In bangare daya na wannan labarin, Na sake nazarin tsarin kwangila da tsari wanda gwamnatin Amurka ta yi amfani da shi don haɓakawa na farko, ƙira, da kuma siyan harbin Covid mRNA, ta amfani da yarjejeniyar BioNTech/Pfizer don kwatanta tsarin.
Na nuna cewa an ba da izinin Amfani da Gaggawa (EUA) ga waɗannan samfuran dangane da gwajin asibiti da tsarin masana'antu da aka gudanar tare da
- ba tare da bin ka'idodin doka ba,
- babu sa ido ko tsari da aka haramta ta doka, kuma
- babu wani magani na doka daga masana'anta don yuwuwar lahani.
A cikin wannan labarin mai zuwa, zan ba da cikakken bincike game da takaddun da ke ƙasa.
Sauran Hukuma/Yarjejeniyar Ma'amala (OTA): Hanyar Samun Soja
The yarjejeniya tsakanin gwamnatin Amurka, wanda Ma'aikatar Tsaro (DoD) ke wakilta, da Pfizer, wakiltar haɗin gwiwar BioNTech/Pfizer, a cikin Yuli 2020, don siyan "alurar rigakafi don hana COVID-19" ba kwangilar siye ba ce ta yau da kullun.
Yarjejeniya ce a ƙarƙashin Sauran Hukumancin Ma'amala (OTA) - hanyar saye wanda, a cewar Jagoran Ma'aikatar Tsaro, an yi amfani da shi tun 1958 don “ ba da izinin hukumar tarayya ta shiga ma'amaloli ban da kwangila, tallafi, ko yarjejeniyar haɗin gwiwa. "
[FUSKA FUSKA]
Ana iya samun cikakken bita na amfani da OTA ta DoD, gami da tarihin doka, a cikin Fabrairu 22, 2019 Rahoton Sabis na Bincike na Majalisa. Wannan rahoto, tare da kowane tattaunawa na OTA, yana ƙayyadaddun cewa wata hanya ce ta saye domin tsaro da soji. Ba a yi niyya ba, kuma ba a taɓa amfani da shi ba kafin Covid, don wani abu da aka yi niyya da farko don farar hula.
Idan kuna nema Dokokin OTA a cikin Lambar Amurka, wannan ita ce hanyar da za ku gangara:
Sojoji -> Dokar Soja ta Janar -> Samun -> Bincike da Injiniya -> Yarjejeniyar -> Hukumar DoD don aiwatar da wasu ayyukan samfuri
Wannan hanyar doka ta nuna a sarari cewa dokokin OTA an yi niyya ne don samun bincike da samfuran injiniya ga sojojin.
A cewar gidan yanar gizon DARPA,
Ma'aikatar Tsaro tana da iko don nau'ikan OT uku daban-daban: (1) binciken OTs, (2) samfurin OTs, da (3) samar da OTs.
Waɗannan nau'ikan OT guda uku suna wakiltar matakai uku na bincike na farko, haɓaka samfuri, da samarwa na ƙarshe.
A cikin waɗannan nau'ikan guda uku, akwai takamaiman nau'ikan ayyuka waɗanda OTA za su iya amfani da su:
- Asali, bisa ga Bayanin OTA DoD ta bayar, Sauran Hukumar Ma'amala ta kasance "iyakantacce don amfani da makamai ko tsarin makaman da DoD ke samarwa ko haɓakawa."
- Daga baya an fadada OTA don haɗawa da "duk wani aikin samfuri kai tsaye da ke da alaƙa da haɓaka tasirin aikin soja da dandamali, tsarin, abubuwan haɗin gwiwa, ko kayan da aka ba da shawarar samu ko haɓaka ta DoD, ko don haɓaka dandamali, tsarin, sassa, ko kayan da Sojojin ke amfani da su."
Ya zuwa yanzu, babu ɗayan waɗannan da ke kama da hanyar siye don miliyoyin sabbin samfuran likitanci waɗanda aka yi niyya da farko don farar hula.
Shin Akwai Wani Keɓance Don Amfani da Farar Hula na OTA Wanda Zai Iya Aiwatar da Alurar rigakafin mRNA?
