Tag: vaccines

Elevated risk of stroke in elderly patients who receive Covid and high dose flu shot at same time

On Jan. 13 2023, the U.S. Food and Drug Administration (FDA) and the U.S. Centers for U.S. Disease Control and Prevention (CDC)) issued a public statement regarding the identification of a preliminary safety signal for ischemic stroke among adults over the age of 65 that occurs between one to 21 days after receiving Pfizer/BioNTech’s monovalent Comirnaty messenger RNA (mRNA) Covid-19 shot and the WT/OMI BA.4/BA.5 bivalent version of it.

The safety signal was detected in the CDC’s Vaccine Safety Datalink (VSD), however, a primary analysis conducted by federal public health officials did not find elevated stroke risk following Covid bivalent shots.

The first CDC analysis evaluated the risk of the stroke following a Covid bivalent shot. The study’s sample population included 5,397,278 adults over 65 years old, who were given either the monovalent Comirnaty bivalent WT/OMI BA.4/BA.5 shot or Moderna/NIAID’s bivalent Spikevax shot.

There were 2,886 cases of NHS; 2,641 cases of transient ischemic attack (TIA); 4,788 cases of NHS/TIA, and 808 cases of hemorrhagic stroke (HS) across both manufacturers of the Covid shots.

Approximately 10-15 percent of the sample cases claimed they had Covid disease between 31 to 365 days prior to suffering a stroke, and 34-45 percent had been given a high-dose or adjuvanted influenza vaccination at the same time.

The findings from the primary analysis showed that there were no statistically significant associations of an increased risk of stroke following administration of the Covid bivalent shots.

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Top FDA Officials Accepted Jobs With Moderna After Playing Key Roles In The Licensure Of COVID-19 Vaccines

A new BMJ investigation reveals a “revolving door” between FDA officials tasked with regulating COVID-19 vaccines and the companies who manufacture them.

Two high-level regulatory officials with the U.S. Food and Drug Administration (FDA) involved in vaccine oversight accepted jobs at Moderna just months after signing off on the licensure of the company’s COVID-19 vaccine, according to a British Medical Journal (BMJ) investigation.

The report by Peter Doshi, associate professor at the University of Maryland School of Pharmacy and senior editor at The BMJ, reveals a long-standing revolving door between the FDA and pharmaceutical companies whose products it regulates and raises questions about the impartiality and independence of top FDA regulators.

Dr. Doran Fink is a “physician/scientist experienced in regulation and clinical development/licensure of vaccines and related biological products” and was deeply involved with vaccine regulation at the FDA for more than 12 years, according to his LinkedIn profile.

According to the BMJ report, Dr. Fink started his FDA career as a clinical reviewer in 2010 and “worked his way up” to Deputy Director of the Division of Vaccines and Related Product Applications within the FDA’s Office of Vaccines Research and Review, where he led a team of medical officers focused on infectious diseases and related biological projects.

During the COVID-19 pandemic, Dr. Fink was a prominent voice on COVID-19 vaccines and which population groups should receive them. He spoke on behalf of the FDA at numerous meetings held by the agency’s vaccine advisors who met to discuss whether to approve COVID-19 vaccines, change their composition, or authorize boosters.

Dr. Fink also presented at meetings held by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices—a group of health experts that develop recommendations on how to use vaccines—as the FDA’s “principal FDA ex officio representative.”

According to the BMJ report and Dr. Fink’s LinkedIn profile, Fink also served on the senior leadership team for COVID-19 vaccine review and policy activities in response to the COVID-19 public health emergency.

As part of his role, he advised vaccine manufacturers on vaccine development throughout the pandemic and coordinated “expedited review of regulatory submissions,” advised U.S. government stakeholders outside the FDA on COVID-19 vaccine science and development, and contributed to FDA guidance on the development, licensure, and emergency use authorization of COVID-19 vaccines.

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Orange County 15-month-old dies 2 days after ‘well-visit’ vaccinations

Melody Rain Palombi-Malmgren was a happy toddler with an infectious smile and laugh. She loved to dance, cuddle, and sit in her swing. 

