Tag: safety

Moderna’s mRNA Flu Vaccine Gets Unanimous Thumbs-Up Despite Risks, Low Efficacy

A federal advisory committee today unanimously voted to endorse Moderna’s mRNA flu vaccine — just months after rejecting the company’s application on the basis that Moderna had not performed an “adequate and well-controlled” clinical trial.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC), which reviews scientific data on the safety and effectiveness of vaccines and other therapeutics on behalf of the U.S. Food and Drug Administration (FDA), voted 9-0 in dual votes to recommend approval of the vaccine for the 50-64 and 65-plus age groups.

Today’s votes took place after several hours of presentations based on the findings of Moderna’s Phase 4 clinical trial data for its mRNA-1010 vaccine. The trial compared the efficacy of mRNA-1010 to that of a conventional, non-mRNA flu vaccine.

Daniel O’Connor, founder and CEO of TrialSite News, told The Defender today’s favorable votes “may reflect the committee’s view that the benefit-risk profile is acceptable.” However, the vote “does not erase the fundamental concerns surrounding this application.”

“Significant questions remain about comparator selection, study design and whether the reported efficacy advantage represents a clinically meaningful improvement for patients or simply a statistical advantage within the framework of the trial,” O’Connor said.

According to an FDA briefing document prepared in advance of today’s meeting, “no major deficiencies were identified” with the vaccine for adults 50 and over. Citing the clinical trial data, the document states that the mRNA-1010 vaccine had a 26.6% relative efficacy rate in adults 50 and over, with similar rates for adults 65 and up.

The mRNA-1010 vaccine also showed a higher immune response than Sanofi’s Fluzone vaccine, the document noted. According to Fierce Biotech, these results met all of the FDA’s “pre-specified criteria for success” and bolstered Moderna’s application for approval.

Karl Jablonowski, Ph.D., senior research scientist for Children’s Health Defense, said today’s vote shifts mRNA-1010 safety monitoring to after licensure.

“VRBPAC meetings proceed to the beat of the rubber stamp. The unanimous vote guarantees a lot of really good questions of harm will have to be answered in the post-marketing period, when that harm manifests in the population,” Jablonowski said.

Moderna seeks traditional approval for the mRNA-1010 vaccine for the 50-64 age group and accelerated approval for the 65-plus age group.

Fierce Biotech reported that the FDA uses VRBPAC meetings to “seek outside counsel on tough or high-profile regulatory decisions.”

The FDA will make an approval decision on mRNA-1010 by Aug. 5 — and while the agency is not bound to VRBPAC’s votes, it “often follows the opinions” of its advisory committees.

Moderna’s stock was up over 4% in trading immediately after the vote, and up 3.50% at the close of market.

mRNA vaccine had higher rate of adverse events than conventional flu shot

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Study Finds Sunscreen Use Linked to Higher Risk of Multiple Skin Cancers

A UK Biobank study involving over 470,000 people found that individuals who reported using sunscreen more frequently had substantially higher risk of multiple skin cancers — even after researchers accounted for major confounding factors like age, sex, skin type, tanning ability, sunburn history, sunlamp use, and time spent outdoors.

The findings are worrisome:

• MELANOMA: +292% higher risk (RR = 3.92)

• BASAL CELL CARCINOMA: +140% higher risk (RR = 2.40)

• SQUAMOUS CELL CARCINOMA: +126% higher risk (RR = 2.26)

The researchers categorized sun protection habits from “never/rarely” to “always” and found the strongest associations among the most frequent sunscreen users.

In other words: the more sunscreen use reported, the higher the observed skin cancer risk.

This was an observational study, meaning it cannot prove sunscreen directly caused cancer. However, the study was also not a simplistic comparison of random sunscreen users versus non-users. Researchers statistically accounted for many of the biggest known skin cancer risk factors — including skin color, hair color, tanning ability, childhood sunburns, tanning bed exposure, outdoor time, age, and sex.

Even after all of that, the association remained.

Many chemical sunscreens contain hormone disruptors that are rapidly absorbed into the bloodstream, including compounds like oxybenzone, octocrylene, and homosalate.

Some formulations have also been found contaminated with benzene, a known human carcinogen.

And then there is the vitamin D issue. Sunlight is how the human body produces vitamin D, a hormone precursor involved in immune regulation, cellular repair, inflammation control, and cancer defense. People who never receive sunlight exposure without sunscreen are likely to become vitamin D deficient.

