FDA approves new Moderna mRNA vaccine without bothering with independent advisers



The U.S. Food and Drug Administration has approved Moderna's mRNA-1345 vaccine, which allegedly protects adults aged 60 and older from respiratory syncytial virus infection-caused lower respiratory tract disease.

The agency's breakthrough therapy designation approval for the drug, which will be marketed as mResvia, is only the second Moderna drug the FDA has approved. More significantly, it is the first mRNA vaccine to have been approved to address a disease other than COVID-19.

'We did not refer your application to the Vaccines and Related Biological Products Advisory Committee.'

Even though that amounts to a big step, it appears the regulator was keen to jump past additional levels of scrutiny.

The FDA noted in its Friday approval letter, "We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your [biologics license application], including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefited from an advisory committee discussion."

The advisory committee's job is to review and evaluate data concerning the "safety, effectiveness, and appropriate use of vaccines and related biological products," then provide independent expert advice to the agency.

According to the pharmaceutical company, the approval was based on "positive data from the Phase 3 clinical trial ConquerRSV, a global study conducted in approximately 37,000 adults ages 60 or older in 22 countries."

Nearly 20,000 of the trial participants were based in the United States. There are at least 11 other studies under way examining the impact of the novel drug on other demographics.

The company claimed in a Feb. 29 overview of its trial data that the vaccine "continued to be efficacious through median 8.6 months follow-up" and was shown to prevent severe RSV disease "base on analysis of shortness of breath and medically attended RSV-[lower respiratory tract disease]."

The vaccine's efficacy is allegedly 83.7%. Reuters noted, however, that the label indicates the shot is only 79% effective at preventing at least two symptoms of RSV, such as fever and cough.

While the overview insisted that the vaccine was relatively effective and safe, it nevertheless highlighted a number of "systemic reactions" reported within seven days of vaccination, such as headache, fatigue, myalgia, arthralgia, and chills, besides customary injection site pain.

A Moderna-funded study published in the New England Journal of Medicine similarly alleged that a single dose of the vaccine "resulted in no evident safety concerns."

Despite similarly having been presented as a safe vaccine, Moderna's COVID-19 vaccine was linked in various studies, including in an FDA-funded study, to an increased risk of myocarditis and pericarditis, particularly in men ages 18-25.

Extra to heart inflammation, the Global COVID Vaccine Safety Project — a Global Vaccine Data Network initiative supported by both the CDC and the Department of Health and Human Services — revealed in a February study in the esteemed journal Vaccine that "Bell's palsy had an increased [observed to expected] ratio after a first dose of [Pfizer's] BNT162b2 and [Moderna's] mRNA-1273."

The study also noted that "there were also increased OE ratios for febrile seizures following a first and second dose of mRNA-1273 ... and for generalized seizures following first mRNA-1273 dose and fourth BNT162b2 dose."

Blaze News previously reported that the University of Auckland, which hosts the Global Vaccine Data Network, noted that there were safety signals for "acute disseminated encephalomyelitis (inflammation and swelling in the brain and spinal cord) after viral vector and mRNA vaccines."

Despite outstanding concerns about its only other approved vaccine, Moderna appears confident in its product and has evidently secured the FDA's confidence as well. Its next stop is the Centers for Disease Control and Prevention, whose Advisory Committee on Immunization Practices will review the vaccine during its June 26-27 meeting.

Analysts estimate Moderna will do roughly $340 million in RSV vaccine sales this year and possibly $830.5 million in 2025, reported Reuters.

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Utah mom left 'disabled' after COVID-19 vaccine trial launches first US lawsuit against AstraZeneca



Prior to the pandemic, Brianne Dressen of Salt Lake City was living the active life she always wanted. She went rock climbing with her husband, a chemist for the U.S. Army; ferried her two children to and from soccer games and piano practices; and taught preschool.

Everything came to a screeching halt in November 2020 — not as a result of the union-driven school closures, the lockdowns, or the outcome of the election, but with her participation in an AstraZeneca vaccine trial.

"I walked into the clinic fine, and walked out the beginning of a nightmare I wouldn't wish on my worst enemy."

The experimental vaccine allegedly left the 42-year-old Utah mother with a debilitating injury.

