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Within three months of the U.S. Food and Drug Administration’s approval of mFLUSIVA, Moderna’s new mRNA flu vaccine, federal health officials received dozens of adverse event reports, including reports of serious medical events that some experts say raise safety concerns.
An analysis of the Vaccine Adverse Event Reporting System (VAERS) database, managed jointly by the FDA and Centers for Disease Control and Prevention (CDC), identified 78 reports involving mFLUSIVA in September and October.
The data, accurate as of Oct. 30, show that two reports were formally classified as serious, while several others described potentially significant medical problems.
Two reports described people who temporarily lost the ability to walk. One, a 71-year-old man, was flagged for a disability less than a day after vaccination when he experienced shaking arms and leg weakness that left him unable to walk.
In another report, an 84-year-old woman temporarily lost the ability to walk within an hour of vaccination. The woman reported severe weakness and being unable to stand, but the report was not formally classified as serious.
Her initial VAERS report listed her as age 71, but an updated version of the report in VAERS’ raw dataset lists her age as 84.
Other reports described a patient of unknown age hospitalized with fever and low oxygen levels, and a 76-year-old man who reported hallucinations after receiving mFLUSIVA and Moderna’s Spikevax COVID-19 shot.
“There are an alarming number of severe systemic reactions, including high fevers, debilitating fatigue and severe body aches and exhaustion” and a “highly concerning” number of cardiovascular adverse reactions,” said internal medicine physician Dr. Clayton J. Baker.
“This suggests significant systemic toxicity very much akin to the disease the shot is supposedly designed to prevent,” Baker said.
An analysis by The Defender found that, among 58 reports that included information on when symptoms began, 51 indicated that the reactions appeared on the day of vaccination or the following day. Baker said that “from a temporal standpoint, this strongly implicates the shots” as the likely cause of those injuries.
The Defender’s analysis also showed that 37 of the 78 reports noted that the individual received a COVID-19 vaccine around the same time they received Moderna’s mFLUSIVA shot.
Of those, 30 reports indicated that both shots were administered on the same day, while seven described vaccinations on different dates. Two reports also listed an RSV vaccine.
Number of adverse events ‘not normal for a flu shot’
The FDA approved Moderna’s mFLUSIVA (mRNA-1010) in August, for adults 50 and older. According to Brian Hooker, Ph.D., chief scientific officer for Children’s Health Defense, the number of VAERS reports filed in such a short period — particularly those involving serious medical conditions — is unusually high.
“The flurry of reports that has accumulated in VAERS in just two months is stunning, especially given that this was a limited launch of the vaccine and the majority of pharmacies didn’t have stock until late September or early October. Also, the proportion of serious adverse events is high,” Hooker said.
Whether serious or not, “78 adverse-event reports within weeks of rollout is not normal for a flu shot, particularly given the severity of some reported events,” said epidemiologist Nicolas Hulscher, administrator at the McCullough Foundation.
Baker agreed. Citing VAERS figures, he said the mFLUSIVA shot has already accounted for more than 1% of all flu vaccine VAERS reports filed since 1990.
Despite an FDA committee’s unanimous approval of mFLUSIVA in June, the vaccine’s clinical trials were fraught with difficulty — and potential safety signals.
Earlier this year, Hulscher co-authored a peer-reviewed reanalysis of mFLUSIVA clinical trial data. He said the analysis, published in the Journal of Independent Medicine, identified “major warning signs,” including deaths among trial participants and a significantly higher rate of severe adverse reactions.
According to Hulscher, the study found that Grade 3 systemic reactions — severe reactions that can prevent normal daily activities and may require medical intervention — were “approximately six times more frequent with mFLUSIVA than with comparator influenza vaccines — 5.5% versus 0.9%.”
“Deaths of unspecified cause occurred in 23 mFLUSIVA recipients versus nine comparator recipients — a 155% higher relative risk,” Hulscher said.
An FDA briefing document found “no major deficiencies” with the mFLUSIVA clinical trial data — yet it reported higher rates of serious adverse events, along with more deaths of unspecified cause in the mFLUSIVA group compared with conventional flu vaccines. It also showed that Moderna didn’t conduct any long-term safety testing or observation.
The concerns outlined in the briefing resemble those the FDA cited last year, when Moderna first filed its application to license its mRNA flu shot. In February, Dr. Vinay Prasad, then-director of the FDA’s Center for Biologics Evaluation and Research, which oversees vaccines, declined to review Moderna’s application for licensure.
