- Elections, Debt, and Taxes: Here’s What to Expect in the 119th Congress
By Arjun Singh
WASHINGTON—The 119th Congress of the United States will take office on Jan. 3, 2025, and last for two years, until Jan. 3, ...
- How a 2nd Trump Administration Might Affect Foreign Policy
By Andrew Thornebrooke and Ryan Morgan
The second administration of President-elect Donald Trump is anticipated to bring great change to America’s foreign policy establishment.
From wars ...
- FBI Identifies Suspected Terrorist in New Orleans Attack, Death Toll Rises to 15
By Jack Phillips
The FBI has identified the suspect who carried out an attack in New Orleans on New Year’s Day that left at least ...
- 10 Dead, Dozens Injured After Vehicle Plows Into Crowd in New Orleans: Officials
By Zachary Stieber
Ten people are dead and dozens of others are injured after a vehicle plowed into a large crowd in New Orleans, officials ...
- Chinese Hackers Breached Workstations, Stole Documents, Treasury Department Says
By Emel Akan
WASHINGTON—Chinese hackers remotely breached the U.S. Treasury Department earlier this month, stealing documents from its workstations, according to a letter the agency ...
- Trump Issues Warning to Republicans on Potential Delays for Cabinet Nominees
By Jack Phillips
President-elect Donald Trump on Tuesday called on Republicans to try to overcome possible Democrat efforts to delay Senate confirmation of his Cabinet ...
- Trump Endorses Mike Johnson for House Speaker
By Joseph Lord
President-elect Donald Trump has given a full endorsement to embattled House Speaker Mike Johnson (R-La.), potentially hedging off a divisive fight later ...
- Jimmy Carter, 39th President and Nobel Peace Prize Winner, Dies at 100
By Jack Phillips and Jacob Burg
Former President Jimmy Carter, the longest-lived president in U.S. history, died at his home, his family and the Carter ...
- Musk, Ramaswamy Defend Foreign Worker Visas Amid Social Media Backlash
By Jacob Burg
After Elon Musk and Vivek Ramaswamy made posts on the social platform X this week endorsing an expansion of the visa program ...
- Trump Issues Christmas Message to Trudeau, Greenland, China, Panama
By T. J. Muscaro
President-elect Donald Trump issued a Christmas message on Truth Social that once again reiterated his stance on resecuring the Panama Canal, ...
- Mexico to Open Shelters for Deported Citizens on Trump’s Inauguration Day
By Bill Pan
Mexico is preparing to receive its citizens who have been living in the United States illegally, with government officials planning to open ...
- Rand Paul Releases Annual ‘Festivus’ List of Wasteful Government Spending
By Jackson Richman
Sen. Rand Paul (R-Ky.) released on Dec. 24 his annual “Festivus” list of wasteful government spending in the past year.
“Festivus” is a ...
![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' 2")
