WASHINGTON, D.C. (LifeSiteNews) — 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 previous 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.