The FY2004 Dokar Izinin Tsaro ta Ƙasa (PL 108-136) ya ƙunshi wani sashe wanda ya bai wa Sauran Hukumar Ma'amala ga "shugaban hukumar zartaswa wanda ke gudanar da bincike na asali, bincike mai aiki, bincike mai zurfi, da ayyukan ci gaba" waɗanda "suna da damar sauƙaƙe tsaro ko murmurewa daga ta'addanci ko makaman nukiliya, nazarin halittu, sinadarai ko harin rediyo."
An tsawaita wannan tanadin har zuwa shekarar 2018, amma bai yi kama da ya wuce waccan shekarar ba. Hakanan, lura cewa ko da a cikin wannan yanayin na musamman na rashin DoD amfani da OTA, lamarin dole ne ya hada da ta'addanci ko kai hari da makaman kare dangi (CBRN).
Wadanne Dokokin OTA Za Su Aiwatar?
Rahoton CRS na 2019 da aka ambata a sama yana ba da wannan ginshiƙi, yana nuna cewa wasu hukumomin da ba na DoD ba suna da wasu OTA ko hukumomin da ke da alaƙa:
Bisa ga wannan tebur, Ma'aikatar Lafiya da Ayyukan Dan Adam (HHS) tana da wasu bincike da haɓaka (R&D) Sauran Hukumomin Ma'amala. Dokar da ta shafi Ikon OT na HHS shine 42 USC §247d-7e.
Ina wannan doka take kuma me ta ce?
Ma'aikatar Kiwon Lafiyar Jama'a da Jindadin Jama'a -> Ma'aikatar Kiwon Lafiyar Jama'a -> Gabaɗaya Iko da Ayyuka -> Haɗin Kai tsakanin Jiha da Tarayya -> Hukumar Bincike da Ci Gaban Halitta (BARDA) -> Hukumomin Ma'amala
Don haka akwai wani wuri a cikin dokar da ke da alaƙa da lafiyar farar hula da walwala inda OTA zai iya amfani da shi, kodayake yana da inganci. kawai don bincike da haɓakawa, ba samfura ko masana'anta ba.
Dokar ta bayyana cewa sakataren BARDA yana da OT Authority
dangane da samfurin da yake ko yana iya zama a m countermeasure ko a ƙwararrun ƙwayar cuta ko samfurin annoba, ayyukan da suka fi yawa -
(i) ana gudanar da su ne bayan bincike na asali da ingantaccen haɓaka samfurin; kuma
(ii) suna da alaƙa da kera samfurin akan sikelin kasuwanci da a cikin wani nau'i wanda ya dace da ka'idodin tsari a ƙarƙashin Tarayya Dokar Abinci, Magunguna, da Kayan kwalliya [21 USC 301 et seq.] ko kasa sashi na 262 na wannan take.
[FUSKA FUSKA]
“Sharuɗɗan ƙa’ida” da aka lissafta a cikin doka suna nufin cewa ba zai yuwu ba BARDA/HHS su shiga yarjejeniya – har ma da R&D kawai – ga kowane samfuran likitanci (kamar allurar mRNA) waɗanda ba su yi gwajin aminci mai tsauri da kuma sa ido kan masana'antu ba.
HHS “Haɗin kai” tare da DoD ɗin Kariya na Farar Hula
Don taƙaita halin da wasu Hukuma/Yarjejeniyoyi na Ma'amala dangane da hukumomin farar hula, gabaɗaya, da kuma rigakafin Covid mRNA, musamman:
- An rubuta OTA kuma an tsara shi azaman hanyar da sojoji za su samu makamai da sauran tsare-tsare da kayan aiki masu mahimmanci ba tare da jajayen aikin hukuma ba. Ya ƙunshi bincike da haɓakawa, samfuri, da masana'anta na gaba.
- OTA kawai na hukumar kula da lafiyar jama'a shine na HHS kuma yana rufe Bincike & Ci gaba kawai, ba samfura ko masana'anta ba.
- Ko da R&D OTA da aka bai wa HHS har yanzu yana buƙatar samfuran da za a kera su "a cikin sigar da ta dace da ƙa'idodi" don amincin magunguna da rigakafin.
A wasu kalmomi: Babu wata hanya da HHS za ta yi amfani da OTA mai iyaka don sanya hannu kan kwangiloli na daruruwan miliyoyin kayan aikin likita na zamani.
To me HHS yayi?
