Tag: moderna

FDA pushes RSV vaccines for kids despite halted Moderna trials

Advisers to the FDA recently met to discuss the future of respiratory syncytial virus (RSV) vaccines for children. This followed Moderna’s forced halt of its mRNA RSV vaccine trials after alarming data showed higher rates of severe RSV in vaccinated infants compared to those given a placebo. Clinical trial data revealed 12.5% of vaccinated children developed severe RSV disease, compared to just 5% in the placebo group.

These outcomes raised alarms due to past experiences with RSV vaccines. In the 1960s, trials of a formalin-inactivated RSV vaccine led to vaccine-associated enhanced respiratory disease (VAERD), where vaccination worsened illness instead of preventing it. That trial resulted in two toddler deaths and hospitalization for 80% of the vaccinated participants. Despite decades of research, the risks tied to VAERD remain unresolved.

FDA advisers emphasized the “unmet need” for pediatric RSV vaccines, framing RSV as a leading cause of infant hospitalizations in the US annually. Vaccine makers, spurred by a projected $13.59 billion global RSV vaccine market by 2030, are developing 26 RSV vaccines or monoclonal antibodies for all age groups.

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Moderna Creates new mRNA Vaccine

If the aftermath of the first widespread mRNA vaccine was not enough to deter the public, the government and the Centers for Disease Control and Prevention (CDC) partnered with Moderna to create a new DNA-altering vaccination for the bird flu.

And here we go again – Moderna said that their most recent vaccine is specifically for this variant (2.3.4.4b) of the flu, which has not spread from person-to-person contact. The Science Translational Medicine published Moderna’s study of the vaccine in which they exposed ferrets to the virus. Moderna won a $176 million federal funding package back in JULY to develop this vaccination.

There are only 60 known cases of this virus among humans, and nearly everyone who contracted it was exposed to infected cattle. California has already declared a state of emergency, and every politician and pharmaceutical company that enjoyed the power grab of the first pandemic is eager for the next. I cannot fathom why anyone would take this vaccine when the last mRNA vaccination FAILED. It failed to prevent the spread or transmission of the virus and injured far more people than it helped. This is why the current investigations into COVID must remain ongoing — we cannot afford a repeat of 2020.

We seriously need MAJOR political reform. Anyone who supports the absolute immunity for the Pharmaceutical Industry should be removed from office – NOW! If one in every 10,000 General Motors cars blew up when you just turned the key but has absolute immunity from lawsuits, why fix the problem? These people know that even with normal vaccines, there is also a portion of people who will die. That is just a matter of fact. That is why they bribed our politicians for absolute immunity. Why ask for that unless you were getting sued?

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‘Reckless Disregard for the Truth’: Shareholders Sue Moderna for Misleading Investors on RSV Shot Efficacy

A group of shareholders is suing Moderna alleging the company knowingly inflated claims about the efficacy of its RSV vaccine for older adults. When the drugmaker later lowered expectations for the vaccine’s efficacy the stock price dropped precipitously.

A class-action lawsuit accuses Moderna of making “materially false and misleading statements” about the efficacy of its respiratory syncytial virus (RSV) shot, leading to significant damages for investors.

The lawsuit, filed Aug. 9 in the U.S. District Court for the District of Massachusetts, covers investors who owned or purchased Moderna stock between Jan. 18, 2023 — the day that Moderna announced that mRNA-1345, its candidate RSV vaccine, met primary efficacy endpoints in Phase 3 clinical trials — and June 25, 2024.

According to the lawsuit, Moderna misled investors by failing to disclose that “mRNA-1345 was less effective than Defendants had led investors to believe” and that “mRNA-1345’s clinical and/or commercial prospects were overstated.”

“As a result, the Company’s public statements were materially false and misleading at all relevant times,” the lawsuit states.

The lawsuit names Moderna and its key executives, including its CEO Stéphane Bancel, Chief Financial Officer James M. Mock and President Stephen Hoge, as defendants.

“Defendants acted with reckless disregard for the truth in that they failed or refused to ascertain and disclose such facts as would reveal the materially false and misleading nature of the statements made, although such facts were readily available to Defendants,” the lawsuit states.

Brian Hooker, Ph.D., chief scientific officer for Children’s Health Defense (CHD), told The Defender he is not surprised by allegations of fraud concerning Moderna.

“It is unfortunate that Moderna lied about the efficacy of the vaccine and misled investors,” Hooker said. But Hooker said the “bigger tragedy here is the lack of safety testing for modified mRNA products such as their RSV shot.”

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Moderna Confirms Link Between COVID mRNA Vaccines and Cancer

Moderna has admitted its mRNA COVID vaccine causes CANCER after billions of DNA fragments were found in vials of the dangerous injection.

The revelation was made after Dr. Robert Malone recently made an appearance at an “Injuries Caused by COVID-19 Vaccines” hearing led by Congresswoman Marjorie Taylor Greene (R-Ga.), at which he revealed how Moderna’s patent shows that its (COVID-19) “vaccine” vials contain billions of DNA fragments and other contaminants linked to birth defects and cancer.

