{"id":1355059,"date":"2022-03-02T13:26:32","date_gmt":"2022-03-02T18:26:32","guid":{"rendered":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=1355059"},"modified":"2022-03-02T13:38:02","modified_gmt":"2022-03-02T18:38:02","slug":"the-most-objective-evidence-on-covid-vaccines","status":"publish","type":"post","link":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/the-most-objective-evidence-on-covid-vaccines\/","title":{"rendered":"The Most Objective Evidence on COVID Vaccines"},"content":{"rendered":"<aside class=\"mashsb-container mashsb-main mashsb-stretched\"><div class=\"mashsb-box\"><div class=\"mashsb-count mash-medium\" style=\"&quot;\"><div class=\"counts mashsbcount\">14<\/div><span class=\"mashsb-sharetext\">SHARES<\/span><\/div><div class=\"mashsb-buttons\"><a class=\"mashicon-facebook mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/www.facebook.com\/sharer.php?u=https%3A%2F%2Fwww.conservativenewsdaily.net%2Fbreaking-news%2Fthe-most-objective-evidence-on-covid-vaccines%2F\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Facebook<\/span><\/a><a class=\"mashicon-twitter mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/twitter.com\/intent\/tweet?text=&amp;url=https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=1355059&amp;via=ConservNewsDly\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Twitter<\/span><\/a><a class=\"mashicon-subscribe mash-medium mash-nomargin mashsb-noshadow\" href=\"#\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Subscribe<\/span><\/a><div class=\"onoffswitch2 mash-medium mashsb-noshadow\" style=\"display:none\"><\/div><\/div>\n            <\/div>\n                <div style=\"clear:both\"><\/div><\/aside>\n            <!-- Share buttons by mashshare.net - Version: 4.0.47--><p><span>By James D. Agresti<\/span><br \/><span>March 2, 2022<\/span><\/p>\n<p><a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2022\/03\/vaccine_production.png\"><img loading=\"lazy\" decoding=\"async\" class=\"no-padding aligncenter wp-image-10268 size-full\" src=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2022\/03\/vaccine_production.png\" alt=\"\" width=\"1300\" height=\"685\" srcset=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2022\/03\/vaccine_production.png 1300w, https:\/\/www.justfactsdaily.com\/wp-content\/uploads\/2022\/03\/vaccine_production-300x158.png 300w, https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2022\/03\/vaccine_production-1024x540-1.png 1024w, https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2022\/03\/vaccine_production-768x405-1.png 768w, https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2022\/03\/vaccine_production-640x337-1.png 640w, https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2022\/03\/vaccine_production-390x205-1.png 390w\" \/><\/a><\/p>\n<p><strong>Overview<\/strong><\/p>\n<p>Medical journals and textbooks are clear that the only way to accurately determine the life-or-death impacts of medical treatments is by measuring \u201call-cause mortality\u201d in \u201crandomized controlled trials.\u201d Clinical lingo aside, this is simply the number of deaths in studies where people are randomly assigned to receive or not receive a certain treatment.<\/p>\n<p>Though widely ignored in media coverage of Covid-19 vaccines, medical journals describe all-cause mortality in randomized controlled trials (RCTs) as:<\/p>\n<p>Beyond the fact that death is the most severe and clearest health outcome, the reason why this measure is more vital than any other is because RCTs <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC3196997\/\">control<\/a> for every possible confounding factor, including those that are not obvious. Thus, a clinical <a href=\"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/full\/10.1111\/1471-0528.15199\">research methods guide<\/a> states that RCTs are the \u201cgold standard\u201d for research because they provide \u201ca rigorous tool to examine cause\u2013effect,\u201d which \u201cis not possible with any other study design.\u201d<\/p>\n<p>Combined with the use of a placebo so that people don\u2019t alter their mindsets or behaviors as a result of knowing they received the treatment, quality RCTs ensure that any significant difference in the total number of deaths among the people who receive and don\u2019t receive a treatment is, in fact, <a href=\"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/full\/10.1111\/1471-0528.15199\">caused by the treatment<\/a>. This eliminates subjective judgments about the root causes of death, which is a major point of contention with C-19 vaccines.<\/p>\n<p>Unlike other data which can be easily manipulated through <a href=\"https:\/\/www.justfacts.com\/immigration#crime_media_statistics\">statistical tampering<\/a>, all-cause mortality in RCTs is straightforward and solid. If an RCT is large enough and properly conducted, a <a href=\"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/full\/10.1111\/1471-0528.15199\">simple tally<\/a> of all deaths among people who receive and don\u2019t receive a treatment proves whether the treatment saves more lives than it takes.