{"id":177711,"date":"2021-06-25T09:59:58","date_gmt":"2021-06-25T13:59:58","guid":{"rendered":"https:\/\/z3news.com\/w\/?p=177711"},"modified":"2021-07-26T15:42:44","modified_gmt":"2021-07-26T19:42:44","slug":"cdc-fda-prepare-mass-distribution-of-a-merck-sanofi-six-in-one-vaccine-for-kids-turning-blind-eye-to-safety-signals","status":"publish","type":"post","link":"https:\/\/z3news.com\/w\/cdc-fda-prepare-mass-distribution-of-a-merck-sanofi-six-in-one-vaccine-for-kids-turning-blind-eye-to-safety-signals\/","title":{"rendered":"CDC, FDA Prepare Mass Distribution of a Merck\/Sanofi Six-in-One Vaccine for Kids, Turning Blind Eye to Safety Signals"},"content":{"rendered":"<p>Since the mid-1980s, the number of childhood shots on the Centers for Disease Control and Prevention (CDC) vaccine schedule has <a href=\"https:\/\/childrenshealthdefense.org\/child-health-topics\/known-culprit\/vaccines-culprit\/cdc-recommended-vaccine-schedule-1986-vs-2019\/\" target=\"_blank\" rel=\"nofollow\">more than quadrupled<\/a>. When parents express reluctance about turning their little ones into perpetual pin cushions, drug makers and doctors have a ready answer \u2014 <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/12564784\/\" target=\"_blank\" rel=\"noopener nofollow\">combination vaccines<\/a> that \u201csimplify\u201d the schedule by decreasing the number of injections administered.<\/p>\n<p>This month marks the U.S. launch of the Merck\/Sanofi joint-venture vaccine, Vaxelis, a six-in-one (hexavalent) combination vaccine that contains diphtheria, tetanus and acellular pertussis (DTaP) components as well as components said to protect against polio, <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK562176\/\" target=\"_blank\" rel=\"noopener nofollow\">Haemophilus influenzae type b<\/a> (Hib) and hepatitis B.<\/p>\n<p>Public health officials optimistically believe that bundling all of these components into one shot will help close <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/28881166\/\" target=\"_blank\" rel=\"noopener nofollow\">noncompliance<\/a> loopholes and increase the likelihood that children will complete \u201call recommended vaccinations.\u201d<\/p>\n<p>Though <a href=\"https:\/\/www.vaxelis.com\/\" target=\"_blank\" rel=\"noopener nofollow\">Vaxelis<\/a> is the nation\u2019s <a href=\"https:\/\/vax.phila.gov\/index.php\/notices\/vaxelis-dtap-ipv-hib-hepb-a-hexavalent-vaccine-is-now-available-for-vfc\/\" target=\"_blank\" rel=\"noopener nofollow\">first<\/a> hexavalent injection, it joins other four- or five-in-one vaccines already on the CDC schedule. The U.S. Food and Drug Administration (FDA) <a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/vaxelis\" target=\"_blank\" rel=\"noopener nofollow\">approved<\/a> Vaxelis in late 2018 \u2014 as a three-dose series for 2-, 4- and 6-month-old infants \u2014 but it is only now, two-and-a-half years later, that the shot is being readied for widespread distribution.<\/p>\n<p><strong>Warning signs were ignored<\/strong><\/p>\n<p>There are numerous <a href=\"https:\/\/childrenshealthdefense.org\/news\/hiding-vaccine-related-deaths-semantic-sleight-hand\/\" target=\"_blank\" rel=\"nofollow\">warning signs<\/a> that potent all-in-one vaccines are too much for immature immune systems to handle. Concerning safety signals have emerged not just for <a href=\"https:\/\/childrenshealthdefense.org\/news\/the-plausible-connection-between-vaccines-and-sids\/\" target=\"_blank\" rel=\"nofollow\">hexavalent<\/a> but also <a href=\"https:\/\/childrenshealthdefense.org\/news\/hiding-vaccine-related-deaths-semantic-sleight-hand\/\" target=\"_blank\" rel=\"nofollow\">pentavalent<\/a> (five-in-one) vaccines.<\/p>\n<p>In Europe, where infants have been given hexavalent vaccines for some years (including Vaxelis since <a href=\"https:\/\/www.prnewswire.co.uk\/news-releases\/vaxelis-new-fully-liquid-paediatric-hexavalent-vaccine-approved-in-the-european-union-569389291.html\" target=\"_blank\" rel=\"noopener nofollow\">2016<\/a>), the formulations have produced many troubling reports of <a href=\"https:\/\/childrenshealthdefense.org\/news\/a-six-in-one-vaccine-associated-with-sudden-infant-death\/\" target=\"_blank\" rel=\"nofollow\">sudden infant death<\/a>.<\/p>\n<p>Absurdly, none of the clinical studies assessing Vaxelis safety and efficacy conducted fair comparisons against an inert placebo. Instead, in the <a href=\"https:\/\/stacks.cdc.gov\/view\/cdc\/78087\" target=\"_blank\" rel=\"noopener nofollow\">two U.S. clinical trials<\/a> for Vaxelis, not only did investigators compare infants receiving Vaxelis to babies who received Sanofi\u2019s five-in-one <a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/vaccines\/pentacel\" target=\"_blank\" rel=\"noopener nofollow\">Pentacel<\/a> \u2014 but babies in both groups also received rotavirus and pneumococcal vaccines at the same time!<\/p>\n<p>In this context, the CDC\u2019s sales pitch to the public \u2014 and its claims that side effects are \u201cusually mild\u201d \u2014 cannot be considered credible.<\/p>\n<p>Here are some of the other facts missing from the CDC\u2019s communications:<\/p>\n<ul>\n<li aria-level=\"1\">In the two U.S. trials six infants <a href=\"https:\/\/stacks.cdc.gov\/view\/cdc\/78087\" target=\"_blank\" rel=\"noopener nofollow\">died<\/a> (slide #27) in the Vaxelis group (some after receiving just one dose); one infant also died in the \u201ccontrol\u201d group that received five-in-one vaccines.<\/li>\n<li aria-level=\"1\">All six Vaxelis recipients died <a href=\"https:\/\/www.fda.gov\/media\/119465\/download\" target=\"_blank\" rel=\"noopener nofollow\">within six weeks<\/a> of vaccination. This timing matches other published accounts of infant deaths \u201c<a href=\"https:\/\/ijme.in\/articles\/infanrix-hexa-and-sudden-death-a-review-of-the-periodic-safety-update-reports-submitted-to-the-european-medicines-agency\/?galley=html\" target=\"_blank\" rel=\"noopener nofollow\">clustering<\/a>\u201d following hexavalent vaccination.<\/li>\n<li aria-level=\"1\">The reported <a href=\"https:\/\/www.fda.gov\/media\/119465\/download\" target=\"_blank\" rel=\"noopener nofollow\">causes of death<\/a> for the infants who received Vaxelis included asphyxia, sepsis, fluid in the brain and sudden infant death syndrome (SIDS). These outcomes correspond to the types of <a href=\"https:\/\/childrenshealthdefense.org\/news\/a-six-in-one-vaccine-associated-with-sudden-infant-death\/\" target=\"_blank\" rel=\"nofollow\">adverse events<\/a> reported following hexavalent vaccination in Europe.<\/li>\n<li aria-level=\"1\"><a href=\"https:\/\/childrenshealthdefense.org\/news\/read-the-fine-print-part-two-nearly-400-adverse-reactions-listed-in-vaccine-package-inserts\/\" target=\"_blank\" rel=\"nofollow\">Package inserts<\/a> for other vaccines on the CDC schedule list similar causes of death, suggesting these fatal Vaxelis outcomes are plausibly associated with vaccination.<\/li>\n<li aria-level=\"1\">In the clinical trials, the rate of fever was <a href=\"https:\/\/www.jwatch.org\/fw116327\/2020\/02\/07\/cdc-issues-guidance-new-hexavalent-vaccine-infants\" target=\"_blank\" rel=\"noopener nofollow\">notably higher<\/a> in Vaxelis recipients even when compared to children receiving five-in-one vaccines (47% vs. 34%).<\/li>\n<\/ul>\n<p><strong>Juicing vaccine sales<\/strong><\/p>\n<p>In the <a href=\"https:\/\/www.congress.gov\/bill\/99th-congress\/house-bill\/5546\" target=\"_blank\" rel=\"noopener nofollow\">no-liability context<\/a> enjoyed by vaccine makers in the U.S., combination vaccines are already quite popular. In fact, market watchers and <a href=\"https:\/\/europepmc.org\/article\/PMC\/4635899\" target=\"_blank\" rel=\"noopener nofollow\">health economists<\/a> praise the jumbo shots as being a catalyst for <a href=\"https:\/\/www.marketwatch.com\/press-release\/merck-and-sanofis-first-and-only-six-in-one-pediatric-combination-vaccine-now-available-in-the-united-states-2021-06-01\" target=\"_blank\" rel=\"noopener nofollow\">positive industry trends<\/a> and a \u201c<a href=\"https:\/\/www.businesswire.com\/news\/home\/20190918005822\/en\/Global-Pediatric-Combination-Vaccines-Drug-Forecast-Market\" target=\"_blank\" rel=\"noopener nofollow\">key to commercial success<\/a>.\u201d<\/p>\n<p>Thus, financial analysts <a href=\"https:\/\/www.businesswire.com\/news\/home\/20190918005822\/en\/Global-Pediatric-Combination-Vaccines-Drug-Forecast-Market\" target=\"_blank\" rel=\"noopener nofollow\">expect<\/a> Vaxelis to \u201cgarner significant patient share following its [U.S.] launch\u201d \u2014 predicting that it will account for almost a third of U.S. DTaP vaccinations by 2028 \u2014 or $841 million in annual sales.<\/p>\n<p>These predictions represent good news for <a href=\"https:\/\/childrenshealthdefense.org\/defender\/serious-injuries-merck-gardasil-hpv-vaccine-significantly-underreported\/\" target=\"_blank\" rel=\"nofollow\">Merck<\/a> and Sanofi, two of the \u201c<a href=\"https:\/\/childrenshealthdefense.org\/news\/laughing-all-the-way-to-the-bank-vaccine-makers-and-liability-protection-conflicts-of-interest-undermine-childrens-health-part-iii\/\" target=\"_blank\" rel=\"noopener nofollow\">big four<\/a>\u201d pharma giants that dominate the childhood vaccine market in the United States. Merck is already doing a <a href=\"https:\/\/www.fool.com\/investing\/2021\/04\/27\/this-pharma-giant-lost-the-vaccine-race-but-its-co\/\" target=\"_blank\" rel=\"noopener nofollow\">booming vaccine business<\/a>, recently reporting annual sales growth of 14.8% for its pneumococcal vaccine (Pneumovax 23) and 5.4% for its human papillomavirus (HPV) vaccine Gardasil-9.<\/p>\n<p>However, Merck also faces proliferating <a href=\"https:\/\/childrenshealthdefense.org\/defender\/gardasil-lawsuit-mercks-hpv-vaccine\/\" target=\"_blank\" rel=\"nofollow\">Gardasil-related lawsuits<\/a> \u2014 including legal actions alleging that the company knew about and ignored life-changing <a href=\"https:\/\/www.msn.com\/en-us\/health\/medical\/local-family-speaks-out-about-lawsuit-against-mercks-gardasil-vaccine\/ar-AAKfTA0\" target=\"_blank\" rel=\"noopener nofollow\">adverse events<\/a> from the get-go, many of which (when not fatal) have involved autoimmunity and chronic pain. In fact, before the advent of emergency use COVID vaccines (responsible for an alarming escalation of vaccine-related <a href=\"https:\/\/childrenshealthdefense.org\/defender\/cdc-vaers-data-deaths-adverse-events-covid-vaccines-including-children\/\" target=\"_blank\" rel=\"nofollow\">adverse events<\/a>), Gardasil had had \u201c<a href=\"https:\/\/www.dailymail.co.uk\/health\/article-4909164\/Teen-died-HPV-jab-experts-brand-vaccine-useless.html\" target=\"_blank\" rel=\"noopener nofollow\">more side effects reported<\/a> than all other vaccines combined.