Day: June 20, 2023

Twelve Infants Die During Clinical Trials for FDA-Endorsed RSV Drug

BY AMBER BAKER

SEE: https://thevaccinereaction.org/2023/06/twelve-infants-die-during-clinical-trials-for-fda-endorsed-rsv-drug/;

Republished below in full unedited for informational, educational, & research purposes.

On June 8, 2023, the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously (21-0) in favor of AstraZeneca and Sanofi’s new nirsevimab (Beyfortus) monoclonal antibody drug believed to provide protection for infants from respiratory syncytial virus (RSV) disease and other lower respiratory tract infections during their first year of life.1

Citing a “favorable benefit-risk profile for the prevention of RSV lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season,” AstraZeneca/Sanofi stated in a press release that the antibody may also have the potential to protect those born healthy at term or preterm, as well as with conditions that make them more susceptible to RSV disease.2

RSV is a common, typically-mild lower respiratory illness. In serious cases, the disease can lead to pneumonia or bronchiolitis, putting infants and the elderly at high risk for complications.

The RSV antibody comes on the heels of the world’s first RSV vaccine, GSK’s Arexvy, which was approved by the FDA last month for use in people 60 years of age and older. Pending final FDA approval, nirsevimab would become the first single-dose pharmaceutical intervention in the U.S. aimed at protecting babies from RSV infections through the age of two years.3

RSV Labeled a Major Public Health Threat After Unprecedented Surge in Cases

After COVID infections decreased, there was an “unprecedented” spike in RSV infections in infants that overwhelmed hospitals in 2022 and prompted pediatric health organizations to call on President Biden to declare a public health emergency after 17 states reported that more than 80 percent of their beds were full last fall.4

While some experts suggest the surge in respiratory viruses is a result of relaxing COVID-19 measures, others attribute the spike to “immunity debt,” or the idea that people’s immune systems were weakened from lack of normal, natural exposure to pathogens like RSV and influenza because of stay-at-home orders, prolonged mask-wearing, and social distancing that persisted for the better part of three years.5

The path to pharmaceutical RSV protection spans several decades, with clinical trials for an RSV vaccine ending abruptly in the 1960s after the shot unexpectedly sickened and hospitalized 80 percent of children in the trial. The inactivated virus used in the shot exacerbated the disease once trial participants caught RSV naturally, leading to two children’s deaths and researchers going back to the drawing board.6

Today, more than 60 years later, 12 infants have died during clinical trials of the new nirsevimab, two from “unknown causes” thought to be linked to sudden infant death syndrome (SIDS).7

Infant Deaths Attributed to Underlying Disease Despite Clinical Trials Requiring Healthy Participants

The other 10 infant deaths were attributed to “underlying disease.” However, according to Pfizer, clinical trials typically include healthy participants to assess the safety of the drug and any side effects, and only certain types of trials—such as those for oncology—would warrant the inclusion of sick patients versus healthy people.7 8

Before joining a clinical trial, according to the U.S. National Institutes of Health (NIH), participants must be given informed consent, as well as any information that allows the research team to determine whether or not they can participate in the study safely.9

As for the other 10 children’s deaths—attributed to a number of varying causes such as cardiac disease, a tumor, COVID, a skull fracture, pneumonia, two from gastroenteritis, and two from unknown causes—FDA official Melissa Baylor, MD said none of the deaths appeared to be related to the experimental drug nirsevimab.7

SIDS and the Importance of Black Box Warnings on Drugs

By definition, SIDS is an unexpected and unexplainable death that occurs in a “seemingly normal, healthy infant under one year of age.” In fact, nine out of 10 deaths in the study occurred around the two- and four-month mark, when well-baby visits to the pediatrician commonly precede the administration of multiple vaccines, such as the combined DTaP (diphtheria, tetanus, and acellular pertussis) in one visit, according to the U.S. Centers for Disease Control and Prevention’s (CDC) Immunization Schedule.10

Many drugs, including some routine childhood vaccinations for newborns, contain black box warnings on the manufacturer’s product inserts. A black box warning, the highest safety-related warning intended to alert the consumer to major risks of the drug, stamps the insert of any drug where trial participants died during clinical studies. Still, more often than not, as with the clinical trials of nirsevimab, the diagnosis of SIDS often overrules the occurrence of a potentially lethal drug reaction as the cause of death in an otherwise healthy infant.11

The FDA is slated to make a final decision on nirsevimab later this year. To date, the agency maintains it has not identified any safety concerns in its review of the drug.7

If you would like to receive an e-mail notice of the most recent articles published in The Vaccine Reaction each week, click here.