<\/p>\n<p>Underscoring all of the above facts, medical textbooks and journals explain that:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.amazon.com\/Rutherfords-Vascular-Surgery-2-Set\/dp\/1455753041\">RCTs<\/a> are \u201cthe pinnacle in clinical design.\u201d<\/li>\n<li><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC3196997\/\">RCTs<\/a> are \u201cthe best way to study the safety and efficacy of new treatments.\u201d<\/li>\n<li>\u201cthe act of randomisation in a large\u201d <a href=\"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/full\/10.1111\/1471-0528.15199\">RCT<\/a> \u201cbalances participant characteristics (both observed and unobserved) between the groups, allowing attribution of any differences in outcome to the intervention.\u201d<\/li>\n<\/ul>\n<p>In this case, the \u201cintervention\u201d is FDA-approved Covid vaccines, and the \u201coutcome\u201d is death. That vital data was gathered in RCTs involving <a href=\"https:\/\/www.justfacts.com\/reference\/covid-19_mrna_vaccines_mortality.xls\">72,663<\/a> adults and older children for the Moderna and Pfizer vaccines. However, the FDA presented these results in a place and manner likely to be overlooked, and no <a href=\"https:\/\/www.google.com\/search?q=Covid-19+%22Pfizer%22+%2221+deaths%22+%22vaccine%22+%2217%22+%22placebo%22&#038;num=100&#038;lr=&#038;safe=images&#038;hl=en&#038;biw=1024&#038;bih=654&#038;source=lnt&#038;tbs=cdr%3A1%2Ccd_min%3A7%2F1%2F2021%2Ccd_max%3A2%2F22%2F2022&#038;tbm=nws\">major<\/a> media <a href=\"https:\/\/www.google.com\/search?q=Covid-19+%22Moderna%22+%2216+deaths%22+%22vaccine%22+%22placebo%22&#038;num=100&#038;lr=&#038;safe=images&#038;hl=en&#038;biw=1536&#038;bih=1028&#038;tbs=cdr%3A1%2Ccd_min%3A7%2F1%2F2021%2Ccd_max%3A2%2F22%2F2022&#038;tbm=nws&#038;ei=sLYWYu-4BJ6yqtsPw4C_qAY&#038;ved=0ahUKEwjv0OCo8Zb2AhUemWoFHUPAD2UQ4dUDCAw&#038;uact=5&#038;oq=Covid-19+%22Moderna%22+%2216+deaths%22+%22vaccine%22+%22placebo%22&#038;gs_lcp=Cgxnd3Mtd2l6LW5ld3MQAzIFCCEQoAEyBQghEKsCMgUIIRCrAlCYC1iYC2DUDmgAcAB4AIABcIgB3AKSAQMyLjKYAQCgAQKgAQHAAQE&#038;sclient=gws-wiz-news\">outlet<\/a> has covered <a href=\"https:\/\/www.justfacts.com\/reference\/covid-19_mrna_vaccines_mortality.xls\">them<\/a>.<\/p>\n<p>The results reveal that <a href=\"https:\/\/www.justfacts.com\/reference\/covid-19_mrna_vaccines_mortality.xls\">70<\/a> people died during the Moderna and Pfizer trials, including <a href=\"https:\/\/www.justfacts.com\/reference\/covid-19_mrna_vaccines_mortality.xls\">37<\/a> who received Covid vaccines and <a href=\"https:\/\/www.justfacts.com\/reference\/covid-19_mrna_vaccines_mortality.xls\">33<\/a> who did not. Combined with the fact that <a href=\"https:\/\/www.justfacts.com\/reference\/covid-19_mrna_vaccines_mortality.xls\">half<\/a> of the study participants were given vaccinations and the other half were given placebos, these crucial results provide no indication that the vaccines save more lives than they take.<\/p>\n<p>Accounting for sampling margins of error\u2014as is common for medical journals and uncommon for the media\u2014the results demonstrate with <a href=\"https:\/\/www.justfacts.com\/reference\/covid-19_mrna_vaccines_mortality.xls\">95% confidence<\/a> that:<\/p>\n<ul>\n<li>neither of the vaccines decreased or increased the absolute risk of death by any more than 0.08% over the course of the trials.<\/li>\n<li>the vaccines could prevent up to two deaths or cause up to three deaths per year among every 1,000 people.<\/li>\n<\/ul>\n<p>Importantly, those results:<\/p>\n<ul>\n<li>apply to adults and older children averaged as a group, and the vaccines\u2019 benefits and risks can vary considerably for each individual.<\/li>\n<li>don\u2019t apply beyond the timeframes of the studies, which were limited to several months.<\/li>\n<li>don\u2019t apply to people who were excluded from the studies, including those who are severely ill, previously had Covid-19, or have an immune disorder like HIV.<\/li>\n<li>don\u2019t apply to the currently dominant SARS-CoV-2 variant (Omicron).<\/li>\n<\/ul>\n<p>Just Facts asked four Ph.D. scholars with contrasting views about Covid vaccines and who specialize in the disciplines addressed in this research to critically review it. Among those who did so, they assessed it as follows:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.jessicasuniverse.com\/\"> Jessica Rose<\/a>, Ph.D. in <a href=\"https:\/\/uploads-ssl.webflow.com\/616004c52e87ed08692f5692\/61b5ee630549c87395373c77_CV%20LIZ.pdf\">Computational Biology<\/a>, Postdoctorate in Molecular Biology, Postdoctorate in Biochemistry: \u201cI rarely have nothing to say when I read something with regard to corrections, but this is accurate and well written.