Akwai shawarwarin Hukumar Lafiya ta Duniya (WHO) a cikin Afrilu, 2021 (Satumba, 2022 buga ta kan layi gabanin Disamba, 2022) wanda jami'an gwamnatin Amurka suka tsara dabarun aiwatar da amincewar rigakafin mRNA na gaba ta FDA. An buga taƙaitaccen taron wannan taro a kan layi, kafin bugawa. Don haka, ba za mu ƙara yin hasashe game da abin da FDA ta yanke shawarar yin la'akari da alluran rigakafin mRNA na gaba da amfani da fakitin bayanan asibiti da suka gabata a matsayin tushen waɗannan alluran rigakafin azaman fasahar “dandamali”.
Tattaunawar ta WHO ta 2021 na yau da kullun game da la'akari da tsari ta tattauna waɗannan batutuwa. Dokta Keith Peden (Cibiyar Nazarin Halittu da Bincike (CBER), Hukumar Abinci da Magunguna ta gabatar da gogewar FDA da matsayinta kan lasisin sabbin samfuran rigakafin mRNA.
Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararru sun kamu da 2022 Dec; 11 (1): 384-391. doi: 10.1080/22221751.2022.2026742.
Daga labarin Hukumar Lafiya ta Duniya:
Bayanan nawa suna cikin baka ( ) a cikin rubutun da ke ƙasa.
Halayen tsari
Dr Keith Peden (Cibiyar Nazarin Halittu da Bincike (CBER), Hukumar Abinci da Magunguna (FDA), Amurka) ya gabatar da Kwarewar FDA tare da allurar rigakafin mRNA, gami da samfur da Chemistry, Masana'antu da Sarrafa (CMC), ƙayyadaddun ƙarfi, karatun farko na asibiti, ƙimar inganci (abin da za a saka idanu da abin da za a yi amfani da shi), kimanta yiwuwar haɓakar rigakafin rigakafin cutar, da tambayar ko ana iya kallon mRNA ko a'a azaman fasahar dandamali..
Ya yi tsokaci cewa ko ya kamata a tantance bangaren LNP daban ko kuma kamar yadda allurar ta kasance mutum NRA yanke shawara. CBER ya yanke shawarar samfurin kawai yakamata a gwada (wannan yana nufin tsari na ƙarshe kawai - alal misali, tare da rigakafin COVID-19, kawai furotin na ƙarshe na mRNA wanda aka tsara kamar yadda allura zai buƙaci a kimanta. Babu wani gwaji daban na abubuwan da aka haɗa guda ɗaya, wanda bai dace da daidaitaccen aikin tsari ba. An tattauna abubuwan da ke da ban tsoro na wannan a ƙasa).
Batun ko allurar mRNA fasaha ce ta dandamali kuma menene abubuwan da za su kasance idan haka ne, an tattauna a FDA (wannan yana nufin alluran rigakafin za su kasance kamar mura - IYAKA mai iyaka kafin asibiti da na asibiti za a buƙaci a yi don cikakken lasisi.).
Wannan yana da tasiri, misali, wane gwaji za a buƙaci don sabon mRNA wanda ke bayyana sabon antigen ta amfani da tsarin LNP iri ɗaya da masana'anta? Waɗanne karatun farko na asibiti za a buƙaci, kuma wanne za a iya ba da su dangane da bayanai daga samfuran irin wannan? Za a iya daidaita tsarin ci gaban rigakafin?
(Ya ci gaba)
CBER ya ƙaddara cewa wannan yana cikin jujjuyawa, kuma bai buƙaci a gudanar da nazarin rarraba kwayoyin halitta akan sabon rigakafin ba idan an riga an yi nazari tare da wani maganin rigakafi ta amfani da tsarin masana'antu iri ɗaya da LNP iri ɗaya.. (WOW. Wannan ya wuce babban rashin gaskiya. Tare da duk wannan sabon rigakafin mRNA da gwaje-gwajen asibiti na mRNA da ake gudanarwa - CBER BAI BUKATAR SABON NAZARI NA RABA BIO!)
