse events] may be coincidental,” the spokesperson said in an emailed statement.


So, anyone suggesting that this paper has “admitted” or established that the COVID-19 vaccine from Pfizer causes blood clots is wrong.

---

 

[SeaMajor7]

Fun fact: There's NEVER been a successful REAL vaccine developed for airborne respiratory viruses.
Still TRUE after this whole Covid lie fest!!!!

 

[LordBrownTrout]

Fun fact: There's NEVER been a successful REAL vaccine developed for airborne respiratory viruses.
Still TRUE after this whole Covid lie fest!!!!

It mutates too fast and becomes weaker each mutation. We've known that for decades. Exactly why all vaccines have failed for coronaviruses.

 

[Dragonlady]

And yet people like RFK Jr. are censored when they say the vaxxes are not safe.

Epoch Times: FDA Refuses to Provide Key COVID-19 Vaccine Safety Analyses:
“U.S. drug regulators are refusing to provide key analyses of a COVID-19 vaccine safety database, claiming that the factual findings cannot be separated by internal discussions protected by law.

The Epoch Times asked the Food and Drug Administration (FDA) in July for all analyses performed by the agency for the COVID-19 vaccines using a method called Empirical Bayesian data mining, which involves comparing the adverse events recorded after a specific COVID-19 vaccine with those recorded after vaccination with non-COVID-19 vaccines.

According to operating procedures laid out by the agency and its partner in January 2021 and February 2022, the FDA would perform data mining “at least biweekly” to identify adverse events “reported more frequently than expected following vaccination with COVID-19 vaccines.” The agency would perform the mining on data from the Vaccine Adverse Event Reporting System (VAERS).

In a recent response, the FDA records office told The Epoch Times that it would not provide any of the analyses, even in redacted form.

The agency cited an exemption to the Freedom of Information Act that lets the government withhold inter-agency and intra-agency memorandums and letters “that would not be available by law to a party other than an agency in litigation with the agency.”

The agency also pointed to the Code of Federal Regulations, which says that “all communications within the Executive Branch of the Federal government which are in written form or which are subsequently reduced to writing may be withheld from public disclosure except that factual information which is reasonably segregable in accordance with the rule established in § 20.22 is available for public disclosure.”

It’s not clear why the FDA could not produce copies of the analyses with non-factual information redacted. The Epoch Times has appealed the determination by the records office. The FDA declined to comment, citing the appeal.”

Nice to see you taking the Chinese media seriously on the subject.

Why do those of you who complain about Joe Biden and China all of the time consistently Chinese owned media like Epoch Times, Chinese government controlled and TikTok?

Essentially you’re promoting Chinese propaganda against Joe Biden? If the Chinese are opposed to Joe Biden, why are you opposed to Joe Biden?