\u201d<\/li>\n<\/ul>\n<ul>\n<li><a href=\"https:\/\/www.baylor.edu\/statistics\/index.php?id=970911\"> Rodney Sturdivant<\/a>, Ph.D. in Biostatistics, Director of the Statistical Consulting Center at Baylor University: \u201cThe facts, so well laid out in this article, are a call for a very careful review and more study before future shots are recommended. All statisticians and scientists should be demanding better from the FDA.\u201d<\/li>\n<\/ul>\n<p><strong>The FDA\u2019s Diversion<\/strong><\/p>\n<p>Despite the import of all-cause mortality, the FDA completely ignored this measure in its press releases announcing approvals of the <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-first-covid-19-vaccine\">Pfizer<\/a> and <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/coronavirus-covid-19-update-fda-takes-key-action-approving-second-covid-19-vaccine\">Moderna<\/a> vaccines. Moreover, the FDA presented the all-cause mortality figures 20+ pages into technical documents alongside the <em>following statements<\/em> that distract from their implications:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.justfacts.com\/document\/pfizer_covid-19_vaccine_approval_summary_fda_2021.pdf#page=23\">Pfizer<\/a>: \u201cFrom Dose 1 through the March 13, 2021 data cutoff date, there were a total of 38 deaths, 21 in the Comirnaty [vaccine] group and 17 in the placebo group. <em>None of the deaths were considered related to vaccination<\/em>.\u201d (Emphasis added.)<\/li>\n<\/ul>\n<ul>\n<li><a href=\"https:\/\/www.justfacts.com\/document\/moderna_covid-19_vaccine_approval_summary_fda_2022.pdf\">Moderna<\/a>: \u201cThere were 32 deaths during the blinded phase of the study: 16 deaths in the vaccine group, and 16 in the placebo group. <em>None of the unsolicited AEs [adverse events] leading to death were considered vaccine-related<\/em>.\u201d (Emphasis added.)<\/li>\n<\/ul>\n<p>Those <em>statements<\/em> are highly subjective and divert naive readers from the fact that only the total number of deaths in each group can determine whether the vaccines save more lives than they take. This is precisely why medical journals call <em>all-cause<\/em> mortality the most \u201c<a href=\"https:\/\/www.sciencedirect.com\/science\/article\/abs\/pii\/S0883944121001143\">objective<\/a>,\u201d \u201c<a href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/S2213260021003313\">relevant<\/a>,\u201d \u201c<a href=\"https:\/\/jamanetwork.com\/journals\/jamainternalmedicine\/article-abstract\/486707\">significant<\/a>,\u201d and \u201c<a href=\"https:\/\/www.sciencedirect.com\/science\/article\/abs\/pii\/S0167527316303205\">important<\/a>\u201d outcome\u2014not deaths <em>considered related<\/em> to the treatment.<\/p>\n<p>Again, RCTs <a href=\"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/full\/10.1111\/1471-0528.15199\">eliminate<\/a> the need for subjective judgments like the FDA made in those statements. This is especially important for vaccines since there are untold ways in which they can alter the risk of death beyond direct effects like <a href=\"https:\/\/www.justfacts.com\/document\/moderna_covid-19_vaccine_approval_summary_fda_2022.pdf#page=19\">preventing Covid-19<\/a> or causing <a href=\"https:\/\/www.heartlungcirc.org\/article\/S1443-9506(21)01156-2\/fulltext\">cardiac events<\/a>, <a href=\"https:\/\/www.mdpi.com\/2075-4426\/11\/4\/285\/htm\">embolisms<\/a>, <a href=\"https:\/\/www.bmj.com\/content\/372\/bmj.n149\">fevers<\/a>, and <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC8330960\/\">seizures<\/a>.<\/p>\n<p>For example, many fatal car accidents are triggered by <a href=\"https:\/\/www.cdc.gov\/sleep\/about_sleep\/drowsy_driving.html\">fatigue<\/a>, and the <a href=\"https:\/\/www.justfacts.com\/document\/pfizer_covid-19_vaccine_approval_summary_fda_2021.pdf#page=22\">Pfizer<\/a> and <a href=\"https:\/\/www.justfacts.com\/document\/moderna_covid-19_vaccine_approval_summary_fda_2022.pdf#page=25\">Moderna<\/a> RCTs found that 70\u201372% of subjects under the age of 55 reported \u201cfatigue\u201d after receiving the vaccine. There is no objective way to account for all such risks and benefits except by measuring all-cause mortality in RCTs.<\/p>\n<p>Even with direct connections, determining whether a vaccine contributed to a death is often inconclusive. As explained in the <em><a href=\"https:\/\/dpbh.nv.gov\/uploadedFiles\/dpbhnvgov\/content\/Boards\/BOH\/Meetings\/2021\/SENEFF~1.PDF\">International Journal of Vaccine Theory, Practice, and Research<\/a><\/em>, \u201cwhen diseases and deaths occur shortly after vaccination with an mRNA vaccine, it can never be definitively determined, even with a full investigation, that the vaccine reaction was <em>not<\/em> a proximal cause.