Twitter in 2021 banned Project Veritas for sharing private information without consent after the group posted a video showing the residence of a Facebook official. Ana Cabrera, a CNN employee, shared the development on Twitter. A CNN article written by Brian Fung also detailed what had transpired.

Four days later, on a CNN program, Cabrera said that “We’re starting to see companies cracking down to try to stop the spread of misinformation and to hold some people who are spreading it accountable.” She noted the ban on Project Veritas before saying “this is part of a much broader crackdown, as we mentioned, by social media giants that are promoting misinformation.”

A U.S. district judge in 2022 turned away a suit brought by Project Veritas over the comments and CNN’s failure to retract them. He said the remarks were substantially true because their effect on the audience was similar to the effect that would have come if CNN had discussed the actual reason Twitter banned Project Veritas.

The distinction between the purported and actual reasons “is not enough to make the statement at issue actionable as both violations are similarly damaging to the journalist’s reputation,” according to that ruling.

The U.S. Court of Appeals for the Eleventh Circuit ruled on Nov. 7 that the previous decision was wrong,

“Cabrera accused Veritas of substantially different behavior than that in which Veritas engaged. Under New York law, such a statement is not substantially true,” U.S. Circuit Judge Elizabeth L. Branch wrote for the unanimous three-judge panel that was assigned the case. “Veritas committed one infraction; CNN accused it of a completely different one.”

Project Veritas has offered sufficient evidence to overcome CNN’s motion to dismiss the case at this stage, Branch said, when the allegations in the complaint are taken as true.

The district court did not decide whether Cabrera’s remarks were done with actual malice, a requirement for state defamation claims under court interpretations of the U.S. Constitution’s First Amendment.

Cabrera’s social media post and Fung’s article show that Cabrera was aware her statements on-air were probably false, the panel said.

Judges Andrew Brasher and Ed Carnes joined in the ruling.

Carnes said in a concurring opinion that “I never thought I’d see a major news organization downplaying the importance of telling the truth in its broadcast” and noted that CNN outside the case repeatedly emphasizes its dedication to truth. Its mission statement, for instance, says that “we are truth-seekers and story tellers.”

The decision reversed the lower court ruling and remanded the case back to the court for proceedings consistent with the new decision.

A lawyer representing CNN did not respond to a request for comment by publication time.

The U.S. government is “looking closely” at the possibility of vaccinating farm workers and others in close contact with the virus, according to Dawn O’Connell, the assistant secretary for preparedness and response at the U.S. Administration for Strategic Preparedness and Response.

Angela Rasmussen, a virologist at the University of Saskatchewan, said she has been in discussions with U.S. and Canadian officials about using vaccines to protect workers after the influenza, or bird flu, jumped from birds to cattle.

The first cases of H5N1, a strain of the flu, in cattle were detected earlier this year, although some scientists say available evidence points to the cases cropping up in late 2023.

Discussions about using vaccines to try to prevent a pandemic are ongoing at the government level and among scientists in several places, including the UK, said Wendy Barclay, chair in influenza virology at University College London, who also researches avian flu for the UK Health Security Agency.

The UK government did not comment but said it is monitoring the situation in the United States.

In the European Union, the European Commission’s Health Emergency Preparedness and Response Authority is working on a joint procurement of CSL Seqirus’s vaccine to “potentially prevent a pandemic” sparked by individuals exposed to infected birds and animals, spokesman Stefan De Keersmaecker said.

A spokeswoman for CSL, which has contracts for pandemic influenza vaccines with 30 governments, said the company has been in talks with several governments about procuring vaccines since 2022.

The U.S. Food and Drug Administration approved a CSL influenza A vaccine in 2020, based largely on immunogenicity and safety results from a small clinical trial of 319 people.

Dr. Peter McCullough, an epidemiologist based in Texas, said on the social media platform X that without larger trials, it’s not possible to know whether the vaccine is safe or effective in humans.

The formulation for the CSL shot has been updated to more closely match the bird flu, which is an influenza A virus.

U.S. officials said recently that they’re planning to produce 4.8 million doses of the updated CSL vaccine. European health officials also said they were in talks to acquire CSL’s shot.

Canadian health officials said they have met with GSK, maker of Canada’s seasonal flu shots, to discuss acquiring and manufacturing a prepandemic bird flu vaccine.

The United States is in talks with Pfizer and Moderna, which make messenger ribonucleic acid (mRNA) COVID-19 vaccines, about potential pandemic vaccines.

University of Pennsylvania researchers said in a May 23 paper that their experimental mRNA bird flu vaccine performed well in preclinical testing in ferrets.

Since the bird flu cases in cattle were first detected, cases have been confirmed in 63 herds across nine states, including Colorado, Michigan, and South Dakota, according to the U.S. Department of Agriculture.