Ana sa ran gyare-gyare ga tsarin masana'antu, kuma mai yiwuwa abubuwan da ke tattare da lipids zasu faru a nan gaba. (aKamfanoni na gaba za su fuskanci wani sabon buƙatu, kamar magance kwanciyar hankali na mRNA a cikin waɗannan alluran rigakafin, zai zama kusan ba zai yuwu a yanzu ƙaura daga wannan tsarin masana'anta da LNP ba. Wannan aikin yana ba da keɓantacce ga kamfanoni na yanzu, da kuma saniya mai alaƙa da tsabar kuɗi a cikin dindindin).
Jerin ayyukan:
CBER ya yanke shawarar cewa ci gaba, tare da sabbin gwaje-gwajen rigakafin mRNA, KAWAI samfurin (tsari na ƙarshe) yakamata a gwada shi muddin Ana amfani da tsarin masana'antu iri ɗaya da LNP. Wannan shi ne duk da cewa CBER bai yi cikakken nazarin rarraba kwayoyin halitta ko toxicity akan waɗannan samfuran ba, kamar yadda aka gano a cikin kunshin FOIA na Jafananci kafin zuwa asibiti kuma kotun Amurka ta ba da umarnin sakin takarda.
Ainihin, CBER ya ketare batutuwan waɗannan alluran rigakafin gaba ɗaya ba tare da cikakken kimantawa na farko na asibiti ba, kuma a cikin Afrilu 2021 sun yanke shawarar cewa sabbin rigakafin mRNA a haɓaka ba za su bi ka'idodin haɓaka rigakafin ba. Wannan shi ne duk allurar rigakafin mRNA a nan gaba, muddin ba su bambanta da abin da aka riga aka yi ba, za su kasance kamar sarrafa su kamar tsarin mura, tare da "nauyin biya" kawai da za a gwada.
A ƙarshe, CBER ta ƙaddara cewa nazarin rarraba halittu akan sabbin alluran rigakafin mRNA ta amfani da wannan “fasaharar dandamali” ba za a sake sabunta su ba, kodayake ba a tantance su da kyau ba tun farko. Wannan ya wuce babban wauta. Za a ba da izinin sabbin samfura su ci gaba da gwajin ɗan adam ba tare da samun cikakkiyar fakitin bayanan asibiti ba - kamar yadda abin da aka ƙaddamar ga FDA aka haɗa tare daga binciken da ya gabata bai cika ba.
Alal misali, an yi amfani da kwayar halitta mai ba da rahoto (luciferase) maimakon furotin mai karu don toxicity da nazarin rarraba halittu, kuma an yi amfani da gwajin mahimmanci don gano furotin a cikin binciken. Sakamakon haka, bayanan rarraba halittu wanda FDA ke dogaro da su shine babban rashin kima na ainihin rarrabawar halittun furotin transgene.
An yi nazarin rarrabawar halittu ta hanyar amfani da fasahohin da ba su iya bambanta rarraba kwayoyin halitta a cikin kyallen takarda. Madadin haka, an yi amfani da hoton dabba gabaɗaya, wanda a zahiri dabara ce ta falo, kuma ba ta ƙididdigewa. Yana da kyau don hotuna akan murfin Rolling Stone, amma ba don ainihin nazarin rarrabawar halittu ba. Wannan ita ce takamaiman matsalar da na kira Dokta Peter Marks game da faɗuwar da ta gabata, kuma ya ba ni tabbacin an magance ta a cikin cikakkun bayanan da Pfizer ya gabatar. Kawai don labari, ya yi min karya.
Abin da wannan duka ke nufi shi ne cewa yin amfani da waɗannan ɓangarorin gwaje-gwaje na farko na asibiti don tallafawa fasahar dandamali an tsara shi tun daga farko. Ta hanyar rashin mai da hankali kan yawan kuɗin da ake biya na allurar, amma a maimakon haka dogaro da ƙayyadaddun ƙayyadaddun tsarin kafin fara gwaji na asibiti, wannan ya ba da damar CBER (da Moderna, da Pfizer/BioNTech) don canja wurin waɗannan fakitin bayanan pre-clinical mara kyau zuwa duk gwajin rigakafin mRNA mai zuwa don sabbin samfuran rigakafin!.