\u201d<\/p>\n<p>Likewise, the <em><a href=\"https:\/\/www.bmj.com\/content\/372\/bmj.n149\">British Medical Journal<\/a><\/em> reported in January 2021 that the Norwegian Medicines Agency investigated the deaths of 13 \u201cvery frail elderly patients\u201d which occurred \u201cshortly after receiving\u201d the Pfizer C-19 vaccine and \u201cconcluded that common adverse reactions of mRNA vaccines, such as fever, nausea, and diarrhea, may have contributed to fatal outcomes in some of the frail patients.\u201d Yet, the medical director of the agency stated, \u201cThere is no certain connection between these deaths and the vaccine.\u201d<\/p>\n<p>Measuring all-cause mortality in RCTs removes that uncertainty, which makes the FDA\u2019s diversion and the media\u2019s failure to report these results all-the-more troublesome.<\/p>\n<p><strong>Inferior Studies<\/strong><\/p>\n<p>While downplaying and ignoring the most objective data, media outlets, government agencies, and large corporations have touted studies that are rife with assumptions and plagued by fatal flaws. For a prime example, <a href=\"https:\/\/www.google.com\/search?q=%22279%2C000%22+%28deaths+OR+lives%29+%22Covid%22+vaccinations+%221.25+million%22+hospitalizations&#038;num=100&#038;lr=&#038;safe=images&#038;hl=en&#038;as_qdr=all&#038;ei=VJoSYuCFOpyrqtsPxYOosAs&#038;ved=0ahUKEwjg_6rbhY_2AhWclWoFHcUBCrYQ4dUDCA0&#038;uact=5&#038;oq=%22279%2C000%22+%28deaths+OR+lives%29+%22Covid%22+vaccinations+%221.25+million%22+hospitalizations&#038;gs_lcp=Cgdnd3Mtd2l6EAM6BwgAEEcQsANKBAhBGABKBAhGGABQzAVYzAVg6ApoAXABeACAAT6IAT6SAQExmAEAoAECoAEByAEIwAEB&#038;sclient=gws-wiz\">more than 100<\/a> such entities publicized the results of a study from the <a href=\"https:\/\/www.commonwealthfund.org\/publications\/issue-briefs\/2021\/jul\/deaths-and-hospitalizations-averted-rapid-us-vaccination-rollout\">Commonwealth Fund<\/a> which estimated that C-19 vaccinations prevented about 279,000 deaths and 1.25 million hospitalizations in the U.S. by the end of June 2021.<\/p>\n<p>Those figures were <a href=\"https:\/\/www.commonwealthfund.org\/publications\/issue-briefs\/2021\/jul\/deaths-and-hospitalizations-averted-rapid-us-vaccination-rollout\">calculated<\/a> by comparing \u201cobserved\u201d Covid-19 trends to a \u201cmodel,\u201d a type of study design that \u201crests upon a host of simplifying assumptions\u201d and \u201ccannot be fully\u201d representative of the real world, as admitted by a <a href=\"https:\/\/www.thelancet.com\/journals\/lanam\/article\/PIIS2667-193X(21)00081-8\/fulltext\">medical journal<\/a> that published a similar study.<\/p>\n<p>Another class of subpar study results uncritically parroted by the media comes from \u201cobservational studies.\u201d These are studies which observe the outcomes of people \u201cin the wild\u201d who have <em>not<\/em> been randomly assigned a certain treatment. As a <a href=\"https:\/\/jasn.asnjournals.org\/content\/10\/2\/429.short\">medical journal<\/a> explains, such studies can \u201crarely\u201d determine the effects of a treatment because a host of other factors are at play.<\/p>\n<p>For instance, observing the death rates of people who are vaccinated and unvaccinated against C-19 cannot prove whether the vaccines are more helpful than harmful because the odds of death are impacted by numerous factors like these:<\/p>\n<ul>\n<li>People who are deathly ill or even temporarily ill tend not to get vaccinated, a phenomenon described in <a href=\"https:\/\/link.springer.com\/article\/10.1186\/s12879-015-1154-y\">medical journals<\/a> as \u201chealthy vaccinee bias.\u201d<\/li>\n<li>Older people\u2014who are more likely to die than younger people\u2014have much higher C-19 <a href=\"https:\/\/covid.cdc.gov\/covid-data-tracker\/#vaccination-demographics-trends\">vaccination rates<\/a> than younger people.<\/li>\n<li>Immunocompromised people\u2014who have conditions like cancer and HIV that increase their risk of death\u2014<a href=\"https:\/\/www.thelancet.com\/action\/showPdf?pii=S0140-6736%2821%2902046-8\">are<\/a> \u201cplausibly more likely to be offered and seek vaccination\u201d because they are very vulnerable to C-19.<\/li>\n<\/ul>\n<p>Researchers commonly use statistical techniques to \u201ccontrol\u201d for such variables, but these methods <a href=\"https:\/\/www.justfacts.com\/news_face_masks_deadly_falsehoods#strong\">cannot rule out<\/a> the possibility that other factors are at play. Also, the techniques used to perform such analyses are <a href=\"https:\/\/www.justfacts.com\/education#introductory\">prone to pitfalls<\/a>.<\/p>\n<p>The root weakness of observational studies is that they can only measure associations, and <a href=\"http:\/\/www.justfacts.com\/immigration#association_causation\">association does not prove causation<\/a>. Although <a href=\"http:\/\/www.corestandards.org\/wp-content\/uploads\/Math_Standards.pdf#page=81\">commonly taught<\/a> in high school math, this vital fact of medical and social science is routinely ignored by <a href=\"https:\/\/www.justfactsdaily.com\/four-fabrications-about-firearms\">commentators<\/a>, <a href=\"https:\/\/www.justfactsdaily.com\/should-the-u-s-adopt-australias-strict-gun-laws\">journalists<\/a>, <a href=\"https:\/\/www.justfacts.com\/immigration#crime_media\">Ph.D.