Human Cases

Two cases in humans—one in Michigan and one in Texas—have also been confirmed. Both have since recovered. Analysis of virus samples from the patients showed high similarities to the virus spreading in cows.

Richard Webby, a St. Jude Children’s Research Hospital virologist who studies flu in animals and birds for the World Health Organization, said the situation in dairy cattle merits vaccine use.

“If we look at the exposure levels that some of these farmers are getting, it’s high,” Mr. Webby said.

The decision on how and when to use the vaccine will hinge on evidence of increased transmission, severity of disease, cases in people with no link to a dairy farm, and mutations in the virus, U.S. Centers for Disease Control and Prevention (CDC) Principal Deputy Director Nirav Shah said.

The agency says on its website that the government is developing bird flu vaccines “in case they are needed.”

Human exposure to the virus in poultry and dairy operations could increase the risk that the virus will mutate and gain the ability to spread easily in people. Vaccines that perform poorly can also increase that risk.

So far, only one change has been detected in the human cases, the CDC said on May 24.

“These data indicate viruses detected in both cows and the two human cases maintain primarily avian genetic characteristics and lack changes that would make them better adapted to infect or transmit between humans,” the agency stated.

For now, CDC officials say the best way to avoid bird flu is to stay away from infected animals, fluids, and feces.

Workers who must come into contact with animals are advised to wear protective equipment and monitor themselves for symptoms, which include fatigue.

People who do become sick can take influenza antivirals, which are more effective when received shortly after symptoms develop.

Health officials also recommend cooking eggs and poultry to at least 165 degrees Fahrenheit, cooking beef to appropriate temperatures, and only consuming pasteurized milk.

Testing of beef found a surrogate virus was still present in burgers cooked rare, according to the Department of Agriculture. High levels of bird flu virus have been detected in raw milk. Some pasteurized samples tested positive, but further testing showed no viable virus, according to the Food and Drug Administration.

Reuters contributed to this report. 

The agency also redacted how multiple children were diagnosed with Kawasaki Disease after receiving a COVID-19 vaccine, according to the documents.

The Epoch Times obtained more than 1,400 pages of emails from the CDC concerning its Clinical Immunization Safety Assessment (CISA) project, which analyzes post-vaccination problems reported by health care providers. The tranche included numerous redactions.

While redactions are allowed under the Freedom of Information Act, there were signs that too much information was being hidden.

The Epoch Times appealed some of the redactions.

The CDC agreed to remove some of them, revealing what the agency initially shielded.

In one email, a provider reports a 30-year-old woman who suffered chest pain and leg twitching following COVID-19 vaccination. The original copy of the email stated in part that she “got vaccine due to [redacted].”

In the updated copy, the CDC removed the redaction, showing that the woman received a vaccine because of a mandate at work.

Several other portions of the emails that are now unredacted show the CDC hid how multiple children, including a 2-year-old, were said to have suffered from a serious inflammatory illness called Kawasaki Disease shortly after receiving a shot.

One girl suffered inflammation around the eyes, swollen lips, high fever, and a rash, and “was admitted last week with Kawasaki,” one of the girl’s parents wrote on Dec. 5, 2021, the new documents show. She received a dose of the Pfizer-BioNTech vaccine two weeks prior.

Dr. Matthew Oster is a cardiologist who works for the CDC.

“The biggest question, of course, here, is whether this was truly [redacted] or whether this was [redacted] related to the vaccine,” Dr. Oster wrote after hearing about the case.

The cleaner copy of the email showed that the redactions covered “KD,” or Kawasaki Disease, and “MIS-C,” or multisystem inflammatory syndrome in children.

“We do now have a small number of cases like this one,” Dr. Oster said.

The CDC has portrayed MIS-C as only being caused by COVID-19, but studies have found that there were MIS-C cases before the COVID-19 pandemic and that some people suffered the syndrome after vaccination without evidence of COVID-19. The CDC says on its website that the agency is “investigating reports of multisystem inflammatory syndrome in children (MIS-C) associated with coronavirus disease 2019 (COVID-19), which may present with Kawasaki disease-like features.”

Another email originally hid the age of a male child and what his doctor suspected he suffered after receipt of a second dose of Moderna’s vaccine.

The boy was 2 years old, the newly obtained documents show, when he was admitted with what a pediatric infectious disease doctor suspected was “atypical Kawasaki Disease.” The documents show that the doctor also considered MIS-C as a diagnosis in light of how the boy’s sister tested positive for COVID-19 on the same day the boy started showing symptoms of fever, although multiple COVID-19 tests on the boy returned negative.

The doctor said he had a “low suspicion” for a COVID-19 vaccine reaction but still submitted a report to the Vaccine Adverse Event Reporting System (VAERS), which the CDC helps run.

