The Food and Drug Administration (FDA) is under fire over requests for medical information from researchers seeking to determine whether the agency is obfuscating any connection between Covid mRNA vaccines and premature deaths in North -younger Americans.
Jessica Adams, a researcher with more than a decade who covers FDA advisory panels based on her personal biographical information, revealed her recent experience trying to obtain critical information from the public health agency.
“On July 4th, I submitted a FOIA request to the FDA to obtain this status and, ideally, the results of the studies needed to evaluate subclinical myocarditis with the COVID mRNA vaccines,” Adams wrote on Twitter. “Details of the study are shown in the attached images.”
On July 4, I submitted a FOIA request to the FDA to obtain this status and, ideally, the results of the studies needed to evaluate subclinical myocarditis with the COVID mRNA vaccines. Details of the study are shown in the attached images.
I asked for expedited processing, which… pic.twitter.com/NcfmVZgivm
— Jessica Adams (@RxRegA) July 10, 2023
“I requested expedited prosecution, which requires a showing of compelling need involving an imminent threat to a person’s life or physical safety,” he continued.
“This is what I stated about it: ‘There are now data from Korea that some cases of vaccine myocarditis are causing sudden death without any clinical myocarditis being reported (Vaccination-related myocarditis COVID-19: a national study Korean). This requires urgent accounting for subclinical myocarditis, because individuals in the United States will again be subject to mandates on these products within 1-2 months (eg, university mandates, youth care worker mandates healthcare).
“This poses an imminent threat to the health of these individuals, and by not releasing the requested information, the FDA is putting public health at risk,” Adams continued. “These post-marketing commitments (PMCs) were required by the FDA and there has been a long delay that is unexplained. The fact that Korea has identified 8 unreported cases of vaccine myocarditis leading to sudden death of a otherwise to its vaccine safety surveillance systems, and the US has explained zero vaccine myocarditis deaths despite a much larger population, it represents an urgent and imminent threat to young people who may be required to take this vaccine, if indeed subclinical myocarditis is a known concern.”
“Although unvaccinated youth during the height of covid received benefit from the vaccine, any benefit from these vaccine boosters is much smaller given pre-immunity, prior vaccination and low prevalence; therefore , subclinical myocarditis would pose a threat to the risk/benefit balance. This needs to be addressed immediately, before the autumn terms,” he added.
“Unfortunately, the FDA has denied my request for expedited processing, stating that I did not demonstrate the necessary compelling need,” he noted. “It is time for the public and the media to demand transparency from the FDA on this issue, which is important to consider before the next vaccine campaign. It is also an important matter of principle that the FDA follow up on PMCs with a significant interest to the public and to public health”.
Epoch Times researcher Zachary Stieber also filed a Freedom of Information Act request with the FDA for related information on the issue of medical data transparency. Stieber covered the results of the Korean national study for the Times.
“Some sudden deaths were caused by COVID-19 vaccines, autopsies have confirmed,” Stieber noted in a June 6 story. “Eight people who died suddenly after receiving a COVID-19 messenger RNA (mRNA) vaccine died from a type of vaccine-induced heart inflammation called myocarditis, South Korean authorities said after review the autopsies.”
“Vaccine-related myocarditis was the only possible cause of death,” said Dr. Kye Hun Kim of Chonnam National University Hospital and other researchers in South Korea.
“All of the sudden cardiac deaths (SCDs) occurred in people 45 years of age or younger, including a 33-year-old man who died just one day after receiving a second dose of Moderna’s vaccine and a 30-year-old woman who died three years. days after receiving the first dose of the Pfizer injection,” Steiber continued. “Myocarditis was not suspected as a clinical diagnosis or cause of death prior to autopsies, the researchers said.”
The report noted that “thirteen additional deaths were reported among those who developed myocarditis after the COVID-19 vaccination, but autopsy results were not detailed. Some of those who died had received the vaccine AstraZeneca’s COVID-19.”
Critically, there was a significant increase in heart attack deaths in the second year of the Covid-19 pandemic, when mRNA vaccines were introduced.
