FDA Launches New AI-Powered System to Track Drug and Vaccine Side Effects

For decades, the system designed to catch dangerous side effects from drugs, vaccines, and consumer products has been failing. Not because the problems weren’t happening — but because the infrastructure meant to track them was too fragmented, too slow, and too burdensome to keep up.

The result was a growing gap between what patients experienced and what showed up in federal safety records. Patterns of harm went undetected or took far too long to surface, and the public was left making health decisions based on an incomplete picture.

Now the U.S. Food and Drug Administration (FDA) is attempting to close that gap with a sweeping technology overhaul — one that could fundamentally change how quickly you see safety signals and how much control you have over your own health choices. Here’s what the new system does, what it replaces, and why it matters.

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Judge Rules Parents Have Less Say In Pediatric Vaccine Schedule

A powerful medical organization and its backers won a legal victory last week in an ongoing struggle against federal efforts to alter vaccine recommendations and return decision-making to parents.

On March 16 U.S. District Judge Brian E. Murphy issued a ruling that effectively halted the government’s lead vaccine recommendation group from meeting and stayed vaccine recommendations published under U.S. Health and Human Services Secretary Robert F. Kennedy.

The American Academy of Pediatrics (AAP) and other left-wing medical groups sued Kennedy in July in response to his removal of pregnant women and healthy children from the Covid-19 vaccine recommended list. The group then amended its suit, filing multiple complaints challenging  Kennedy’s reconstituted immunization advisory panel and its votes. The AAP also challenged the revised pediatric schedule that the CDC published in January, which aligned the U.S. schedule with most developed nations by removing six vaccinations from the current schedule.

The American Academy of Pediatrics requested a ban on Advisory Committee on Immunization Practices (ACIP) meetings; Murphy acquiesced in part, granting a stay on the ACIP appointment rather than an injunction, the same day the Supreme Court stayed another of his decisions. The March meeting of ACIP, at which the committee was poised to address Covid-19 vaccine injuries and recommendation processes, is now indefinitely postponed.

“The same day he is stayed for repeatedly refusing to follow the law, he issues another activist decision,” wrote Deputy Attorney General Todd Blanche on X. “We will keep appealing these lawless decisions, and we will keep winning.”

In his 45-page ruling, Murphy wrote that the government has “undermined the integrity of its actions” by sidestepping ACIP in the vaccine schedule revision process and replacing members without the use of “rigorous screening.” The newly appointed members, Murphy wrote, represent a “procedural failure … that … fails to comport with governing law.” Violation of the Administrative Procedure Act will likely be proven, he concluded.

Responding to Murphy’s decision, HHS spokesman Andrew Nixon said that the department “looks forward to this judge’s decision being overturned” in a statement to The Defender.

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The Lives Ruined by Covid Jabs

The Daily Telegraph has run a feature on the “lives ruined by Covid jabs”, including the more than 2,500 deaths reported to the MHRA. Does this mean it’s finally acceptable for the mainstream media to talk about this? Here’s an excerpt.

Having been a dental nurse for more than a decade, Nikola Brindley was familiar with vaccination requirements for healthcare workers. So when she was asked to have AstraZeneca’s Covid jab in July 2021, she agreed without hesitation.

But within hours, Brindley was in A&E fighting for her life as an allergic reaction began to shut down multiple organ systems. “I collapsed on the doorway, and pretty much lost the ability to walk,” she recalls. “My husband rushed me to hospital, my heart rate had soared and I couldn’t speak. We were told that if I’d been 10 minutes later, there would have been nothing they could have done.”

Nearly five years later, the 36 year-old, who lives on the Isle of Man, remains profoundly affected. She lives with ongoing brain fog, chronic pain, headaches and gastrointestinal problems, and requires monitoring from a variety of specialists. Her worsening fatigue has left her requiring a wheelchair, while some days, she struggles to keep down food. Previously active and sporty, she is so disabled that her two children, aged eight and 11, have been certified as young carers.

“I genuinely thought that it was just going to be another vaccine,” she says. “Take it, get on with things. Instead, my life has been reduced to trying to manage symptoms every single day.”

Horrendous side effects represent the darker legacy of the Covid vaccine rollout, which, years on, remains a deeply thorny topic in public health. …

Yet while the vast majority of the 50 million people in the UK (and in other nations) who received Covid vaccines experienced few or no ill effects, there are those like Brindley, who either suffered serious harm or, most tragically of all, lost their lives.

There are no official statistics on how many people were impacted in this way. However, data from the Medicines and Healthcare Products Regulatory Agency (MHRA) indicates that the numbers are not insignificant. While these reports are not proof of the Covid vaccines causing serious harm and death, in the UK, as of February 24th, there had been:

For all the data collected, the plight of people who suffered Covid vaccine injuries has been handled markedly differently around the world. Authorities in Japan and South Korea have officially recognised a wide range of cases of vaccine-induced harm, from heart inflammation to sudden hearing loss, and have compensated tens of thousands of people accordingly.