That does not mean people should recklessly burn in the sun. Sunburns are clearly harmful. Aim for sensible sunlight exposure — spending enough time in the sun reap the benefits without reaching the point of burning. If you’ll be out in the sun for hours on end during mid summer, consider opting for zinc-based (mineral) sunscreens rather than heavily absorbed chemical formulations.

The takeaway is not to fear sunlight, but to respect it.

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Report: Prince Harry ‘Distraught’ as Plea for Special Protection During UK Visit Denied

Don’t you know who I am? A “distraught” Prince Harry may well be asking this very question after his request for special police protection during an upcoming UK visit with his family was denied, the BBC reports, with the son of King Charles III now reconsidering whether to go ahead with the trip.

The Duke of Sussex, his wife Meghan and his two children, Archie and Lilibet, were due to make a family visit to the UK for the first time in four years.

His team had put in a formal request for police security while in the UK but it is understood they were told on Friday no taxpayer funded security would be provided.

Instead he would have to put his hand in his own pocket and pay his own way.

The BBC reports, “Sources say that Prince Harry is distraught about the decision, made just days before the family is due to arrive, but he would still like to find a way to make the trip work.”

A government spokesman confirmed to the outlet its protective security system was “rigorous and proportionate.”

“It is our long-standing policy not to provide detailed information on those arrangements, as doing so could compromise their integrity and affect individuals’ security,” the spokesman added.

Prince Harry and Meghan had already accepted an offer to stay on a royal estate during the trip as a guest of King Charles, although the location of the royal residence selected had not been made public.

The California residents were also expected to use private accommodation while in the land of his birth.

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Montana Puts Behavioral Health Reform in China‑Linked Hands and a Boy Ends Up with Traumatic Brain Injury

Montana’s lawmakers promised a historic fix. With a $300 million behavioral health investment and a high‑priced consulting firm, the State’s lawmakers said they would “transform” and “mend” a system that had failed vulnerable people for years. Behind that language was a decision AbleChild flagged from the start: the state handed the redesign of its behavioral health system to Alvarez & Marsal, a private firm with business ties in China, instead of building transparent, accountable capacity in Montana. That choice was not a technical detail. It was the blueprint for what would count as “reform.”

A $300 Million “Mend” That Left a 13‑Year‑Old in a Hospital Bed

While consultants and state lawmakers talked about strategy and transformation, the state continued quietly sending children to Provo Canyon School in Utah, for-profit residential psychiatric and behavioral facility with a long history of complaints and abuse allegations. Montana has paid Provo Canyon roughly $26 million over the last decade, proving this was a pipeline, not a one‑off placement.

Then a 13‑year‑old Montana boy allegedly suffered a traumatic brain injury at Provo Canyon. Families, backed by Paris Hilton, have now taken the facility to court, alleging delays and failures in his care. Only after that catastrophic harm did Montana officials suspend new referrals to the facility.  This is what “mend” looks like in practice: a child badly injured in a facility the state has patronized for years, and reform arriving only after the fact.

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The China Question No One in Power Wants to Ask

The China connection is not about Provo Canyon being a Chinese institution. It is about who Montana chose to trust with redesigning its behavioral health system and how it impacts national security and vulnerable children.

Alvarez & Marsal is a global consulting firm that does business in and with China. Montana’s decision was to pay that firm, at hundreds of dollars an hour, help steer how a $300 million “Future Generations” behavioral health investment would be structured and spent. That included advising on the overall continuum of care, financing strategies, and the shape of state services.

At a minimum, the choice raises a basic question the public deserves answered: why would any American state outsource the redesign of its already failing behavioral health system to a consulting firm tied to China, instead of building transparent, accountable capacity at home? If the result of that choice is a polished reform narrative on paper and a child with a brain injury in real life, then the outsourcing model—not just its implementation—has to be on trial.

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Inspector General: Secret Service’s Failure to Secure Mobile Devices Heightened Risk for U.S. Leaders

The U.S. Secret Service failed to secure mobile devices that became security risks, the Office of Inspector General (OIG) said pertaining to a review of the attempted assassination of President Donald Trump at a rally in Butler, Pennsylvania, on July 13, 2024.

