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Federal legal challenges have temporarily enjoined the Biden Administration’s sweeping large business, health care worker, and federal contractor covid-19 vaccine mandates. Notwithstanding these injunctions staying primary covid-19 vaccine mandates, “amendments” mandating booster covid-19 vaccinations have already been issued, as examples, for New Mexico healthcare workers, and University of Massachusetts-Amherst students.
Dr. Allon Friedman’s recent Brownstone essay, citing randomized, controlled trial data on primary covid-19 vaccination, demonstrated, “The Pfizer and Moderna trials show that in lower risk populations (which account for most of society) COVID-19 vaccines do not reduce mortality.” Friedman concluded, “Therefore, [covid-19] vaccine mandates, which are enormously costly and terribly divisive, are a cure worse than the disease.”
Why did Dr. Friedman rely exclusively—and appositely—upon randomized, controlled trial data to justify his conclusion? Almost sixty years ago (in 1963) Campbell and Stanley published their seminal monograph on research methodology entitled “Experimental and Quasi-Experimental Designs for Research.” This work, which shaped research designs ever since highlighted the major threats to validity that are avoided, uniquely, by the randomized controlled trial—a true experimental design.
Observational studies and all other non-randomized designs lacking parallel control groups, which they referred to as “quasi-experimental,” are fraught with known biases investigators attempt to control for, after the fact, with limited success. Worse still are intractable, unknown biases which the randomization process, alone, accounts for. Guyatt and colleagues, in their 2008 British Medical Journal paper “GRADE: an emerging consensus on rating quality of evidence and strength of recommendations”, updated and reinforced these ideas, appropriately assigning highest priority to randomized, controlled trial evidence.
On Friday, November 19, 2021, CDC Director Dr. Walensky endorsed the expanded recommendations of the CDC Advisory Committee on Immunization Practices (ACIP) that booster (third dose) shots be provided to all adults 18 years of age, and older, who received their second Pfizer or Moderna mRNA vaccine second doses, at least 6-months earlier.
What randomized, controlled trial evidence were the basis for this “unanimous decision,” touted by Dr. Walensky?
Although two small, published, randomized, placebo-controlled trials—one in kidney transplant recipients, and another in a general population—revealed enhanced immune responses to boosters, CDC’s recommendation clearly hinged upon a large, unpublished Pfizer randomized, placebo-controlled clinical trial.
A month before the CDC expanded booster recommendation was announced, Pfizer’s “randomized trial results by press release” were issued (10/21/21). The ~10,000 person, placebo-controlled randomized covid-19 vaccine booster trial, yielded a 95.6% reduction in symptomatic covid-19 infections (i.e., 109 in the placebo group; 9 in the boosted group), after a median 2.5 months of follow-up. The press release also included this important caveat:
“The observed relative vaccine efficacy of 95.6% (95% CI: 89.3, 98.6) reflects the reduction in disease occurrence in the boosted group versus the non-boosted group in those without evidence of prior SARS-CoV-2 infection.”
The November 19, 2021, ACIP presentation of Pfizer’s Dr. John Perez included enough data about prior infection to conclude boosters did not reduce covid-19 infections relative to placebo in this clinically relevant, ever burgeoning subgroup. Simple calculations (based upon the slides from pages 16 and 17) indicate there were only 2 symptomatic covid-19 infections among the 524 trial participants with a history of prior SARS-CoV-2 infection, 1/275 who received boosters, and 1/249 given placebo injections (p=0.944 for incidence rate difference of 0.038%).
Moreover, CDC’s Dr. Oliver, in her ACIP review (p. 25) of Pfizer’s booster trial data, acknowledged that within the full cohort of ~10,000 there were no covid-19 hospitalizations or deaths, and no data to assess any impact on SARS-CoV-2 transmission.
These findings comprise a striking paucity of randomized trial evidence on the “efficacy” of boosters—literally none on the most clinically relevant outcomes of serious covid-19 morbidity and mortality. Even the potential effect of boosters on SARS-CoV-2 transmission remains unaddressed.
Rapidly accumulating data strongly suggest prior covid-19 infection, “natural immunity,” is more robust, flexible, and enduring than exclusive covid-19 vaccine-acquired immunity. Pfizer’s covid-19 booster trial data confirm boosters afford no benefit in preventing covid-19 infections among those with natural immunity.
Given these overall randomized trial findings regarding covid-19 vaccine boosters—absence of even a short- term reduction in mild covid-19 infections in those with natural immunity, and no data establishing that boosters prevent covid-19 hospitalizations, deaths, or SARS-CoV-2 transmission—there is no rational, evidence-based justification for covid-19 vaccine “booster mandates.”
Author:
Andrew Bostom, M.D. MS, is an academic clinical trialist and epidemiologist, who is currently a Research Physician at the Brown University Center For Primary Care and Prevention of Kent-Memorial Hospital in Rhode Island.
Image via CalMatters. Article cross-posted from Brownstone Institute.