At the hearing, Dr. Malone spoke about how Moderna acknowledges in its patent that RNA is preferable to DNA in vaccines because of the risks involved, but that the company’s mRNA injection, which was administered to tens of millions of people, is contaminated with the latter.

“Moderna has a patent on the use of RNA for vaccines,” Dr Malone stated. “And in that, Moderna explicitly acknowledges that RNA is superior to DNA for vaccine purposes because problems, including the possibility of insertional mutagenesis that could lead to the activation of oncogenes or the inactivation of tumour suppressor genes.”

“FDA says they’re not aware of any concerns, but Moderna, in its own patent, lays out exactly the same concerns that exist about DNA in insertional mutagenesis and genotoxicity.

“So, Moderna knows it – DNA is a contaminant. It is left in because of the way they make it … they use DNA to make RNA, and then they degrade the DNA, and then they have to purify the degraded DNA away from the RNA, and the process they are using is not that good.”

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U.S. Will Pay Moderna $176 Million to Develop mRNA Bird Flu Vaccine

The United States government will pay vaccine manufacturer Moderna $176 million to develop a new mRNA vaccine to treat bird flu.

The U.S. Department of Health and Human Services will pay Moderna $176 million for a vaccine containing the same mRNA technology as the company’s COVID-19 vaccine.

Bird flu, or H5N1, has been reported in dairy cows and has infected three people in the United States.

In total, 135 dairy herds have been infected with bird flu in 12 states.

Per AP:

The U.S. government will pay the vaccine maker Moderna $176 million to develop a pandemic vaccine that could be used to treat bird flu in people as cases in dairy cows continue to mount across the country, federal officials announced Tuesday.

The funds are targeted for release through the U.S. Department of Health and Human Services and will pay for continued development of a vaccine that uses the same mRNA technology that allowed rapid development and rollout of vaccines to protect against COVID-19. The award was made through the Biomedical Advanced Research and Development Authority, or BARDA, a program focusing on medical treatments for potential pandemics.

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Moderna Stops mRNA COVID Biologics Plant Construction in Kenya

Moderna, Inc. announced recently that it has suspended its efforts to build a $200–$500 million mRNA (messenger ribonucleic acid) biologics manufacturing facility in Kenya while it determines projected future demand for mRNA biologics in Africa. Company officials concluded that, since the end of the COVID pandemic,  interest in COVID-19 biologics in Kenya and Africa has declined and is insufficient to support the viability of the proposed mRNA biologics manufacturing plant. Moderna confirmed that it has not received any orders for its Spikevax mRNA COVID biologic from Africa since 2022 and that previous orders for the product have been cancelled.1

Vaccine Plant in Kenya Would Have Supplied Vaccines and Drugs to African Countries

In 2021, Moderna announced that they were partnering with the Government of Kenya to build a state-of-the-art mRNA COVID biologics plant in Kenya to produce up to 500 million doses of Spikevax each year. The company expected the new facility to initiate drug substance and drug product manufacturing for Kenya and other countries in Africa. In addition, Moderna stressed that the facility would have had the capacity to quickly respond to public health emergencies in Africa.2

According to Moderna, orders for Spikevax that were cancelled resulted in over $1 billion in lost revenue for the company. Although Moderna was a major player during the COVID-19 pandemic distributing its mRNA COVID biologic globally, it has remained a relatively a small biotechnology company with Spikevax being the only pharmaceutical product approved for distribution and use in the U.S. and other countries. Since the decline in the overall demand for COVID shots, Moderna’s revenue from sales of Spikevax is projected to decline to $4 billion this year compared to $18.4 billion in 2022 and $6.7 billion in 2023. The company has also experienced a drop in its share price by more than 75 percent during the past two years.3

The company said that the cost savings from suspending construction of its Kenyan manufacturing facility will allow them to focus on other products.

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Moderna Shares Rise On Report US Gov’t Preparing Funding For mRNA Bird Flu Vax

Shares of Moderna are up more than 4% in the New York premarket trading session following a report by the Financial Times that the US government is preparing to “bankroll a late-stage trial of Moderna’s mRNA pandemic bird flu vaccine.” H5N1 is spreading across the US ahead of the November presidential elections, and some prominent doctors have already warned about university labs experimenting with H5N1 gain-of-function. 

Sources familiar with the talks between Moderna and the government’s Biomedical Advanced Research and Development Authority, known as Barda, say federal funding could be allocated to the pharma company as early as next month. 

“It is expected to total several tens of millions of dollars, and could be accompanied by a commitment to procure doses if the phase-three trials are successful,” they said.

Moderna has previously said it was trialing H5N1 flu vaccines, with interim data expected soon. 

Moderna is currently testing an H5N1 vaccine, from the 2.3.4.4b subset of viruses, in people. That trial began last summer.

But the trial’s listing in the Clinicaltrials.gov database is cagey about the dosages Moderna is testing, calling them simply dose number 1, 2 and 3. -Statnews

As of Wednesday, the US Department of Agriculture has detected 67 dairy cow herds with H5N1 infections in nine states: Texas, Kansas, New Mexico, Michigan, Idaho, North Carolina, South Dakota, Ohio, and Colorado. 