\u2019s<\/a>, and government agencies like the <a href=\"https:\/\/www.justfacts.com\/news_face_masks_deadly_falsehoods#observational\">CDC<\/a>.<\/p>\n<p>Highlighting the necessity of measuring all-cause mortality and the fact that observational studies cannot match the reliability of RCTs:<\/p>\n<ul>\n<li>a 2013 article in <em><a href=\"https:\/\/jamanetwork.com\/journals\/jamainternalmedicine\/fullarticle\/1558451\">JAMA Internal Medicine<\/a><\/em> documents that 80% of \u201ctraditional RCTs\u201d measure \u201cmortality, a hard and important end point.\u201d<\/li>\n<\/ul>\n<ul>\n<li>a 2018 paper in the <em><a href=\"https:\/\/academic.oup.com\/eurheartj\/article\/39\/37\/3417\/5063542\">European Heart Journal<\/a><\/em> compares RCT and non-RCT studies on drugs to prevent heart failure and finds that:\n<ul>\n<li>the observational studies routinely conflict with the RCTs.<\/li>\n<li>\u201cit is not possible to make reliable therapeutic inferences from observational associations.\u201d<\/li>\n<li>RCTs \u201cclearly remain the best guide to the treatment of patients.\u201d<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li>a 2005 paper in <em><a href=\"https:\/\/jamanetwork.com\/journals\/jamainternalmedicine\/article-abstract\/486707\">JAMA Internal Medicine<\/a><\/em> presents a \u201csystematic review of randomized controlled trials\u201d on treatments for people hospitalized with uncommon types of pneumonia and reports, \u201cAlthough mortality is the most significant outcome in a potentially lethal infection, all studies chose clinical failure as their primary outcome. This end point is subjective and should be studied with care. Our review clearly demonstrates its potential for bias.\u201d<\/li>\n<\/ul>\n<ul>\n<li>the medical book <em><a href=\"https:\/\/www.elsevier.com\/books\/principles-and-practice-of-clinical-research\/gallin\/978-0-12-382167-6\">Principles and Practice of Clinical Research<\/a><\/em> documents that:\n<ul>\n<li>\u201cwhile consistency in the findings of a large number of observational studies can lead to the belief that the associations are causal, this belief is a fallacy.\u201d<\/li>\n<li>\u201ca well-designed\u201d RCT \u201covercomes the major weaknesses of all other types of study designs\u2026.\u201d<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li>a commentary published by the <em><a href=\"https:\/\/www.bmj.com\/content\/371\/bmj.m4058\">British Medical Journal<\/a><\/em> in October 2020 explains:\n<ul>\n<li>\u201cSixty years after influenza vaccination became routinely recommended for people aged 65 or older in the US, we still don\u2019t know if vaccination lowers mortality\u201d because \u201crandomised trials with this outcome have never been done.\u201d<\/li>\n<li>\u201cObservational studies with results in both directions can be cited, and without definitive randomised evidence the debate will go on.\u201d<\/li>\n<li>\u201cUnless we act now, we risk repeating this sorry state of affairs with Covid-19 vaccines.\u201d<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>None of this means that models and observational studies are clinically useless. They can illuminate paths for additional research, and in <a href=\"https:\/\/jasn.asnjournals.org\/content\/10\/2\/429.short\">rare cases<\/a> where their results are mathematically and logically overwhelming, they can estimate the effects of a treatment. However, their results should be taken with a grain of salt, especially if there are RCTs to the contrary.<\/p>\n<p><strong>Underpowered?<\/strong><\/p>\n<p>Some may argue that the Moderna and Pfizer RCTs were \u201c<a href=\"https:\/\/medical-dictionary.thefreedictionary.com\/underpowered+clinical+trial\">underpowered<\/a>,\u201d a medical term for clinical trials that don\u2019t enroll enough participants to detect an effect. However, Moderna enrolled <a href=\"https:\/\/www.justfacts.com\/document\/moderna_covid-19_vaccine_approval_summary_fda_2022.pdf#page=16\">more than 30,000<\/a> people in its RCT, Pfizer enrolled <a href=\"https:\/\/www.justfacts.com\/document\/pfizer_covid-19_vaccine_approval_summary_fda_2021.pdf#page=19\">more than 40,000<\/a>, and an additional <a href=\"https:\/\/www.justfacts.com\/reference\/covid-19_mrna_vaccines_mortality.xls\">10 deaths<\/a> in the Pfizer vaccine group\u2014or only 0.05% of the vaccinees\u2014would have shown with 95% confidence that the vaccine costs lives on net.