Click here to view References:

1 Pinsk A. A New Shot Prevents Serious Illness from RSV. Johns Hopkins Bloomberg School of Public Health Mar. 30, 2022.
2 Press Release. Nirsevimab unanimously recommended by FDA Advisory Committee for the prevention of RSV lower respiratory tract disease in infants. AstraZeneca June 8, 2023.
3 Press Release. FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine. U.S. Food and Drug Administration May 3, 2023.
4 Kimball S. Children’s hospitals call on Biden to declare emergency in response to ‘unprecedented’ RSV surge. CNBC Nov. 18, 2022.
5 Christensen J. Pandemic ‘immunity gap’ is probably behind surge in RSV cases, scientists say. CNN Oct. 28, 2022.
6 Harding A. Research shows why 1960s RSV shot sickened children. Reuters Dec. 3, 2008.
7 Kimball S. FDA advisors recommend AstraZeneca, Sanofi antibody to protect babies from RSV. CNBC June 8, 2023.
8 Reed J. Do You Have What It Takes to Join a Phase 1 Clinical Trial? Pfizer 2021.
9 U.S. National Institutes of Health. NIH Clinical Research Trials and You, The Basics. Oct. 3, 2022.
10 Sudden Infant Death Syndrome (SIDS). Boston Children’s Hospital 2012.
11 Vitamin K Injection [PACKAGE INSERT]. Novaplus 2021.

Deep State Declares War on Trump Voters

What the latest "indictment" really proves.

BY

SEE: https://www.frontpagemag.com/deep-state-declares-war-on-trump-voters/

Until now, American voters have been allowed to select our next president without interference by federal prosecutors. In a free election the People can decide which issues are significant, such as entanglement in foreign wars, and which are petty, such as the location of some old papers from the previous administration.

But the federal workers who pursue political prosecutions of Trump and his supporters are as hostile to democracy as they are clueless about the loyalty of Trump voters. Special prosecutor Jack Smith, who disgracefully prosecuted Republican Gov. Bob McDonnell until Smith was reversed by the Supreme Court, now demands that Trump face a speedy trial, so that Smith’s office rather than the voters can decide the reelection of Trump.

Jack Smith’s unprecedented indictment will be heard by Judge Aileen Cannon, who had previously smacked down the feds after their excessive raid of Trump’s home at Mar-a-Lago last August. In that case she told the federal Trump-haters to back off, and she properly appointed a respected former judge to review the documents that were seized in the raid.

On appeal to a higher court, Judge Britt Grant, whose husband worked for nearly a decade for the Deep State at the CIA, showed improper rudeness to Trump’s attorney. Also on the panel was Judge Bill Pryor, who is often a rubber-stamp for prosecutors, and they reversed Judge Cannon’s fair ruling.

Yet now the liberal media, led by the New York Times, are complaining about the random assignment of the Trump indictment to Judge Cannon, despite her lack of any conflict of interest. What liberals dislike is her independence from politics, which is what a good judge should display.

Few Americans would base their vote on where President Trump stored boxes of documents relating to his presidency when he moved out of his residence at the White House. Many public officials take copies of documents with them when they leave office, as Joe Biden did when he left the White House in 2017 and Biden has not been charged with anything.

But many federal workers in D.C. are too virulently anti-Trump to allow the democratic process to work without interference by fanatical federal prosecutors. They have no employable skills outside of government and yet are bankrolled by an unlimited spigot of taxpayer dollars, which would have been shut off had the debt ceiling been enforced on June 1.

The timing of this federal indictment to be less than one week after suspension of the debt ceiling, which keeps the money flowing to them, seems to be more than a coincidence. The GOP majority in the House does not have to allow taxpayer millions to be spent on biased investigators taking pictures of boxes of obscure documents stored in an unused bathroom.

Trump has built successful companies and skyscrapers, employed thousands, and defeated the idol of most federal workers: Hillary Clinton. Then Trump committed unforgivable sins in the eyes of the feds by firing their FBI director, James Comey, and by pardoning the victims of Department of Justice political prosecutions, including Lt. Gen. Michael Flynn.

The January 6 protests were, on top of all that, a thorough humiliation of the Deep State in D.C. for which it has been retaliating ever since. All Trump did on that day was to give a speech while serving as president, and it is very difficult to convert a presidential address into some kind of crime.

So Trump-haters hatched this plan to accuse this former and future president of “willful retention” of his own presidential papers, abusing a century-old law that has never before been used in this way. The federal bullies also indicted a U.S. Navy veteran from Guam who has been a personal assistant to Trump, Walt Nauta, over the phony separate crime of supposedly lying to the FBI as Nauta voluntarily described his service to the former president.