The OIG, which operates under the U.S. Department of Homeland Security (DHS), said in its report published Monday it found the Secret Service “did not effectively secure and manage mobile devices, including during protective operations. As a result, adversaries could have intercepted and exploited Secret Service information, placing at risk our Nation’s leaders, other protectees, and employees — especially when unsecured devices were used overseas.”

The office noted that during other reviews after the attempted assassination in Butler, officials learned, “Secret Service personnel frequently used personal cell phones for official business, raising security concerns. We conducted this review to determine whether the Secret Service effectively manages and secures mobile devices used to conduct official Government business, including its protective mission.”

Furthermore, the OIG report said:

This heightened risk occurred because the Secret Service’s process for identifying and implementing mobile device capabilities did not always fully identify employees’ operational needs, leaving employees without essential capabilities such that they resorted to using personal devices. The Secret Service’s processes for securing mobile devices for international use were insufficient, and it did not have a policy of testing mobile device app code before installation.

The OIG noted it made five recommendations to improve mobile device security and “reduce the use of unmanaged personal mobile devices,” adding the Secret Service concurred with those recommendations.

President Trump’s right ear was bloodied when a bullet grazed it and members of the Secret Service rushed him offstage moments after shots were fired in an assassination attempt during the Butler rally, Breitbart News reported at the time.

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Supreme Court ruling blocks thousands of lawsuits against maker of Roundup weedkiller

The Supreme Court sided with the maker of the Roundup weedkiller Thursday in a ruling expected to block thousands of lawsuits alleging it failed to warn people the product could cause cancer.

The case came before the justices after a tidal wave of litigation that included some multibillion-dollar verdicts against the global agrochemical manufacturer Bayer, which acquired Roundup when it bought its original manufacturer Monsanto in 2018.

The decision is a victory for the Trump administration, but one that could be tricky politically since allies in the Make America Healthy Again movement want to rein in pesticide use.

The high court, in a 7-2 ruling, found that the company can’t be sued in state courts because federal regulations have found a cancer link unlikely and do not require a warning label.

The decision “is good for science, farmers, and industries that depend on regulatory clarity for innovation,” Bayer said in a statement. “It should help significantly contain the Roundup litigation after nearly a decade of legal battles.”

Though Bayer said the ruling should result in the dismissal of pending lawsuits containing failure-to-warn allegations, the company said it plans to proceed with a proposed $7.25 billion class-action settlement intended to resolve many of the remaining claims.

Lawyers for some residents pursuing Roundup litigation criticized the court’s decision.

“This Supreme Court ruling wrongly slams the courthouse door on Americans sickened by pesticides,” said attorney Christopher Seeger, who is proposed as a claimants’ representative in the settlement. But he said a settlement still would allow some people to receive compensation.

The case before the Supreme Court was filed by Missouri resident John Durnell. He developed a cancer called non-Hodgkin’s lymphoma after more than 20 years of serving as the neighborhood association’s “spray guy,” using Roundup on parks in his historic St. Louis community.

A jury agreed that the company failed to warn him about possible cancer dangers and awarded him $1.25 million. It’s one of thousands of similar cases, including some multibillion-dollar damage awards.

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FDA Approves Merck Pneumococcal Vaccine for ‘At-Risk’ Kids as Young as 2

The U.S. Food and Drug Administration (FDA) expanded its approval of Merck’s pneumococcal vaccine Capvaxive for use in children ages 2 and up who are considered at increased risk for the disease.

The drug was specifically designed for adults, Merck said in a statement, but “may” offer additional protection for high-risk kids.

Critics pointed out that the vaccine adds to the list of childhood vaccines not tested against a placebo, and that it contains an ingredient linked to high rates of adverse events.

Children and teens with chronic conditions, including pneumonia, meningitis and bloodstream infections, can get the vaccine in addition to the pneumococcal conjugate vaccine (PCV) they already get as part of routine pediatric shots recommended by the Centers for Disease Control and Prevention (CDC).

The decision makes Capvaxive the only PCV approved as an extra vaccine for this group.

The vaccine protects against Streptococcus pneumoniae, which causes a wide range of bacterial infections, including pneumonia, bacterial meningitis and middle ear infections. The illnesses are typically treated with antibiotics.

CRM197: a questionable platform for childhood vaccines

The FDA based its expanded approval of the drug on results from a Phase 3 trial that enrolled 882 children and adolescents with chronic conditions.

The trial compared Capvaxive against PPSV23 (pneumococcal 23-valent polysaccharide vaccine), another vaccine that protects against pneumococcal illness — meaning it was not tested against an inert placebo.