\u201d<\/p>\n<p>Sanofi, too, is embroiled in <a href=\"https:\/\/newsinfo.inquirer.net\/973959\/sanofi-swamped-with-2000-lawsuits\" target=\"_blank\" rel=\"noopener nofollow\">thousands of lawsuits<\/a> worldwide \u2014 notably for its disastrous and sometimes fatal <a href=\"https:\/\/childrenshealthdefense.org\/news\/government-corruption\/the-dengvaxia-disaster-was-twenty-years-in-the-making-what-will-happen-with-a-rushed-covid-19-vaccine\/\" target=\"_blank\" rel=\"nofollow\">dengue vaccine<\/a>. As with Merck, this has not dampened overall vaccine sales growth, which continues its strong <a href=\"https:\/\/finance.yahoo.com\/news\/sanofi-continued-growth-trajectory-strong-053000973.html\" target=\"_blank\" rel=\"noopener nofollow\">upward trajectory<\/a>, likely to be further strengthened by the U.S. Vaxelis rollout.<\/p>\n<p>Although Sanofi has not been a front-runner in the <a href=\"https:\/\/childrenshealthdefense.org\/defender_category\/covid\/\" target=\"_blank\" rel=\"nofollow\">COVID<\/a> vaccine race, the company is currently running clinical trials for <a href=\"https:\/\/childrenshealthdefense.org\/news\/editorial\/an-mrna-vaccine-against-sars-cov-2-preliminary-report-a-researcher-reacts\/\" target=\"_blank\" rel=\"nofollow\">messenger RNA<\/a> (mRNA) vaccines for both <a href=\"https:\/\/www.sanofi.com\/en\/our-covid-19-vaccine-candidates\/mrna-vaccine\" target=\"_blank\" rel=\"noopener nofollow\">COVID<\/a> and <a href=\"https:\/\/sports.yahoo.com\/sanofi-translate-bio-initiate-phase-050000827.html\" target=\"_blank\" rel=\"noopener nofollow\">seasonal influenza<\/a>.<\/p>\n<p><strong>Aluminum secrecy and grandfathered ingredients<\/strong><\/p>\n<p>Merck\u2019s proprietary, \u201c<a href=\"https:\/\/childrenshealthdefense.org\/news\/court-hears-gardasil-science-and-moves-forward\/\" target=\"_blank\" rel=\"nofollow\">super-powered<\/a>\u201d aluminum adjuvant \u2014 amorphous aluminum hydroxyphosphate sulfate (AAHS) \u2014 which is believed to play a significant role in Gardasil\u2019s risk profile, is also present in Vaxelis.<\/p>\n<p>After Merck developed AAHS, it began to \u201c<a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC6223008\/?fbclid=IwAR03AWmVmpVjLLd9RgD1t8WbkGck-1_8CdrZFaQHirv5R9YYbILya4MXKxs\" target=\"_blank\" rel=\"noopener nofollow\">preferentially<\/a>\u201d feature AAHS in its vaccines even though, as Danish scientists outlined <a href=\"https:\/\/ebm.bmj.com\/content\/early\/2020\/11\/08\/bmjebm-2020-111419\" target=\"_blank\" rel=\"noopener nofollow\">last year<\/a>, the company appears to have disregarded procedures ordinarily required for approval of new adjuvants.<\/p>\n<p>According to the Danes, at the time AAHS appeared, it represented a \u201c<a href=\"https:\/\/ebm.bmj.com\/content\/early\/2020\/11\/08\/bmjebm-2020-111419\" target=\"_blank\" rel=\"noopener nofollow\">new type of aluminium adjuvant<\/a> with excipients that [had] not been used earlier in [European Medicines Agency] authorised vaccines.\u201d It should have been \u2014 but apparently was not \u2014 tested against an inert placebo. For this and other reasons, the Danish scientists question the ethical underpinnings of the Gardasil clinical trials.<\/p>\n<p>In noting that Merck also \u201cseems to have prevented independent studies of AAHS,\u201d the Danes <a href=\"https:\/\/ebm.bmj.com\/content\/early\/2020\/11\/08\/bmjebm-2020-111419\" target=\"_blank\" rel=\"noopener nofollow\">repeated a critique<\/a> aired by world-famous aluminum expert <a href=\"https:\/\/childrenshealthdefense.org\/defender\/aluminum-infant-vaccines\/\" target=\"_blank\" rel=\"nofollow\">Christopher Exley<\/a> in 2018. In an <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC6223008\/?fbclid=IwAR03AWmVmpVjLLd9RgD1t8WbkGck-1_8CdrZFaQHirv5R9YYbILya4MXKxs\" target=\"_blank\" rel=\"noopener nofollow\">extensive discussion<\/a> of different aluminum-based adjuvants and their immunological mechanisms of action, Exley and co-authors emphasized the importance of studying aluminum adjuvants one by one, as each is \u201cchemically and biologically dissimilar with concomitantly potentially distinct roles in vaccine-related adverse events.\u201d<\/p>\n<p>Concerningly, the Vaxelis liquid suspension is adjuvanted onto not just AAHS, but also another aluminum adjuvant \u2014 aluminum phosphate). The package insert disingenuously shorthands the combination of adjuvants as \u201c<a href=\"https:\/\/www.fda.gov\/media\/119465\/download\" target=\"_blank\" rel=\"noopener nofollow\">aluminum salts<\/a>.\u201d<\/p>\n<p>How this double whammy of aluminum (319 micrograms per vaccine dose) interacts with the vaccine\u2019s six antigens, or Vaxelis\u2019s numerous other ingredients, or the <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/29773196\/\" target=\"_blank\" rel=\"noopener nofollow\">heavy aluminum load<\/a> in other childhood vaccines is largely unknown.<\/p>\n<p>According to the Vaxelis <a href=\"https:\/\/www.fda.gov\/media\/119465\/download\" target=\"_blank\" rel=\"noopener nofollow\">package insert<\/a>, the vaccine also includes: polysorbate 80 (an ingredient flagged for its propensity to induce <a href=\"https:\/\/childrenshealthdefense.org\/defender\/inactive-ingredients-covid-vaccines-allergic-reactions\/\" target=\"_blank\" rel=\"nofollow\">hypersensitivity reactions<\/a>); glutaraldehyde and formaldehyde (problematic chemicals deemed necessary to inactivate <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/26973066\/\" target=\"_blank\" rel=\"noopener nofollow\">pertussis toxin<\/a>); <a href=\"https:\/\/vaccines.procon.org\/vaccine-ingredients-and-manufacturer-information\/#bovine\" target=\"_blank\" rel=\"noopener nofollow\">bovine serum albumin<\/a> (often harvested from bovine fetuses when female cows are found to be pregnant at slaughter); three different antibiotics (neomycin, streptomycin and polymyxin B); <a href=\"https:\/\/www.merriam-webster.com\/dictionary\/ammonium%20thiocyanate\" target=\"_blank\" rel=\"noopener nofollow\">ammonium thiocyanate<\/a> (also a rust inhibitor, weedkiller and defoliant); and yeast protein (associated, notably in hepatitis B vaccines, with <a href=\"https:\/\/childrenshealthdefense.org\/news\/yeast-in-vaccines-tied-to-autoimmune-diseases\/\" target=\"_blank\" rel=\"nofollow\">autoimmune reactions<\/a>).<\/p>\n<p>Regulatory loopholes allow manufacturers to \u201cgrandfather\u201d ingredients into new vaccines if the components are already present in other licensed vaccines \u2014 regardless of how inadequate the original safety testing may have been.<\/p>\n<p>Thus, Merck and Sanofi perceived no need to test Vaxelis for <a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/assessment-report\/vaxelis-epar-public-assessment-report_en.pdf\" target=\"_blank\" rel=\"noopener nofollow\">DNA-damaging or cancer-causing effects<\/a>, and conducted <a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/assessment-report\/vaxelis-epar-public-assessment-report_en.pdf\" target=\"_blank\" rel=\"noopener nofollow\">no studies<\/a> of the ingredients\u2019 <a href=\"https:\/\/www.merckmanuals.com\/professional\/clinical-pharmacology\/pharmacokinetics\/overview-of-pharmacokinetics\" target=\"_blank\" rel=\"noopener nofollow\">pharmokinetics<\/a> (i.e., how the substances move \u201cinto, through, and out of the body\u201d).<\/p>\n<p>The main cautionary note sounded in the meager Vaxelis patient information sheet is to not give Vaxelis to children if they are \u201c<a href=\"https:\/\/www.fda.gov\/media\/143328\/download\" target=\"_blank\" rel=\"noopener nofollow\">allergic<\/a> to any of the ingredients.\u201d<\/p>\n<p><strong>For thee and thee \u2026 but not for me?<\/strong><\/p>\n<p>The CDC seems to be particularly interested in ensuring that poor and non-white children get Vaxelis. The agency began laying the groundwork to offer Vaxelis through the <a href=\"https:\/\/www.cdc.gov\/vaccines\/programs\/vfc\/index.html\" target=\"_blank\" rel=\"noopener nofollow\">Vaccines for Children (VFC) Program<\/a> \u2014 the agency\u2019s vaccine program for the poor \u2014 over two years ago, in <a href=\"https:\/\/www.hrsa.gov\/sites\/default\/files\/hrsa\/advisory-committees\/vaccines\/meetings\/2019\/030819-cdc-update.pdf\" target=\"_blank\" rel=\"noopener nofollow\">March 2019<\/a>.<\/p>\n<p>In <a href=\"https:\/\/www.hrsa.gov\/sites\/default\/files\/hrsa\/advisory-committees\/vaccines\/meetings\/2019\/09062019-cdc-update.pdf\" target=\"_blank\" rel=\"noopener nofollow\">September<\/a> of that year, the CDC followed up with an affirmative vote. Public health departments have been <a href=\"https:\/\/vax.phila.gov\/wp-content\/uploads\/2021\/06\/v4Vaxelis_ImmunizationUpdate_5-27-21.pdf\" target=\"_blank\" rel=\"noopener nofollow\">promoting<\/a> Vaxelis to participating VFC providers since early June 2021.<\/p>\n<p>At its September 2019 meeting, CDC outlined another topic deemed important for discussion in the near future \u2014 raising the issue of whether Vaxelis should be \u201cpreferentially recommended\u201d for the American Indian\/Alaskan Native (AI\/AN) pediatric population.<\/p>\n<p>The tenuous rationale, according to the <a href=\"https:\/\/www.hrsa.gov\/sites\/default\/files\/hrsa\/advisory-committees\/vaccines\/meetings\/2019\/09062019-cdc-update.pdf\" target=\"_blank\" rel=\"noopener nofollow\">meeting notes<\/a>, was because, \u201cin the pre-vaccine era\u201d (more than 35 years ago), \u201cHib disease occurred at a younger age among the AI\/AN population compared to the general population.\u201d<\/p>\n<p><strong>Wave of the future?<\/strong><\/p>\n<p>Judging from its website, the CDC perceives combination vaccines to be the <a href=\"https:\/\/www.cdc.gov\/vaccines\/parents\/why-vaccinate\/combination-vaccines.html\" target=\"_blank\" rel=\"noopener nofollow\">wave of the future<\/a>, and has signaled its strong endorsement of Vaxelis by incorporating the new vaccine into its <a href=\"https:\/\/www.cdc.gov\/vaccines\/schedules\/downloads\/child\/0-18yrs-child-combined-schedule.pdf\" target=\"_blank\" rel=\"noopener nofollow\">2021 vaccine schedule<\/a>.