Kawasaki Disease was detected as a safety signal for the Pfizer and Moderna vaccines among children aged 5 to 11 when the CDC first ran an analysis on VAERS data in 2022, according to files previously obtained by The Epoch Times. The analysis did not include children younger than 5. Kawasaki disease after COVID-19 vaccination has been reported in the literature, although a study on patients with a history of the disease who contracted COVID-19 or were vaccinated uncovered no signs of problems.

An internal CDC message, now fully unredacted, showed that an official described there being “another CISA ‘inquiry’ about a child with atypical Kawasaki Disease.” Another official said the reports were “very rare” while a third said the normal CDC processes were sufficient to monitor for the disease post-vaccination “unless there’s a specific ask or data need.”

Other removed redactions show that:

• A person reporting symptoms after COVID-19 vaccination was reporting that the symptoms included Coxsackievirus and that he himself was the patient. The provider wrote, “I … don’t know whether to fear another vax more or less than the risk of infection.”
• A patient who was reported as suffering heart inflammation after a third Pfizer dose, and came back with the inflammation one year later, was 17 and a male.
• The CISA expert who said the woman who suffered chest pain could get additional vaccine doses was Dr. Oster. Previously disclosed emails showed the program repeatedly said people with post-vaccination symptoms should receive more doses.
• A patient with “intense malaise” and other symptoms about six months after a Pfizer shot had an elevated heart rate, per a portable electrocardiogram, and sinus tachycardia per a cardiology consultation.

Words and phrases that were redacted originally, but not any longer, include “your daughter”, “hospitalist”, “the parents”, “cardiac workup”, “a physician”, “I believe”, “patient was started on a course of Prednisone”, and “does not drink, smoke, or use any drugs.”

Every single email chain for which redactions were protested was returned with at least some redactions cleared.

The original version claimed that the redactions were appropriate under exceptions outlined in the Freedom of Information Act, including an exception that protects “personnel and medical files and similar files” if their disclosure “would constitute a clearly unwarranted invasion of personal privacy.”

A CDC official told The Epoch Times in an email that the agency, after receiving the appeal, conducted a “careful review” and removed some of the redactions. The official did not explain why the CDC wrongly redacted so much information.

The CDC “has provided modified records for the pages listed in your appeal,” an official with the U.S. Department of Health and Human Services, the CDC’s parent agency, told The Epoch Times in an email. Appeals of CDC Freedom of Information Act requests are lodged with the department.

Fits Pattern

Any person can request information through the Freedom of Infection Act (FOIA), and agencies across the government typically redact portions of responsive documents or withhold them entirely. Agencies “often use FOIA exemptions improperly, withholding records simply because they may reveal problems at the agency or just ‘paint the agency in a bad light,’” Melissa Wasser, a lawyer at the Project On Government Oversight, told senators in 2022. People “consistently receive large swaths of arbitrarily redacted information,” she added.

When presented with signs that information was improperly redacted or withheld, people primarily have two options: lodge an appeal or sue.

Both methods have worked to extract information from the CDC during the pandemic.

An Epoch Times appeal in another case, for example, returned a copy that removed significant redactions that were applied to an internal email describing what Pfizer and Moderna told them about studies that were being done regarding heart inflammation and COVID-19 vaccines.

The unredacted information showed that Moderna had not tested samples from vaccine recipients for subclinical myocarditis because it was waiting for a “specific cardiac biomarker [to] be identified.” An outside study from Switzerland later found signs of subclinical heart inflammation in about one out of 35 people.

The CDC acknowledged that the information had been wrongly redacted. It reasoned that the information “cannot be considered confidential” because it was shared before and “is readily available to the public,” although some of the details had never been made public previously.

Among other lawsuits, meanwhile, one led to the release by the CDC of answers from its V-safe surveillance survey while a second prompted the disclosure of what participants wrote in free-text fields after the CDC left off adverse events of special interest from the survey. Some of the data had never before been described publicly, while other information from the system had only been outlined in CDC-authored studies and presentations.

The 780,000 reports were received shortly after the COVID-19 vaccines were rolled out, and show people experienced a wide range of post-vaccination problems, including heart inflammation, miscarriages, and seizures.

“Loss of consciousness and seizure immediately following injection. Went to ER by ambulance,” one person reported.

“Diagnosed with Bells Palsy today due to left-sided facial numbness and paralysis,” another said.

People lodged the reports with V-safe, a text-message system created by the CDC to monitor for possible side effects of COVID-19 vaccines.

The CDC, for years, declined to make the V-safe data public, instead publishing studies that described the reports as providing reassurance about the safety of the shots. However, according to data released in 2022, nearly 8 percent of the 10 million users required medical attention or hospital care after vaccination, and many others reported missing school, work, or other normal activities.

That topline data came from check-the-box surveys.