<\/p>\n<p>Moderna and Pfizer could have made their RCTs larger, leaving little doubt as to whether the vaccines save more lives than they take, but the companies chose not to do this. In <a href=\"https:\/\/www.bmj.com\/content\/371\/bmj.m4058\">September 2020<\/a> after months of people \u201ccampaigning for greater openness,\u201d Covid vaccine manufacturers released important information about the designs of their RCTs. Summarizing these plans, the <em><a href=\"https:\/\/www.bmj.com\/content\/371\/bmj.m4037\">British Medical Journal<\/a><\/em> reported that the studies were <em>not<\/em> designed to \u201cdetermine whether they can interrupt transmission of the virus\u201d or \u201cdetect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths.\u201d<\/p>\n<p>Explaining why Moderna chose to construct a study that couldn\u2019t determine if its vaccine saves lives, Tal Zaks, the company\u2019s chief medical officer <a href=\"https:\/\/www.bmj.com\/content\/371\/bmj.m4037\">claimed<\/a> that \u201ctoo many would die waiting for the results before we ever knew\u201d if the vaccine \u201cprevents mortality.\u201d He also declared that it would cost $5\u201310 billion dollars to conduct a trial big enough to measure the impact on death and said:<\/p>\n<blockquote>\n<p>I think the public purse and operational capabilities and capacities we have are rightly spent not betting the farm on one vaccine, but, as Operation Warp is trying to do, making sure that we\u2019re funding several vaccines in parallel.<\/p>\n<\/blockquote>\n<p>The first of those excuses is transparently false, as Moderna could have included more participants in the study at the same time. It is also self-contradicting, as Zaks can\u2019t know if \u201ctoo many would die waiting\u201d if he doesn\u2019t know that the vaccine \u201cprevents mortality.\u201d Furthermore, C-19 vaccine study results are reviewed on a <a href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/S0149291822000054\">rolling basis<\/a>, allowing people to act on the available data without waiting for the final results.<\/p>\n<p>Zak\u2019s second excuse is belied by the fact that the U.S. government has enacted six \u201cCovid relief\u201d laws with a <a href=\"https:\/\/www.justfacts.com\/socialspending#overview\">total cost<\/a> of about $5.3 trillion, or 530 times Zaks\u2019 upper-end estimate. Including the money spent by other nations, a handful of $10 billion studies is a relative drop in the bucket.<\/p>\n<p>Larger studies would have narrowed the sampling margins of error and provided more resolution about whether the vaccines save more lives than they cost, but even the current studies are large enough to show with 95% confidence that the Moderna and Pfizer vaccines did not decrease or increase the absolute risk of death by any more than <a href=\"https:\/\/www.justfacts.com\/reference\/covid-19_mrna_vaccines_mortality.xls\">0.08%<\/a> over the course of the trials.<\/p>\n<p><strong>Longer-Term Effects<\/strong><\/p>\n<p>All studies have their limitations, and a major one of the Moderna and Pfizer RCTs is that most of the participants were enrolled for only several months after their second dose of the vaccine. For Moderna, this period was a median of <a href=\"https:\/\/www.justfacts.com\/document\/moderna_covid-19_vaccine_approval_summary_fda_2022.pdf#page=25\">four months<\/a>, and for Pfizer, it was an average of <a href=\"https:\/\/www.justfacts.com\/reference\/covid-19_mrna_vaccines_mortality.xls\">3.3 months<\/a>.<\/p>\n<p>Here again, this weakness of the studies is a direct result of choices made by the vaccine manufacturers. That\u2019s because <a href=\"https:\/\/www.justfacts.com\/document\/pfizer_covid-19_vaccine_approval_summary_fda_2021.pdf#page=17\">Pfizer<\/a> and <a href=\"https:\/\/www.justfacts.com\/document\/moderna_covid-19_vaccine_approval_summary_fda_2022.pdf#page=19\">Moderna<\/a> began removing people from their RCTs through a process called \u201cunblinding\u201d as they became eligible to receive the vaccines under \u201clocal recommendations.\u201d<\/p>\n<p>Those decisions were made in defiance of guidance issued by a global association of 24 healthcare regulatory agencies called the International Coalition of Medicines Regulatory Authorities. This group <a href=\"https:\/\/www.icmra.info\/drupal\/participatingRegulatoryAuthorities\">includes<\/a> the FDA and its counterparts in Canada, Australia, China, France, Germany, Mexico, Japan, Nigeria, India, and other nations.<\/p>\n<p>In a <a href=\"http:\/\/www.icmra.info\/drupal\/covid-19\/statement_on_continuation_of_vaccine_trials\">statement<\/a> released in November 2020, this international coalition of government agencies made the following points (and others) about why longer-term RCTs are necessary for C-19 vaccines:<\/p>\n<ul>\n<li>\u201cTo determine that the benefit of a vaccine outweighs its potential risk, regulators need robust and convincing evidence of the safety and efficacy that is obtained from well-designed randomised and controlled trials.\u201d<\/li>\n<\/ul>\n<ul>\n<li>\u201cThus, continued evaluation of the vaccinated and the unvaccinated\u201d participants \u201cfor as long as feasible will provide invaluable information.