Capvaxive contains CRM197, a protein. It is a mutant of the diphtheria toxin used to boost the immune response in some vaccines. In Capvaxive, bacterial sugars from 21 strains of pneumococcus are individually linked, or conjugated, to the CRM197, which enhances the body’s immune response to each of the bacteria.

Children’s Health Defense (CHD) Chief Scientific Officer Brian Hooker warned that giving a vaccine containing CRM197 to at-risk kids will be “another train wreck for children, but a boon for Merck as it opens up a fresh new market of children.”

That’s because research has found that other vaccines using the platform have high rates of adverse events.

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Five things to know about pesticides, cancer and a pending Supreme Court ruling

After years of lawsuits against agrichemical companies and battles over environmental regulations, the nation’s highest court is expected to rule this summer on a case that could significantly alter the pesticide industry.

The U.S. Supreme Court is expected to rule next month on whether lawsuits can be brought against pesticide and herbicide makers over claims their products have caused cancer. 

The court heard arguments in the case in April, and the justices appeared split.

With a ruling weeks away, here are five things to know about the topic of pesticide use and cancer.

1. Geographic correlation between heavy pesticide use and high cancer rates

Numerous studies and an analysis of federal data have shown a potential correlation between pesticide use and cancer. Out of the 500 U.S. counties with the highest pesticide use per square mile (largely concentrated in corn, soybean and fruit-producing states like Iowa, Illinois, Missouri, California and Florida), 60% have cancer rates higher than the national average of 460 cases per 100,000 people. A 2024 study in Frontiers in Cancer Control and Society suggests the impact of pesticide use on cancer incidence may rival that of smoking.

2. Thousands of lawsuits have been won against agrichemical companies

State courts have also found that correlation credible, as Bayer, the maker of the herbicide Roundup, has lost thousands of cases and agreed to pay more than $12 billion in settlements, including individual jury verdicts such as an initial $2 billion award in California and a recent $1.25 million verdict in Missouri. According to the company, more than 65,000 lawsuits have been filed by farmers, gardeners and other users alleging the chemical caused their cancer.

3. Companies push for ‘liability shields‘

In response to these lawsuits, agrichemical companies have aggressively lobbied for state-level bans on this type of litigation. Often referred to as “liability shield” laws, they would essentially say that because the U.S. Environmental Protection Agency has not warned of a link to cancer, state-level claims would be void. Georgia and North Dakota are the only two states that have passed these liability shield laws. 

4. The Trump administration has largely sided with pesticide makers

The push for stricter pesticide regulation has created unusual alliances between left-leaning environmentalists and conservative health advocates under the “Make America Healthy Again” (MAHA) banner. 

After an initial Health and Human Services report linked pesticide overuse to childhood health issues, the agency’s final report last year walked back all regulatory calls and instead pivoted to promote public confidence in current EPA standards. President Trump also signed an executive order this year declaring glyphosate critical to national security, and his administration actively sided with Bayer during oral arguments before the Supreme Court.

In April, MAHA activists celebrated a win after the House voted to remove a pesticide industry-backed provision from its farm bill. The debate is expected to continue as the Senate drafts its own version of the farm bill. 

5. Supreme Court hears arguments on national ‘liability shield’ ban

In April, the U.S. Supreme Court heard arguments in Monsanto v. Durnell, in which Monsanto (owned by Bayer) argued that because the EPA has ruled glyphosate is unlikely to be carcinogenic, federal law preempts states from requiring cancer warning labels or awarding damages through state juries. A decision is expected in July.

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He ‘Lied’: Tulsi Gabbard Releases Evidence Fauci Allegedly Directed Funding for ‘Risky’ Coronavirus Research Linked to Big Pharma and Pursuit of ‘Universal Vaccines’

Director of National Intelligence (DNI) Tulsi Gabbard used her last day in office to release a trove of evidence that Dr. Anthony Fauci – former director of the National Institute of Allergy and Infectious Diseases (NIAID) – lied to Congress and directed U.S. funding for gain-of-function research linked to Big Pharma’s pursuit of “universal vaccines,” all while influencing and manipulating the intelligence community to cover up his role in the coronavirus pandemic. 

Gabbard, who is leaving her post to help her husband as he battles an “extremely rare” form of cancer, released a trove of documents on her last day in office showcasing what many have said for years: Fauci lied to cover up his own alleged wrongdoing.