In July, the little girl celebrated her first birthday, but no one could have imagined it’d also be her last. 

“Everything about her was just pure joy,” says Melody’s mother, Katherine Palombi. “I’m in complete shock. This is a child that was perfectly healthy.”  

Palombi says she brought Melody to her pediatrician’s office, the Herbert Kania Pediatric Group in Warwick, on Oct. 17 for her 15-month well-visit where she received three vaccines. Two days later, without showing any signs that anything was wrong, Palombi says her daughter stopped breathing and went into cardiac arrest.  

“It was the most horrible day of my life. I got to work. She waved goodbye to me that morning and then my mother called saying she was having trouble breathing. I just kept saying, she just had vaccines, she just had vaccines,” says Palombi. 

Melody was brought to St. Anthony’s Hospital by ambulance. She says the child’s grandmother, who was caring for her that day, was instructed by 911 to perform CPR until paramedics could arrive. She says emergency medical personnel and hospital staff attempted lifesaving measures for several hours to no avail. 

“They brought me in the room, and I saw her laying there,” recalls Palombi. “They said time of death 11:13. I just completely hit the floor. I completely passed out.” 

Hospital records obtained by News 12 show the baby suffered liver and kidney failure, as well as cardiac arrest. 

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Billions Of Copies Of Residual DNA In A Single Dose Of COVID-19 mRNA Vaccine: Preprint

A new preprint study up for peer review finds billions of residual DNA fragments in the COVID-19 mRNA vaccine vials.

The lead author of the study, molecular virologist David Speicher, who has a doctorate in virology, told The Epoch Times that their study is “the largest study” on residual DNA in COVID-19 vaccines to date.

“In our study, we measured DNA copies of spike, ori (origin of replication), and SV40 enhancer genes,” he told The Epoch Times. “The loads of SV40 enhancer-promoter, ori, and virus spike in Pfizer are up to 186 billion copies per dose.”

The spike he refers to is the DNA sequence of the SARS-CoV-2 spike protein, which can be transcribed to spike mRNA to be used in the COVID-19 mRNA vaccines to be translated to spike protein. The other two DNAs—SV40 enhancer genes and ori—help facilitate the replication of spike DNA.

However, the final mRNA vaccines should only include RNA and not residual DNA instructions for spike production.

The researchers sequenced the gene material in 27 mRNA vaccine vials from 12 different lots. Nineteen vials were from Moderna, and eight were from Pfizer.

“Further work is needed to investigate if anything in these vaccines is actually integrating into the human genome and what effect that may have,” the lead author wrote.

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Getting flu and COVID shot together still reasonable amid safety review of potential stroke risk: Experts

Older adults who received last year’s COVID booster and a high-dose version of the flu vaccine in the same visit may have a potential increased risk of stroke, according to a new FDA-funded study.

Experts urged that the results were preliminary and may be explained by other factors such as the fact that older adults are already at a higher risk for stroke due to their age.

“There is no need for panic, and emphatically no need to stop giving COVID and flu shots at the same time to older adults,” said Dr. Peter Chin-Hong, an infectious diseases specialist at the University of California, San Francisco, while he reiterated that more research is needed.

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How Pfizer Hid Nearly 80% of COVID Vaccine Trial Deaths From Regulators

Pfizer-BioNTech delayed reporting vaccine-associated deaths among BNT162b2 clinical trial participants until after the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the product.

The vaccine makers also failed to account for a large number of subjects who dropped out of the trial.

Together, these strategies kept regulators and the public ignorant of a 3.7-fold increase in cardiac deaths among subjects who received the vaccine, according to analysis in the International Journal of Vaccine Theory, Practice, and Research.

The authors of the paper described it as a “forensic analysis,” defined by the U.S. National Institute for Standards and Technology as “the use of scientific methods or expertise to investigate crimes or examine evidence that might be presented in a court of law.”

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FDA finds potential ‘safety signal’ of seizures in 2-5 yr olds after getting Covid-19 shots

A new preprint study led by the U.S. Food and Drug Administration (FDA) has detected a potential “safety signal” for seizures and convulsions in young children after receiving the monovalent Pfizer or Moderna mRNA Covid-19 vaccines.