Dressen cannot bring a product liability action against the company on account of the federal Public Readiness and Emergency Preparedness Act. She can, however, possibly ding the British-Swedish pharmaceutical giant for breach of contract, which is exactly what she aims to do.

Dressen filed a lawsuit in the U.S. District Court for the District of Utah Monday alleging that she developed a debilitating neurological condition as a result of the Oxford-AstraZeneca COVID-19 vaccine and that the British-Swedish pharmaceutical giant failed to cover the cost of her medical care as promised.

When presented with Dressen's complaint, Daniel Horowitz, the host of "Conservative Review with Daniel Horowitz" on the Blaze Podcast Network and author of "Rise of the Fourth Reich: Confronting COVID Fascism with a New Nuremberg Trial So This Never Happens Again," told Blaze News, "It is shocking how we now have thousands of academic and case studies of injuries affecting every organ system, yet victims remain alone with little legal recourse for compensation."

"We have VAERS, V-Safe, documents from the vaccine manufacturers, and European Medicines Agency reporting, all showing catastrophic levels of injury, yet there is no critical mass of a political movement in any country at this point to repeal unbridled indemnity of these criminal enterprises," continued Horowitz. "It's also peculiar how AstraZeneca was taken off the market, but the mRNA shots, which are even worse, remain funded and promoted by government."

Background

The Oxford-AstraZeneca COVID-19 vaccine was a viral-vector vaccine developed in collaboration with Oxford University and produced for various companies by the Serum Institute of India.

While 32,000 Americans like Dressen participated in vaccine trials in the homeland and the Biden administration agreed to share up to 60 million doses with other nations, the AstraZeneca vaccine was never rolled out in the United States. It was, however, administered billions of times worldwide.

It quickly became clear that the vaccine was not as "safe and effective" as health authorities throughout the Anglosphere had guaranteed. After all, there were numerous reports of otherwise healthy recipients experiencing abnormal bleeding, low blood platelets, blood clots, and even dying.

German and Nordic researchers determined that some recipients were developing a clotting disorder called "vaccine-induced immune thrombotic thrombocytopenia," which produced antibodies that activated platelets and led to clots.

Despite a growing number of likely victims, AstraZeneca suggested there was "no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, gender, batch or in any particular country."

The company's claims have aged like milk.

Last year, Jamie Scott, a father of two left with a permanent clot-related brain injury, filed suit against the company. His complaint was followed by dozens more and ultimately a class-action lawsuit.

Several months after Scott sued AstraZeneca, the company admitted in a February court document that "it is admitted that the AZ vaccine can, in very rare cases, cause [thrombosis with thrombocytopenia syndrome]. The causal mechanism is not known."

The following month, the company withdrew its "marketing authorization" in the European Union. That application went into effect last week. The Telegraph reported that AstraZeneca is expected to remove the vaccine from all other markets where it was approved.

'Hollowed out'

Dressen's lawsuit, reportedly the first to be launched stateside against AstraZeneca, claims the company offered various written promises to participants in its vaccine trial, including financial reimbursement for each completed visit to the test clinic for various procedures; financial reimbursement for each completed phone call linked to the study; and compensation for study-related injuries.

"At the moment the substance entered Bri's blood, a solemn contract had been formed."

"Defendants defined 'research injuries' as '[i]njuries that have been caused by the vaccine, tests or procedures,'" said the lawsuit. "Defendants promised that 'Sponsor will pay the costs of medical treatment for research injuries, provided that the costs are reasonable, and you did not cause the injury yourself.'"

"At the moment the substance entered Bri's blood, a solemn contract had been formed," said the complaint. "Her performance was complete and Defendants' promises were irrevocable."

When things went south, the lawsuit claims the company effectively left Dressen hanging.

"I was a completely hollowed out version of who I once was."

Within an hour of receiving the shot, Dressen claims she experienced tingling in her arm. The paraesthesia apparently was not temporary or localized. It soon spread to her other arm.

"That evening other progressively worrying symptoms emerged: blurred vision, double vision, headache, sound sensitivity, a loud ringing in the ears (tinnitus), nausea, vomiting, fever, and chills," said the lawsuit.

In the weeks that followed, a prickling sensation reportedly spread to Dressen's legs. She indicated she lost 20 pounds from constant vomiting while this and her other symptoms worsened.