\u201d<\/li>\n<\/ul>\n<ul>\n<li>Such information includes but is not limited to \u201cadditional and more precise information on longer-term safety,\u201d \u201cpotential risks of vaccine-induced enhanced disease,\u201d and \u201cwhether protection against Covid-19 disease wanes over time.\u201d<\/li>\n<\/ul>\n<ul>\n<li>\u201cTherefore, unless maintaining participants in their randomised treatment groups (vaccinated or control) after a vaccine is approved is clearly infeasible, we recommend that clinical trials should proceed as initially planned with a follow-up of at least one year or more from completion of assigned doses.\u201d<\/li>\n<\/ul>\n<p>Pfizer and Moderna flouted that guidance, and the journal <em><a href=\"https:\/\/ebm.bmj.com\/content\/early\/2021\/08\/08\/bmjebm-2021-111735\">BMJ Evidence-Based Medicine<\/a><\/em> reported in July 2021 that \u201cplacebo controlled follow-up, originally planned for 2 years in many trials, was eliminated after a few months, when manufacturers began offering vaccine to placebo recipients within weeks of receiving emergency use authorisations.\u201d<\/p>\n<p>Decisions to hastily end the RCTs also:<\/p>\n<ul>\n<li>hindered their ability to detect any effects of herd immunity as the broader society became vaccinated.<\/li>\n<\/ul>\n<ul>\n<li>prevent everyone from knowing with certainty how the vaccines protect against recent SARS-CoV-2 variants <a href=\"https:\/\/www.justfacts.com\/document\/moderna_covid-19_vaccine_approval_summary_fda_2022.pdf#page=20\">because<\/a> the trials <a href=\"https:\/\/www.justfacts.com\/document\/pfizer_covid-19_vaccine_approval_summary_fda_2021.pdf#page=23\">ended<\/a> before Delta became common and before Omicron emerged.<\/li>\n<\/ul>\n<ul>\n<li>have proven to be ill-advised given that a wide range of studies are finding that the immunity conferred by the current C-19 vaccines wanes over time, such as:\n<\/li>\n<\/ul>\n<p>Since all of those are observational studies, they don\u2019t have the surety of RCTs and are therefore tentative. This is precisely why <a href=\"https:\/\/www.linkedin.com\/in\/doran-fink-473a20a3\">Dr. Doran Fink<\/a>, Deputy Director of the FDA\u2019s Division of Vaccines and Related Products Applications, warned at an <a href=\"https:\/\/www.fda.gov\/media\/143982\/download#page=196\">FDA committee meeting<\/a> in October 2020:<\/p>\n<blockquote>\n<p>Once a decision is made to unblind an ongoing placebo-controlled trial, that decision cannot be walked back. And that controlled follow up is lost forever.<\/p>\n<\/blockquote>\n<p>Medical ethics require that RCTs be <a href=\"https:\/\/arthritis-research.biomedcentral.com\/articles\/10.1186\/ar1170\">barred or ended<\/a> if they would undoubtedly harm people. Thus, some <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC8264198\/\">allege<\/a> that the RCTs should have been shortened based on their findings that the vaccines have large and statistically significant effects on reducing the risk of severe Covid-19. The <a href=\"https:\/\/www.justfacts.com\/document\/pfizer_covid-19_vaccine_approval_summary_fda_2021.pdf#page=20\">Pfizer RCT<\/a>, for example, found that the vaccine decreases the incidence of severe Covid-19 among people aged 16 and older by 70.9% to 100.0% (with 95% confidence).<\/p>\n<p>However, those results don\u2019t account for any side effects of the vaccines or whether their benefits wane over time. Moreover, the all-cause mortality data provided no indication that the vaccines were saving more lives than they cost.<\/p>\n<p><strong>What the RCTs Can\u2019t Reveal<\/strong><\/p>\n<p>One of the most dangerous errors in medicine is interpreting the results of studies more broadly than the evidence warrants. This is called \u201covergeneralizing,\u201d and academic works on <a href=\"https:\/\/www.worldcat.org\/title\/applied-statistics-from-bivariate-through-multivariate-techniques\/oclc\/1109179663?referer=di&#038;ht=edition\">applied statistics<\/a> warn that \u201cresearchers in the behavioral and social sciences almost always want to make inferences beyond their samples,\u201d but this practice \u201cis always risky,\u201d especially when the study subjects are \u201cdrastically different\u201d from the people to whom the results are applied.<\/p>\n<p>Media outlets often foster such deadly misinterpretations by failing to report the limits and caveats of studies. A prime example is the main <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-first-covid-19-vaccine\">Pfizer<\/a> and <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/coronavirus-covid-19-update-fda-takes-key-action-approving-second-covid-19-vaccine\">Moderna<\/a> RCTs that yielded the all-cause mortality data and the widely trumpeted results that the vaccines are more than 90% effective in preventing Covid-19. Beyond the fact that the RCTs were limited to several months, <a href=\"https:\/\/clinicaltrials.gov\/ct2\/history\/NCT04470427?V_1=View#StudyPageTop\">both<\/a> of <a href=\"https:\/\/clinicaltrials.gov\/ct2\/history\/NCT04368728?V_15=View#StudyPageTop\">them<\/a> excluded people:<\/p>\n<ul>\n<li>who are <a href=\"https:\/\/www.nature.com\/articles\/s41577-020-0351-0\">very vulnerable<\/a> to C-19, like those who are severely ill or have certain immune disorders.