The Trump administration is blowing the lid off the coverup completely, showcasing Fauci’s role in providing millions in U.S. taxpayer dollars to fund dangerous gain-of-function research at the Wuhan Institute of Virology – where that specific coronavirus is suspected to originate.

Gabbard said:

Today, on my final day as Director of National Intelligence, I’m releasing never before seen communications and documents that expose exactly how Fauci worked with politicized career leadership in the intelligence community to suppress the truth about his actions, the virus’s lab leak origins, and his role in directing U.S. funding for this dangerous research that caused immeasurable harm and countless lost lives.

Gabbard alleged that those documents clearly “expose Fauci’s direct role in influencing and manipulating IC assessments on COVID-19, and how Fauci lied to Congress in 2024 when, under oath, he denied knowledge of or participation in discussions with intelligence officials about viral research.”

Gabbard also revealed they have testimony from intelligence community whistleblowers “who reported retaliation for challenging the intelligence community’s manipulation of intelligence on the virus’s origins.”

Ultimately, Gabbard said Fauci was able to use his “close relationships” with the intelligence community to “shield him from scrutiny.” During that time, Fauci funded gain-of-function coronavirus research “linked to big pharma and their pursuit of universal vaccines worth trillions of dollars,” Gabbard explained.

She also said Fauci pressed the intelligence community to push the “natural” animal origin narrative of the virus to cover for himself, and he became “the nation’s pandemic pundit” where he was able to freely push his alleged lies and censorship of critics.

Gabbard said the documents show Fauci pushed a “fraudulent” paper and “blatantly lied to Congress during his 2024 testimony to the House Select Subcommittee on the coronavirus pandemic, denying that he ever spoke to any intelligence agency about COVID.”

“The correspondence I’m releasing today directly contradicts his sworn testimony,” she said, “and we received statements from multiple whistleblowers revealing that the intelligence analysts who dared to challenge Dr. Fauci’s COVID origin conclusions faced threats of retaliation, marginalization, and many suffered career setbacks.”

“The COVID pandemic caused tremendous hardship and pain for millions of our fellow Americans and countless people around the world. Now, after years of lies and censorship and cover-ups, the American people deserve transparency, truth, and accountability,” Gabbard continued.

“The tactics that were used to hide the truth are straight from the deep state playbook,” she said, declaring that it is now time for the American people to have the truth. “Politicized, self-serving leaders like Dr. Fauci covered up their own wrongdoing and abuses of power, manipulated intelligence, lied to Congress, and undermined a duly elected president by restricting his access to the vital facts he needed to keep the country safe.”

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Trucking Group Asks Federal Court To Strip New York, California Of CDL Authority

The Small Business in Transportation Coalition (SBTC) has filed a court petition seeking to force federal regulators to decertify the commercial driver’s license programs of New York and California.

The petition, filed June 10, asks the court to review actions by the Federal Motor Carrier Safety Administration and the U.S. Department of Transportation and order the agencies to revoke the authority of New York and California to issue CDLs, escalating a dispute over immigration-related licensing policies and English-language proficiency requirements for commercial drivers.

SBTC argues that FMCSA has already determined both states were in “substantial noncompliance” with federal CDL regulations and therefore must be decertified under federal law. The organization contends that federal statutes require the transportation secretary to prohibit a state from issuing CDLs once such a determination is made.

The filing, made in the U.S. Court of Appeals for the District of Columbia Circuit, specifically challenges FMCSA’s April 16 final determination regarding New York and also seeks relief related to a Jan. 7 determination involving California.

SBTC alleges the agency improperly failed to act on a petition it submitted in May 2025 requesting decertification orders against several states, including New York and California.

Virginia crash cited in petition

The lawsuit comes less than two weeks after a fatal bus crash on Interstate 95 in Virginia that killed five people and injured dozens more.

According to the court filing, SBTC points to the May 29 crash as evidence that stronger enforcement of federal licensing standards is needed. The organization alleges the bus driver involved held a New York-issued CDL despite concerns about English-language proficiency.

The crash involved a bus operated by E&P Travel Inc. Federal investigators are examining the company’s connections to a broader network of bus operators in the Northeast, according to CBS News. The driver, identified by CBS News as Jing S. Dong of Staten Island, New York, faces five felony involuntary manslaughter charges.

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