"I walked in to the clinic fine, and walked out the beginning of a nightmare I wouldn't wish on my worst enemy," recalled Dressen. "My little girl's voice was too painful for my ears. My little boy's hand was too painful for touch. There was no break, no reprieve, no escape. No answers, no help, only questions, and fear of what was overtaking my body more and more each day as new symptoms piled on."

"I was a completely hollowed out version of who I once was," added Dressen.

In June 2021, a team of neurologists from the National Institute of Health reportedly diagnosed Dressen as having "Post Vaccine Neuropathy."

According to the lawsuit, Dressen is still "disabled" three years later; "a shadow of her former self: unable to work, unable to do any athletic activity, unable to parent the way she had, and unable to drive more than a few blocks at a time."

Dressen told the Telegraph that the worse part is that her children, now aged nine and 11, can't remember the kind of person their mother was before the injury.

"It really sucks. The worse part, the biggest punishment of all of this, is the impact on my kids," said Dressen.

Painful and costly

Dressen's lawsuit claims that AstraZeneca ignored multiple requests for support until finally coughing up a meager $1,243.30, "a minuscule fraction of the medical bills and lost wages, among other financial costs, that Bri had incurred and will continue to incur."

After all, Dressen's biweekly medication supposedly ran her $3,500 per session. One of her current medications would cost her over $430,000 a year. With the help of insurance, she is presently paying roughly $119,000.

"The way we have been and continue to be treated is simply appalling."

In order to access the $1,243.30, Dressen would have to release AstraZeneca of further responsibility for her care.

"The way we have been and continue to be treated is simply appalling," Brian Dressen, the plaintiff's husband, is quoted as saying in the complaint.

The Telegraph reported that Utah law enables complainants who sue for breach of contract to claim for damages and costs resulting from the alleged breach. While Dressen is not suing for a specific amount, she could possibly have AstraZeneca on the hook, not only for her legal and medical bills, but for additional damages — including for lost income and emotional distress.

A spokeswoman for the company told the Telegraph that AstraZeneca would not comment on ongoing litigation. She did, however, say, "Patient safety is our highest priority. From the body of evidence in clinical trials and real-world data, the AstraZeneca-Oxford vaccine has continuously been shown to have an acceptable safety profile and regulators around the world consistently state that the benefits of vaccination outweigh the risks of extremely rare potential side effects."

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Exclusive: Texas AG Ken Paxton Sues Pfizer For ‘False, Deceptive’ Covid Jab Con

The lawsuit alleges Pfizer ‘engaged in false, deceptive, and misleading acts and practices by making unsupported claims’ about its Covid jab.

The US military discharged over 8,000 service members who rejected the COVID-19 shot. Only 43 have rejoined.



The Pentagon's vaccine mandate is no longer in effect, but its repercussions continue to be felt. Of the over 8,000 service members discharged for refusing the shot, only 43 have rejoined over the past eight months.

What's the background?

After first rolling out a vaccination program on a voluntary basis, Secretary of Defense Lloyd Austin announced the mandate in 2021, penalizing all service members who resisted.

The Military Times indicated that roughly 17,000 service members ultimately refused to take the vaccine.

While around 1,200 secured exemptions, Defense Department records indicate that 3,717 Marines, 1,816 soldiers, and 2,064 sailors were discharged for refusing the vaccine, reported Reuters. Further, 834 Air Force/Space Force service members were apparently also discharged.

Approximately 70% of those ousted for their refusal to take the novel mRNA vaccine reportedly received general discharges.

The mandate and the ousters were roundly criticized.

Twenty governors, in a Nov. 30, 2022, letter demanding the mandate's repeal, stated, "The Biden vaccine mandate on our military creates a national security risk that severely impacts our defense capabilities abroad and our state readiness here at home."

About-face

The mandate remained in effect from August 2021 until January 2023, when Republicans ensured its nullification as part of the 2023 National Defense Authorization Act.

Republican Sens. Ron Johnson (Wis.), Ted Cruz (Texas), and others also proposed that military members who had been discharged for refusing the vaccine be reinstated, reported CNN. However, this amendment to the defense bill in the Senate did not pass.