Local prosecutors who prosecute real crimes do not regard lying to authorities as a separate crime, yet that is the federal prosecutors’ favorite fake crime to invoke. They used it improperly against Lt. Gen. Michael Flynn, in what was later discovered to have been a premeditated ambush by the FBI, and threatened the respected author Dr. Jerome Corsi with this until he publicized the injustice.

Senate Majority leader Chuck Schumer, a Democrat from New York, famously warned Trump that the intelligence community, also known as the Deep State, has “six ways from Sunday at getting back at you.” Just before Trump was inaugurated to his first term, Schumer said on national television that “from what I am told, they are very upset with how he has talked about them.”

This new indictment proves how vindictively the Deep State will retaliate. It needs to be defunded.

Officials at Federal Gov’t Agencies, White House Sued for

Officials at Federal Gov’t Agencies, White House Sued for Censoring COVID Information

BY CAROLYN HENDLER, JD

SEE: https://thevaccinereaction.org/2023/06/officials-at-federal-govt-agencies-white-house-sued-for-censoring-covid-information/;

Republished below in full unedited for informational, educational, & research purposes.

Sixty-seven U.S. federal government agencies and officials, including senior officials in the White House, have been accused of engaging in a widespread campaign of pressuring and colluding with social media platforms to censor users in violation of the First Amendment of the U.S. Constitution. Former Missouri Attorney General, Eric Schmitt and Louisiana Attorney General, Jeff Landry, brought the lawsuit, Missouri v Biden, in an attempt to expose government officials and the coordinated efforts of Big Tech companies such as Twitter, Meta, YouTube and Facebook to censor information related to COVID-19, COVID countermeasures and election integrity.1 2

Defendants include the White House press secretaries; Dr. Anthony Fauci, former White House senior COVID advisor and chief medical advisor to the president; FBI special agents; the Food and Drug Administration (FDA); the Department of Homeland Security (DHS); the Department of Health and Human Services (HHS); the State Department and the U.S. Election Assistance Commission.3 4

The lawsuit filed in federal court in the Western District of Louisiana on May 5, 2022, alleges that the defendants not only violated the First Amendment but that the Biden administration officials acted illegally and exceeded their authority in their communications with Big Tech companies and that DHS and HHS violated the Administrative Procedures Act. Included in the allegations are that White House Press Secretary Jen Psaki and Surgeon General Vivek Murthy, MD specifically ordered Big Tech platforms to take expanded actions to combat information posted online that White House officials judged to be misinformation.6 7 8

Former Missouri Attorney General Eric Schmitt stated:

In direct contravention to the First Amendment and freedom of speech, the Biden Administration has been engaged in a pernicious campaign to both pressure social media giants to censor and suppress speech and work directly with those platforms to achieve that censorship in a misguided and Orwellian campaign against ‘misinformation.’9

The lawsuit takes issue with the creation of a Disinformation Governance Board by DHS for the purpose of combating what DHS officials believed was “misinformation” posted online. Critics have claimed that this includes silencing speech that may be critical of the Biden administration’s policies.10 11 The case also calls out YouTube’s silencing of discussions by U.S. Senator Rand Paul of Kentucky and Florida’s Governor Ron DeSantis about whether wearing cloth masks was effective in preventing infection with and transmission of the SARS-CoV-2 virus.12

Attorney General Landry explained:

Big Tech has become an extension of Biden’s Big Government, and neither are protecting the freedoms of Americans; rather, they are suppressing truth and demonizing those who think differently. Ripped from the playbook of Stalin and his ilk, Biden has been colluding with Big Tech to censor free speech and propagandize the masses. We are fighting back to ensure the rule of law and prevent the government from unconstitutional banning, chilling, and stifling of speech.13

Plaintiffs Recently Submitted Evidence in Support of a Preliminary Injunction

In March 2023, plaintiffs filed a Brief in support of their Motion for a Preliminary Injunction against the U.S. government arguing that they are entitled to a Preliminary Injunction because they are likely to succeed on the merits of the case. Plaintiffs assert that by colluding with private companies, the government is responsible for what amounts to private conduct and that their social media censorship violated the First Amendment. They point out that equitable factors such as “a substantial threat of irreparable injury” exists and are greater than any harms should the injunction be denied and that granting the injunction, “will not disserve the public interest.”

Plaintiffs also request that granting a class-wide injunctive relief under Rule 23(b)(2) is warranted as the U.S. government’s “large-scale civil-rights violations targeting entire classes of people.”14

In support of their Motion for Preliminary Injunctive relief, plaintiffs cite more than 1,400 pieces of information gleaned from internal government documents.