Kamar yadda Ofishin Asusun Gwamnati (GAO) ya lura a cikin ta Rahoton Yuli 2021 kan "Kwangilar COVID-19:" HHS "haɗin gwiwa" tare da DoD don "yi amfani da hukumomin OTA na DoD… wanda HHS ya rasa." (shafi 24)
Menene Hukumomin OT na DoD don Samfuran Lafiya?
Kamar yadda aka tattauna, OTA an yi niyya ne don taimaka wa sojoji su sami kayan aiki da fasaha ba tare da ɗimbin matsalolin aikin hukuma ba. Babu ɗaya daga cikin ainihin dokokin da suka shafi OTA da aka ambata wani abu ban da "dandamali, tsarin, kayan aiki, ko kayan aiki" da aka yi niyya don "ƙarfafa tasirin aikin soja."
Amma shekaru biyar kafin Covid, an gabatar da amfani na musamman na OTA:
A shekarar 2015, DoD ya sanar A kafa na Cibiyar Cibiyar Cibiyar Cibiyar Likita ta Cibiyar Likita, wacce manufar OTA zuwa "Aiki tare da Dofin Zamani don Ci gaban FDA [FDA = Gudanar da Abinci da Magunguna]
Kamar yadda aka bayyana a cikin sanarwar 2015, wannan ya haɗa da "fasaha na samfuri don hanyoyin magance magunguna da ke niyya da ƙwayoyin cuta, ƙwayoyin cuta, da maƙasudin guba na halitta na sha'awar DoD." Jerin wakilai sun haɗa da manyan ƙwayoyin cuta na biowarfare, irin su anthrax, ebola, da marburg.
Sanarwar ta ci gaba da bayyana cewa "fasaha mai ba da damar iya haɗawa da nau'ikan dabbobi na hoto ko bidiyo mai zagaya yanar gizo da sauri, cututtukan ƙwayoyin cuta ko cututtukan ƙwayoyin cuta da kuma pathogenesis (hanyoyi masu yawa na fallasa), ƙididdiga, fasahar bincike ko wasu fasahohin dandamali waɗanda za a iya amfani da su don haɓakar MCMs da aka yarda da su ko masu lasisi [maganganun magunguna]."
Ko da yake wannan har yanzu bai yi kama da samar da alluran rigakafi miliyan 100 don amfanin farar hula ba, yana ba da ƙarin fa'ida ga OTA fiye da ƙayyadaddun Hukuncin Ma'amala da aka baiwa HHS.
Yayin da HHS OTA na buƙatar bin ƙa'idodin haɓakawa da ƙa'idodin ƙira, hanyar OTA don DoD don haɓaka matakan rigakafin likita yana buƙatar "lasisi na FDA kawai."
Don haka, ta yin amfani da DoD Sauran Hukumomin Ma'amala, a haƙiƙa zai yiwu a ketare kowane ƙa'idodin aminci - ya danganta da buƙatun lasisin FDA na samfurin da aka samar da OTA. Kamar yadda za mu gani, game da alurar rigakafin Covid mRNA, an ba da izinin Amfani da Gaggawa, ba tare da buƙatar sa ido kan amincin doka ba kwata-kwata.
Izinin Amfani da Gaggawa (EUA)
Ga yadda Hukumar Abinci & Magunguna (FDA) ta bayyana ikonta na EUA:
Sashe na 564 na Dokar FD&C (21 USC 360bbb-3) ba da damar FDA don ƙarfafa kariyar lafiyar jama'a daga kwayoyin halitta, sinadarai, nukiliya, da kuma na'urorin rediyo.
Tare da wannan ikon EUA, FDA na iya taimakawa wajen tabbatar da cewa za a iya amfani da matakan likita a cikin gaggawa don ganowa, magani, ko hana cututtuka masu haɗari ko masu barazana ga rayuwa ko yanayin da ke haifar da kwayoyin halitta, sinadarai, makaman nukiliya, ko na rediyo lokacin da babu isassun, yarda, da kuma samuwa madadin (cikin wasu sharudda).
Yana da matukar mahimmanci a fahimci cewa an ba da waɗannan iko na EU a cikin 2004 a ƙarƙashin takamaiman yanayi na musamman da suka shafi shirye-shiryen hare-hare ta hanyar makaman da ke halaka jama'a, in ba haka ba da aka sani da CBRN (sinadaran, nazarin halittu, rediyo, da makaman nukiliya).