The same judge who ordered the release of that data ordered the agency in January to disclose free-text entries from a different section where individuals could describe their experiences. U.S. District Judge Matthew Kacsmaryk, appointed by former President Donald Trump, dismissed the government’s arguments that processing the responses and redacting sensitive information would require too much work.

The first two tranches, comprising 780,000 reports from some 523,000 people, include dozens of reports of heart inflammation, hundreds of reports of facial paralysis, and thousands of reports of tinnitus.

“For 24 hrs after [the] shot I was so fatigued I could not stay awake. I also have some very strong suicidal thoughts. Zero appetite,” one individual wrote.

Another person said they experienced symptoms of an allergic reaction. “I read where [sic] this vaccine should not be administered to anyone allergic to PEG and I am allergic to PEG. It would be incredibly reassuring if someone would call me as all I run into is dead ends,” the individual said.

The free-text portion of the surveys was the only place for people to report adverse events, including heart inflammation, even though the CDC knew the shots might cause those events, previously released documents showed. Other documents showed the CDC became aware of the vaccines possibly causing myocarditis, or heart inflammation, and a related condition called pericarditis early in 2021 but hid the knowledge from the public.

Judge Kacsmaryk’s order came in litigation brought by the Informed Consent Action Network (ICAN), a nonprofit that has compelled the release of a number of government files since the COVID-19 pandemic started.

“ICAN had to sue the Centers for Disease Control in order to gain access to the COVID-19 shot V-safe adverse event data, which is yet another shameful chapter in the decades-long history of federal health officials trying to cover up vaccine risks by ignoring patterns of vaccine reaction symptoms in reports made to the government,” Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, told The Epoch Times after reviewing the new data.

“When people report the same symptoms over and over again after getting a biological product—in this case ’shortness of breath‘ and ’heart palpitations,’ which are both symptoms of myocarditis that has been causally linked to mRNA COVID shots—the public should be warned, not kept in the dark. It raises questions about what else government health officials are hiding,” she added.

The free-text entries are not dated. Elizabeth Brehm, an attorney representing ICAN, said the group is seeking the dates of the reports from the CDC. The group does know that the entries are the earliest ones received by the CDC. V-safe was launched as the vaccines were rolled out in late 2020. The rest of the entries are expected to be produced on a rolling basis.

A CDC spokesperson declined to answer many questions, including those related to the dates of entries.

“V-safe participants who reported that they received medical care after vaccination were called and encouraged to submit a VAERS report. If they submitted a VAERS report and the adverse events were classified as serious (as defined in the Code of Federal Regulations), CDC attempted to obtain additional information (medical records, hospital records, etc.) about the reported adverse event,” the spokesperson told The Epoch Times. “All data collected from VAERS is processed and analyzed for unusual patterns or unusually high numbers of rare and serious adverse events after vaccination.”

She said the information from VAERS helped detect problems the agency now acknowledges are caused by the vaccines, including myocarditis.

A third of 60 patients with follow-up cardiac imaging done more than 12 months after their myocarditis diagnosis had persistent late gadolinium enhancement (LGE), which is, in the majority of cases, reflective of heart scarring, Australian researchers reported in a preprint of a new study, published on March 22.

Myocarditis is a form of heart inflammation.

The median time from receipt of a vaccine to follow-up imaging was 548 days, with the longest interval being 603 days.

“We found that the incidence of persistent myocardial fibrosis is high, seen in almost a third of patients at >12 months post diagnosis, which could have implications for the management and prognosis of this predominantly young cohort,” the researchers wrote.

“The long-term clinical implications of LGE in this condition are as yet unknown, but LGE has been demonstrated to confer worse prognosis in non-COVID-19 vaccine-associated myocarditis, especially if it persists beyond six months,” they added later, pointing to several previous papers.

Researchers in one of the previous papers, for instance, found that LGE was a “powerful prognosticator” of adverse outcomes in myocarditis patients.

Before the new testing, nine patients were determined to definitely have myocarditis, and 58 patients were labeled as probably having myocarditis. The findings of persistent LGE resulted in reclassifying 16 of the cases from probable myocarditis to definite myocarditis.

Exclusions included patients who were pregnant or allergic to agents used in gadolinium testing.

Among a subset of 20 patients who underwent imaging shortly after vaccination, 19 had LGE. In follow-up imaging, LGE was no longer visible in 10 of those patients. In five, it was reduced, but in four it was unchanged.

Andrew Taylor, a professor at Monash University’s Central Clinical School, and his co-authors conducted the study by recruiting patients who were diagnosed with myocarditis associated with COVID-19 vaccination between August 2021 and March 2022. The patients were invited to undergo imaging at Alfred Hospital or Royal Children’s Hospital in Melbourne, Australia.

The study population with follow-up imaging included 44 adults and 16 adolescents.

Most of the patients had received a Pfizer-BioNTech shot. A minority had received a Moderna or AstraZeneca vaccination. The companies did not respond to requests for comment.