<\/p>\n<p>As if exposure to six antigens were not enough, FDA and CDC also say it is okay for healthcare providers to administer the six-in-one shot <a href=\"https:\/\/www.fda.gov\/media\/143328\/download\" target=\"_blank\" rel=\"noopener nofollow\">at the same time as other vaccines<\/a>.<\/p>\n<p>These agencies\u2019 characterization of the Vaxelis safety profile as \u201cacceptable\u201d indicates they have either not done their due diligence, or are willing to accept a high level of collateral damage in exchange for the \u201cconvenience\u201d of six-in-one shots.<\/p>\n<p>However, as the \u201coverwhelmed by guilt\u201d parents of <a href=\"https:\/\/childrenshealthdefense.org\/defender\/isaiah-harris-teen-heart-attack-pfizer-covid-vaccine\/\" target=\"_blank\" rel=\"nofollow\">COVID-vaccine-injured teen<\/a>s are increasingly finding out, convenience is <a href=\"https:\/\/childrenshealthdefense.org\/defender\/isaiah-harris-teen-heart-attack-pfizer-covid-vaccine\/\" target=\"_blank\" rel=\"nofollow\">poor consolation<\/a> for life-changing or life-threatening adverse outcomes.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Defender is experiencing censorship on many social channels. Be sure to stay in touch with the news that matters by subscribing to our top news of the day. It&#8217;s free.<br \/>\n            Since the mid-1980s, the number of childhood shots on the Centers for Disease Control and Prevention (CDC) vaccine schedule has more than quadrupled. When parents express reluctance about turning their little ones into perpetual pin cushions, drug makers and doctors have a ready answer \u2014 combination vaccines that \u201csimplify\u201d the schedule by decreasing the number of injections administered.<br \/>\nThis month marks the U.S. launch of the Merck\/Sanofi joint-venture vaccine, Vaxelis, a six-in-one (hexavalent) combination vaccine that contains diphtheria, tetanus and acellular pertussis (DTaP) components as well as components said to protect against polio, Haemophilus influenzae type b (Hib) and hepatitis B.<br \/>\nPublic health officials optimistically believe that bundling all of these components into one shot will help close noncompliance loopholes and increase the likelihood that children will complete \u201call recommended vaccinations.\u201d<br \/>\nThough Vaxelis is the nation\u2019s first hexavalent injection, it joins other four- or five-in-one vaccines already on the CDC schedule. The U.S. Food and Drug Administration (FDA) approved Vaxelis in late 2018 \u2014 as a three-dose series for 2-, 4- and 6-month-old infants \u2014 but it is only now, two-and-a-half years later, that the shot is being readied for widespread distribution.<\/p>\n<p>Warning signs were ignored<br \/>\nThere are numerous warning signs that potent all-in-one vaccines are too much for immature immune systems to handle. Concerning safety signals have emerged not just for hexavalent but also pentavalent (five-in-one) vaccines.<br \/>\nIn Europe, where infants have been given hexavalent vaccines for some years (including Vaxelis since 2016), the formulations have produced many troubling reports of sudden infant death.<br \/>\nAbsurdly, none of the clinical studies assessing Vaxelis safety and efficacy conducted fair comparisons against an inert placebo. Instead, in the two U.S. clinical trials for Vaxelis, not only did investigators compare infants receiving Vaxelis to babies who received Sanofi\u2019s five-in-one Pentacel \u2014 but babies in both groups also received rotavirus and pneumococcal vaccines at the same time!<br \/>\nIn this context, the CDC\u2019s sales pitch to the public \u2014 and its claims that side effects are \u201cusually mild\u201d \u2014 cannot be considered credible.<br \/>\nHere are some of the other facts missing from the CDC\u2019s communications:<\/p>\n<p>In the two U.S. trials six infants died (slide #27) in the Vaxelis group (some after receiving just one dose); one infant also died in the \u201ccontrol\u201d group that received five-in-one vaccines.<br \/>\nAll six Vaxelis recipients died within six weeks of vaccination. This timing matches other published accounts of infant deaths \u201cclustering\u201d following hexavalent vaccination.<br \/>\nThe reported causes of death for the infants who received Vaxelis included asphyxia, sepsis, fluid in the brain and sudden infant death syndrome (SIDS). These outcomes correspond to the types of adverse events reported following hexavalent vaccination in Europe.<br \/>\nPackage inserts for other vaccines on the CDC schedule list similar causes of death, suggesting these fatal Vaxelis outcomes are plausibly associated with vaccination.<br \/>\nIn the clinical trials, the rate of fever was notably higher in Vaxelis recipients even when compared to children receiving five-in-one vaccines (47% vs. 34%).<\/p>\n<p>Juicing vaccine sales<br \/>\nIn the no-liability context enjoyed by vaccine makers in the U.S., combination vaccines are already quite popular. In fact, market watchers and health economists praise the jumbo shots as being a catalyst for positive industry trends and a \u201ckey to commercial success.\u201d<br \/>\nThus, financial analysts expect Vaxelis to \u201cgarner significant patient share following its [U.S.] launch\u201d \u2014 predicting that it will account for almost a third of U.S. DTaP vaccinations by 2028 \u2014 or $841 million in annual sales.<br \/>\nThese predictions represent good news for Merck and Sanofi, two of the \u201cbig four\u201d pharma giants that dominate the childhood vaccine market in the United States. Merck is already doing a booming vaccine business, recently reporting annual sales growth of 14.8% for its pneumococcal vaccine (Pneumovax 23) and 5.4% for its human papillomavirus (HPV) vaccine Gardasil-9.<br \/>\nHowever, Merck also faces proliferating Gardasil-related lawsuits \u2014 including legal actions alleging that the company knew about and ignored life-changing adverse events from the get-go, many of which (when not fatal) have involved autoimmunity and chronic pain. In fact, before the advent of emergency use COVID vaccines (responsible for an alarming escalation of vaccine-related adverse events), Gardasil had had \u201cmore side effects reported than all other vaccines combined.\u201d<br \/>\nSanofi, too, is embroiled in thousands of lawsuits worldwide \u2014 notably for its disastrous and sometimes fatal dengue vaccine. As with Merck, this has not dampened overall vaccine sales growth, which continues its strong upward trajectory, likely to be further strengthened by the U.S. Vaxelis rollout.<br \/>\nAlthough Sanofi has not been a front-runner in the COVID vaccine race, the company is currently running clinical trials for messenger RNA (mRNA) vaccines for both COVID and seasonal influenza.<\/p>\n<p>      Subscribe to The Defender &#8211; It\u2019s Free!<\/p>\n<p>Aluminum secrecy and grandfathered ingredients<br \/>\nMerck\u2019s proprietary, \u201csuper-powered\u201d aluminum adjuvant \u2014 amorphous aluminum hydroxyphosphate sulfate (AAHS) \u2014 which is believed to play a significant role in Gardasil\u2019s risk profile, is also present in Vaxelis.<br \/>\nAfter Merck developed AAHS, it began to \u201cpreferentially\u201d feature AAHS in its vaccines even though, as Danish scientists outlined last year, the company appears to have disregarded procedures ordinarily required for approval of new adjuvants.<br \/>\nAccording to the Danes, at the time AAHS appeared, it represented a \u201cnew type of aluminium adjuvant with excipients that [had] not been used earlier in [European Medicines Agency] authorised vaccines.\u201d It should have been \u2014 but apparently was not \u2014 tested against an inert placebo. For this and other reasons, the Danish scientists question the ethical underpinnings of the Gardasil clinical trials.<br \/>\nIn noting that Merck also \u201cseems to have prevented independent studies of AAHS,\u201d the Danes repeated a critique aired by world-famous aluminum expert Christopher Exley in 2018. In an extensive discussion of different aluminum-based adjuvants and their immunological mechanisms of action, Exley and co-authors emphasized the importance of studying aluminum adjuvants one by one, as each is \u201cchemically and biologically dissimilar with concomitantly potentially distinct roles in vaccine-related adverse events.\u201d<br \/>\nConcerningly, the Vaxelis liquid suspension is adjuvanted onto not just AAHS, but also another aluminum adjuvant \u2014 aluminum phosphate). The package insert disingenuously shorthands the combination of adjuvants as \u201caluminum salts.\u201d<br \/>\nHow this double whammy of aluminum (319 micrograms per vaccine dose) interacts with the vaccine\u2019s six antigens, or Vaxelis\u2019s numerous other ingredients, or the heavy aluminum load in other childhood vaccines is largely unknown.<br \/>\nAccording to the Vaxelis package insert, the vaccine also includes: polysorbate 80 (an ingredient flagged for its propensity to induce hypersensitivity reactions); glutaraldehyde and formaldehyde (problematic chemicals deemed necessary to inactivate pertussis toxin); bovine serum albumin (often harvested from bovine fetuses when female cows are found to be pregnant at slaughter); three different antibiotics (neomycin, streptomycin and polymyxin B); ammonium thiocyanate (also a rust inhibitor, weedkiller and defoliant); and yeast protein (associated, notably in hepatitis B vaccines, with autoimmune reactions).<br \/>\nRegulatory loopholes allow manufacturers to \u201cgrandfather\u201d ingredients into new vaccines if the components are already present in other licensed vaccines \u2014 regardless of how inadequate the original safety testing may have been.<br \/>\nThus, Merck and Sanofi perceived no need to test Vaxelis for DNA-damaging or cancer-causing effects, and conducted no studies of the ingredients\u2019 pharmokinetics (i.e., how the substances move \u201cinto, through, and out of the body\u201d).<br \/>\nThe main cautionary note sounded in the meager Vaxelis patient information sheet is to not give Vaxelis to children if they are \u201callergic to any of the ingredients.\u201d<br \/>\nFor thee and thee \u2026 but not for me?<br \/>\nThe CDC seems to be particularly interested in ensuring that poor and non-white children get Vaxelis. The agency began laying the groundwork to offer Vaxelis through the Vaccines for Children (VFC) Program \u2014 the agency\u2019s vaccine program for the poor \u2014 over two years ago, in March 2019.