Tag: fda

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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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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FDA Altered Autopsy Results of Children Who Died After COVID Vaccines

Scientists at the U.S. Food and Drug Administration (FDA) revised the autopsy results of children who died after receiving the COVID-19 vaccine, reducing the number of children the agency classified as having likely died as a result of their vaccination, according to documents released last week by Sen. Ron Johnson (R-Wis.).

The documents show that in November 2025, the FDA’s Center for Biologics Evaluation and Research (CBER) identified 10 child deaths related to the COVID-19 shots. But in December 2025, it reduced the number to seven and downgraded the probability that those deaths were connected to the children’s vaccination.

The Daily Caller, which first reported, quoted two former FDA officials and a forensic pathologist who performed two of the children’s autopsies. One of the FDA officials told the outlet the emails reveal “a coverup” by the FDA and the Centers for Disease Control and Prevention (CDC).

Johnson included the documents in a letter sent last week to U.S. Health Secretary Robert F. Kennedy Jr., CDC Acting Director Jay Bhattacharya and FDA Acting Commissioner Kyle Diamantas.

Even the reduced number of deaths was enough to trigger concern among some FDA scientists about the safety of the COVID-19 shots, Johnson’s letter stated.

“Although what drove the decision to change these three cases remains to be seen, what is clear is that these officials appear to have determined that the seven cases warranted warning about the risks,” Johnson wrote. These risks “should have raised serious concerns at HHS and CDC about the mRNA COVID-19 Injections.”

Even after the downgrade, the FDA’s Division of Pharmacovigilance recommended revising the label of the Pfizer and Moderna mRNA COVID-19 vaccines to include a warning about the risk of “myocarditis with fatal outcomes.”

The change was never made, for reasons that are not clear.

Myocarditis is widely associated with the mRNA COVID-19 vaccines and, with reports of deaths connected to the vaccines, particularly among teenage and young adult males.

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Despite Over 100 Deaths in Moderna’s mRNA Flu Trial – Committee Recommends that the FDA Move Forward with Approval

June 18, 2026: Moderna just announced that, “the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 9-0 that the benefits of mRNA-1010, Moderna’s investigational seasonal influenza vaccine, outweigh its risks for the prevention of influenza disease in adults 50 through 64 years of age and in adults 65 years of age and older.”

This is despite the fact that Moderna reported 102 deaths in the mRNA group and 97 deaths in the ‘enhanced vaccine’ group.

102 reported deaths out of 35,965 mRNA injected study participants equate to a 0.3% fatal adverse event (death) rate in less than a year of being injected.

Adults aged 50-64 have a 0.015% of dying from the flu vs. 0.3% from a flu injection = a 20-fold (1900%) increase).

Adults 65 and older have a 0.05% chance of dying from the flu vs 0.3% from a flu injection = 6-fold (500%) increase.

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Senate Investigation Finds FDA Officials Covered-Up 25 COVID Shot Safety Signals

A new Majority Staff Interim Report from Sen. Ron Johnson’s Permanent Subcommittee on Investigations was released today (April 29, 2026), titled Unmasked: How Biden Health Officials Purposely Turned a Blind Eye Toward COVID-19 Vaccine Safety Signals.

In early 2021 — just weeks after the COVID-19 vaccines rolled out under EUA — FDA senior medical officer Dr. Ana Szarfman (a key developer of the agency’s own data mining system) teamed up with Dr. William DuMouchel (the statistician who literally invented FDA’s “gold standard” EB data mining algorithm) to run an upgraded analysis on VAERS data.

Their new method (Regression-Adjusted Gamma Poisson Shrinker — RGPS) fixed a known flaw called “masking” — where signals for one COVID vaccine get drowned out by the sheer volume of reports from the others.

What they found was explosive:

  • 49 examples of extreme masking
  • ~25 new statistically significant safety signals that FDA’s standard MGPS method completely missed
  • Signals included: sudden cardiac death, acute myocardial infarction, pulmonary infarction, Bell’s palsy, non-site specific embolism/thrombosis, dementia, and “Death and sudden death” — for Pfizer, Moderna, and J&J shots

Dr. Szarfman repeatedly shared these findings with senior CBER officials (the very people in charge of vaccine safety), including Dr. Peter Marks, in March, April, May, and July 2021.

Their response?

  • Told her to “hold off” on creating and sending any more data mining reports
  • Called her work a “major distraction”
  • Worried it would “create erroneous conflicts that feed into anti-vaccination rhetoric”
  • Eventually ordered her to “cease and desist”

Later, FDA quietly locked down distribution of its own weekly data mining reports to CDC — right around the time FOIA requests and Sen. Johnson’s letters started coming in. One CDC official even admitted they may have asked FDA to stop sending them “because of the FOIAs.”