Following the passage of the NDAA, Austin wrote in an unapologetic memo, "Section 525 of the NDAA for FY 2023 requires me to rescind the mandate that members of the Armed Forces be vaccinated against COVID-19, issued in my August 24, 2021 memorandum, 'Mandatory Coronavirus Disease 2019 Vaccination of Department of Defense Service Members.' I hereby rescind that memorandum."

Accordingly, troops would no longer have to take the vaccine against their will or undergo segregation "on the basis of their refusal to receive the COVID-19 vaccination if they sought an accommodation on religious, administrative, or medical grounds."

Despite this reversal and the provision of general discharges, thousands of ousted troops have not returned.

Gone for good

Alabama Sen. Tommy Tuberville (R) wrote to Navy Secretary Carlos Del Toro, Air Force Secretary Frank Kendall, and Army Secretary Christine Wormuth last month demanding answers about how many service members have rejoined as well as about the services' plan "to ensure continued readiness after the mandate went into effect, knowing that thousands of service members would be discharged."

Tuberville said in a corresponding statement, "Joe Biden firing thousands of healthy and dedicated service members made us weaker and never had any basis in science."

"The Senate — and, more importantly, military families — deserve a full accounting of the effects of this policy up and down the chain of command. The Pentagon needs to stop stonewalling and give us the answers we deserve."

CNN reported that, according to data provided by the military branches, since January, only 19 soldiers have rejoined the Army and 12 have rejoined the Marines. As for the Air Force and Navy, only one and two have returned, respectively.

Some analysts have suggested that the lost manpower is a drop in the bucket.

J. Stephen Morrison, director of the Global Health Policy Center at the Center for Strategic and International Studies, told CNN the numbers are "minuscule."

"I don't think there was ever any real evidence that it was getting in the way of recruitment or retention," said Morrison. "There was some grumbling, but you know the reality if you enter the military and you submit to a whole battery of different medical measures."

Last year, Marine Corps Commandant Gen. David Berger suggested the mandate had in fact impacted recruitment, particularly "in parts of the country [where] there's still myths and misbeliefs about the back story behind it," reported Military.com.

Outgoing Chairman of the Joint Chiefs of Staff Gen. Mark Milley said in a House Armed Services Committee hearing in early 2022, "I think if 2,000 are kicked out [of the Army], I think that would hurt."

In addition to having trouble luring back those able-bodied patriots it discharged during the pandemic, the military appears to be struggling with recruitment and retention.

For instance, TheBlaze reported Tuesday that the Army has found itself having to make "sweeping changes" to its recruiting enterprise after struggling to meet its end-strength goal.

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Uncle Sam’s Making Me Take The Covid Jab To Become An American Citizen

Give me liberty or give me subclinical myocarditis.

'There's something going on': Scientists acknowledge the severity of 'long vax' as well as their reluctance to pursue research that might furnish skeptics with a 'sensational headline'



Science, the peer-reviewed academic journal of the American Association for the Advancement of Science, has just published damning admissions substantiating fears about COVID-19 vaccines that would have up until recently been verboten to express online.

Just as there is allegedly "long COVID," in which persons who contracted the virus suffer various symptoms long after they should have recovered, the American medical establishment now appears comfortable admitting there is similarly "long vax."

After the obligatory claim that COVID-19 vaccines have saved lives, Science correspondents Gretchen Vogel and Jennifer Couzin-Frankel noted that COVID-19 vaccines aren't just causing side effects, such as "abnormal blood clotting and heart inflammation," but have been linked to "a debilitating suite of symptoms that resembles Long Covid."

"You see one or two patients and you wonder if it’s a coincidence," Dr. Anne Louis Oaklander, neurologist and researcher at Harvard Medical School, told the journal. "But by the time you’ve seen 10, 20. .... Where there's smoke, there's fire."

Vogel and Couzin-Frankel suggested that symptoms of vaccine fallout "can include persistent headaches, severe fatigue, and abnormal heart rate and blood pressure. They appear hours, days, or weeks after vaccination and are difficult to study. But researchers and clinicians are increasingly finding some alignment with known medical conditions."

One of these conditions is reportedly small fiber neuropathy, whereby "nerve damage can cause tingling or electric shock-like sensations, burning pain, and blood circulation problems."

