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COVID-19

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

Published

2 months ago

4 minute read

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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WATCH: Big Pharma scientist admits COVID shot not ‘safe and effective’ to O’Keefe journalist

COVID-19

WATCH: Big Pharma scientist admits COVID shot not ‘safe and effective’ to O’Keefe journalist

Published on July 17, 2025

By

From LifeSiteNews

By Doug Mainwaring

‘None of that stuff was safe and effective. We didn’t do the typical tests,’ Joshua Rys of Johnson & Johnson said to one of James O’Keefe’s undercover journalists.

A lead scientist for a global pharmaceutical firm disclosed on hidden camera that his firm’s COVID-19 vaccine underwent rushed testing, lacked research, and admitted that, in direct contradiction to the Biden administration’s constant refrain, the drug was not “safe and effective.”

“None of that stuff was safe and effective. We didn’t do the typical tests,” said Joshua Rys, a lead regulatory affairs scientist for Johnson & Johnson (J&J), not realizing that he was being filmed by one of James O’Keefe’s undercover journalists.

Rys explained that normally a new drug undergoes an extended period of testing, including human trials, but the COVID-19 vaccine circumvented those safety measures in order to rush the product to the public.

“This was just, ‘Let’s test it on some lab-rat models, analyze and see if it works,” said Rys, “and just throw it to the wind and see what happens.”

“I’m sure somebody is going to get sued for that stuff, eventually,” he predicted.

“Do you have any idea [of] the lack of research that was done on those products?” asked the J&J lead scientist.

“People wanted it. We gave it to them,” said Rys.

O’Keefe later approached Rys to ask what led him to tell a total stranger that his product was not safe and effective, but Rys evaded O’Keefe and his probing. 

O’Keefe explained that the work of his O’Keefe Media Group (OMG) undercover journalists is crucial because, he claimed, up to 80 percent of the revenue cable and other news organizations derive from ads comes from Big Pharma.

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COVID-19

Japan disposes $1.6 billion worth of COVID drugs nobody used

Published on July 17, 2025

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From LifeSiteNews

By Calvin Freiburger

The nation’s health ministry has already trashed 2 million doses of PaxlovidPACK and Lagevrio, and will dispose of 1.77 million doses of Xocova by the end of February 2026.

Japan is disposing of $1.6 billion worth of COVID-19 drugs that went unused and are now expired in a dramatic disconnect between government projections and reality.

The Japanese Broadcasting Corporation reported that the nation’s health ministry has already trashed 1.75 million patients’ worth of PaxlovidPACK and 780,000 patients’ worth of Lagevrio doses, and will dispose of 1.77 million patients’ worth of Xocova by the end of February 2026.

The government had been required by law to purchase enough oral COVID drugs for 5.6 million people, to be distributed free of charge through May 2023, at which point the virus was downgraded to the same threat level as normal seasonal influenza. But 2.5 million, a little under half the supply, remained unused by the time they hit their expiration dates.

The Star added that the value of the destroyed drugs is estimated to be roughly 240 billion yen, or 1.6 billion US dollars.

Across the world, governments took drastic action to counter the COVID pandemic, based in large part on exaggerated assumptions about the virus’s transmissibility and threat to non-elderly individuals without comorbidities. A large body of evidence has found that mass restrictions on personal and economic activity undertaken in 2020 and part of 2021 caused far more harm than good in terms of personal freedom and economics as well as public health, and that lives could have been saved through far less burdensome methods, such as the promotion of established therapeutic drugs, narrower protections focused on those most at risk (such as the elderly and infirm), and increasing vitamin D intake.

In Florida, the first report by a grand jury impaneled by Republican Gov. Ron DeSantis determined that lockdowns did more harm than good, that masks were ineffective at stopping COVID transmission, that COVID was “statistically almost harmless” to children and most adults, and that it is “highly likely” that COVID hospitalization numbers were inflated.

Much like the controversial COVID vaccines, concerns were raised about the safety and effectiveness of COVID therapeutics such as Paxlovid and Lagevrio as well.

In May, former Japanese minister of internal affairs and communications Kazuhiro Haraguchi announced he had cancer, and said testing of the lesions linked it to spike proteins from the COVID-19 vaccine he had received two years before.

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