In wani labari Substack post, Sasha Latypova ta tambaya "Shin Pfizer Ya Yi Gwajin Tsaro don Rigakafinta na Covid-19 mRNA a cikin Nazarin Preclinical?" kuma ya zo ga ƙarshe cewa kamfanin kawai ya tsallake mahimman nau'ikan gwaji na yau da kullun, watau gwaji akan dabbobi, don matsawa zuwa asibiti, watau mutane, gwaji.
Babu shakka wannan gaskiya ne, sai dai ba Pfizer ne ya yi haka ba, sai dai BioNTech, kamfani na Jamus wanda ke da abin da aka fi sani da shi cikin kuskure da allurar "Pfizer" wanda ke da alhakin aiwatar da shirin.
Babu bukatar daukar maganata. Wadanda suka kafa BioNTech, Shugaba Ugur Sahin da CMO Özlem Türeci, sun ce da kansu. Alurar riga kafi: A cikin tseren don shawo kan annobar COVID-19: asusun auto-hagiographical na ƙoƙarin da suke yi na samar da rigakafin Covid-19 wanda suka haɗa tare da ɗan jarida Joe Miller.
Don haka, a shafi na 43 na Alurar rigakafin, mun karanta cewa ainihin lokacin haɓakar miyagun ƙwayoyi ya kasance "gaba ɗaya ƙarƙashin ikon BioNTech." The Gabatarwar FDA mai shafi 466 A kan ainihin shirin da Latypova ya tattauna shi ne ƙaddamarwar Pfizer a madadin BioNTech.
Kamar yadda aka bayyana a cikin Alurar rigakafin, BioNTech ɓullo da preclinical shirin a cikin shawarwari tare da Jamus Hukumar gudanarwa, Cibiyar Paul Ehrlich (PEI), wacce, kamar yadda littafin ma ya bayyana (shafi na 44-45), ya riga ya daɗe kuma, bari mu ce, ɗan ɗan jin daɗi. Kuma Latypova yayi daidai - watau daidai game da BioNTech duk da cewa ta ce "Pfizer" - BioNTech hakika yana cikin gaggawa don wuce ƙa'idar, gwajin dabba, lokaci, don farawa da gwajin ɗan adam.
Sai dai wannan ba shi da wata alaka da shirin gwamnatin Amurka na Operation Warp Speed, kamar yadda Latypova ya nuna. A kan asusun Sahin da Türeci, BioNTech ya ƙaddamar da nasa aikin don haɓaka rigakafin Covid-19, wanda aka yiwa lakabi da "Project Lightspeed," tuni a ƙarshen Janairu 2020 - ƙasa da wata guda bayan an ba da rahoton bullar Covid-19 na farko a Wuhan kuma kafin barkewar cutar ma ta ayyana cutar ta WHO! Wannan shi ne, haka ma, wajen wata biyar kafin gwamnatin Amurka ta kaddamar da Operation Warp Speed a hukumance a watan Mayu.
Babi na 7 na Alurar rigakafin, mai suna "Na Farko a cikin Mutum," ya ruwaito Sahin da Türeci kokarin da zazzabi ya yi don rage lokacin gwaji na asali. A nasa lissafin, buƙatar kammala binciken kimiyyar guba na zahiri game da dabbobi kafin a yi wa ɗan takararsa allurar rigakafi a cikin mutane yana da ban sha'awa musamman ga Sahin. Sahin ya so binciken toxicology maimakon "a gudanar da shi lokaci guda tare da gwaje-gwaje na asibiti ko kuma a tsallake shi gaba daya" (shafi na 158).
Abin mamaki, PEI na Jamus ya yarda da shawarar da ta gabata - duk da cewa duk abin da aka yi a cikin binciken ilimin toxicology shine tabbatar da cewa ba shi da lafiya a ci gaba da gwajin ɗan adam! Tabbacin da BioNTech ya bayar ya dogara da a Rahoton daftarin WHO na 2017 kan allurar rigakafin cutar Ebola mai saurin kisa. Rahoton daftarin 2017 da kuma Rahoton karshe na 2018 (shafi na 132) yana ba da shawarar cewa bayanan wucin gadi daga binciken binciken toxicology wanda bai cika ba "zai iya isa" don ci gaba da gwajin asibiti na Phase 1 a lokacin gaggawa na lafiyar jama'a.
Ya kamata a lura cewa duk abubuwan da suka faru a baya kafin BioNTech sun ma ɗauki Pfizer a matsayin abokin tarayya don kiwon ɗan takarar rigakafinta ta hanyar sashin asibiti na tsarin izini da kuma tallata shi a kan wasu (amma ba duka) kasuwanni da zarar an amince da su. A cewar Sahin da Türeci (shafi na 51), BioNTech na farko ya sadu da PEI don tattauna shirinsu a ranar 6 ga Fabrairu. Za a fara gudanar da bincike na toxicology na farko a ranar 17 ga Maris (shafi na 161) - watakila ba kwatsam ba, ranar da ta kasance. yarjejeniyar haɗin gwiwar BioNTech-Pfizer aka kammala.