<br \/>\nIn September of that year, the CDC followed up with an affirmative vote. Public health departments have been promoting Vaxelis to participating VFC providers since early June 2021.<br \/>\nAt its September 2019 meeting, CDC outlined another topic deemed important for discussion in the near future \u2014 raising the issue of whether Vaxelis should be \u201cpreferentially recommended\u201d for the American Indian\/Alaskan Native (AI\/AN) pediatric population.<br \/>\nThe tenuous rationale, according to the meeting notes, was because, \u201cin the pre-vaccine era\u201d (more than 35 years ago), \u201cHib disease occurred at a younger age among the AI\/AN population compared to the general population.\u201d<br \/>\nWave of the future?<br \/>\nJudging from its website, the CDC perceives combination vaccines to be the wave of the future, and has signaled its strong endorsement of Vaxelis by incorporating the new vaccine into its 2021 vaccine schedule.<br \/>\nAs if exposure to six antigens were not enough, FDA and CDC also say it is okay for healthcare providers to administer the six-in-one shot at the same time as other vaccines.<br \/>\nThese agencies\u2019 characterization of the Vaxelis safety profile as \u201cacceptable\u201d indicates they have either not done their due diligence, or are willing to accept a high level of collateral damage in exchange for the \u201cconvenience\u201d of six-in-one shots.<br \/>\nHowever, as the \u201coverwhelmed by guilt\u201d parents of COVID-vaccine-injured teens are increasingly finding out, convenience is poor consolation for life-changing or life-threatening adverse outcomes.<\/p>\n","protected":false},"author":653,"featured_media":161439,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"sfsi_plus_gutenberg_text_before_share":"","sfsi_plus_gutenberg_show_text_before_share":"","sfsi_plus_gutenberg_icon_type":"","sfsi_plus_gutenberg_icon_alignemt":"","sfsi_plus_gutenburg_max_per_row":"","_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":"","_ppma_block_editor_authors":""},"categories":[371,359,196],"tags":[],"ppma_author":[720],"class_list":["post-177711","post","type-post","status-publish","format-standard","has-post-thumbnail","category-cdc","category-fda","category-vaccines","entry"],"aioseo_notices":[],"aioseo_head":"\n\t\t<!-- All in One SEO 5.0.2.1 - aioseo.com -->\n\t<meta name=\"description\" content=\"The Defender is experiencing censorship on many social channels. Be sure to stay in touch with the news that matters by subscribing to our top news of the day. It&#039;s free. Since the mid-1980s, the number of childhood shots on the Centers for Disease Control and Prevention (CDC) vaccine schedule has more than quadrupled. When parents express reluctance about turning their little ones into perpetual pin cushions, drug makers and doctors have a ready answer \u2014 combination vaccines that \u201csimplify\u201d the schedule by decreasing the number of injections administered. This month marks the U.S. launch of the Merck\/Sanofi joint-venture vaccine, Vaxelis, a six-in-one (hexavalent) combination vaccine that contains diphtheria, tetanus and acellular pertussis (DTaP) components as well as components said to protect against polio, Haemophilus influenzae type b (Hib) and hepatitis B. Public health officials optimistically believe that bundling all of these components into one shot will help close noncompliance loopholes and increase the likelihood that children will complete \u201call recommended vaccinations.\u201d Though Vaxelis is the nation\u2019s first hexavalent injection, it joins other four- or five-in-one vaccines already on the CDC schedule. The U.S. Food and Drug Administration (FDA) approved Vaxelis in late 2018 \u2014 as a three-dose series for 2-, 4- and 6-month-old infants \u2014 but it is only now, two-and-a-half years later, that the shot is being readied for widespread distribution. Warning signs were ignored There are numerous warning signs that potent all-in-one vaccines are too much for immature immune systems to handle. Concerning safety signals have emerged not just for hexavalent but also pentavalent (five-in-one) vaccines. In Europe, where infants have been given hexavalent vaccines for some years (including Vaxelis since 2016), the formulations have produced many troubling reports of sudden infant death. Absurdly, none of the clinical studies assessing Vaxelis safety and efficacy conducted fair comparisons against an inert placebo. Instead, in the two U.S. clinical trials for Vaxelis, not only did investigators compare infants receiving Vaxelis to babies who received Sanofi\u2019s five-in-one Pentacel \u2014 but babies in both groups also received rotavirus and pneumococcal vaccines at the same time! In this context, the CDC\u2019s sales pitch to the public \u2014 and its claims that side effects are \u201cusually mild\u201d \u2014 cannot be considered credible. Here are some of the other facts missing from the CDC\u2019s communications: In the two U.S. trials six infants died (slide #27) in the Vaxelis group (some after receiving just one dose); one infant also died in the \u201ccontrol\u201d group that received five-in-one vaccines. All six Vaxelis recipients died within six weeks of vaccination. This timing matches other published accounts of infant deaths \u201cclustering\u201d following hexavalent vaccination. The reported causes of death for the infants who received Vaxelis included asphyxia, sepsis, fluid in the brain and sudden infant death syndrome (SIDS). These outcomes correspond to the types of adverse events reported following hexavalent vaccination in Europe. Package inserts for other vaccines on the CDC schedule list similar causes of death, suggesting these fatal Vaxelis outcomes are plausibly associated with vaccination. In the clinical trials, the rate of fever was notably higher in Vaxelis recipients even when compared to children receiving five-in-one vaccines (47% vs. 34%). Juicing vaccine sales In the no-liability context enjoyed by vaccine makers in the U.S., combination vaccines are already quite popular. In fact, market watchers and health economists praise the jumbo shots as being a catalyst for positive industry trends and a \u201ckey to commercial success.\u201d Thus, financial analysts expect Vaxelis to \u201cgarner significant patient share following its [U.S.] launch\u201d \u2014 predicting that it will account for almost a third of U.S. DTaP vaccinations by 2028 \u2014 or $841 million in annual sales. These predictions represent good news for Merck and Sanofi, two of the \u201cbig four\u201d pharma giants that dominate the childhood vaccine market in the United States. Merck is already doing a booming vaccine business, recently reporting annual sales growth of 14.8% for its pneumococcal vaccine (Pneumovax 23) and 5.4% for its human papillomavirus (HPV) vaccine Gardasil-9. However, Merck also faces proliferating Gardasil-related lawsuits \u2014 including legal actions alleging that the company knew about and ignored life-changing adverse events from the get-go, many of which (when not fatal) have involved autoimmunity and chronic pain. In fact, before the advent of emergency use COVID vaccines (responsible for an alarming escalation of vaccine-related adverse events), Gardasil had had \u201cmore side effects reported than all other vaccines combined.\u201d Sanofi, too, is embroiled in thousands of lawsuits worldwide \u2014 notably for its disastrous and sometimes fatal dengue vaccine. As with Merck, this has not dampened overall vaccine sales growth, which continues its strong upward trajectory, likely to be further strengthened by the U.S. Vaxelis rollout. Although Sanofi has not been a front-runner in the COVID vaccine race, the company is currently running clinical trials for messenger RNA (mRNA) vaccines for both COVID and seasonal influenza. Subscribe to The Defender - It\u2019s Free! Aluminum secrecy and grandfathered ingredients Merck\u2019s proprietary, \u201csuper-powered\u201d aluminum adjuvant \u2014 amorphous aluminum hydroxyphosphate sulfate (AAHS) \u2014 which is believed to play a significant role in Gardasil\u2019s risk profile, is also present in Vaxelis. After Merck developed AAHS, it began to \u201cpreferentially\u201d feature AAHS in its vaccines even though, as Danish scientists outlined last year, the company appears to have disregarded procedures ordinarily required for approval of new adjuvants. According to the Danes, at the time AAHS appeared, it represented a \u201cnew type of aluminium adjuvant with excipients that [had] not been used earlier in [European Medicines Agency] authorised vaccines.\u201d It should have been \u2014 but apparently was not \u2014 tested against an inert placebo. For this and other reasons, the Danish scientists question the ethical underpinnings of the Gardasil clinical trials. In noting that Merck also \u201cseems to have prevented independent studies of AAHS,\u201d the Danes repeated a critique aired by world-famous aluminum expert Christopher Exley in 2018. In an extensive discussion of different aluminum-based adjuvants and their immunological mechanisms of action, Exley and co-authors emphasized the importance of studying aluminum adjuvants one by one, as each is \u201cchemically and biologically dissimilar with concomitantly potentially distinct roles in vaccine-related adverse events.\u201d Concerningly, the Vaxelis liquid suspension is adjuvanted onto not just AAHS, but also another aluminum adjuvant \u2014 aluminum phosphate). The package insert disingenuously shorthands the combination of adjuvants as \u201caluminum salts.\u201d How this double whammy of aluminum (319 micrograms per vaccine dose) interacts with the vaccine\u2019s six antigens, or Vaxelis\u2019s numerous other ingredients, or the heavy aluminum load in other childhood vaccines is largely unknown. According to the Vaxelis package insert, the vaccine also includes: polysorbate 80 (an ingredient flagged for its propensity to induce hypersensitivity reactions); glutaraldehyde and formaldehyde (problematic chemicals deemed necessary to inactivate pertussis toxin); bovine serum albumin (often harvested from bovine fetuses when female cows are found to be pregnant at slaughter); three different antibiotics (neomycin, streptomycin and polymyxin B); ammonium thiocyanate (also a rust inhibitor, weedkiller and defoliant); and yeast protein (associated, notably in hepatitis B vaccines, with autoimmune reactions). Regulatory loopholes allow manufacturers to \u201cgrandfather\u201d ingredients into new vaccines if the components are already present in other licensed vaccines \u2014 regardless of how inadequate the original safety testing may have been. Thus, Merck and Sanofi perceived no need to test Vaxelis for DNA-damaging or cancer-causing effects, and conducted no studies of the ingredients\u2019 pharmokinetics (i.e., how the substances move \u201cinto, through, and out of the body\u201d). The main cautionary note sounded in the meager Vaxelis patient information sheet is to not give Vaxelis to children if they are \u201callergic to any of the ingredients.