The ongoing outbreak is linked to dairy cattle. Only two H5N1 cases have been detected among humans. The first was in April, with a Texas dairy worker, and the second was from a Michigan dairy farm last week. Both had mild infections and have since recovered.

FT also said the federal government is in talks with Pfizer about an mRNA vaccine targeting H5N1. 

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Moderna Stops New mRNA Vaxx Trials after High Rate of Side Effects

The phase 1 trial of Moderna’s new mRNA HIV vaccine has been halted after a high rate of “puzzling skin side effects” were reported.

The new vaccine requires a series of mRNA shots to be delivered, but an “unusually high percentage of recipients developed rashes, welts or other skin irritation,” according to Science magazine.

“We are taking this very seriously,” Carl Dieffenbach told Science. Dieffenbach heads the Division of AIDS at the National Institute of Allergy and Infectious Diseases, which funded the phase 1 trial.

It’s unclear at this stage whether the problem is caused by the “cumulative effect from multiple mRNA shots,” the genetic background of the recipients or the HIV sequence.

Different versions of this vaccine have already been tested, but in every instance skin problems occurred at a worryingly high level. In one study, 11 out of 60 recipients ended up developing some form of skin problem.

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CDC Concealed Evidence Linking Deaths to Pfizer and Moderna COVID-19 Vaccines, Internal Documents Reveal

U.S. Centers for Disease Control and Prevention (CDC) officials found evidence that the Pfizer-BioNTech and Moderna COVID-19 vaccines caused multiple deaths before claiming that there was no evidence linking the vaccines to any deaths.

The US public health regime and the bootlicking media have been routinely downplaying the risk of developing myocarditis after taking the vaccine, calling the occurrence “mild” and “rare,” and systematically burying any evidence to the contrary.

According to the documents obtained by The Epoch Times, CDC employees conducted investigations into reported post-vaccination deaths, particularly focusing on cases involving myocarditis, a known side effect of the Pfizer-BioNTech and Moderna COVID-19 vaccines.

Their findings, spanning the end of 2021, highlighted instances where myocarditis was listed on death certificates and in autopsies for some individuals who had received the vaccines. In some cases, myocarditis was even attributed directly to vaccination.

The file also showed instances where deaths met the CDC’s definition for myocarditis, with symptoms appearing within 42 days of vaccination and no virus-related symptoms present.

Despite these findings, the CDC maintained that it had seen no signs linking the Moderna and Pfizer mRNA vaccines to any deaths reported to the Vaccine Adverse Event Reporting System (VAERS).

The VAERS database contains information on unverified reports of adverse events (illnesses, health problems and/or symptoms) following immunization with US-licensed vaccines.  The CDC government website links to the VAERS platform.

What VAERS Says: “‘VAERS occasionally receives case reports from US manufacturers that were reported to their foreign subsidiaries. Under FDA regulations, if a manufacturer is notified of a foreign case report that describes an event that is both serious and unexpected (in other words, it does not appear in the product labeling), they are required to submit it to VAERS.”

Dr. Clare Craig, a British pathologist, and Dr. Andrew Bostom, a heart expert, both expressed concerns about the CDC’s stance. Dr. Craig told The Epoch Times that it was “absolutely” safe to say that the vaccines caused the deaths in cases where myocarditis was listed as the cause and met the CDC’s definition.

Dr. Bostom accused the CDC of “concealing these deaths” and “putting out a dishonest line” by claiming there were no deaths related to the mRNA vaccines.

A CDC spokeswoman declined to explain why the agency doesn’t consider autopsies or death certificates as evidence of causality and did not address questions about specific deaths outlined in the file, citing privacy concerns.

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Doctors Confirm Vaccine Connection after Young Ontario Woman Paralyzed after Moderna Shot – Then Offer Her Euthanasia as Remedy

A young mother’s life has been turned upside down in the wake of receiving her Moderna COVID-19 booster shot, which has left her paralyzed from the neck down, The Canadian Independent reported.

Kayla Pollock, a 37-year-old from Mount Albert, Ontario, has had her vibrant life of motherhood and community involvement brought to a sudden halt due to what doctors have diagnosed as a severe vaccine-related reaction.

Kayla, who suffered an abusive childhood, had overcome her past to find joy in her work as a behavioral trainer for exotic animals and later as an educational assistant. The single mother, known for her active lifestyle, was compelled to get vaccinated to ensure she could continue visiting her father in his long-term care facility.

However, after receiving her booster shot on January 11, 2022, Kayla began experiencing alarming symptoms, culminating in her complete paralysis less than two weeks later. Despite initial skepticism from emergency department staff, an MRI revealed a significant lesion on her spinal cord.

A neurologist, documented on an audio recording, expressed his belief that the vaccine was the likely cause of Kayla’s condition, a view later confirmed with a diagnosis of transverse myelitis – a rare inflammatory disorder caused by damage to the spinal cord.

The once active mother has since spent several months in hospital and rehabilitation centers, even being offered MAID – Medical Assistance in Dying – which she refused.

Medical Assistance in Dying (MAID) in Canada is a legal and voluntary form of euthanasia, allowing eligible adults to request assistance from a medical practitioner to end their lives.

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