Even after Dr. Szarfman and DuMouchel published their findings in Drug Safety (2022) showing masking was eight times more likely with COVID vaccines, and Dr. Robert Califf replied “Thanks. These are good,” no changes were made to the methodology.

This is documented, internal FDA communication showing deliberate suppression of safety signals at the exact moment millions of Americans were being told the shots were “safe and effective.”

The cover-up continues to unravel. Accountability is urgently warranted.

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Inside The FDA’s “Cover-Up” Of Child Deaths Linked To Covid Vaccines

In September 2025, then-US Food and Drug Administration (FDA) Commissioner Dr Marty Makary publicly acknowledged that the agency was investigating reports of child deaths following Covid-19 vaccination.

“We do know at the FDA…that there had been children who have died from the COVID vaccine,” Makary said during a CNN interview.

By that stage, however, a fierce internal dispute had already emerged inside the FDA over what investigators believed the evidence showed – and whether the public should ever see the full findings.

“It really did feel like there was some sort of cover-up going on about the Covid-19 vaccines,” said one individual familiar with the discussions.

MD Reports spoke with several current/former agency officials, advisers, and individuals briefed on the discussions, all of whom requested anonymity because they were not authorised to publicly discuss internal FDA deliberations.

At the centre of the controversy was an internal FDA review led by Dr Tracy Beth Høeg, a physician-scientist who was working as a senior scientist inside the FDA’s vaccine division at the time.

FDA officials examined roughly 96 paediatric death reports submitted to the Vaccine Adverse Event Reporting System (VAERS), the government database used to detect potential vaccine-related adverse events.

The review included medical records, autopsy reports, pathology findings, and follow-up investigations conducted by agency staff.

About 25 deaths following Covid vaccination were ultimately considered serious enough for high-level internal discussion inside the agency.

The findings were expected to be presented at a September 2025 meeting of the CDC’s Advisory Committee on Immunisation Practices (ACIP), the federal panel that shapes US vaccine recommendations.

But before that could happen, details of the review leaked to the New York Times and the Washington Post.

Høeg quickly became the focus of intense media scrutiny and criticism from vaccine advocates and unnamed FDA officials who argued she was relying too heavily on VAERS reports and overstating preliminary findings.

People familiar with the fallout said some FDA staff strongly objected to Høeg’s methods and conclusions and allegedly sought to undermine her credibility by leaking details of the review.

The leak effectively ended plans for a public ACIP discussion and deepened divisions within the FDA over how the findings should be handled.

Some officials believed the findings warranted stronger warnings and greater transparency. Others feared public acknowledgement of vaccine-linked child deaths would damage confidence in the Covid vaccines.

“We know that there are these deaths that are due to the vaccine,” said one source, referring to myocarditis cases and published reports from countries including Korea and Israel.

The controversy intensified after then-FDA vaccine chief Dr Vinay Prasad ordered additional investigation into the deaths identified in Høeg’s review.

Months later, another leak brought the issue back into public view.

In November 2025, an internal memo circulated by Prasad became public. In it, Prasad acknowledged that “at least 10” children had died “after and because of receiving Covid-19 vaccination.”

He described the findings as “a profound revelation.”

“COVID-19 vaccines did result in the death of children,” Prasad wrote. “Dr. Hoeg was correct in her assessment.”

The memo triggered another round of backlash from media outlets and vaccine advocates, many of whom accused Prasad of overstating the evidence before the agency’s analysis had been finalised.

Inside Medicine reported on a Dec 5 memo about a subsequent FDA analysis using a World Health Organization causality framework, which classified zero deaths as “certain,” two as “probable/likely,” and five as “possible.”

But individuals involved in the discussions said pressure steadily mounted inside the agency to “downgrade” the findings with each successive review.

“It seemed like there was a lot of pressure to keep decreasing the number of deaths,” said one source.

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New website unmasks the VAERS safety data exposed by Senator Johnson

There are only two things you need to know about the documents released by Senator Johnson relating to the VAERS safety signals:

  1. The safety signals were real and serious
  2. The people at the FDA and CDC ignored them

You have to realize that on all these emails, they ALL knew it would be subject to FOIA. So they can’t write “she’s right, but we need to silence her.” They all are aware that the conversations are being recorded.

There is now a new website that organizes all the data.

This took just 4 days to create by one person, Marjorie Roswell. It is absolutely amazing.

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FDA Ousts Another Top Official: Who’s Behind the Shakeup — and Why?

Tracy Beth Høeg, M.D., Ph.D., an epidemiologist and sports physician who supported studying — and reducing — the recommended childhood vaccination schedule, was fired by the U.S. Food and Drug Administration (FDA). Høeg was acting director of the FDA’s Center for Drug Evaluation and Research (CDER).

In a post on X last Friday, Høeg wrote that she “learned so much” and is leaving the FDA “with no regrets.”