<\/li>\n<li>who are <a href=\"https:\/\/www.justfactsdaily.com\/omicron-delta-naturally-acquired-immunity-vaccines#mutations\">highly resistant<\/a> to Covid-19 because they previously had the disease and now have natural acquired immunity to it.<\/li>\n<\/ul>\n<p>Thus, it is extremely important to realize that even though the Covid vaccines did not decrease or increase the absolute risk of death by any more than <a href=\"https:\/\/www.justfacts.com\/reference\/covid-19_mrna_vaccines_mortality.xls\">0.08%<\/a> over the course of the RCTs, this only applies to the pre-Omicron era and generally healthy adults who don\u2019t yet have naturally acquired immunity.<\/p>\n<p>Moreover, that result is merely an average, and the benefits and risks of the vaccines could vary widely depending upon factors like weight, age, sex, and a host of other variables. For instance, the risk of being harmed by Covid-19 <a href=\"https:\/\/www.justfacts.com\/news_covid-19_essential_facts#rates\">greatly declines<\/a> at younger ages, while the major known risks of the vaccine <a href=\"https:\/\/www.gov.il\/en\/departments\/news\/01062021-03\">increase<\/a>.<\/p>\n<p><strong>Summary<\/strong><\/p>\n<p>On February 5, 2020, President Biden <a href=\"https:\/\/twitter.com\/POTUS\/status\/1490086336971386880\">tweeted<\/a>, \u201cHere\u2019s the deal: Unvaccinated individuals are 97 times more likely to die compared to those who are boosted.\u201d This claim\u2014which Biden did not support but seems to be a gross distortion of a <a href=\"https:\/\/www.justfactsdaily.com\/omicron-delta-naturally-acquired-immunity-vaccines#unvaccinated\">bogus statistic<\/a> from CDC director <a href=\"https:\/\/www.whitehouse.gov\/briefing-room\/press-briefings\/2022\/02\/02\/press-briefing-by-white-house-covid-19-response-team-and-public-health-officials-81\/\">Rochelle Walensky<\/a>\u2014clashes with the most objective, relevant, and important evidence on this matter.<\/p>\n<p>That evidence consists of two large RCTs for the Pfizer and Moderna vaccines, which were the FDA\u2019s main basis for approving them. These studies involved 72,663 generally healthy adults and older children in the pre-Delta\/Omicron era who didn\u2019t yet have naturally acquired immunity to C-19. After half of the subjects were randomly given a vaccine and the other half a placebo, 37 people died who received a vaccine, and 33 died who received a placebo.<\/p>\n<p>On a superficial basis, these figures suggest that the vaccines increased the relative risk of death by 13%. However, the death rate in both groups was so small (0.1%) that the difference between them is statistically insignificant. More specifically, the results demonstrate with 95% confidence that:<\/p>\n<ul>\n<li>neither of the vaccines decreased or increased the absolute risk of death by any more than 0.08%.<\/li>\n<li>the vaccines could prevent up to two deaths or cause up to three deaths per year among every 1,000 people.<\/li>\n<\/ul>\n<p>In short, the strongest available evidence shows no indication that the mRNA Covid vaccines save more lives than they take. However, the benefits and risks of the vaccines can vary greatly for each individual.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>By James D. AgrestiMarch 2, 2022 Overview Medical journals and textbooks are clear that the only way to accurately determine the life-or-death impacts of medical treatments is by measuring<\/p>\n","protected":false},"author":1,"featured_media":1894085,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_mo_disable_npp":"","fifu_image_url":"https:\/\/cndimages.nyc3.digitaloceanspaces.com\/breaking-news\/wp-content\/uploads\/2021\/01\/IMG_2758-scaled-1.jpg","fifu_image_alt":"","footnotes":""},"categories":[],"tags":[],"class_list":["post-1355059","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry"],"fifu_image_url":"https:\/\/cndimages.nyc3.digitaloceanspaces.com\/breaking-news\/wp-content\/uploads\/2021\/01\/IMG_2758-scaled-1.jpg","_links":{"self":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/1355059","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/comments?post=1355059"}],"version-history":[{"count":0,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/1355059\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media\/1894085"}],"wp:attachment":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media?parent=1355059"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/categories?post=1355059"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/tags?post=1355059"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}