Another is postural orthostatic tachycardia syndrome (POTS), which can manifest as "muscle weakness, swings in heart rate and blood pressure, fatigue, and brain fog."

The National Institutes of Health noted in December 2022 that researchers examining linkages between COVID-19 vaccines and "uncommon side effects" had found "a slight increase in the number of people who have experienced postural orthostatic tachycardia syndrome (POTS) following vaccination."

Some patients are reportedly unfortunate enough to suffer "features of one or both conditions."

Peter Marks, director of the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research, which oversees vaccines, told the journal, "We can't rule out rare cases" where vaccines have triggered small fiber neuropathy or POTS and further stressed the importance of health care providers taking "seriously the concept [of] a vaccine side effect."

However, Marks appears to be worried that admitting vaccines are hurting people in the long term could give rise to a "sensational headline" that would, as Vogel and Couzin-Frankel phrased it, "mislead the public."

The article alludes to the German health minister's recent acknowledgement that COVID-19 vaccines, which were similarly de facto mandatory in his country, have been shown to result in long-term consequences.

Karl Lauterbach, the minister in question, reportedly told Christian Sievers of the ZDF Heute Journal that what has happened to people affected by vaccine injuries "is absolutely dismaying and every single case is one too many. I honestly feel very sorry for these people. There are severe disabilities, and some of them will be permanent," adding "1 in 10,000 is the frequency of serious side effects."

DW reported that the Paul Ehrlich Institute, the German Federal Institute for Vaccines and Biomedical Drugs, "has registered 333,492 cases of suspected harmful vaccination side effects and 50,833 suspected cases of serious side effects since the start of the vaccination campaign: a reporting rate of 1.78 per 1,000 vaccine doses."

Vogel and Couzin-Frankel stressed that researchers studying the long-term fallout of the vaccines, such as Harlan Krumholz, a cardiologist at Yale University, are worried about "undermining trust."

Krumholz reportedly indicated he was initially reluctant to "dive in" for fear of bringing to light truths that might be seized upon by vaccine critics.

Notwithstanding his reservations, Krumholz said, "I’m persuaded that there’s something going on” with these side effects. "It’s my obligation, if I truly am a scientist, to have an open mind and learn if there’s something that can be done."

Krumholz and Yale immunologist Akiko Iwasaki have started a post-vaccination study called LISTEN, for Listen to Immune, Symptom and Treatment Experiences Now, reported the New York Post.

They are attempting to "understand long COVID, post-vaccine adverse events and the corresponding immune responses by collecting information about symptoms and medical history from participants."

Theirs is not the only show in town, however.

Researchers at Cedars-Sinai Medical Center analyzed a health database of nearly 300,000 people in Los Angeles, all of whom had received at least one COVID-19 shot.

"They found that within 90 days after a shot, the rate of POTS-related symptoms was about 33% higher than in the 3 months before; 2581 people were diagnosed with POTS-related symptoms after vaccination, compared with 1945 beforehand," Vogel and Couzin-Frankel indicated.

Some researchers suspect that the SARS-CoV-2 spike protein, delivered by the vaccines, may be responsible for "long vax," as it may instigate an immune overreaction and destabilize ACE2 signaling.

Although the specifics of how precisely the vaccines are upending some patients' lives are presently being worked out, Lawrence Purpura, an infectious disease specialist at Columbia University, is certain about the consequences.

Postvaccination illness is "a long, relentless disease," said Purpura.

In recent years, amid a broader effort to censor down vaccine skepticism, the Biden White House has pressured social media companies to silence those who raised concerns about the short- and long-term effects of COVID-19 vaccines, including Tucker Carlson.

While curbing dissenting views and squelching expressions of concern, the Biden administration imposed vaccine mandates, knowing full well there were "breakthrough" infections despite COVID-19 vaccination, contrary to how they were sold to the public.

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New York Supreme Court Reinstates NYC Workers Fired Under ‘Arbitrary And Capricious’ Covid Jab Mandate

'The vaccination for City employees was not just about safety and public health; it was about compliance,' the court concluded.
Wut? The FDA Approves Fifth Booster | 3/29/22

Wut? The FDA Approves Fifth Booster | 3/29/22