\u201d For thee and thee \u2026 but not for me? The CDC seems to be particularly interested in ensuring that poor and non-white children get Vaxelis. The agency began laying the groundwork to offer Vaxelis through the Vaccines for Children (VFC) Program \u2014 the agency\u2019s vaccine program for the poor \u2014 over two years ago, in March 2019. In September of that year, the CDC followed up with an affirmative vote. Public health departments have been promoting Vaxelis to participating VFC providers since early June 2021. At its September 2019 meeting, CDC outlined another topic deemed important for discussion in the near future \u2014 raising the issue of whether Vaxelis should be \u201cpreferentially recommended\u201d for the American Indian\/Alaskan Native (AI\/AN) pediatric population. The tenuous rationale, according to the meeting notes, was because, \u201cin the pre-vaccine era\u201d (more than 35 years ago), \u201cHib disease occurred at a younger age among the AI\/AN population compared to the general population.\u201d Wave of the future? Judging from its website, the CDC perceives combination vaccines to be the wave of the future, and has signaled its strong endorsement of Vaxelis by incorporating the new vaccine into its 2021 vaccine schedule. As if exposure to six antigens were not enough, FDA and CDC also say it is okay for healthcare providers to administer the six-in-one shot at the same time as other vaccines. These agencies\u2019 characterization of the Vaxelis safety profile as \u201cacceptable\u201d indicates they have either not done their due diligence, or are willing to accept a high level of collateral damage in exchange for the \u201cconvenience\u201d of six-in-one shots. However, as the \u201coverwhelmed by guilt\u201d parents of COVID-vaccine-injured teens are increasingly finding out, convenience is poor consolation for life-changing or life-threatening adverse outcomes.\" \/>\n\t<meta name=\"robots\" content=\"max-image-preview:large\" \/>\n\t<meta name=\"author\" content=\"Children&#039;s Health Defense\"\/>\n\t<link rel=\"canonical\" href=\"https:\/\/z3news.com\/w\/cdc-fda-prepare-mass-distribution-of-a-merck-sanofi-six-in-one-vaccine-for-kids-turning-blind-eye-to-safety-signals\/\" \/>\n\t<meta name=\"generator\" content=\"All in One SEO (AIOSEO) 5.0.2.1\" \/>\n\t\t<script type=\"application\/ld+json\" class=\"aioseo-schema\">\n\t\t\t{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/z3news.com\\\/w\\\/cdc-fda-prepare-mass-distribution-of-a-merck-sanofi-six-in-one-vaccine-for-kids-turning-blind-eye-to-safety-signals\\\/#article\",\"name\":\"CDC, FDA Prepare Mass Distribution of a Merck\\\/Sanofi Six-in-One Vaccine for Kids, Turning Blind Eye to Safety Signals | Z3 News\",\"headline\":\"CDC, FDA Prepare Mass Distribution of a Merck\\\/Sanofi Six-in-One Vaccine for Kids, Turning Blind Eye to Safety 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on many social channels. Be sure to stay in touch with the news that matters by subscribing to our top news of the day. It's free. Since the mid-1980s, the number of childhood shots on the Centers for Disease Control and Prevention (CDC) vaccine schedule has more than quadrupled. When parents express reluctance about turning their little ones into perpetual pin cushions, drug makers and doctors have a ready answer \\u2014 combination vaccines that \\u201csimplify\\u201d the schedule by decreasing the number of injections administered. This month marks the U.S. launch of the Merck\\\/Sanofi joint-venture vaccine, Vaxelis, a six-in-one (hexavalent) combination vaccine that contains diphtheria, tetanus and acellular pertussis (DTaP) components as well as components said to protect against polio, Haemophilus influenzae type b (Hib) and hepatitis B. Public health officials optimistically believe that bundling all of these components into one shot will help close noncompliance loopholes and increase the likelihood that children will complete \\u201call recommended vaccinations.\\u201d Though Vaxelis is the nation\\u2019s first hexavalent injection, it joins other four- or five-in-one vaccines already on the CDC schedule. The U.S. Food and Drug Administration (FDA) approved Vaxelis in late 2018 \\u2014 as a three-dose series for 2-, 4- and 6-month-old infants \\u2014 but it is only now, two-and-a-half years later, that the shot is being readied for widespread distribution. Warning signs were ignored There are numerous warning signs that potent all-in-one vaccines are too much for immature immune systems to handle. Concerning safety signals have emerged not just for hexavalent but also pentavalent (five-in-one) vaccines. In Europe, where infants have been given hexavalent vaccines for some years (including Vaxelis since 2016), the formulations have produced many troubling reports of sudden infant death. Absurdly, none of the clinical studies assessing Vaxelis safety and efficacy conducted fair comparisons against an inert placebo. Instead, in the two U.S. clinical trials for Vaxelis, not only did investigators compare infants receiving Vaxelis to babies who received Sanofi\\u2019s five-in-one Pentacel \\u2014 but babies in both groups also received rotavirus and pneumococcal vaccines at the same time! In this context, the CDC\\u2019s sales pitch to the public \\u2014 and its claims that side effects are \\u201cusually mild\\u201d \\u2014 cannot be considered credible. Here are some of the other facts missing from the CDC\\u2019s communications: In the two U.S. trials six infants died (slide #27) in the Vaxelis group (some after receiving just one dose); one infant also died in the \\u201ccontrol\\u201d group that received five-in-one vaccines. All six Vaxelis recipients died within six weeks of vaccination. This timing matches other published accounts of infant deaths \\u201cclustering\\u201d following hexavalent vaccination. The reported causes of death for the infants who received Vaxelis included asphyxia, sepsis, fluid in the brain and sudden infant death syndrome (SIDS). These outcomes correspond to the types of adverse events reported following hexavalent vaccination in Europe. Package inserts for other vaccines on the CDC schedule list similar causes of death, suggesting these fatal Vaxelis outcomes are plausibly associated with vaccination. In the clinical trials, the rate of fever was notably higher in Vaxelis recipients even when compared to children receiving five-in-one vaccines (47% vs. 34%). Juicing vaccine sales In the no-liability context enjoyed by vaccine makers in the U.S., combination vaccines are already quite popular. In fact, market watchers and health economists praise the jumbo shots as being a catalyst for positive industry trends and a \\u201ckey to commercial success.\\u201d Thus, financial analysts expect Vaxelis to \\u201cgarner significant patient share following its [U.S.] launch\\u201d \\u2014 predicting that it will account for almost a third of U.S. DTaP vaccinations by 2028 \\u2014 or $841 million in annual sales. These predictions represent good news for Merck and Sanofi, two of the \\u201cbig four\\u201d pharma giants that dominate the childhood vaccine market in the United States. Merck is already doing a booming vaccine business, recently reporting annual sales growth of 14.8% for its pneumococcal vaccine (Pneumovax 23) and 5.4% for its human papillomavirus (HPV) vaccine Gardasil-9. However, Merck also faces proliferating Gardasil-related lawsuits \\u2014 including legal actions alleging that the company knew about and ignored life-changing adverse events from the get-go, many of which (when not fatal) have involved autoimmunity and chronic pain. In fact, before the advent of emergency use COVID vaccines (responsible for an alarming escalation of vaccine-related adverse events), Gardasil had had \\u201cmore side effects reported than all other vaccines combined.\\u201d Sanofi, too, is embroiled in thousands of lawsuits worldwide \\u2014 notably for its disastrous and sometimes fatal dengue vaccine. As with Merck, this has not dampened overall vaccine sales growth, which continues its strong upward trajectory, likely to be further strengthened by the U.S. Vaxelis rollout. Although Sanofi has not been a front-runner in the COVID vaccine race, the company is currently running clinical trials for messenger RNA (mRNA) vaccines for both COVID and seasonal influenza. Subscribe to The Defender - It\\u2019s Free! Aluminum secrecy and grandfathered ingredients Merck\\u2019s proprietary, \\u201csuper-powered\\u201d aluminum adjuvant \\u2014 amorphous aluminum hydroxyphosphate sulfate (AAHS) \\u2014 which is believed to play a significant role in Gardasil\\u2019s risk profile, is also present in Vaxelis. After Merck developed AAHS, it began to \\u201cpreferentially\\u201d feature AAHS in its vaccines even though, as Danish scientists outlined last year, the company appears to have disregarded procedures ordinarily required for approval of new adjuvants. According to the Danes, at the time AAHS appeared, it represented a \\u201cnew type of aluminium adjuvant with excipients that [had] not been used earlier in [European Medicines Agency] authorised vaccines.\\u201d It should have been \\u2014 but apparently was not \\u2014 tested against an inert placebo. For this and other reasons, the Danish scientists question the ethical underpinnings of the Gardasil clinical trials. In noting that Merck also \\u201cseems to have prevented independent studies of AAHS,\\u201d the Danes repeated a critique aired by world-famous aluminum expert Christopher Exley in 2018. In an extensive discussion of different aluminum-based adjuvants and their immunological mechanisms of action, Exley and co-authors emphasized the importance of studying aluminum adjuvants one by one, as each is \\u201cchemically and biologically dissimilar with concomitantly potentially distinct roles in vaccine-related adverse events.