Limitations of the paper, which was published ahead of peer review, included possible selection bias, since participation in the study was voluntary. Authors listed no conflicts of interest or funding.

Another Paper

In the other recent paper, researchers in Canada reported finding about half of patients referred for imaging due to possible post-vaccination myocarditis had persistent LGE in follow-up imaging.
Overall, 60 patients were included in the retrospective study. Of those, seven reported persistent symptoms.

In a subset of 21 patients for whom follow-up MRIs were available, 10 had persistent LGE, the researchers said. On the other hand, function of the left ventricle, which pumps blood, had normalized in all patients.

The persistent LGE “likely reflects replacement fibrosis,” or heart scarring, Dr. Kate Hanneman, with the University of Toronto’s Department of Medical Imaging, and her co-authors wrote. They cited some of the same papers as the Australian group, including the study that found patients with persistent LGE had a higher risk of adverse outcomes, as well as a paper on what it represents when LGE is found on MRI in patients with myocarditis.

“However, the significance of LGE is uncertain in patients post-myocarditis with recovered normal left ventricular systolic function,” the researchers said. They called for additional studies to evaluate patients with persistent LGE and a recovered left ventricle.

The study included adult patients who were referred to a hospital network with suspected myocarditis and had new cardiac symptoms such as chest pain within 14 days of COVID-19 vaccination. The patients all received either the Pfizer or Moderna shot.

Limitations of the study, which was published by the Journal of Cardiovascular Magnetic Resonance, included a lack of biopsy-confirmed myocarditis.

The authors declared no funding and listed only one competing interest, that an author is an associate editor of the journal.

The corresponding authors for the two papers did not respond to requests for comment.

“My concern from reading these two studies is that myocardial damage and scarring is present in a significant number of COVID vaccine injured individuals at up to 18 months after vaccination. This suggests potential for permanent heart damage from the vaccines,” Dr. Danice Hertz, the research lead for the U.S. group React19, told The Epoch Times in an email. “The long-term implications are not yet known but need to be studied carefully.”

Earlier Findings

The new papers add to earlier studies, which found that LGE persists for months in some people following a COVID-19 shot.

Researchers in Washington state reported in 2022 that LGE persisted in children for up to eight months after vaccination. Later that year, the U.S. Centers for Disease Control and Prevention (CDC) said that more than half of 151 patients with follow-up imaging had residual LGE, which was described as “suggestive of myocardial scarring.”

The CDC has longer-term data on the patients, the agency confirmed to The Epoch Times in January, but has not yet published another paper describing that data. The CDC, which failed to warn the public about the risk of post-vaccination myocarditis, declined to comment on the new Australian and Canadian papers.

Hong Kong researchers in 2023 reported finding that about half of 40 patients with follow-up MRIs months after vaccination had LGE.

Symptoms have also persisted in some patients with post-vaccination myocarditis.

The CDC, describing preliminary updated results from its longer-term study, said in early 2023 that there were patients still suffering from symptoms more than one year after a shot. Researchers in Australia in late 2023 said that symptoms persisted at least six months after a shot in a majority of patients they followed. And some patients also told The Epoch Times they have lingering health issues years after vaccination.

The Danish Medicines Agency review of data from Denmark and the European Union validated a safety signal that arose for chronic hives, or chronic urticaria, and Moderna’s shot, the agency said on March 20.

Of 360 cases reported in Europe following the Moderna or Pfizer-BioNTech vaccine, 58 were deemed probably caused by vaccination and 228 were determined to be possibly caused by the vaccination, Martin Zahle Larsen from the Danish Medicines Agency said in a statement.

Most of the cases were reported by patients, doctors, or pharmaceutical companies.

The study found that in Denmark, it was expected based on background rates of chronic hives that 175 people who received Pfizer’s shot would experience chronic hives following vaccination and that 18 people who received Moderna’s shot would experience the issue.

While the 105 reported cases after Pfizer vaccination came in under the expected number, the 55 reported cases following Moderna vaccination came in well above the expected number.

The risk of developing chronic hives was calculated to be three times higher for Moderna recipients, compared to the general population. Researchers also stratified the risk by gender and age and found the risk was the highest—5.2 times higher than the background rate—among young men.

Most cases of chronic hives occurred from 7 to 13 days following vaccination.

The results of the study are the validation of a safety signal, or a sign that a vaccine or vaccines causes a specific health issue, Danish authorities said in a document describing the results.

Mr. Larsen, though, told Danish media that additional studies are required to confirm a connection and that scientists think the cases stem from the vaccine’s impact on the immune system.

