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FDA says Pfizer, Moderna must expand warnings for COVID shots to young men

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From LifeSiteNews

Pfizer and Moderna must warn young men ages 16-25 that their COVID shots are linked to heart diseases, the FDA said.

The Food and Drug Administration (FDA) has expanded its warnings about the dangers of mRNA COVID jabs.

“The Food and Drug Administration is telling Pfizer and Moderna to expand the warning labels on their COVID-19 vaccines about the risk of a possible heart injury side effect linked to the mRNA shots, primarily in teen boys and young men, citing findings from a study published last year and new agency data,” CBS News reported.

“Both vaccines previously carried warnings about how the risk of the heart side effects — which doctors call myocarditis (an inflammation of the heart muscle) and pericarditis (inflammation of the membrane surrounding the heart) — looked to be higher in young men, generally within the first week after vaccination,” CBS added. “While the earlier labels specified ages 18 to 24 years old for Moderna’s vaccine and 12 to 17 years old for Pfizer’s, the new warning will apply to males ages 16 to 25 for both vaccines.”

The warnings reflect a more cautious approach to the jabs, which were rushed through under President Donald Trump’s “Operation Warp Speed.”

For many key health roles, Trump has appointed officials who have supported vaccine safety, including Dr. Marty Makary as FDA commissioner. Furthermore, Secretary of Health and Human Services Robert F. Kennedy Jr. has a track record advocating for food and medicinal safety. However, they have not taken an aggressive approach yet to the vaccines while in office.

Furthermore, Makary recently announced that the FDA plans to continue recommending that pregnant women receive the COVID shot, even though there are links between getting jabbed and miscarrying a preborn baby.

The shots have been a point of contention between Trump supporters and the president, who still holds that Operation Warp Speed, and rushing through the shots, was a good idea.

As LifeSiteNews reported:

For the past four years, Trump has refused such appeals about the evidence against the COVID shots, which were developed in record time by his administration’s Operation Warp Speed initiative.

Since leaving office, he repeatedly promoted the shots as “one of the greatest achievements of mankind.” The negative reception to such comments got him to drop the subject for a while, but in July 2022, he complained that “we did so much in terms of therapeutics and a word that I’m not allowed to mention. But I’m still proud of that word, because we did that in nine months, and it was supposed to take five years to 12 years. Nobody else could have done it. But I’m not mentioning it in front of my people.”

Yet, the shots have a long record of being linked to numerous problems, including heart inflammation, stroke, death, and menstrual problems.

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COVID-19

FDA requires new warning on mRNA COVID shots due to heart damage in young men

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From LifeSiteNews

By Doug Mainwaring

Pfizer and Moderna’s mRNA COVID shots must now include warnings that they cause ‘extremely high risk’ of heart inflammation and irreversible damage in males up to age 24.

The Trump administration’s Food and Drug Administration (FDA) announced it will now require updated safety warnings on mRNA COVID-19 shots to include the “extremely high risk” of myocarditis/pericarditis and the likelihood of  long-term, irreversible heart damage for teen boys and young men up to age 24.

The required safety updates apply to Comirnaty, the mRNA COVID shot manufactured by Pfizer Inc., and Spikevax, the mRNA COVID shot manufactured ModernaTX, Inc.

According to a press release, the FDA now requires each of those manufacturers to update the warning about the risks of myocarditis and pericarditis to include information about:

  1. the estimated unadjusted incidence of myocarditis and/or pericarditis following administration of the 2023-2024 Formula of mRNA COVID-19 shots and
  2. the results of a study that collected information on cardiac magnetic resonance imaging (cardiac MRI) in people who developed myocarditis after receiving an mRNA COVID-19 injection.

The FDA has also required the manufacturers to describe the new safety information in the adverse reactions section of the prescribing information and in the information for recipients and caregivers.

Additionally, the fact sheets for healthcare providers and for recipients and caregivers for Moderna COVID-19 shot and Pfizer-BioNTech COVID-19 shot, which are authorized for emergency use in individuals 6 months through 11 years of age, have also been updated to include the new safety information in alignment with the Comirnaty and Spikevax prescribing information and information for recipients and caregivers.

In a video published on social media, Dr. Vinay Prasad, director of the Center for Biologics Evaluation & Research Chief Medical and Scientific Officer, explained the alarming reasons for the warning updates.

While heart problems arose in approximately 8 out of 1 million persons ages 6 months to 64 years following reception of the cited shots, that number more than triples to 27 per million for males ages 12 to 24.

Prasad noted that multiple studies have arrived at similar findings.

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COVID-19

Court compels RCMP and TD Bank to hand over records related to freezing of peaceful protestor’s bank accounts

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Justice Centre for Constitutional Freedoms

The Justice Centre for Constitutional Freedoms announces that a judge of the Ontario Court of Justice has ordered the RCMP and TD Bank to produce records relating to the freezing of Mr. Evan Blackman’s bank accounts during the 2022 Freedom Convoy protest.

Mr. Blackman was arrested in downtown Ottawa on February 18, 2022, during the federal government’s unprecedented use of the Emergencies Act. He was charged with mischief and obstruction, but he was acquitted of these charges at trial in October 2023. 

However, the Crown appealed Mr. Blackman’s acquittal in 2024, and a new trial is scheduled to begin on August 14, 2025. 

Mr. Blackman is seeking the records concerning the freezing of his bank accounts to support an application under the Charter at his upcoming retrial.

His lawyers plan to argue that the freezing of his bank accounts was a serious violation of his rights, and are asking the court to stay the case accordingly.

“The freezing of Mr. Blackman’s bank accounts was an extreme overreach on the part of the police and the federal government,” says constitutional lawyer Chris Fleury.

“These records will hopefully reveal exactly how and why Mr. Blackman’s accounts were frozen,” he says.

Mr. Blackman agreed, saying, “I’m delighted that we will finally get records that may reveal why my bank accounts were frozen.” 

This ruling marks a significant step in what is believed to be the first criminal case in Canada involving a proposed Charter application based on the freezing of personal bank accounts under the Emergencies Act. 

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