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.
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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.”
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.
Will America-First News Outlets Make it to 2023?
Things are looking grim for conservative and populist news sites.
There’s something happening behind the scenes at several popular conservative news outlets. 2021 was bad, but 2022 is proving to be disastrous for news sites that aren’t “playing ball” with the corporate media narrative. It’s being said that advertisers are cracking down, forcing some of the biggest ad networks like Google and Yahoo to pull their inventory from conservative outlets. This has had two major effects. First, it has cooled most conservative outlets from discussing “taboo” topics like Pandemic Panic Theater, voter fraud, or The Great Reset. Second, it has isolated those ad networks that aren’t playing ball.
Certain topics are anathema for most ad networks. Speaking out against vaccines or vaccine mandates is a certain path to being demonetized. Highlighting voter fraud in the 2020 and future elections is another instant advertising death penalty. Throw in truthful stories about climate change hysteria, Critical Race Theory, and the border crisis and it’s easy to understand how difficult it is for America-First news outlets to spread the facts, share conservative opinions, and still pay the bills.
Without naming names, I have been told of several news outlets who have been forced to either consolidate with larger organizations or who have backed down on covering certain topics out of fear of being “canceled” by the ad networks. I get it. This is a business for many of us and it’s not very profitable. Those of us who do this for a living are often barely squeaking by, so loss of additional revenue can often mean being forced to make cuts. That means not being able to cover the topics properly. Its a Catch-22: Tell the truth and lose the money necessary to keep telling the truth, or avoid the truth and make enough money to survive. Those who have chosen survival simply aren’t able to spread the truth properly.
We will never avoid the truth. The Lord will provide if it is His will. Our job is simply to share the facts, spread the Gospel, and educate as many Americans as possible while exposing the forces of evil.
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Thank you, and God Bless!
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JD Rucker – EIC