The cases began being reported after the COVID-19 vaccines were introduced and Norway reported a safety signal for chronic hives in late 2021. The Danish Medicines Agency examined reports of chronic hives after Moderna vaccination but reached the position that the cases were not strong enough to establish a safety signal, it said in September 2022. But data from the county’s compensation system for vaccine injuries subsequently indicated an investigation into the possible side effect should be reopened, prompting a fresh look that led to the new results.

The review was strengthened by gaining access to medical records from the compensation, the agency said.

Moderna did not return a request for comment.

Based in part on the results, the European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended labeling for Moderna’s shot be updated to list chronic hives as a possible side effect. Non-chronic hives is already listed as a possible side effect. If the European Union Commission approves the change, the labeling will be updated to include chronic hives.

Previous Studies

Some previous studies have detailed cases of chronic hives following COVID-19 vaccination.

U.S. researchers, for instance, reported in 2022 three new chronic hives cases after Pfizer and Moderna vaccination, including one case in a 24-year-old woman who received a booster of Moderna despite suffering persistent skin problems after the first and second doses.

Swiss researchers in 2023 said they analyzed new chronic hives cases after Pfizer and Moderna vaccination and that the results suggested a link between a booster dose of Moderna’s vaccine and the health problem.

U.S. researchers in January reported a case series of seven patients who developed chronic urticaria within weeks of Moderna vaccination and said the series indicated a “potential correlation” between the shot and the issue. Two of the patients, they noted, went on to receive a Pfizer dose with no problem.

Hives have also been associated with COVID-19, but researchers aren’t sure whether there is a causal link.

The incidence of febrile seizures was 2.5 times higher among children zero to one day after a Moderna shot, compared to the same children eight to 63 days after vaccination, the researchers said.

That risk was “significantly elevated,” they wrote in a preprint paper describing the results.

There was also a higher risk for febrile seizures zero to one day after receipt of a Pfizer-BioNTech dose, compared to the same 8–63 day window following vaccination, but that elevated risk was not statistically significant.

Richard Forshee, deputy director of the FDA’s Office of Biostatistics and Pharmacovigilance, and other researchers conducted the self-controlled case series by analyzing data from commercial databases. The data came from CVS Health, Optum, and Carelon Research. The children were 2 to 5 years old.

Fever is a common side effect of the COVID-19 vaccines. Some 19 percent of children aged 2 to 3, for instance, in Pfizer’s clinical trial suffered fever after a second dose. Fever may result in some cases in febrile seizures, health officials said.

The study was carried out after the researchers identified seizures/convulsions as a safety signal among children aged 2 to 4 following receipt of Pfizer’s shot and among children aged 2 to 5 after a Moderna jab. Further research was needed because the method of identification, near real-time surveillance, “was designed to be sensitive but not specific for screening and detection purposes,” the researchers said. Febrile seizures became the focus because most of the cases identified in the prior study were seizures of that type.

The two-day window utilized in the new study ensures the seizure cases “are more likely to be associated with vaccination rather than other causes,” the researchers said.

There were 88 febrile seizures after the Pfizer vaccination among the study population. Seven of those cases happened the day of, or the day after, vaccination.

There were 67 cases after the Moderna vaccination. Ten happened in the two-day window.

Seizures that happened two to seven days after vaccination were excluded from the primary analysis.

In a secondary analysis, using a longer risk interval within seven days of vaccination, researchers identified 103 febrile seizures and 135 seizures/convulsions after Pfizer vaccination, including 22 febrile seizures and 32 seizures/convulsions within seven days of a shot. The secondary analysis showed 78 febrile seizures and 106 seizures/convulsions after Moderna vaccination, including 21 febrile seizures and 28 seizures/convulsions in the longer risk interval.

No statistically significant findings showed up for that secondary analysis, or any other secondary analyses, after researchers applied adjustments to the data.

Exclusions included children who received more doses than approved. Researchers analyzed data from the Carelon database from June 2022 to February 2023, from June 2022 to March 2023 from the CVS database, and from June 2022 to May 2023 in the Optum database.

The FDA authorized new versions of vaccines from Pfizer, Moderna, and Novavax in late 2023, relying on clinical trial data from just 50 humans. Those currently available versions are not covered by the research.

The FDA funded the new study. Limitations of the research included the small number of cases, according to the researchers.

Dr. Harvey Risch, professor emeritus of epidemiology at the Yale School of Public Health, who was not involved in the research, agreed. “These small numbers are not large enough for a reliable statistical analysis, which makes the paper scientifically weak,” Dr. Risch told The Epoch Times in an email.

The corresponding author, Mr. Forshee, did not respond to a request for comment. The FDA declined to comment. Moderna and Pfizer did not return inquiries.

Despite the finding of elevated risk, the researchers claimed that “based on the current body of scientific evidence, the safety profile of the monovalent mRNA vaccines remains favorable for use in young children.”

The time to self-reported recovery was a median of two days faster among the ivermectin recipients, according to the large UK study.