Researchers observed the condition in children ages 2-4 for the Pfizer vaccine, and ages 2-5 for the Moderna vaccine.

The total number of cases was 72, with over 50% meeting the definition for febrile seizures.

The median time between vaccination and seizures or convulsions was two days, with 32% occurring the day of or the day after vaccination. All seizures and convulsions took place within seven days of vaccination.

The signal emerged through near real-time surveillance of more than 4 million vaccinated children.

The researchers of the preprint study cautioned that the results “should be interpreted carefully given study limitations.”

The study also identified a myocarditis/pericarditis safety signal in mostly male children 12-17 years old.

However, since each of these conditions were a “known adverse outcome,” according to the researchers, they did not conduct any further follow-up.

Data for the study were collected through health claims records from CVS Health, Optum and Carelon Research, which participate in the FDA’s Center for Biologics Evaluation and Research, and supplemented with data from state and local immunization information systems databases.

The study covered reports through January, February or March of this year — as little as 6 months after the approval of vaccinations for younger children.

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How Mastercard’s Digital ID Project Is Being Used by Governments To Track Health and Vaccination

In Mastercard’s ongoing technological pursuits, there seems to be an agenda of consolidating digital dominance. The so-called “Community Pass” project, helmed by Tara Nathan, Mastercard’s executive vice president, claims to integrate marginalized communities into the digital world. However, with only 3.5 million users so far, skeptics of digital ID plans may wonder about its real reach and intentions.

Nathan’s recent appearance on the company-sponsored podcast “What’s Next In,” touted the supposed merits of the Community Pass. Launched in 2019, this platform ostensibly provides individuals in Sub-Saharan Africa and Asia-Pacific with a digital ID and wallet, allowing them access to services such as government benefits and humanitarian assistance.

Nathan waxed eloquent about the supposed benefits of digitization for developing economies. But her emphasis on using offline digital channels to supposedly empower marginalized individuals raises eyebrows. Is this another case of a multinational company trying to sell its tech solutions to unsuspecting communities under the guise of altruism?

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COVID-19 Vaccines ‘May Trigger’ Rheumatic Inflammatory Diseases: Study

A new review suggests that COVID vaccines “may trigger” rheumatic immune-mediated inflammatory diseases, including arthritis, vasculitis, lupus, and adult-onset Still’s disease.

On average, patients developed rheumatic diseases 11 days after vaccine administration, according to the study. Seventy-five (over 27 percent) of these patients experienced total disease remission, and about 50 percent improved following treatment. Eight were admitted to intensive care, and two died from their symptoms.

“The short time span between COVID-19 vaccine administration and the onset of R-IMIDs suggests the potential possibility of a cause-and-effect relationship,” the authors wrote.

Rheumatic immune-mediated inflammatory diseases (R-IMIDs) involve inflammation that manifests in the joints, tendons, muscles, and bones due to an unknown cause.

The study, led by researchers from the National Health Service in the United Kingdom, examined 271 participants from 190 case studies published worldwide.

Over 80 percent of the patients developed symptoms after their first or second dose of the COVID-19 vaccine, and most were treated and improved with corticosteroids.

Almost 57 percent of the injured patients received the Pfizer vaccine, nearly a quarter received the AstraZeneca vaccine, and 12 percent of the rheumatic diseases manifested after the administration of the Moderna vaccine.

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Dozens of Death Certificates List COVID-19 Vaccination as Cause of Death

Dozens of people were killed by COVID-19 vaccines in the United States, death certificates show.

COVID-19 vaccination is listed on 26 death certificates across five states, an Epoch Times review found.

That includes a 78-year-old Minnesota man who died on Jan. 5, 2021. The man suffered sudden cardiac death just 10 hours after receiving a second COVID-19 vaccine dose.

Certifiers listed COVID-19 vaccination on part one of some certificates. According to guidance from the U.S. Centers for Disease Control and Prevention (CDC), part one of a certificate is for causes that lead directly to death.

In other instances, the vaccination was listed in part two. That part is for “other significant conditions that contributed to the death,” according to instructions from the CDC for medical examiners and coroners.

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