From LifeSiteNews

By Robert Malone M.D.

I think I am developing a bad case of “Warp Speed” whiplash.

On May 20, 2025, the New England Journal of Medicine published an article authored by Vinay Prasad, M.D., M.P.H. (FDA/CBER Director), and Martin A. Makary, M.D., M.P.H. (FDA Commissioner) titled “An Evidence-Based Approach to Covid-19 Vaccination.” The “new” FDA position was that pregnancy and recent pregnancy, as well as many other pre-existing conditions, are associated with a greater risk of severe COVID outcomes. The agency said it would approve new versions of the vaccine (based on antibody production only) for adults 65 years of age and older as well as for people with one or more risk factors for severe COVID-19 outcomes.

These risk factors include medical conditions such as asthma, cancer, chronic kidney disease, heart disease, diabetes, and pregnancy. At that time, the agency indicated that healthy younger adults and children who fall outside of these groups may not be eligible to receive the COVID-19 shot this fall. Vaccine manufacturers will have to conduct clinical trials to demonstrate that the vaccine benefits low-risk groups.

On May 22, 2025, the groundbreaking MAHA Commission Report was announced and published. Never before has such a wide-ranging, comprehensive, and fearless report on the state of children’s health in the United States been published by the U.S. government. Titled “Making Our Children Healthy Again,” the report addresses concerns about the U.S. childhood vaccine schedule as part of its broader focus on chronic disease in children. Key statements about vaccines include:

• Increased Scrutiny Needed: The report calls for a reassessment of the childhood vaccine schedule, highlighting that the number of recommended vaccines has risen from 7 injections in 1986 to 29 by age one. It notes that many vaccines were tested in small participant groups, lacked inert placebo-controlled trials, and had limited safety monitoring (some lasting six months or less), raising concerns about detecting rare or long-term adverse effects.
• Comparative Analysis: It points out that Denmark’s vaccine schedule includes nearly half as many vaccines as the U.S., yet no trials have compared the safety or advisability of the U.S. schedule against other nations’.
• Vaccine Safety and Corporate Influence: The report questions the safety of the current schedule, suggesting that the National Childhood Vaccine Injury Act of 1986 shields manufacturers from liability, creating a unique regulatory framework that may limit open dialogue and safety reporting. It advocates for “true” placebo studies and more research into potential adverse effects.
• No Causal Claims: The report does not explicitly link vaccines to chronic diseases like autism, obesity, or diabetes, but it raises concerns about insufficient investigation into potential associations.
• Acknowledgment of Benefits: It acknowledges that vaccines protect children from infectious diseases but emphasizes balancing benefits with potential risks, and calls for more rigorous clinical trial designs.
• Ongoing Research: Health and Human Services Secretary Robert F. Kennedy Jr. stated that research into vaccine safety, including the autism crisis, is already underway, with policy recommendations to follow within 100 days.
• What the report did not do was to address specific concerns regarding the adverse events associated with the COVID-19 mRNA products in children, pregnant women, pre-born or post-natal babies.

READ: CDC no longer recommending COVID shots for healthy pregnant women, children

Following these key back-to-back announcements, vocal critics within the MAHA movement immediately launched a campaign attacking Secretary Kennedy and FDA Commissioner Makary for failing to ban all mRNA-based COVID products. Some with longstanding ties to the feminist movement went so far as to assert (on Substack and podcasts) that there was a coordinated effort by the “patriarchy” to shut down female social media influencers who were attacking Kennedy and Makary for failing to act swiftly and comprehensively to withdraw all FDA marketing authorization for these COVID-19 mRNA-based products.

What these attacks failed to do was gather information concerning the political decision-making process within the administration of President Trump that led to these policy decisions. According to sources in close contact with the administration, I have been informed that President Trump and his chief of staff made the decision to leave the COVID mRNA-based products on the recommended CDC vaccine schedule and related guidance. Not Kennedy or Makary.

One version of this narrative emphasizes the president’s political calculus, particularly concerns about alienating the pharmaceutical industry (and its potential donations to senators) as the midterm elections approach. So once again, the nattering nabob “influencer” caste directed their hate and ire at the wrong target. Curiously, many of these “influencers” are directly sponsored by a company seeking to associate itself with “medical freedom,” and not so curiously, some have a long history of Trump Derangement Syndrome symptoms. At least one of these sponsored “influencers” actively seeks to damage both the president and the entire MAHA movement politically.

What none of these appear to recognize is that, because of “small rooming” and the emerging dynamics of the splinternet, they were primarily communicating with the MAHA base, actively promoting anger by the base against Secretary Kennedy, and perhaps most importantly demoralizing both the overall MAHA base including the “MAHA Moms” that became disenchanted with the Democrat Party and played such a role in tipping the 2014 election in favor of President Trump and the Republican Party. The damage was becoming significant. Over the last few days, I have had long conversations with leaders and donors backing key MAHA-aligned online publications and non-profit advocacy organizations who were deeply troubled about the anger and divisiveness that was consuming their groups over this issue of CDC pediatric and pregnancy guidance concerning the COVID-19 mRNA products.

This is the context for today’s announcement by HHS Secretary Kennedy, FDA Commissioner Makary, and NIH Director Bhattacharya. Whether reports that the prior decision not to take these steps occurred at the level of the president and his chief of staff were gossip or fact, the Trump administration has now taken yet another step towards withdrawing these products.

First we had the Secretary of Defense boldly stating that the products mandated and deployed to warfighters and other members of the Armed Services on pain of dishonorable discharge were not FDA licensed (as federal law requires) and that those orders were illegal. Then the FDA Commissioner and his chief deputy, responsible for Vaccine regulatory policy, announced “new rules” for COVID booster authorization. Then, the groundbreaking MAHA commission report. And now this.

Finally Someone Said It: @RobertKennedyJr Takes on Big Pharma Over Child COVID Vaccines

'Healthy Kids & Pregnant Women DON'T Need It' pic.twitter.com/TxJQsNWhc8

— LifeSiteNews (@LifeSite) May 27, 2025

Like many, I would prefer that these COVID gene therapy-based technology products that cause your entire body to manufacture the genetically modified, highly toxic SARS-CoV-2 spike protein for extended periods be withdrawn from the US market. On the basis of data from all over the world, approximately three years ago it was my impression that the risk/benefit ratio of these products did not merit continued use in any cohort, as the same cohorts at elevated risk for significant COVID disease or death were also at elevated risk of disease or death attributable to these genetic vaccines. But to date, that has remained a minority opinion.

Frankly, given the current political landscape and President Trump’s belief that both Operation Warp Speed and these products were one of the great successes of his first administration, I am amazed that policy changes regarding these products have advanced so quickly under Secretary Kennedy and President Trump.

But I am also under no illusion that those “influencers” promoting the attacks, targeted splintering and demoralization, and intentional damage to the MAHA movement and its momentum will tone down their breathless, angry rhetoric. After all, anger sells. It generates clicks, likes, engagement, follows, influence and revenue. And is actively exploited and driven by bot farms.

But for one brief moment, let’s celebrate the win. This is progress. This is the consequence of new leadership at HHS doing what it can to Make America (and its children) Healthy Again.

Never forget, in politics and all other things, perfect is the enemy of the good. And patience is a virtue.

Reprinted with permission from Robert Malone.

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.