FDA minimizes side effects of Updated COVID-19 Vaccines

Updated COVID-19 vaccines may cause heart inflammation and severe allergic shock, according to a new study from the U.S. Food and Drug Administration (FDA).

Researchers with the FDA, the U.S. National Institutes of Health, and companies like CVS looked at health care databases to try to figure out if there were signs the Moderna and Pfizer bivalent COVID-19 vaccines might be linked to any health issues.

They found several safety signals. One signal was for myocarditis, a form of heart inflammation, and a related condition called pericarditis following Pfizer vaccination in adults aged 18 to 35. Another was for anaphylaxis, or severe allergic shock, following Moderna and Pfizer vaccination in people aged 18 to 64.

The signals were detected in a database from Carelon Research.

The incidence rate for anaphylaxis was 74.5 cases per 100,000 person-years following Pfizer vaccination and 109.4 cases per 100,000 person-years following Moderna vaccination.

Researchers arrived at an incidence rate of 131.4 cases of myocarditis/pericarditis per 100,000 person-years after a Pfizer shot.

No stratification was done by gender, despite myocarditis, according to many studies, disproportionately affecting males.

Person-years is a measure used in some studies. In this study, all time during post-vaccination periods of time known as risk intervals were included. The risk intervals were different depending on the health outcome. For anaphylaxis, the risk interval was 0 to 1 day; for myocarditis/pericarditis, it was 0 to 7 days or 0 to 21 days.

Additional issues were also identified in the four databases that were analyzed, but none rose to the level of a safety signal, a set criteria that is an indication of a vaccine causing an issue.

The study analyzed data from people aged 6 months and older from August 2022 to July 2023. The bivalent shots were replaced soon after by updated vaccines because their effects, which already started low, were shown to wane in observational studies.

Researchers only included people who were continuously enrolled in an insurance plan and did not suffer health issues during a “clean interval,” or if the health outcome in question did not occur during a certain interval.

“References for the clean interval could not be located in the literature and are based on clinician input,” the authors said in a footnote.

Patricia Lloyd, an FDA researcher, and her co-authors said the study “supports the safety of these vaccines” and “supports the conclusion that the benefits of vaccination outweigh the risks.”

Asked for evidence to support those conclusions, Ms. Lloyd referred a request for comment to the FDA.

“With over a billion doses of the mRNA vaccines administered, available scientific evidence supports the conclusion that the vaccines are safe and effective. The FDA stands behind its findings of quality, safety, and efficacy for the mRNA vaccines. Additionally, it is simply a fact that millions of lives have been saved because of the COVID-19 mRNA vaccines, which most Americans undergoing vaccination have received,” an FDA spokesperson claimed.

The agency provided a single citation from the Commonwealth Fund, a foundation that used modeling to estimate that through November 2022, the vaccines prevented millions of deaths.
The study was published ahead of peer review on the medRxiv server.

Dr. Peter McCullough, a cardiologist and president of the McCullough Foundation, told The Epoch Times in an email that results from the paper show “cardiovascular and neurological safety events are numerous and unacceptable on a population basis.”

Dr. McCullough, who was not involved with the paper, noted that the study did not analyze COVID-19 vaccine effectiveness.

“The FDA’s conclusion on risk benefit is not valid and reflects agency bias in attempting to promote the unsafe, ineffective products,” he said. “Our regulatory agencies should not be promoting or advertising the products they are charged with regulating.”

The FDA clears vaccines. The agency in 2022 authorized and approved the bivalent vaccines despite there being no clinical trial data available.

Limitations of the new paper included the lack of medical record review. Many authors reported their employment for health care companies as conflicts of interest.

A previous study analyzing the health claims databases detected signals for seizures/convulsions among children aged 2 to 4 after Pfizer vaccination and children aged 2 to 5 following Moderna vaccination. That study analyzed the version of the vaccines that preceded the bivalent shots.

In another new study, co-authored by Dr. McCullough, researchers reported finding a spike in reports of myocarditis in the federally-run Vaccine Adverse Event Reporting System in 2021.

“We found the number of myocarditis reports in VAERS after COVID-19 vaccination in 2021 was 223 times higher than the average of all vaccines combined for the past 30 years,” the researchers said.

Applying causality principles, the researchers said that COVID-19 vaccination was “strongly associated with a serious adverse safety signal of myocarditis, particularly in children and young adults resulting in hospitalization and death.”

Federal officials have said that the COVID-19 vaccines cause myocarditis, pericarditis, and anaphylaxis, but that the vaccines also provide protection against infection and severe illness, tilting the risk-benefit balance in their favor. They have increasingly cited, in lieu of clinical trials, observational studies from the FDA and U.S. Centers for Disease Control and Prevention (CDC), some of which lack peer review.

Current U.S. recommendations are for essentially all Americans aged 6 months and older to get one of the newest COVID-19 vaccines, introduced in 2023. That contrasts with a number of other countries, such as the United Kingdom, which have stopped offering or no longer recommend COVID-19 vaccination for wide swaths of their populations.

https://www.theepochtimes.com/health/fda-finds-safety-signals-for-updated-covid-19-vaccines-5576152

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Australia: Daniel was forced to have a Covid jab to keep his job. Then he fell gravely ill. Now he has secured a HUGE legal victory

A public servant who was forced to get a Covid vaccination to keep his job, but then fell gravely ill, has won a major legal battle and will be paid compensation.

Daniel Shepherd, 44, received two Covid-19 vaccinations when he was a youth worker at Baptist Care South Australia in 2021 and suffered adverse reactions to the jab.

The father of one started a new job with the Department for Child Protection (DCP) on October 19 that year, but was told on January 28, 2022, that he had to get a booster shot to keep his job as a child and youth worker.

Mr Sheperd was given a Pfizer mRNA jab on February 24, 2022, but a day later he had serious chest pains.

The pain kept getting worse until March 11, when he thought he was having a heart attack and was rushed to Adelaide's Ashford Hospital. There he was diagnosed with post-vaccine pericarditis - an inflammation of the membrane around the heart.

The illness meant Mr Shepherd was only able to work for a few months in a part-time administrative capacity.

DCP acknowledged the pericarditis was caused by the Pfizer mRNA booster shot, but it denied workers compensation liability, saying it was a legal government directive and so was excluded under the SA Emergency Management Act.

But Judge Mark Calligeros, the SA Employment Tribunal's deputy president, rejected the DCP's arguments.

'It is not surprising that some people who receive a dose of Covid-19 vaccine will sustain injury as a result,' he wrote in his judgment.

'It would be astonishing if parliament intended that an employee of the state, injured adhering to an EM (Emergency Management) Act direction, was to be precluded from receiving workers compensation.

'I am not satisfied that parliament intended to deny compensation to employees of the state injured by heeding a vaccination mandate designed to protect the health and welfare of citizens.'

Judge Calligeros added that Mr Shepherd was required to be vaccinated to continue working in healthcare.

This was 'because (the state) sought to protect and reduce the risk of infection to the public and general and those members of the public receiving healthcare services in particular.

'It would be ironic and unjust if Mr Shepherd was denied financial and medical support by complying with the state's desire to preserve public health.'

In a landmark ruling, the judge ordered that Mr Shepherd should get weekly income support payments and the payment of medical expenses.

The ruling came despite SA Health still enforcing a mandatory Covid vaccination policy for some employees, even though similar policies have been dropped in other states.

https://www.dailymail.co.uk/news/article-13023211/Covid-jab-legal-victory-Daniel-Shepherd.html

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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