In a “refusal-to-file” letter, Prasad said Moderna’s clinical trial did not meet the standard for an “adequate and well-controlled” study because it failed to use the “best-available standard of care” as a comparison case during the clinical trial.
But less than two weeks later, the FDA reversed course and accepted Moderna’s application. Prasad left the FDA in April — his second departure in less than a year.
In August, figures buried in the appendix of a New England Journal of Medicine article confirmed that Moderna’s mRNA flu shot was associated with significantly more serious adverse events during its clinical trial than the conventional flu vaccine it was tested against.
For Hooker, mFLUSIVA data show that “the risk far exceeds the benefit.” Hulscher said these concerns prompted him to co-author the reanalysis, as he believes the evidence shows that the FDA had “an unacceptable basis” for approving mFLUSIVA.
Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, called the Hulscher paper “an important reanalysis” of the FDA’s clinical trial — one that presents “evidence for a highly unfavorable risk-benefit profile, especially for the elderly.” Yet the FDA approved the shot for precisely this age group.
Experts question safety of administering mRNA flu and COVID shots together
Several experts said mFLUSIVA’s clinical trials did not evaluate the safety of receiving the shot alongside a COVID-19 vaccine, despite public health guidance encouraging people to get both shots during the fall cold and flu season.
Immunize Colorado states that receiving COVID-19, flu and even RSV vaccines during the same visit is “completely safe.” The guidance does not distinguish between conventional and mRNA flu vaccines.
Hooker said public health authorities recommend concurrent vaccination even though “these shots have not been tested in combination” and the mFLUSIVA trials did not use a saline placebo.
Despite the lack of combination-specific trial data, Hooker said, “the proportion of patients receiving multiple shots in a single visit is extremely high.”
“Combining two dangerous gene therapies in one visit will amplify the risk of adverse events,” Hulscher said.
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Experts raise alarm about potential risks of mRNA technology
Experts also suggested a possible mechanism that they believe could contribute to serious adverse reactions reported after mRNA vaccination.
Hulscher said the mFLUSIVA vaccine “uses lipid nanoparticles to deliver nucleoside-modified mRNA that instructs human cells in vital organs to manufacture toxic influenza hemagglutinin proteins.” According to Hulscher, “this will unsurprisingly result in disabling reactions.”
In mRNA COVID-19 shots, lipid nanoparticles deliver mRNA to human cells. However, lipid nanoparticles have been found to transfer excess mRNA, spike protein and DNA contaminants to other cells and throughout the body.
Immunologist and biochemist Jessica Rose, Ph.D., said that administering mRNA flu and COVID-19 shots — both of which use the lipid nanoparticle platform — is “definitely” a “contributing factor to the reported injuries” seen in the VAERS database. She said the reports in VAERS are enough to constitute a safety signal.
Fisher said VAERS data also raise concerns about the safety of mRNA technology, given the record number of adverse event reports associated with mRNA shots.
“The two mRNA COVID shots together have generated over 1.5 million adverse event reports to VAERS — the most reaction reports related to one vaccine filed with VAERS since 1990,” Fisher said.
However, the actual number of serious adverse events may be significantly higher, as adverse events following vaccination have historically been underreported and undercounted. A 2011 Harvard Pilgrim study found that fewer than 1% of vaccine-related adverse events are reported to VAERS.
“Based on past analysis, three adverse events is not three, but more like 300,” Hooker said.
Fisher said mFLUSIVA’s clinical trial data should have been sufficient to prevent its approval and warrant its withdrawal from the market. Other experts suggested that the VAERS reports strengthen calls to suspend the use of mRNA products.
Fisher said the mFLUVISA’s clinical trial data was sufficient to block the shot’s licensure and withdraw it from the market.
“This extreme risk-benefit profile warrants the immediate suspension and market removal of Moderna’s mFLUSIVA,” Hulscher said.
Related articles in The Defender
- Doctors Call on RFK Jr. to Withdraw Moderna mRNA Flu Vaccine After Review of FDA Data Shows Risks Outweigh Benefits
- Moderna’s mRNA Flu Vaccine: How FDA Hid ‘Serious’ Safety Signal
- Breaking: Moderna’s mRNA Flu Vaccine Gets Unanimous Thumbs-Up Despite Risks, Low Efficacy
- ‘Textbook Conflict of Interest’: Did Blackstone Pressure FDA to Reverse Course on Moderna mRNA Flu Vaccine?
- Moderna ‘Shocked’ After FDA Scuttles Review of New mRNA Flu Vaccine
- Scientists Petition FDA to Suspend or Withdraw mRNA COVID Vaccines