\\u201d Concerningly, the Vaxelis liquid suspension is adjuvanted onto not just AAHS, but also another aluminum adjuvant \\u2014 aluminum phosphate). The package insert disingenuously shorthands the combination of adjuvants as \\u201caluminum salts.\\u201d How this double whammy of aluminum (319 micrograms per vaccine dose) interacts with the vaccine\\u2019s six antigens, or Vaxelis\\u2019s numerous other ingredients, or the heavy aluminum load in other childhood vaccines is largely unknown. According to the Vaxelis package insert, the vaccine also includes: polysorbate 80 (an ingredient flagged for its propensity to induce hypersensitivity reactions); glutaraldehyde and formaldehyde (problematic chemicals deemed necessary to inactivate pertussis toxin); bovine serum albumin (often harvested from bovine fetuses when female cows are found to be pregnant at slaughter); three different antibiotics (neomycin, streptomycin and polymyxin B); ammonium thiocyanate (also a rust inhibitor, weedkiller and defoliant); and yeast protein (associated, notably in hepatitis B vaccines, with autoimmune reactions). Regulatory loopholes allow manufacturers to \\u201cgrandfather\\u201d ingredients into new vaccines if the components are already present in other licensed vaccines \\u2014 regardless of how inadequate the original safety testing may have been. Thus, Merck and Sanofi perceived no need to test Vaxelis for DNA-damaging or cancer-causing effects, and conducted no studies of the ingredients\\u2019 pharmokinetics (i.e., how the substances move \\u201cinto, through, and out of the body\\u201d). The main cautionary note sounded in the meager Vaxelis patient information sheet is to not give Vaxelis to children if they are \\u201callergic to any of the ingredients.\\u201d For thee and thee \\u2026 but not for me? The CDC seems to be particularly interested in ensuring that poor and non-white children get Vaxelis. The agency began laying the groundwork to offer Vaxelis through the Vaccines for Children (VFC) Program \\u2014 the agency\\u2019s vaccine program for the poor \\u2014 over two years ago, in March 2019. In September of that year, the CDC followed up with an affirmative vote. Public health departments have been promoting Vaxelis to participating VFC providers since early June 2021. At its September 2019 meeting, CDC outlined another topic deemed important for discussion in the near future \\u2014 raising the issue of whether Vaxelis should be \\u201cpreferentially recommended\\u201d for the American Indian\\\/Alaskan Native (AI\\\/AN) pediatric population. The tenuous rationale, according to the meeting notes, was because, \\u201cin the pre-vaccine era\\u201d (more than 35 years ago), \\u201cHib disease occurred at a younger age among the AI\\\/AN population compared to the general population.\\u201d Wave of the future? Judging from its website, the CDC perceives combination vaccines to be the wave of the future, and has signaled its strong endorsement of Vaxelis by incorporating the new vaccine into its 2021 vaccine schedule. As if exposure to six antigens were not enough, FDA and CDC also say it is okay for healthcare providers to administer the six-in-one shot at the same time as other vaccines. These agencies\\u2019 characterization of the Vaxelis safety profile as \\u201cacceptable\\u201d indicates they have either not done their due diligence, or are willing to accept a high level of collateral damage in exchange for the \\u201cconvenience\\u201d of six-in-one shots. However, as the \\u201coverwhelmed by guilt\\u201d parents of COVID-vaccine-injured teens are increasingly finding out, convenience is poor consolation for life-changing or life-threatening adverse outcomes.\",\"inLanguage\":\"en-US\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/z3news.com\\\/w\\\/#website\"},\"breadcrumb\":{\"@id\":\"https:\\\/\\\/z3news.com\\\/w\\\/cdc-fda-prepare-mass-distribution-of-a-merck-sanofi-six-in-one-vaccine-for-kids-turning-blind-eye-to-safety-signals\\\/#breadcrumblist\"},\"author\":{\"@id\":\"https:\\\/\\\/z3news.com\\\/w\\\/author\\\/rfk\\\/#author\"},\"creator\":{\"@id\":\"https:\\\/\\\/z3news.com\\\/w\\\/author\\\/rfk\\\/#author\"},\"image\":{\"@type\":\"ImageObject\",\"url\":\"https:\\\/\\\/z3news.com\\\/w\\\/wp-content\\\/uploads\\\/2021\\\/01\\\/covid-vaccine-injuries-deaths-feature-620.jpg\",\"@id\":\"https:\\\/\\\/z3news.com\\\/w\\\/cdc-fda-prepare-mass-distribution-of-a-merck-sanofi-six-in-one-vaccine-for-kids-turning-blind-eye-to-safety-signals\\\/#mainImage\",\"width\":620,\"height\":323},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/z3news.com\\\/w\\\/cdc-fda-prepare-mass-distribution-of-a-merck-sanofi-six-in-one-vaccine-for-kids-turning-blind-eye-to-safety-signals\\\/#mainImage\"},\"datePublished\":\"2021-06-25T09:59:58-04:00\",\"dateModified\":\"2021-07-26T15:42:44-04:00\"},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/z3news.com\\\/w\\\/#website\",\"url\":\"https:\\\/\\\/z3news.com\\\/w\\\/\",\"name\":\"Z3 News\",\"description\":\"Revealing Mystery Babylon\",\"inLanguage\":\"en-US\",\"publisher\":{\"@id\":\"https:\\\/\\\/z3news.com\\\/w\\\/#organization\"}}]}\n\t\t<\/script>\n\t\t<!-- All in One SEO -->\n\n","aioseo_head_json":{"title":"CDC, FDA Prepare Mass Distribution of a Merck\/Sanofi Six-in-One Vaccine for Kids, Turning Blind Eye to Safety Signals | Z3 News","description":"The Defender is experiencing censorship on many social channels. Be sure to stay in touch with the news that matters by subscribing to our top news of the day. It's free. Since the mid-1980s, the number of childhood shots on the Centers for Disease Control and Prevention (CDC) vaccine schedule has more than quadrupled. When parents express reluctance about turning their little ones into perpetual pin cushions, drug makers and doctors have a ready answer \u2014 combination vaccines that \u201csimplify\u201d the schedule by decreasing the number of injections administered. This month marks the U.S. launch of the Merck\/Sanofi joint-venture vaccine, Vaxelis, a six-in-one (hexavalent) combination vaccine that contains diphtheria, tetanus and acellular pertussis (DTaP) components as well as components said to protect against polio, Haemophilus influenzae type b (Hib) and hepatitis B. Public health officials optimistically believe that bundling all of these components into one shot will help close noncompliance loopholes and increase the likelihood that children will complete \u201call recommended vaccinations.\u201d Though Vaxelis is the nation\u2019s first hexavalent injection, it joins other four- or five-in-one vaccines already on the CDC schedule. The U.S. Food and Drug Administration (FDA) approved Vaxelis in late 2018 \u2014 as a three-dose series for 2-, 4- and 6-month-old infants \u2014 but it is only now, two-and-a-half years later, that the shot is being readied for widespread distribution. Warning signs were ignored There are numerous warning signs that potent all-in-one vaccines are too much for immature immune systems to handle. Concerning safety signals have emerged not just for hexavalent but also pentavalent (five-in-one) vaccines. In Europe, where infants have been given hexavalent vaccines for some years (including Vaxelis since 2016), the formulations have produced many troubling reports of sudden infant death. Absurdly, none of the clinical studies assessing Vaxelis safety and efficacy conducted fair comparisons against an inert placebo. Instead, in the two U.S. clinical trials for Vaxelis, not only did investigators compare infants receiving Vaxelis to babies who received Sanofi\u2019s five-in-one Pentacel \u2014 but babies in both groups also received rotavirus and pneumococcal vaccines at the same time! In this context, the CDC\u2019s sales pitch to the public \u2014 and its claims that side effects are \u201cusually mild\u201d \u2014 cannot be considered credible. Here are some of the other facts missing from the CDC\u2019s communications: In the two U.S. trials six infants died (slide #27) in the Vaxelis group (some after receiving just one dose); one infant also died in the \u201ccontrol\u201d group that received five-in-one vaccines. All six Vaxelis recipients died within six weeks of vaccination. This timing matches other published accounts of infant deaths \u201cclustering\u201d following hexavalent vaccination. The reported causes of death for the infants who received Vaxelis included asphyxia, sepsis, fluid in the brain and sudden infant death syndrome (SIDS). These outcomes correspond to the types of adverse events reported following hexavalent vaccination in Europe. Package inserts for other vaccines on the CDC schedule list similar causes of death, suggesting these fatal Vaxelis outcomes are plausibly associated with vaccination. In the clinical trials, the rate of fever was notably higher in Vaxelis recipients even when compared to children receiving five-in-one vaccines (47% vs. 34%). Juicing vaccine sales In the no-liability context enjoyed by vaccine makers in the U.S., combination vaccines are already quite popular. In fact, market watchers and health economists praise the jumbo shots as being a catalyst for positive industry trends and a \u201ckey to commercial success.\u201d Thus, financial analysts expect Vaxelis to \u201cgarner significant patient share following its [U.S.] launch\u201d \u2014 predicting that it will account for almost a third of U.S. DTaP vaccinations by 2028 \u2014 or $841 million in annual sales. These predictions represent good news for Merck and Sanofi, two of the \u201cbig four\u201d pharma giants that dominate the childhood vaccine market in the United States. Merck is already doing a booming vaccine business, recently reporting annual sales growth of 14.8% for its pneumococcal vaccine (Pneumovax 23) and 5.4% for its human papillomavirus (HPV) vaccine Gardasil-9. However, Merck also faces proliferating Gardasil-related lawsuits \u2014 including legal actions alleging that the company knew about and ignored life-changing adverse events from the get-go, many of which (when not fatal) have involved autoimmunity and chronic pain. In fact, before the advent of emergency use COVID vaccines (responsible for an alarming escalation of vaccine-related adverse events), Gardasil had had \u201cmore side effects reported than all other vaccines combined.