And in an interview with MD Reports published shortly after her firing, Høeg said she first learned about the agency’s plans to fire her earlier in the week, through media reports.

On May 15, two unnamed FDA officials offered her the choice to resign or be fired. When she refused to resign, she was fired on the spot.

“I said I didn’t want to resign,” Høeg told MD Reports. “I said I’m not signing a letter of resignation if it’s not my choice.”

During her time at the FDA, Høeg was involved in several research initiatives broadly tied to the Make America Healthy Again (MAHA) agenda. According to The New York Times, this included work on an “intense investigation” last year that linked the COVID-19 vaccines to “at least” 10 child deaths.

Høeg also authored a report recommending that the number of diseases covered by the recommended childhood vaccination schedule be reduced from 17 to 11.

In January, U.S. Health Secretary Robert F. Kennedy Jr. implemented these recommendations. However, in March, a federal court issued a stay pausing adoption of the new schedule.

According to The Associated Press, Høeg was most recently involved in the FDA’s review of a petition to add new warnings to antidepressants about risks to pregnant women, “including fetal abnormalities that could lead to autism and other disorders.”

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Appeals Court Blocks Nationwide Access to Abortion Pills Via Mail

A federal appeals court on Friday blocked nationwide access to abortion pill prescriptions via telehealth and mail.

A three-judge panel on the Fifth Circuit Court of Appeals unanimously ruled that abortion pills such as Mifepristone must be distributed in person.

Louisiana filed the lawsuit after the FDA allowed Mifepristone to be distributed via telehealth and mail during the Covid pandemic.

In 2023, the ‘Covid’ change to how abortion pills were distributed became permanent.

The American Civil Liberties Union (ACLU) lashed out at Louisiana’s ‘anti-abortion politicians’ after the ruling came down from the appeals court.

“Anti-abortion politicians have just made it much harder for people everywhere in the country to get a medication that abortion and miscarriage patients have been safely using for more than 25 years,” said Julia Kaye, senior staff attorney for the Reproductive Freedom Project of the ACLU.

“Louisiana’s legal attack on mifepristone shamelessly packaged lies and propaganda as an excuse to restrict abortion — and the Fifth Circuit rubber-stamped it,” they said.

“This decision defies clear science and settled law and advances an anti-abortion agenda that is deeply unpopular with the American people,” the ACLU said.

“For countless people, especially those who live in rural areas, face intimate partner violence, or live with disabilities, losing a telemedicine option will mean losing access to this vital medication altogether,” the ACLU added.

NBC News reported:

A federal appeals court on Friday granted the state of Louisiana’s request to reinstate a nationwide requirement that abortion pills be dispensed in person.

The ruling represents a victory for opponents of abortion rights, since it limits access by blocking people’s ability to obtain mifepristone — one of the two pills used in medication abortions — through telehealth and by mail.

Telehealth prescriptions have been key to maintaining abortion access in states that outlawed or restricted the practice after the Supreme Court overturned Roe v. Wade in 2022.

During the Covid pandemic, the Food and Drug Administration temporarily eliminated a requirement for mifepristone to be dispensed only in clinics, medical offices and hospitals. The change was then made permanent in 2023.

Louisiana challenged that FDA regulation in federal court last year, alleging that the data to support it was flawed or nonexistent. Multiple studies have shown that mifepristone is safe and effective when taken at home after a consultation with a clinician.

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Behind Closed Doors vs. Public Messaging: What Health Officials Knew—and What They Didn’t Say

The FDA knew the COVID shots would kill and maim countless Americans.

They kept injecting anyway.

One government employee tried to sound the alarm about “49 examples” of deadly side effects that conventional safety analyses weren’t detecting.

She was shut down.

Her name was Dr. Ana Szarfman.

On March 1, 2021, less than three months after the rollout of the COVID-19 injections, Dr. Ana Szarfman, an employee at CDER and safety data mining developer, warned that the FDA’s existing system could hide vaccine safety signals due to a flaw called “masking.”

She proposed a newer method developed by statistician Dr. William DuMouchel that corrected for this issue and, when applied, detected “49 examples of extreme masking” that the standard system did not.

These “49 examples of extreme masking” include not “minor” but serious adverse events:

• Bell’s palsy

• Cardiac failure

• Acute left ventricular failure

• Agonal rhythm (severe end-of-life arrhythmia)

• Pulmonary infarction

• Cerebral artery occlusion

• Aortic stenosis

• Sudden cardiac death

• Hypertensive emergency

• Basal ganglia stroke

When Dr. Szarfman proposed a new method, she was told to “hold off on creating and sending data mining reports and analyses.”

Later, they “made it clear” that she “needs to focus on her assigned work” and “should not be discussing or providing internal analyses externally.”

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