Mysterious “Skyquakes” Are Causing Strange “Booms” in the Sky, and Scientists Have No Explanation
by Michael Snyder
(End of the American Dream)—What is causing the extremely loud “booms” that people are hearing in the sky all over the world? We are being told that “skyquakes” are responsible, but scientists have no idea why these “skyquakes” are occurring. In some cases, the “skyquakes” cause such powerful shaking that…
The Biggest Sale on Long-Term Storage Beef EVER
by Sponsored Post
Let’s cut to the chase. Prepper All-Naturals is offering an unprecedented 40% off for it’s “Beef Steak” survival bags with promo code “steak40”. With a 25-year shelf life and a single ingredient (beef, of course), our most popular product is available for a very limited time with the biggest discount…
Seattle Is Ordered to Stop Blocking Illegal Alien Deportations in the Most Hilarious Court Decision Ever
by PJ Media
A federal court has just pooped in the oatmeal of the West Coast, Messed Coast™governors and local election officials suffering from acute cases of Trump Derangement Syndrome who think they can stop illegal alien deportations. And after this hilarious and thorough legal takedown from the 9th Circuit Court of Appeals,…
Illegal Alien Terror Suspect Found Dead in Cook County Jail Cell
by Slay News
An Islamic illegal alien has been found dead in his jail cell after being arrested on terrorism charges. According to CWBChicago, 22-year-old Sidi Mohamed Abdallahi was found dead at the Cook County jail in Illinois on Saturday. Abdallahi was arrested on felony terrorism and hate crime charges in October. He…
Trump’s Wild Bunch Is Ready for Action
by Frank Miele
If for no other reason than that it will elicit fear in the hearts of autocracy-phobics, I propose that Donald Trump’s second-term Cabinet be known as “The Wild Bunch.” The name is best known as the title of Sam Peckinpah’s classic 1969 western featuring a colorful cast of aging outlaws…
FAA Issues Flight Restrictions Over Questionable Drone Activity Near Trump’s Bedminster Golf Course
by Just The News
The Federal Aviation Administration (FAA) on Tuesday said that it has issued two flight restrictions on the area surrounding President-elect Donald Trump’s Bedminster golf club in New Jersey, following questionable drone activity. The drone sightings were first reported on Nov. 18, but have continued into this week, according to Fox…
Ex-FBI Agent Convicted for Stealing From Jan 6 Defendant During Raid
by Trending Politics
A former Houston-based FBI agent has been convicted of stealing valuables and cash while conducting searches. In one instance, the agent stole cash and silver bars from a non-violent January 6 defendant’s home. Nicholas Anthony Williams, 36, was indicted on January 31 in the Southern District of Texas. Williams, who…
Democrats, Media Elite Urge Biden to Pardon Trump’s Alleged ‘Enemies List’
by Breitbart
President Joe Biden should issue preemptive pardons to his political allies and those deemed to be on President-elect Donald Trump’s alleged “enemies list,” Democrats and their media allies believe. Delivering a preemptive pardon indicates an admission of guilt, although Democrats claim a preemptive pardon would only be intended to block…
Fani Willis Forced to Release All Communications With Jack Smith, J6 Committee
by Trending Politics
The Fulton County Superior Court has ruled against District Attorney Fani Willis, ordering her to disclose communications with Special Counsel Jack Smith and the House January 6 Committee. The decision, announced on Tuesday, follows a lawsuit brought by Judicial Watch, a conservative watchdog group, which accused Willis of violating Georgia’s…
Lindsey Graham Is the Warmongering NeoCon Leading the Charge to Upend Pete Hegseth
by JD Rucker
Pete Hegseth represents a shift away from the wokeness that has infected the United States military. This is possibly the biggest reason President-Elect Donald Trump tapped him to be the next Secretary of Defense and the vast majority of Republicans on Capitol Hill can support this, at least for the…
‘Where Are Black Democrats?’: Charles Payne Tells Personal Story to Call Out ‘Huge Double Standard’ of Biden Family
by Nicole Silverio, DCNF
(DCNF)—Fox Business host Charles Payne called out the alleged “huge double standard” of President Joe Biden’s family Tuesday by revealing that his brother, who struggles with a crack addiction, is currently serving a jail sentence. Payne said his brother, who is getting out of jail on Friday, is likely one…
Zelensky Admits Ukraine Can’t Retake All Its Land: ‘We Must Seek Diplomatic Means’
by Breitbart
Ukrainian President Volodymyr Zelensky conceded in an interview on Tuesday that Ukraine does not have “enough forces” to restore sovereignty over Russian-occupied Crimea and “must seek diplomatic means” to end the Russian invasion and regain its land. The state-run Ukrinform outlet reported that Zelensky described Crimea – which Russia colonized…
Ultra-Processed Foods: How Bad Are They for Your Health?
by Olivia Cook
(Natural News)—Despite the serious health risks associated with eating junk food, they remain the most consumed food products in many countries, particularly developed ones. But a review published in The BMJ, which studied 9.8 million people, warns that eating a lot of ultra-processed foods can increase your risk for 32 diseases. Among these are heart…
“Already Pretty Far Down the Line”: The Container Store Could File for Bankruptcy as Soon as Next Year
by Tyler Durden, Zero Hedge
(Zero Hedge)—As the retail apocalypse that started with Amazon and e-commerce continues, the latest victim is The Container Store. The retail giant could file for bankruptcy as soon as next year, according to the New York Post, who said the retailer is blaming its recent descent on “a weak housing…
Mysterious ‘Car-Sized Drones’ Over New Jersey Prompt FBI Investigation
by Zero Hedge
Several weeks of mysterious drone swarms over the skies of one New Jersey county near the military research and manufacturing facility Picatinny Arsenal have sparked concerns among residents and prompted an FBI investigation. “It’s kind of unsettling,” Mike Walsh, a Morris County resident who has spotted the drones on numerous…
UNESCO’s New Mission: Train Influencers About Combatting Online “Misinformation”
by Reclaim the Net
The UN Educational, Scientific and Cultural Organization (UNESCO) is now incorporating teaching influencers how to “fact check” into its activities. UNESCO claims that influencers have become “primary sources of news and cultural information” around the world – which prompted it to carry out a survey into how these online personalities…
I want to see the evidence that Fauci has been vaccinated amd boostered, on-time and in real time.