Abubuwan da ke tattare da hakan suna da yawa. Na farko, cikakken gazawar tsari ne da kuma ƙarin shaidar kama tsari. Na biyu, cewa an yi amfani da wannan “annobar” don fitar da amincewar fasahar dandalin mRNA - ta yadda kamfanoni biyu ne kawai za a ba su damar yin gasa (waɗanda suka kammala fakitin farko na asibiti biyu da aka amince da su).
Mun san yanzu cewa mRNA mai ɗauke da pseudouridine baya rushewa tsawon watanni. Amma a maimakon haka, yana tsayawa a cikin jiki yana samar da furotin. Wannan ba mRNA na halitta ba ne ta kowane shimfidar tunani, kuma baya nuna halin mRNA na halitta. Wannan fasaha, kamar yadda Moderna da Pfizer/BioNTech ke yi a halin yanzu, tana ɗaukar wani sabon abu na polymeric biomolecule, waɗanda ba a san su da kyau ba.
Ba a san matakan furotin da waɗannan alluran ke samarwa ba, ba a san tsawon lokacin samar da furotin ba, kuma ba a san yadda ake rarraba furotin ba. Kuma FDA da sauran hukumomin kula da harkokin duniya duk sun gamsu da wannan ??
A matsayin misali na ɗaya daga cikin hatsarori tare da rashin sanin matakan furotin, rarrabawa da kuma tsawon lokacin bayyanar transgene, mun sani daga yawancin nazarin haƙuri na rigakafi da yawa cewa antigen da yawa (furotin a cikin wannan yanayin), na iya haifar da "haƙuri." Wato ainihin inda tsarin rigakafi ya daina ganin barazanar.
Waɗannan alluran rigakafin na iya haifar da juriya cikin sauƙi a kan ƙwayar cuta. Mun sani daga takaddun da aka yi bitar takwarorinsu da yawa daga manyan dakunan gwaje-gwaje na duniya cewa suna haifar da "matsalolin rigakafin rigakafi" ko "matsalolin asali na antigenic" a cikin mutane (ba kawai beraye ba). Wannan ba ka'ida bane. Haƙiƙa ne, kuma ana ƙara ta'azzara ta da "maganin ƙarfafawa" (kamar FDA) ko "sabbin alluran rigakafi" (kalmomin Fadar White House ta Amurka).
A nan gaba, yayin da kamfanoni za su fuskanci wani sabon buƙatu, kamar magance kwanciyar hankali na mRNA a cikin waɗannan alluran rigakafin, zai zama kusan ba zai yuwu a yanzu ficewa daga wannan tsarin masana'anta da LNP ba. Wannan zai zama fasahar dandamali saboda ƙarancin hangen nesa da FDA/CBER ta ɗauka.
Wani batu kuma shine wannan mRNA na roba (an maye gurbin pseudouridine don uridine) shine cewa yana da rigakafi. Samun wannan mRNA a cikin jiki ba wai kawai ikon yaƙar ƙwayoyin cuta na DNA na ɓoye ba kamar shingles, EBV da CMV ba, yana yiwuwa kuma yana danne ikon tsarin rigakafi don gano kansa.
A nan gaba, CBER na FDA dole ne ya yarda da gaskiyar cewa gwajin farko na asibiti bai isa ba, amma duk da haka suna da gwajin rigakafin mRNA 50+ a halin yanzu suna yin rajista kuma sama da 150 akan hanya dangane da wannan fakitin bayanan pre-asilinci mai rauni sosai. Binciken gaggawa a clinicaltrials.gov yana samar da bayanan matsalar da suka haifar.
A halin yanzu bincike kan rigakafin mRNA yana haifar da sakamako da yawa, da yawa na gwaje-gwajen asibiti waɗanda a bayyane suke amfani da kunshin bayanan da bai cika ba daga allurar COVID-19 a matsayin "fasaharar dandamali." Akalla 50 daga cikin waɗannan gwaje-gwajen asibiti na rigakafin mRNA suna yin rajista a halin yanzu.
An sake buga shi daga Mayarwa
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Robert W. Malone likita ne kuma masanin ilimin halittu. Ayyukansa sun mayar da hankali kan fasahar mRNA, magunguna, da bincike na sake fasalin ƙwayoyi.
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