A press release from current Missouri Attorney General Andrew Bailey reads:

The motion for preliminary injunction highlights 1,432 facts showing that top officials in the federal government are coercing and colluding with big tech social media companies to censor free speech… This case is the most important free speech lawsuit in a generation, as we highlight more than 1,400 facts showing the Biden Administration’s blatant coercion and collusion with Big Tech social media companies to suppress speech it disagrees with. I will not rest until the court blocks unelected bureaucrats from violating our constitutional right to free and open debate.15

FOIA Requests Reveal Government Officials Pressured Big Tech to Censor Information

Freedom of Information Act (FOIA) requests reveal that government officials pressured Facebook and Instagram to censor information and online posts. The U.S. Centers for Disease Control and Prevention (CDC) went as far as pointing out specific posts that they considered misinformation to social media companies. An e-mail disclosed that a White House official pressured Facebook to take action against not only information they considered misinformation or disinformation but any content that could induce hesitancy among the public. In response, Facebook not only complied with requests to remove posts, but it also removed groups pertaining to COVID vaccine injuries.16

Facebook co-founder Mark Zuckerberg said that certain pressure tactics were “punitive or vengeful” such as… “I want you to do this thing, and if you don’t, then I’m going to make your life difficult in a lot of ways.”

Government and Big Tech’s Coordinated Efforts to Censor Information Has Far-Reaching Consequences

The outcome of Missouri v. Biden has significant implications that extend far beyond COVID and the 2020 election. Writing about the government and private partnership that has resulted in factual information being deemed fake news or censored from the internet altogether, Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center (NVIC) warned in 2018:

An electronic wall is being built to block you from getting information you want so you only get information someone else decides you need. An electronic burning of the books has begun, and the people are being silently herded into a virtual Dark Age. While this censorship is starting with conversations about health and vaccination, it will not end there.

Those who have bought and control the Internet now have the power to restrict or block any kind of information they do not want you to see or talk about with your family, friends and others you connect with online.17

Biden administration and Iran holding secret talks

BY CHRISTINE DOUGLASS-WILLIAMS

SEE:https://www.jihadwatch.org/2023/06/biden-adminstration-and-iran-holding-secret-talks;

Republished below in full unedited for informational, educational, & research purposes.

The Biden administration noted for disastrous failures such as the Afghanistan debacle and mishandled former negotiations with Iran, is now holding secret talks with Iran.

A key point:

President Joe Biden’s administration does not want to appear to be “giving concessions to Iran”, Mahjoob Zweiri, director of the Gulf Studies Center at Qatar University, said, especially ahead of next year’s presidential election.

But that’s exactly what the Biden administration is most likely doing, based on its history of bad negotiations. The secret talks are reminiscent of a 2016 report; Iran was believed to have received $33.6 BILLION in secret cash and gold payments facilitated by the Obama administration in an appeasement deal.

Trump and the Democrats were diametrically opposed on how to deal with Iran, the latter believing that appeasement and stuffing the pockets of the Iranian Islamic regime would somehow curb Iran’s ambitions. In January, the Biden administration still wanted to make a deal with the Iranian mullahs, despite the fact that by Iran’s own admission, the 2015 deal was based on lies. By February, the Biden administration gave Iran and Russia the green light to continue work at Iranian nuclear enrichment sites.

The new round of meetings between the Biden administration and Iran is disturbing at best. It will further serve the interests of Iran.

“US, Iran in talks to cool tensions with a mutual ‘understanding,'” by Parisa Hafezi, John Irish and Arshad Mohammed, Reuters, June 16, 2023:

DUBAI/PARIS, June 16 (Reuters) – The United States is holding talks with Iran to sketch out steps that could limit the Iranian nuclear programme, release some detained U.S. citizens and unfreeze some Iranian assets abroad, according to Iranian and Western officials.

These steps would be cast as an “understanding” rather than an agreement requiring review by the U.S. Congress, where many lawmakers oppose giving Iran benefits because of its military aid to Russia, its domestic repression and its support for proxies that have attacked U.S. interests in the region.

Having failed to revive a 2015 Iran nuclear deal, U.S. President Joe Biden’s administration hopes to restore some limits on Iran to keep it from getting a nuclear weapon that could threaten Israel and trigger a regional arms race. Iran says it has no ambition to develop a nuclear weapon.

The 2015 deal, which then-President Donald Trump abandoned in 2018, had capped Iran’s uranium enrichment at 3.67% purity and its stockpile of this material at 202.8 kg (447 pounds) – limits Tehran has since far exceeded.

U.S. and European officials have been searching for ways to curb Tehran’s nuclear efforts since the breakdown of indirect American-Iranian talks. The willingness to restart discussions illustrates the rising sense of urgency in Western capitals about Iran’s program.