\u201d Sanofi, too, is embroiled in thousands of lawsuits worldwide \u2014 notably for its disastrous and sometimes fatal dengue vaccine. As with Merck, this has not dampened overall vaccine sales growth, which continues its strong upward trajectory, likely to be further strengthened by the U.S. Vaxelis rollout. Although Sanofi has not been a front-runner in the COVID vaccine race, the company is currently running clinical trials for messenger RNA (mRNA) vaccines for both COVID and seasonal influenza. Subscribe to The Defender - It\u2019s Free! Aluminum secrecy and grandfathered ingredients Merck\u2019s proprietary, \u201csuper-powered\u201d aluminum adjuvant \u2014 amorphous aluminum hydroxyphosphate sulfate (AAHS) \u2014 which is believed to play a significant role in Gardasil\u2019s risk profile, is also present in Vaxelis. After Merck developed AAHS, it began to \u201cpreferentially\u201d feature AAHS in its vaccines even though, as Danish scientists outlined last year, the company appears to have disregarded procedures ordinarily required for approval of new adjuvants. According to the Danes, at the time AAHS appeared, it represented a \u201cnew type of aluminium adjuvant with excipients that [had] not been used earlier in [European Medicines Agency] authorised vaccines.\u201d It should have been \u2014 but apparently was not \u2014 tested against an inert placebo. For this and other reasons, the Danish scientists question the ethical underpinnings of the Gardasil clinical trials. In noting that Merck also \u201cseems to have prevented independent studies of AAHS,\u201d the Danes repeated a critique aired by world-famous aluminum expert Christopher Exley in 2018. In an extensive discussion of different aluminum-based adjuvants and their immunological mechanisms of action, Exley and co-authors emphasized the importance of studying aluminum adjuvants one by one, as each is \u201cchemically and biologically dissimilar with concomitantly potentially distinct roles in vaccine-related adverse events.\u201d Concerningly, the Vaxelis liquid suspension is adjuvanted onto not just AAHS, but also another aluminum adjuvant \u2014 aluminum phosphate). The package insert disingenuously shorthands the combination of adjuvants as \u201caluminum salts.\u201d How this double whammy of aluminum (319 micrograms per vaccine dose) interacts with the vaccine\u2019s six antigens, or Vaxelis\u2019s numerous other ingredients, or the heavy aluminum load in other childhood vaccines is largely unknown. According to the Vaxelis package insert, the vaccine also includes: polysorbate 80 (an ingredient flagged for its propensity to induce hypersensitivity reactions); glutaraldehyde and formaldehyde (problematic chemicals deemed necessary to inactivate pertussis toxin); bovine serum albumin (often harvested from bovine fetuses when female cows are found to be pregnant at slaughter); three different antibiotics (neomycin, streptomycin and polymyxin B); ammonium thiocyanate (also a rust inhibitor, weedkiller and defoliant); and yeast protein (associated, notably in hepatitis B vaccines, with autoimmune reactions). Regulatory loopholes allow manufacturers to \u201cgrandfather\u201d ingredients into new vaccines if the components are already present in other licensed vaccines \u2014 regardless of how inadequate the original safety testing may have been. Thus, Merck and Sanofi perceived no need to test Vaxelis for DNA-damaging or cancer-causing effects, and conducted no studies of the ingredients\u2019 pharmokinetics (i.e., how the substances move \u201cinto, through, and out of the body\u201d). The main cautionary note sounded in the meager Vaxelis patient information sheet is to not give Vaxelis to children if they are \u201callergic to any of the ingredients.\u201d For thee and thee \u2026 but not for me? The CDC seems to be particularly interested in ensuring that poor and non-white children get Vaxelis. The agency began laying the groundwork to offer Vaxelis through the Vaccines for Children (VFC) Program \u2014 the agency\u2019s vaccine program for the poor \u2014 over two years ago, in March 2019. In September of that year, the CDC followed up with an affirmative vote. Public health departments have been promoting Vaxelis to participating VFC providers since early June 2021. At its September 2019 meeting, CDC outlined another topic deemed important for discussion in the near future \u2014 raising the issue of whether Vaxelis should be \u201cpreferentially recommended\u201d for the American Indian\/Alaskan Native (AI\/AN) pediatric population. The tenuous rationale, according to the meeting notes, was because, \u201cin the pre-vaccine era\u201d (more than 35 years ago), \u201cHib disease occurred at a younger age among the AI\/AN population compared to the general population.\u201d Wave of the future? Judging from its website, the CDC perceives combination vaccines to be the wave of the future, and has signaled its strong endorsement of Vaxelis by incorporating the new vaccine into its 2021 vaccine schedule. As if exposure to six antigens were not enough, FDA and CDC also say it is okay for healthcare providers to administer the six-in-one shot at the same time as other vaccines. These agencies\u2019 characterization of the Vaxelis safety profile as \u201cacceptable\u201d indicates they have either not done their due diligence, or are willing to accept a high level of collateral damage in exchange for the \u201cconvenience\u201d of six-in-one shots. However, as the \u201coverwhelmed by guilt\u201d parents of COVID-vaccine-injured teens are increasingly finding out, convenience is poor consolation for life-changing or life-threatening adverse outcomes.","canonical_url":"https:\/\/z3news.com\/w\/cdc-fda-prepare-mass-distribution-of-a-merck-sanofi-six-in-one-vaccine-for-kids-turning-blind-eye-to-safety-signals\/","robots":"max-image-preview:large","keywords":"","webmasterTools":{"miscellaneous":""},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/z3news.com\/w\/cdc-fda-prepare-mass-distribution-of-a-merck-sanofi-six-in-one-vaccine-for-kids-turning-blind-eye-to-safety-signals\/#article","name":"CDC, FDA Prepare Mass Distribution of a Merck\/Sanofi Six-in-One Vaccine for Kids, Turning Blind Eye to Safety Signals | Z3 News","headline":"CDC, FDA Prepare Mass Distribution of a Merck\/Sanofi Six-in-One Vaccine for Kids, Turning Blind Eye to Safety 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Be sure to stay in touch with the news that matters by subscribing to our top news of the day. It's free. Since the mid-1980s, the number of childhood shots on the Centers for Disease Control and Prevention (CDC) vaccine schedule has more than quadrupled. When parents express reluctance about turning their little ones into perpetual pin cushions, drug makers and doctors have a ready answer \u2014 combination vaccines that \u201csimplify\u201d the schedule by decreasing the number of injections administered. This month marks the U.S. launch of the Merck\/Sanofi joint-venture vaccine, Vaxelis, a six-in-one (hexavalent) combination vaccine that contains diphtheria, tetanus and acellular pertussis (DTaP) components as well as components said to protect against polio, Haemophilus influenzae type b (Hib) and hepatitis B. Public health officials optimistically believe that bundling all of these components into one shot will help close noncompliance loopholes and increase the likelihood that children will complete \u201call recommended vaccinations.\u201d Though Vaxelis is the nation\u2019s first hexavalent injection, it joins other four- or five-in-one vaccines already on the CDC schedule. The U.S. Food and Drug Administration (FDA) approved Vaxelis in late 2018 \u2014 as a three-dose series for 2-, 4- and 6-month-old infants \u2014 but it is only now, two-and-a-half years later, that the shot is being readied for widespread distribution. Warning signs were ignored There are numerous warning signs that potent all-in-one vaccines are too much for immature immune systems to handle. Concerning safety signals have emerged not just for hexavalent but also pentavalent (five-in-one) vaccines. In Europe, where infants have been given hexavalent vaccines for some years (including Vaxelis since 2016), the formulations have produced many troubling reports of sudden infant death. Absurdly, none of the clinical studies assessing Vaxelis safety and efficacy conducted fair comparisons against an inert placebo. Instead, in the two U.S. clinical trials for Vaxelis, not only did investigators compare infants receiving Vaxelis to babies who received Sanofi\u2019s five-in-one Pentacel \u2014 but babies in both groups also received rotavirus and pneumococcal vaccines at the same time! In this context, the CDC\u2019s sales pitch to the public \u2014 and its claims that side effects are \u201cusually mild\u201d \u2014 cannot be considered credible. Here are some of the other facts missing from the CDC\u2019s communications: In the two U.S. trials six infants died (slide #27) in the Vaxelis group (some after receiving just one dose); one infant also died in the \u201ccontrol\u201d group that received five-in-one vaccines. All six Vaxelis recipients died within six weeks of vaccination. This timing matches other published accounts of infant deaths \u201cclustering\u201d following hexavalent vaccination. The reported causes of death for the infants who received Vaxelis included asphyxia, sepsis, fluid in the brain and sudden infant death syndrome (SIDS). These outcomes correspond to the types of adverse events reported following hexavalent vaccination in Europe. Package inserts for other vaccines on the CDC schedule list similar causes of death, suggesting these fatal Vaxelis outcomes are plausibly associated with vaccination. In the clinical trials, the rate of fever was notably higher in Vaxelis recipients even when compared to children receiving five-in-one vaccines (47% vs. 34%). Juicing vaccine sales In the no-liability context enjoyed by vaccine makers in the U.S., combination vaccines are already quite popular. In fact, market watchers and health economists praise the jumbo shots as being a catalyst for positive industry trends and a \u201ckey to commercial success.