The quicker recovery period was statistically significant.

People who received ivermectin were also less likely to be hospitalized or die, with 1.6 percent of ivermectin recipients being hospitalized or dying versus 4 percent of the comparison group, which received typical care, which in the UK is largely focused on managing symptoms.

Ivermectin recipients also enjoyed a reduction of severe symptoms and sustained recovery, according to the study.

The paper was published by the Journal of Infection on Feb. 29.

The study covered an open-label trial that involved 2,157 ivermectin recipients and 3,256 who received typical care from June 23, 2021, to July 1, 2022. Participants were randomized and reported symptoms and recovery.

Researchers Say Findings Don’t Support Using Ivermectin

The authors, including Christopher Butler, a University of Oxford professor and joint chief investigator of the trial, downplayed the positive findings in part because the hazard ratio of 1.14 was lower than what authors pre-specified as a meaningful ratio, or 1.2. Hazard ratios are a way to determine whether a treatment is beneficial.

The authors also focused on the lack of differences in the number of days participants felt sick in the previous two weeks, impact on work, and likelihood of using the health care system at 3, 6, and 12 months following treatment.

“Overall, these findings, while evidencing a small benefit in symptom duration, do not support the use of ivermectin as treatment for COVID-19 in the community among a largely vaccinated population at the dose and duration we used,” the authors said.

Funding for the research came from the UK government.

Conflicts of interest included one researcher receiving grants from pharmaceutical companies, including AstraZeneca, and other authors receiving grants from the University of Oxford.

The trial, known as PRINCIPLE, was touted by investigators as “the world’s largest clinical trial of possible COVID-19 treatments for recovery at home and in other non-hospital settings.”

“Ivermectin is readily available globally, has been in wide use for many other infectious conditions so it’s a well-known medicine with a good safety profile, and because of the early promising results in some studies it is already being widely used to treat COVID-19 in several countries,” Dr. Christopher Butler, a University of Oxford professor and joint chief investigator of the trial, said when it was announced ivermectin would be assessed. “By including ivermectin in a large-scale trial like PRINCIPLE, we hope to generate robust evidence to determine how effective the treatment is against COVID-19, and whether there are benefits or harms associated with its use.”

Doctors Weigh In

Dr. Pierre Kory, an American physician who was not involved in the trial, said that the authors wrongly downplayed how ivermectin improved recovery from COVID-19.

“PRINCIPLE was a profoundly positive study that was instead analyzed and written up as a negative one,” Dr. Kory, who has long promoted ivermectin as a COVID-19 treatment, wrote in an essay.

He accused the authors of undertaking “statistical chicanery” by coming up with the pre-specified hazard ratio (HR), noting that no such level was used in other parts of the PRINCIPLE trial.

“A hazard ratio does not need a pre-specified level. If the HR is > 1.0, and it is statistically significant, it is a robust finding,” he said.

The positive findings should also be interpreted in the context of recipients only receiving one dose per day across three days and being directed not to eat food before ivermectin, Dr. Kory said.

Dr. Butler and his co-authors said “no food should be taken two hours before or after administration” despite previous research finding that taking ivermectin with food increases plasma concentration.

Participants also received ivermectin a median of five days after symptom onset, a period of time considered by some to be too late to have much of an impact. Ivermectin works best when applied within 24 hours of symptom manifestation, according to a meta-regression of ivermectin studies.
Dr. Butler did not respond to a request for comment.

There have been additional studies that found ivermectin worked against COVID-19. The drug, commonly used for purposes such as combating malaria, has divided scientists since 2020, when doctors around the world began using it to treat COVID-19.

Some other research, including a U.S. trial, has found that ivermectin did not improve time to recovery.

Dr. David Boulware, another American doctor, who helped run that trial, argued on X that the faster recovery recorded in the UK trial was similar to the quicker recovery reported in an open-label trial of molnupiravir, an antiviral sometimes used to treat COVID-19.

“Molnupiravir also had a 2 day faster improvement in symptoms over ‘usual care’ yet no benefit existed in double-blind trial,” Dr. Boulware said on X. “Placebo effect influences self-reported symptoms.”

The U.S. Centers for Disease Control and Prevention (CDC) was preparing to issue an alert about postvaccination myocarditis, or heart inflammation, through its Health Alert Network in May 2021. But that plan changed after meeting with the U.S. Food and Drug Administration (FDA), according to the emails.

“The initial draft is with Rochelle now,” Sherri Berger, a top CDC official, wrote in an email on May 26, 2021. Dr. Rochelle Walensky was the CDC’s director at the time.

Hours later, a CDC spokesperson, Abbigail Tumpey, informed colleagues and officials with the U.S. Department of Health and Human Services that “we are still discussing the strategy on this topic.”

