- Trump says US will be ‘very careful’ after intel community warns of election interference from rival nations
By Adam Shaw | Fox News
‘We’re going to look at it very closely.’
President Trump on Friday said the U.S. will be “very careful” after the intelligence community warned ...
- Group sends hundreds of thousands of ‘potentially misleading’ ballot applications
By Morgan Phillips | Fox News
The mailings contain legitimate ballot applications but appear to be from a government source.
A voter registration group is sending hundreds of ...
- Biden walks back African American ‘diversity’ remarks, lauds community’s ‘diversity of thought’
By Joseph A. Wulfsohn | Fox News
‘In no way did I mean to suggest the African American community is a monolith,’ ex-VP says.
Presumptive Democratic presidential nominee Joe Biden attempted ...
- Trump claims Biden ‘no longer worthy of the Black Vote’ in wake of diversity comment
By Brooke Singman | Fox News
‘Sleepy Joe Biden just lost the Black Vote,’ Trump first said in a now-deleted tweet.
President Trump on Friday said his presumptive ...
- NRA fights back, files its own suit against NY attorney general seeking to disband organization
By Stephanie Pagones | Fox News
President Trump slammed AG Letitia James’ suit against the group, calling it ‘a very terrible thing’.
The National Rifle Association is fighting back against ...
- Washington Post issues major correction after botching Trump-Twitter post
By Joseph A. Wulfsohn | Fox News
The Washington Post sparked massive confusion Wednesday evening after erroneously reporting that President Trump was banned from tweeting because of a claim he ...
- Cities go to extremes with quarantine crackdowns: Checkpoints, power shutoffs, steep fines
By Tyler Olson | Fox News
Some travelers will be stopped in NYC. The interstate in Chicago has signs warning about quarantine requirements.
With the daily number of coronavirus cases ...
- Pelosi blasts Trump for saying he may deliver convention speech from White House: ‘He can’t do that’
By Megan Henney | Fox News
She questioned whether the move was ‘legally wrong’ or ‘ethically out of the question’.
House Speaker Nancy Pelosi slammed President Trump for suggesting that ...
- Trump downplays Republican concerns about giving nomination acceptance at White House: ‘It is legal, there is no Hatch Act’
By Morgan Phillips | Fox News
President Trump played down fears from a Republican senator that him giving his speech accepting the Republican nomination from the White House ...
- Trump rips athletes kneeling for anthem, calls Black Lives Matter a ‘Marxist group’
By Joshua Nelson | Fox News
‘They’re not looking for good things for our country,’ he said.
President Trump called Black Lives Matter a Marxist group on Wednesday, pushing ...
- Carolyn Maloney declared winner in New York congressional race marred by mail-in ballot problems
By By Gregg Re | Fox News
Trump had called for a do-over in the contest, calling it a ‘total disaster’.
Election officials in New York finally declared winners late ...
- DB Cooper case gets new clues in tiny algae found on ransom money, study says
By Chris Ciaccia | Fox News
In a cold case for nearly 50 years ago, a scientist has uncovered new clues in the D.B. Cooper case by ...
![Recent documents disclosed as part of a Freedom of Information Act (FOIA) lawsuit against the U.S. Food and Drug Administration (FDA) show the agency knew its safety monitoring system was “not sufficient” for assessing the risk of heart conditions associated with Pfizer’s COVID-19 vaccine when it licensed the company's “Comirnaty” vaccine. Documents also reveal numerous manufacturing problems in Pfizer batches released to the public and show the FDA knew about a phenomenon known as vaccine-associated enhanced disease (VAED) in those vaccinated who experience breakthrough COVID-19. The FDA released the final batch of documents it relied upon in licensing Pfizer’s Comirnaty COVID-19 vaccine for ages 16 and up—more than 800 days after the agency approved the shot. The memo states: “The CBER Sentinel Program is NOT sufficient to assess the serious risks of myocarditis and pericarditis, and subclinical myocarditis associated with COMIRNATY (BNT162b2) in lieu of PMR safety studies under FDAAA [Food and Drug Administration Amendments Act]. “At the time of BLA [Biologics License Application] approval, the data sources in the CBER Sentinel Program are not sufficient to identify the outcomes due to lack of sufficient power to assess the magnitude of risk in patients 12-30 years of age. In addition, CBER Sentinel Program is not sufficient to follow up cases for recovery status and long-term sequelae, or for identification and characterization of subclinical myocarditis cases.” Cardiac Disorders Higher in Vaccine Trial Group According to an Aug. 23, 2021, BLA Clinical Review Memorandum, there were more cardiac disorders in trial participants who received Pfizer’s COVID-19 vaccine compared to the placebo group and more instances of tachycardia in the younger vaccinated age group. Cardiac conditions were reported as the cause of death in nine participants 25 to 128 days after having received at least one dose of Pfizer’s COVID-19 vaccine, including seven cases of cardiac arrest, one case of cardiovascular disease, and one case