Bayan wata ɗaya, a ranar 23 ga Afrilu, BioNTech da kanta za ta fara gwajin ɗan adam na Mataki na 1 a Jamus kuma, nb, har yanzu ba tare da sa hannun Pfizer ba. (Shigarwar Rajista na Gwajin Clinical na EU shine nan.) A cewar Sahin da Türeci (shafi na 171), an kammala rahoton wucin gadi da ake buƙata akan binciken binciken ƙwayoyin cuta na zahiri a cikin watanni biyu kacal.
Amma akwai matsala a bayyane a nan: kwanakin ba su ƙara ba. Watanni biyu daga ranar 17 ga Maris zai kai mu Iya 17. Sabanin shawarwarin da ke cikin rahoton rigakafin cutar Ebola na WHO, BioNTech da alama ya ci gaba da gwajin ɗan adam tare da albarkar PEI har ma. kafin an kammala rahoton na wucin gadi.
Kamar yadda ƙaddamarwar FDA da Latypova ta tattauna ya bayyana a sarari, wasu nau'ikan gwaje-gwaje na gwaji kawai an cire su gaba ɗaya. Waɗannan sun haɗa da abin da ake kira nazarin ilimin harhada magunguna na aminci, wanda, per 2005 WHO jagororin, an yi niyya ne don bincika tasirin rigakafin ɗan takara akan “ayyukan ilimin lissafi (misali tsarin juyayi na tsakiya, ayyukan numfashi, cututtukan zuciya da na koda) ban da na tsarin garkuwar jiki.”
Waɗannan jagororin WHO ne na 2005 waɗanda Pfizer ya ambata a cikin ƙaddamarwar FDA don tabbatar da rashin kowane nazarin ilimin harhada magunguna. Daga cikin wasu wurare, ana samun abin da ake magana a kai, alal misali a cikin ƙarin bayani mai taken “Justification for the rashin karatu.”
Hakanan Hukumar Kula da Magunguna ta Turai ta kawo irin wannan ƙa'idodin a cikin Fabrairu 2021 Rahoton kima na comirnaty, Inda ya lura cewa "Ba a gudanar da nazarin ilimin likitanci na aminci tare da BNT162b2. Mai nema yana nufin cewa ba a la'akari da su dole ne bisa ga ka'idar WHO (WHO, 2005)." Kamar yadda lamarin yake a cikin Aikace-aikacen lasisin Halittu na Amurka ga FDA, ba zato ba tsammani, “mai nema” anan shine BioNTech, ba Pfizer.
Amma shin jagororin WHO na 2005 a zahiri sun ba da hujjar watsi da karatun a matsayin "ba lallai ba ne?" A cikin sabon littafinsa Ya mutu mRNA Maschine (Mashin na mRNA), David O. Fischer yayi nazarin sassan da suka dace na jagororin WHO, da kuma na farkon jagororin EMA na 2001 wanda jagororin WHO ke nufi, kuma ya zo daidai da akasin ƙarshe: wato, jagororin. buƙatar irin wannan karatun, "musamman don sababbin hanyoyin magunguna" kamar maganin rigakafi na mRNA (shafi na 85).
Fischer (wani mai suna ga masanin ilmin halitta kuma tsohon shugaban masana'antar harhada magunguna) ya rubuta: "Ta hanyar kawar da kowane irin nazarin ilimin kimiyyar harhada magunguna, BioNTech ya keta waɗannan buƙatun gabaɗaya ta hanyar da za a iya kwatanta shi azaman tagulla" (shafi na 85).
(Mawallafin Fassara daga Jamusanci.)
Postscript: Kamar yadda aka ambata a sama, a cikin littafinsu, Ugur Sahin da Özlem Türeci sun yi iƙirarin cewa aikin rigakafin Covid-19 na BioNTech ya fara aiki a ranar 27 ga Janairu, 2020. Amma bayanan da aka fitar a ƙarƙashin Dokar 'Yancin Bayanai ta Amurka ta ba da labari na dabam. A Rahoton binciken BioNTech kunshe a cikin abin da ake kira "Pfizer Documents" ya nuna cewa BioNTech a gaskiya ya riga ya fara gwajin dabba Janairu 14 - kwana daya kacal bayan buga kwayar halittar SARS-CoV-2! Duba p. 8 na rahoton na kwanakin binciken.
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Robert Kogon shi ne sunan alkalami na wani ɗan jarida da ake bugawa da yawa wanda ke yin rubuce-rubuce kan al'amuran Turai.
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