Recent data analysis by the Smidt Heart Institute at Cedars-Sinai has revealed a significant increase in heart attack deaths during pandemic waves, including the recent Omicron COVID-19 variant. This alarming trend marks a reversal of the previously observed decline in heart attack-related deaths before the pandemic.
Heart attacks were already the leading cause of death globally before the COVID-19 outbreak, but had been steadily declining. However, the October 2022 study, published in the peer-reviewed Journal of Medical Virology, indicates a sharp increase in death rates from heart attacks in all age groups during the pandemic.
Key findings from the study include:
In the year before the pandemic, there were 143,787 heart attack deaths; within first year of the pandemic, this number had increased by 14% to 164,096. Excess mortality associated with acute myocardial infarction has persisted throughout the pandemic, even during the most recent period marked by an increase in the presumed less virulent Omicron variant. The researchers found that while deaths from acute myocardial infarction during the pandemic increased in all age groups, the relative increase was most significant for the youngest group, ages 25 to 44. second year of the pandemic, “observed” versus “predicted” rates of heart attack death it increased 29.9% for adults 25-44, 19.6% for adults 45-64, and 13.7% for adults 65 and older.
A University of Oxford study previously showed that the risk of myocarditis is greater from “getting vaccinated” with the mRNA injections than from contracting the virus itself. The study was originally published in Nature Medicine in December.
“This is the largest study to date of acute cardiac outcomes after SARS-CoV-2 vaccination or infection, the first to compare the risk of cardiac events between different vaccine products and SARS-CoV2 infection and the first to investigate the association between cardiac events and the ChAdOx1 vaccine,” the study states.
“Our findings are relevant to the public, clinicians and policy makers,” the researchers note. “First, there was an increased risk of myocarditis within one week of receiving the first dose of both adenovirus and mRNA vaccines, and a greater increased risk after the second dose of both mRNA vaccines.”
Alarmingly, a reanalysis of clinical trial data has found that the Pfizer and Moderna COVID-19 vaccines had no significant impact on overall mortality. The study, published in the journal Cell in April, found that while the mRNA-based vaccines effectively protected against deaths from COVID-19, vaccinated participants in the trials were more likely to suffer cardiovascular-related deaths .
In contrast, vaccines using adenoviruses, such as Johnson & Johnson’s vaccine, were found to have a positive impact on both COVID-19 mortality and overall mortality, according to the reanalysis. The research team looked at data from randomized clinical trials (RCTs) conducted by the vaccine manufacturers themselves.
“In RCTs with the longest blinded follow-up possible, mRNA vaccines had no effect on overall mortality despite protecting against some deaths from COVID-19. On the other hand, adenovirus vector vaccines were associated with lower overall mortality,” the researchers said.
Excess death rates remain high in many Western nations with high Covid vaccination rates, including the United States. A major factor exacerbating susceptibility to heart disease in the United States is obesity, the authors note.
“The US has higher death rates than its peers due to a variety of causes,” notes Patrick Heuveline. “The prevalence of cardiovascular disease has been an important driver of changes in life expectancy worldwide in recent decades. But while death rates from cardiovascular disease have continued to decline in other parts of the world, these rates have stagnated in the US.”
“A key reason for this trend is the increase in obesity, as research shows that obesity increases the risk of death from cardiovascular disease,” he adds. “The high prevalence of obesity in the United States also contributed to relatively high death rates from COVID-19.”
According to a new report from the Brownstone Institute, the Centers for Disease Control and Prevention (CDC) hid references to COVID-19 vaccines on Minnesota death certificates, ensuring fatalities were recorded as a anything other than vaccine related. The source of these allegations has chosen to remain anonymous, but has provided copies of Minnesota death certificates from 2015 to the present.
Documents obtained in the report appear to show that the CDC has misled the public about US death data and vaccine safety. The report alleges that the CDC has engaged in data fraud by omitting the ICD 10 code for vaccine side effects in cases where COVID-19 vaccines were identified as the cause of death in certificates
The report shows a number of cases where the mRNA vaccine was administered very close to the cause of the patient’s death, but the ICD 10 codes for the Covid vaccines were missing from the death certificates. It is unclear how widespread this practice was at CDC during the pandemic, but further systematic investigation is warranted and would be greatly facilitated by congressional subpoenas and compliance with FOIA requests.
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