\u201d Thus, financial analysts expect Vaxelis to \u201cgarner significant patient share following its [U.S.] launch\u201d \u2014 predicting that it will account for almost a third of U.S. DTaP vaccinations by 2028 \u2014 or $841 million in annual sales. These predictions represent good news for Merck and Sanofi, two of the \u201cbig four\u201d pharma giants that dominate the childhood vaccine market in the United States. Merck is already doing a booming vaccine business, recently reporting annual sales growth of 14.8% for its pneumococcal vaccine (Pneumovax 23) and 5.4% for its human papillomavirus (HPV) vaccine Gardasil-9. However, Merck also faces proliferating Gardasil-related lawsuits \u2014 including legal actions alleging that the company knew about and ignored life-changing adverse events from the get-go, many of which (when not fatal) have involved autoimmunity and chronic pain. In fact, before the advent of emergency use COVID vaccines (responsible for an alarming escalation of vaccine-related adverse events), Gardasil had had \u201cmore side effects reported than all other vaccines combined.\u201d Sanofi, too, is embroiled in thousands of lawsuits worldwide \u2014 notably for its disastrous and sometimes fatal dengue vaccine. As with Merck, this has not dampened overall vaccine sales growth, which continues its strong upward trajectory, likely to be further strengthened by the U.S. Vaxelis rollout. Although Sanofi has not been a front-runner in the COVID vaccine race, the company is currently running clinical trials for messenger RNA (mRNA) vaccines for both COVID and seasonal influenza. Subscribe to The Defender - It\u2019s Free! Aluminum secrecy and grandfathered ingredients Merck\u2019s proprietary, \u201csuper-powered\u201d aluminum adjuvant \u2014 amorphous aluminum hydroxyphosphate sulfate (AAHS) \u2014 which is believed to play a significant role in Gardasil\u2019s risk profile, is also present in Vaxelis. After Merck developed AAHS, it began to \u201cpreferentially\u201d feature AAHS in its vaccines even though, as Danish scientists outlined last year, the company appears to have disregarded procedures ordinarily required for approval of new adjuvants. According to the Danes, at the time AAHS appeared, it represented a \u201cnew type of aluminium adjuvant with excipients that [had] not been used earlier in [European Medicines Agency] authorised vaccines.\u201d It should have been \u2014 but apparently was not \u2014 tested against an inert placebo. For this and other reasons, the Danish scientists question the ethical underpinnings of the Gardasil clinical trials. In noting that Merck also \u201cseems to have prevented independent studies of AAHS,\u201d the Danes repeated a critique aired by world-famous aluminum expert Christopher Exley in 2018. In an extensive discussion of different aluminum-based adjuvants and their immunological mechanisms of action, Exley and co-authors emphasized the importance of studying aluminum adjuvants one by one, as each is \u201cchemically and biologically dissimilar with concomitantly potentially distinct roles in vaccine-related adverse events.\u201d Concerningly, the Vaxelis liquid suspension is adjuvanted onto not just AAHS, but also another aluminum adjuvant \u2014 aluminum phosphate). The package insert disingenuously shorthands the combination of adjuvants as \u201caluminum salts.\u201d How this double whammy of aluminum (319 micrograms per vaccine dose) interacts with the vaccine\u2019s six antigens, or Vaxelis\u2019s numerous other ingredients, or the heavy aluminum load in other childhood vaccines is largely unknown. According to the Vaxelis package insert, the vaccine also includes: polysorbate 80 (an ingredient flagged for its propensity to induce hypersensitivity reactions); glutaraldehyde and formaldehyde (problematic chemicals deemed necessary to inactivate pertussis toxin); bovine serum albumin (often harvested from bovine fetuses when female cows are found to be pregnant at slaughter); three different antibiotics (neomycin, streptomycin and polymyxin B); ammonium thiocyanate (also a rust inhibitor, weedkiller and defoliant); and yeast protein (associated, notably in hepatitis B vaccines, with autoimmune reactions). Regulatory loopholes allow manufacturers to \u201cgrandfather\u201d ingredients into new vaccines if the components are already present in other licensed vaccines \u2014 regardless of how inadequate the original safety testing may have been. Thus, Merck and Sanofi perceived no need to test Vaxelis for DNA-damaging or cancer-causing effects, and conducted no studies of the ingredients\u2019 pharmokinetics (i.e., how the substances move \u201cinto, through, and out of the body\u201d). The main cautionary note sounded in the meager Vaxelis patient information sheet is to not give Vaxelis to children if they are \u201callergic to any of the ingredients.\u201d For thee and thee \u2026 but not for me? The CDC seems to be particularly interested in ensuring that poor and non-white children get Vaxelis. The agency began laying the groundwork to offer Vaxelis through the Vaccines for Children (VFC) Program \u2014 the agency\u2019s vaccine program for the poor \u2014 over two years ago, in March 2019. In September of that year, the CDC followed up with an affirmative vote. Public health departments have been promoting Vaxelis to participating VFC providers since early June 2021. At its September 2019 meeting, CDC outlined another topic deemed important for discussion in the near future \u2014 raising the issue of whether Vaxelis should be \u201cpreferentially recommended\u201d for the American Indian\/Alaskan Native (AI\/AN) pediatric population. The tenuous rationale, according to the meeting notes, was because, \u201cin the pre-vaccine era\u201d (more than 35 years ago), \u201cHib disease occurred at a younger age among the AI\/AN population compared to the general population.\u201d Wave of the future? Judging from its website, the CDC perceives combination vaccines to be the wave of the future, and has signaled its strong endorsement of Vaxelis by incorporating the new vaccine into its 2021 vaccine schedule. As if exposure to six antigens were not enough, FDA and CDC also say it is okay for healthcare providers to administer the six-in-one shot at the same time as other vaccines. These agencies\u2019 characterization of the Vaxelis safety profile as \u201cacceptable\u201d indicates they have either not done their due diligence, or are willing to accept a high level of collateral damage in exchange for the \u201cconvenience\u201d of six-in-one shots. However, as the \u201coverwhelmed by guilt\u201d parents of COVID-vaccine-injured teens are increasingly finding out, convenience is poor consolation for life-changing or life-threatening adverse 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15:24:25","updated":"2025-07-16 10:50:20","seo_analyzer_scan_date":null,"focus_keyword":null,"additional_keywords":null,"truseo_locale":null},"aioseo_breadcrumb":"<div class=\"aioseo-breadcrumbs\"><span class=\"aioseo-breadcrumb\">\n\t\t\t<a href=\"https:\/\/z3news.com\/w\/\" title=\"Home\">Home<\/a>\n\t\t<\/span><span class=\"aioseo-breadcrumb-separator\">\u00bb<\/span><span class=\"aioseo-breadcrumb\">\n\t\t\t<a href=\"https:\/\/z3news.com\/w\/category\/news\/\" title=\"News\">News<\/a>\n\t\t<\/span><span class=\"aioseo-breadcrumb-separator\">\u00bb<\/span><span class=\"aioseo-breadcrumb\">\n\t\t\t<a href=\"https:\/\/z3news.com\/w\/category\/news\/jesuit-led-organizations\/\" title=\"Jesuit Controlled Organizations\">Jesuit Controlled Organizations<\/a>\n\t\t<\/span><span class=\"aioseo-breadcrumb-separator\">\u00bb<\/span><span class=\"aioseo-breadcrumb\">\n\t\t\t<a href=\"https:\/\/z3news.com\/w\/category\/news\/jesuit-led-organizations\/fda\/\" title=\"FDA\">FDA<\/a>\n\t\t<\/span><span class=\"aioseo-breadcrumb-separator\">\u00bb<\/span><span class=\"aioseo-breadcrumb\">\n\t\t\tCDC, FDA Prepare Mass Distribution of a Merck\/Sanofi Six-in-One Vaccine for Kids, Turning Blind Eye to Safety Signals\n\t\t<\/span><\/div>","aioseo_breadcrumb_json":[{"label":"Home","link":"https:\/\/z3news.com\/w\/"},{"label":"News","link":"https:\/\/z3news.com\/w\/category\/news\/"},{"label":"Jesuit Controlled Organizations","link":"https:\/\/z3news.com\/w\/category\/news\/jesuit-led-organizations\/"},{"label":"FDA","link":"https:\/\/z3news.com\/w\/category\/news\/jesuit-led-organizations\/fda\/"},{"label":"CDC, FDA Prepare Mass Distribution of a Merck\/Sanofi Six-in-One Vaccine for Kids, Turning Blind Eye to Safety Signals","link":"https:\/\/z3news.com\/w\/cdc-fda-prepare-mass-distribution-of-a-merck-sanofi-six-in-one-vaccine-for-kids-turning-blind-eye-to-safety-signals\/"}],"authors":[{"term_id":720,"user_id":653,"is_guest":0,"slug":"rfk","display_name":"Children's Health Defense","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/16a49e975702ee8693d757e604b0d8ba429231c71f1be26f2d93598654f49407?s=96&d=blank&r=g","author_category":"","user_url":"https:\/\/childrenshealthdefense.org\/","last_name":"Defense","first_name":"Children's Health","job_title":"","description":"The mission of Children\u2019s Health Defense is to end childhood health epidemics by working aggressively to eliminate harmful exposures, hold those responsible accountable, and to establish safeguards so this never happens again. CHD was founded by Robert F. Kennedy, Jr. and he serves as Chairman. For over three decades, he has been one of the world\u2019s leading advocates of humanitarian and environmental causes. He is also founder and president of Waterkeeper Alliance, the umbrella group for 300 local waterkeeper organizations, in 34 countries, that track down and sue polluters. His father, Robert F. Kennedy, served as United States Attorney General (1961-1964) and United States Senator from New York (1965-1968)."}],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/z3news.com\/w\/wp-json\/wp\/v2\/posts\/177711","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/z3news.com\/w\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/z3news.com\/w\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/z3news.com\/w\/wp-json\/wp\/v2\/users\/653"}],"replies":[{"embeddable":true,"href":"https:\/\/z3news.com\/w\/wp-json\/wp\/v2\/comments?post=177711"}],"version-history":[{"count":0,"href":"https:\/\/z3news.com\/w\/wp-json\/wp\/v2\/posts\/177711\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/z3news.com\/w\/wp-json\/wp\/v2\/media\/161439"}],"wp:attachment":[{"href":"https:\/\/z3news.com\/w\/wp-json\/wp\/v2\/media?parent=177711"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/z3news.com\/w\/wp-json\/wp\/v2\/categories?post=177711"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/z3news.com\/w\/wp-json\/wp\/v2\/tags?post=177711"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/z3news.com\/w\/wp-json\/wp\/v2\/ppma_author?post=177711"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}