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Former Pussycat Dolls member Jessica Sutta talks about her COVID jab injury and mother’s death

Former Pussycat Dolls member Jessica Sutta has claimed she was gravely injured by a Covid-19 vaccine and that her mother died after receiving a dose from what she described as a “deadly lot”, in an interview published online this week.

Speaking to Apollo the Original, Sutta said she felt a responsibility to speak out, saying her experience had led to professional fallout in Hollywood and warning that “there are too many people dying”.

In the interview, posted to YouTube on March 23, 2026, Sutta said she received a vaccine in 2021 shortly after having a baby, and later described her mother becoming seriously ill months after vaccination, losing weight and suffering breathing issues before her death. She also criticised what she called the “mainstream narrative” and said people were being discouraged from questioning vaccine safety.

Sutta said COVID vaccine-related injuries were being misdiagnosed and underreported, and said she would continue speaking publicly about her experience.

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Biden officials pushed COVID booster harder after surveillance found stroke increase: Sen. Johnson

The Biden administration pushed COVID-19 boosters for elderly people even harder after its vaccine safety surveillance systems discovered, as early as November 2022, “statistically significant safety signals for ischemic stroke” in that age group following uptake of the Pfizer bivalent, Sen. Ron Johnson, R-Wis., told Secretary of Health and Human Services Robert F. Kennedy in a letter Monday, disclosed Wednesday.

The Permanent Subcommittee on Investigations chair released nearly 2,000 pages of “relevant HHS records” in conjunction with the letter, in 10 batches, documenting the stroke signal and internal communications between officials “acknowledging significant statistical limitations in their ability to detect safety signals through their data analyses.”

The Biden White House next made edits to a draft Centers for Disease Control and Prevention and Food and Drug Administration “communications plan” to increase booster uptake, in January 2023, that “downplayed the significance of the safety signal, changing a sentence that stated that the ‘signal is moderately elevated’ to the ‘signal is slightly elevated,'” Johnson told Kennedy.

“Biden health officials posted on FDA’s website that ‘no change is recommended in COVID-19 vaccination practice,'” the same month, even as they “initiated multiple studies and statistical analyses — including a so-called ‘Stroke Project” — to investigate the validity of their assertion” through at least September 2025, Johnson’s office said.

He asked Kennedy for more information about detection of ischemic stroke following the booster because “the full extent of HHS’s awareness of the ischemic stroke safety signal remains incomplete and key records are still missing.”

Biden officials downplayed the risk of ischemic stroke they found in coadministered COVID and flu vaccines in fall 2023.

Several months earlier they approved “additional investigation” of the booster stroke signal even while emphasizing they weren’t changing vaccine recommendations, but quickly dismissed the signal after using a “different methodology.

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Bayer’s Monsanto sues mRNA COVID-19 vaccine makers

Bayer’s agrochemicals unit Monsanto has filed lawsuits in the US against the manufacturers of mRNA-based COVID-19 vaccines, claiming that they used its patent-protected technology in their products.

One lawsuit – filed in a federal court in Delaware – asserts that Pfizer/BioNTech’s Comirnaty and Moderna’s Spikevax vaccines, which generated tens of billions of dollars in revenues during the pandemic, used technology developed by Monsanto in the 1980s designed to eliminate ‘problem’ coding sequences in the building blocks of cells “to improve mRNA stability and the amount or quality of protein produced” in crops.

The technology was awarded a US patent in 2010 (No. 7,741,118) and is not due to expire until June 2027. According to the suit, Pfizer/BioNTech and Moderna used it to stabilise their mRNA vaccines.

“To develop effective mRNA medicines, defendants needed to stabilise the mRNA molecule and optimise its protein expression,” it claims, adding that they “optimised and manufactured their infringing mRNA vaccine products starting with a DNA template” and using Monsanto’s patented process.

Meanwhile, Reuters has also reported that Bayer independently filed a similar lawsuit against Johnson & Johnson in a New Jersey federal court, contending that a DNA-based process the company used in manufacturing its adenovirus vector-based COVID-19 vaccine also infringes the patent.

The shot – known as the Janssen vaccine – won emergency authorisations in the US and other markets and made blockbuster sales in the pandemic before its use diminished due to concerns about rare clotting side effects. It was withdrawn from sale in the US in 2023.

While sales are well down on their peak, Comirnaty brought in worldwide revenues of more than $3.3 billion for Pfizer and BioNTech last year, with Moderna earning $3.2 billion from Spikevax.

Bayer has said it does not intend to do anything that would restrict the commercial use of the COVID-19 vaccines – although, that is already being achieved due to changing immunisation policies in the US under the Trump administration – but is seeking damages “in an amount adequate to compensate” for the infringement of its intellectual property and royalties on sales.

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Air Force Officer Continues His Fight Against Vindictiveness and Intolerance Over COVID-19 Shot Mandate

An Air Force officer continues to battle one of the most egregious cases of vindictiveness and intolerance stemming from the military’s 2021 COVID-19 shot mandate, which was rescinded in January 2023 and deemed “unlawful as implemented” across all military departments in May 2025.