of congestive heart failure. Five cardiac-related deaths in the placebo group occurred 15 to 81 days after having received a placebo, including two cases of myocardial infarction, one aortic rupture, and two cardiac arrests. “Because COVID-19 mRNA and its Spike protein are found in the human heart at autopsy causing inflammation and heart damage, it is incontrovertible that the COVID-19 vaccines are cardiotoxic,” cardiologist Dr. Peter McCullough told The Epoch Times in an email. “Younger individuals with healthy hearts take up more of the damaging vaccine into the cardiac tissue resulting in symptoms of chest pain, palpitations, fluctuations in blood pressure, dizziness, and sadly, some, end up with cardiac arrest either during exercise or in the early morning waking hours. At both time periods, an internal surge of adrenalin appears to be the trigger for the fatal arrhythmia in those with COVID-19 vaccine myocarditis,” he added. Despite nearly double the number of reported cardiac events in vaccine recipients versus placebo recipients, the FDA concluded the deaths were “unlikely to be related to vaccination.” “As a cardiologist, these serious adverse events are unacceptable,” Dr. McCullough said. “I have called for all COVID-19 vaccines to be removed from the market with an urgent push for research strategies to prevent cardiac death after injection.” Vaccines Released Despite Manufacturing Issues According to the Pfizer Andover Response to Form FDA 483 included in the released documents, numerous manufacturing issues and inadequacies in quality oversight were also identified. Several batches of COVID-19 vaccines were flagged for deviating from product quality standards, yet the affected batches were released to the public in various lots, the numbers of which were redacted. In November 2021, whistleblower Brook Jackson, who worked as a regional director at testing sites by Pfizer contractor Ventavia, told the British Medical Journal that Pfizer's trial was riddled with issues. Ms. Jackson said the company “falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial.” Ms. Jackson, a trained clinical trial auditor with more than 15 years of experience in clinical research coordination and management, emailed a complaint to the FDA and was fired later that day. She subsequently filed a lawsuit against Ventavia and Pfizer, alleging Pfizer had defrauded the government while developing its COVID-19 vaccine. FDA Acknowledges Vaccine-Associated Enhanced Disease In its Pharmacovigilance Plan Review Memorandum, the FDA referenced a condition called “vaccine-associated enhanced disease.” According to the journal Vaccine, VAED is the modified presentation of a clinical infection affecting individuals exposed to the wild-type pathogen after having received a vaccine for the same pathogen. In its memo, the FDA stated there are reported deaths in the Vaccine Adverse Event Reporting System (VAERS) in patients reported to be fully vaccinated. Although the agency said that passive surveillance and spontaneous adverse event reporting generally cannot be used to conclude vaccine effectiveness because of the lack of a control group, reporter bias, and underreporting, “severe manifestations and death from COVID-19” increase the possibility of developing VAED, which has “overlapping clinical manifestations with natural SARS-CoV-2 infection, making it difficult to differentiate VAED from severe COVID-19 disease in individual VAERS reports.” The FDA said Pfizer was assessing the condition in its continuation of Phase 3 clinical studies and active surveillance studies. VAED has been observed in other vaccine trials involving the dengue virus, respiratory syncytial virus, and measles. FDA Took Over 800 Days to Release Data The Public Health and Medical Professionals for Transparency (PHMPT), a nonprofit consisting of public health and medical professionals, scientists, and journalists, filed a FOIA lawsuit against the FDA in September 2021 to force the release of hundreds of thousands of documents relied upon by the agency in licensing Pfizer’s COVID-19 vaccine for individuals age 16 and older. Even though the FDA said in a news release it was committed to “ensuring full transparency, dialogue and efficiency” regarding COVID-19 vaccines and reiterated its commitment to full transparency when it licensed Pfizer's Comirnaty vaccine, they wanted 75 years to produce an estimated 451,000 documents at a rate of 500 pages per month. It previously estimated it had 329,000 pages of responsive records and wanted 55 years to release them to the public. Attorney Aaron Siri, who filed the lawsuit on behalf of the group, said the federal government was shielding Pfizer from liability, gave it billions of dollars, and forced Americans to get vaccinated while preventing the safety and efficacy data supporting the licensure of Pfizer’s COVID-19 vaccine from being released until the year 2076. Yet it only took 108 days from when Pfizer started producing records to the agency for the FDA to license its vaccine.](https://www.usnn.news/wp-content/uploads/2023/12/Final-Batch-of-Pfizer-Documents-Released-Shows-FDA-Knew-Safety-Monitoring-System-Was-Not-Sufficient.jpg "Final Batch of Pfizer Documents Released Shows FDA Knew Safety Monitoring System Was 'Not Sufficient' 9")