“However, after discussions internally and with FDA, we will likely [redacted],” she wrote. “Our team is on a call with FDA now. I will share the messaging shortly.”

Ms. Tumpey later emailed to say that the CDC had opted to issue a document called clinical considerations rather than an alert.

The CDC issued the online considerations on May 28, 2021. They stated that “increased cases of myocarditis and pericarditis have been reported in the United States after mRNA COVID-19 vaccination (Pfizer-BioNTech and Moderna)” but that every person aged 12 years and up should still get vaccinated.

Ms. Berger and Ms. Tumpey, both of whom have since left the CDC, did not respond to requests for comment.

The FDA did not deny influencing the decision not to send the alert.

“The FDA continues to work collaboratively with the CDC to monitor for known safety risks related to vaccines and determine how best to ensure any relevant safety information is conveyed to the public, health care providers and clinicians,” a spokesperson told The Epoch Times in an email. “After thorough assessment and when the potential risk was clear, the FDA updated the fact sheets for the COVID-19 vaccines and communicated with the public in a manner that was determined to be appropriate for the assessed risk.”

The FDA, which authorized the Pfizer and Moderna shots, did not add warnings about myocarditis until June 25, 2021.

A CDC spokesperson declined to say why the CDC decided not to send an alert. The spokesperson told The Epoch Times via email that the same audience of healthcare providers received the considerations but did not supply any evidence supporting that claim.

Documents previously acquired by The Epoch Times showed that the CDC and FDA were aware of post-vaccination myocarditis cases by February 2021, including a “large number” of patients in Israel and cases among the U.S. military.

The emails about the CDC-FDA call were obtained by The Daily Clout through a FOIA request. The CDC alert was planned to be targeted at emergency departments “rather than a broad advisory,” another email showed.

Prepared to Review

Other emails from the same tranche showed that two top officials in President Joe Biden’s administration asked, and were going to be able to, review the warning before it was sent out.

Dr. Rachel Levine, the administration’s assistant secretary for health, and Dawn O’Connell, the administration’s assistant secretary for preparedness and response, were going to be sent a draft of the alert after Dr. Walensky reviewed it, according to the emails.

“Dawn and Sarah need an early heads up and to see the language before hand,” Ms. Berger wrote in one missive, referring to Ms. O’Connell and Sarah Boateng, another official with the Department of Health and Human Services.

“I would also very much appreciate the opportunity to see the HAN before it is final,” Dr. Levine wrote.

“Initial draft with Walensky now. Flagging that you’d like to review as well,” Ms. Berger replied.

Dr. Levine was also in touch separately with Dr. Walensky on myocarditis, promoting claims that the heart inflammation might be unrelated to the vaccines.

“Myocarditis with COVID-19 is uncommon and even more uncommon with the vaccines- if it is associated at all with the vaccines,” Dr. Levine wrote after meeting with doctors from the American Academy of Pediatrics (AAP).

Still, the AAP experts conveyed that “significant risks that can be associated with adolescent myocarditis” and that youth with the heart inflammation should be placed under exercise limitations for at least three months, according to the emails.

The AAP put out guidance around the same time that encouraged people to get vaccinated despite the apparent risk of heart inflammation. It has since deleted that guidance but still maintains a similar position.

In another call with the AAP, experts shared that “the cases are infrequent and mild and seem to resolve without treatment,” Dr. Levine wrote. In reality, a number of the cases do not resolve for months, if at all.

“Wow, thank you so much for this super helpful engagement,” Dr. Walensky said in a reply. The CDC planned to meet with the AAP on the matter, according to the emails.

Dr. Levine was later invited as a panelist for a call with public health partners to discuss the myocarditis cases, other missives showed.

Dr. Levine and the AAP did not respond to requests. A spokesperson for Ms. O’Connell declined to comment.

President Biden received the payments starting in September 2018, according to the records, which were obtained and released by the U.S. House of Representatives Oversight Committee.

The records show former Vice President Biden signing to receive $1,380 on a monthly basis from Owasco PC, one of Hunter Biden’s businesses.

“Payments from Hunter’s business entity to Joe Biden are now part of a pattern revealing Joe Biden knew about, participated in, and benefited from his family’s influence peddling schemes,” Rep. James Comer (R-Ky.), chairman of the committee, said in a video statement.

BREAKING

Hunter Biden’s business entity, Owasco P.C., made DIRECT monthly payments to Joe Biden.
@RepJamesComer explains pic.twitter.com/7bXyGYmWVZ

— Oversight Committee (@GOPoversight) December 4, 2023

The White House and a lawyer for Mr. Biden did not immediately respond to requests for comment.

The records were obtained as part of the House probe into President Biden and his family, which centers on business transactions made while he was vice president and in the time between when he left the government and assumed the presidency.

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Image by Louise Palanker via Flickr, cropped, CC BY-SA 2.0 DEED.