Following up on a story from September 2025, The Gateway Pundit spoke to Captain Anthony Monteleone to get an update on his case at the Air Force Board for Correction of Military Records (AFBCMR).

On July 8, 2025, as directed by the Department of War, Capt. Monteleone submitted his packet to the AFBCMR to correct the harms from the unlawful mandate in collaboration with his attorney, Jeffrey Addicott, Director of the Warrior Defense Project, and Mike Rose, Executive Vice President and General Counsel of Stand Together Against Racism and Radicalism in the Services (STARRS).

Two months later, on September 03, 2025, the AFBCMR denied his application, stating that his request “falls outside the jurisdiction of the AFBCMR,” and then reversed itself and accepted his case due to the directives from President Donald Trump and War Department leadership.

However, a grueling nine months after he submitted his package, and despite Congressional Representatives and multiple high-ranking Air Force officials reaching out to the AFBCMR on several occasions on behalf of Capt. Monteleone to stress the immediate need for relief in his case, the Board continues to delay the processing of his package.

As reported multiple times by The Gateway Pundit, numerous service members claim that the BCMR process is largely ineffective and that the Board’s willingness to engage amounts to little more than a superficial effort.

In short, despite the explicit directives from President Trump, Secretary of War Pete Hegseth, Undersecretary of War for Personnel and Readiness Anthony Tata, and the Secretary of the Air Force Troy E. Meink, Capt. Monteleone continues to have active derogatory paperwork in his personnel file. He is still experiencing significant and ongoing damage to his career due to the unlawful COVID-19 shot mandate, which is solely attributed to the prolonged time it is taking for the Board to review his case.

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Pfizer Says Lyme Vaccine Missed Trial Target, Will Still Seek Approval

Pfizer and its partner Valneva said on March 23 that their experimental Lyme disease vaccine did not meet the target in a clinical trial, but that the results were strong enough that the firms will seek regulatory approval for the shot.

The vaccine, known as LB6V, was about 75 percent efficacious in reducing confirmed Lyme in recipients compared with placebo recipients, the companies said. The efficacy was measured one day after the fourth vaccine dose, and was similar to the 73 percent efficacy observed 28 days after the fourth shot.

The drugmakers said that because there were fewer Lyme cases than expected during the trial, dubbed VALOR, the predetermined statistical target was not met. However, because the efficacy was “clinically meaningful,” the companies expressed confidence in the shot and said they would be filing for approval.

“The efficacy shown in the VALOR study of more than 70 percent is highly encouraging and creates confidence in the vaccine’s potential to protect against this disease that can be debilitating,” Annaliesa Anderson, Pfizer’s chief vaccines officer, said in a statement.

Valneva CEO Thomas Lingelbach said: “[The results] bring us a step closer to our goal of delivering a much-needed vaccine.

“We are grateful to our partner Pfizer for their strong commitment which we both share in developing this vaccine as quickly as possible.”

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Chinese scientists have turned mosquitoes into flying vaccines — that can still bite humans

Researchers from the nation that likely unleashed COVID-19 unto the world have transformed mosquitoes into flying syringes.

Some researchers, including a group at the Bill Gates Foundation-backed Leiden University Medical Center in the Netherlands, have already attempted in recent years to fashion mosquitoes into flying vaccine delivery systems with human targets in mind.

Now, scientists at the state-controlled Chinese Academy of Sciences — an institution that has a strategic partnership with the People’s Liberation Army Academy of Military Sciences — have targeted bats, purportedly designing mosquitoes to instead deliver recombinant vesicular stomatitis virus-based rabies and Nipah vaccines to the flying mammals.

Like rabies, Nipah virus is a potentially deadly virus found in animals. Whereas rabies has nearly a 100% fatality rate in humans once symptoms manifest, the estimated case fatality rate for Nipah virus ranges from 40% to 75%.

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Why your flu shot may work differently than you think

Two decades of federal surveillance data reveal how immune imprinting and an aging immune system undermine flu vaccine effectiveness. Current universal vaccination policy has not caught up to the biology.

Every autumn, public health authorities deliver a message that is simultaneously accurate and misleading: get your flu shot. All Americans aged six months and older are recommended to receive one. The guidance is consistent, reassuring, and considerably more complicated than it sounds.

A synthesis of two decades of CDC surveillance data, which will be published separately in Malone.News makes an argument that has been quietly building in the immunology literature for years: the current one-size-fits-all approach to seasonal influenza vaccination fails to account for two fundamental features of how the immune system actually works. The first is that your first flu exposure as a child permanently shapes how you respond to every flu vaccine you will ever receive. The second is that the immune system ages in ways that make older adults both the most important target for vaccination and the least reliable responders to it.

This is not a case against flu vaccination. It is a case for being honest about what the vaccine does and does not do, and for whom. In other words, it is a case for open and transparent informed consent.

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