From LifeSiteNews

By  Emily Mangiaracina

The new placebo-trial protocol for COVID boosters is part of a health safety initiative of HHS head Robert F. Kennedy Jr.

The Food and Drug Administration (FDA) plans to require new, placebo-controlled trials before approving COVID “vaccine” booster shots for healthy Americans under 65 years old.

The change was announced by FDA Commissioner Dr. Marty Makary and vaccine chief Dr. Vinay Prasad in a paper published by the New England Journal of Medicine, as part of a health safety initiative of Robert F. Kennedy Jr., head of the Department of Health and Human Services (HHS).

In May, Kennedy ordered that all new vaccines be required to undergo placebo-controlled safety trials ​​in a break with longstanding establishment policy, triggering protests from mainstream media outlets.

For years, Kennedy has criticized the fact that vaccines have been exempted from a placebo trial requirement in place for medicines. Placebo trials allow researchers to identify adverse side effects from a drug, clarifying that symptoms are not due to other factors such as the disease the drug seeks to protect against. For this reason, placebo trials are “critical for determining the safety profile of the new drug,” as BioPharma Services has noted.

The prior COVID shot policy, Makary and Prasad wrote, “has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations.”

“We reject this view,” they added, suggesting that the risk of a COVID booster shot not tested through a placebo-controlled trial is greater than the risk of COVID itself, especially the healthy, under-65 population. COVID often does not pose serious risks even to the elderly if treated correctly.

Previously, COVID shot boosters only underwent research designed to gauge the body’s immune response to the injections, two of which — the Moderna and Pfizer shots — used experimental mRNA technology.

However, many doctors and scientists have said that not only the COVID booster shots but the original COVID shots have not undergone sufficient safety studies. Earlier this year, the McCullough Foundation published a study titled, “Review of Calls for Market Removal of COVID-19 Vaccines Intensify: Risks Far Outweigh Theoretical Benefits,” citing grave harm caused by the COVID shots, including severe injuries and deaths.

“The total number of COVID-19 vaccine deaths reported to VAERS (37,544 among all participating countries) have far exceeded the recall limits of past vaccine withdrawals by up to 375,340%,” the authors noted.

They stated that “no large-scale, conclusive, randomized, double-blind, placebo-controlled trials have demonstrated reduction in infection transmission, hospitalization, or death as primary endpoints” for the COVID “vaccines.”

Makary, Trump’s pick for head of the FDA, and Prasad, the FDA’s pick for the Center for Biologics Evaluation and Research, have both gained prominence as outspoken critics of the government and medical industry’s handling of the COVID-19 outbreak.

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.

The dangers recently lead attorney Tom Renz, an expert on vaccine injuries, to call for an “immediate halt” on self-amplifying mRNA vaccines, as LifeSiteNews reported.