Kamar yadda aka yi bayani a cikin Dokar Lafiya ta Harvard,
Daga ƙarshe, Yaƙin Ta'addanci ne zai ba da izinin yin amfani da gaggawa. Bayan abubuwan da suka faru a ranar 11 ga Satumba, 2001 da kuma hare-haren anthrax na gaba, Majalisa ta zartar da dokar. Dokar Bioshield Project na 2004. Dokar ta yi kira da a ware biliyoyin daloli don siyan alluran rigakafi a shirye-shiryen harin ta'addanci, da kuma tara hanyoyin magance gaggawa. Don samun damar yin aiki da sauri a cikin gaggawa, Majalisa ta ƙyale FDA ta ba da izini ga samfuran da ba a yarda da su ba don amfani da gaggawa a kan barazanar lafiyar jama'a da aminci (bisa ga sanarwar gaggawa ta HHS). The rikodin ya nuna cewa Majalisa ta mai da hankali kan barazanar ta'addanci musamman, ba kan shirye-shiryen barkewar cutar ta dabi'a ba.
The dokokin EU yana jaddada gaskiyar cewa an yi nufin amfani da shi a yanayin da ya shafi makaman kare dangi. Anan ga yanayi 4 waɗanda EUA za a iya bayarwa:
- ƙudirin da Sakataren Tsaron Cikin Gida ya yi cewa akwai gaggawar cikin gida, ko wata muhimmiyar yuwuwar gaggawar cikin gida, wanda ya haɗa da haɓakar haɗarin hari tare da wakili na halitta, sinadarai, rediyo, ko makaman nukiliya ko wakilai;
- yunƙurin da Sakataren Tsaro ya yi cewa akwai gaggawar soji, ko kuma wani gagarumin yuwuwar gaggawar soji, wanda ya haɗa da haɗarin haɗari ga United Amirka sojojin, ciki har da ma'aikatan da ke aiki a ƙarƙashin ikon Title 10 ko Title 50, na kai hari tare da -
- kwayoyin halitta, sinadarai, rediyo, ko wakili ko wakilai; ko
- wakili ko wakilai waɗanda zasu iya haifar, ko kuma suna da alaƙa da su, wani haɗari mai haɗari da rayuwa da ke kusa da United Amirka sojojin soja;
- Ƙaddara ta hanyar Sakataren cewa akwai wani gaggawar lafiyar jama'a, ko wata muhimmiyar yuwuwar ga gaggawar lafiyar jama'a, wanda ke shafar, ko kuma yana da babban yuwuwar tasiri, tsaron ƙasa ko lafiya da tsaro na United Amirka 'yan ƙasa da ke zaune a ƙasashen waje, kuma wanda ya haɗa da kwayoyin halitta, sinadarai, rediyo, ko makaman nukiliya ko wakilai, ko cuta ko yanayin da zai iya kasancewa ga irin wannan wakili ko wakilai; ko
- gano barazanar abu bisa ga sashe na 319F-2 na Dokar Sabis na Kiwon Lafiyar Jama'a [42 USC 247d–6b] ya isa ya shafi tsaron ƙasa ko lafiya da tsaro na United Amirka 'yan kasa mazauna kasashen waje.
Babu inda a cikin waɗannan yanayi guda huɗu da babu wani ambaton annoba da ke faruwa ta dabi'a, annoba, ko kowane irin yanayin lafiyar jama'a wanda ba ya haifar da "kwayoyin halitta, sinadarai, rediyo ko wakili / s."
Shin SARS-CoV-2 na iya cancanta a matsayin irin wannan wakili?
Idan ka nemo ma'anar "kwayoyin halitta” a cikin Tsarin Dokokin Amurka, zaku bi hanya mai zuwa:
Laifuka da Tsarin Laifuka -> Laifuka -> Makamai Na Halittu -> Ma'anar
Don haka a cikin mahallin dokar Amurka, kalmar “masu aikin halitta” na nufin makaman halittu, kuma ana ɗaukar amfani da irin waɗannan wakilai/makamai a matsayin laifi.
Wikipedia ya ba da wannan definition:
Wakilin halitta (wanda kuma ake kira bio-agent, wakili na barazanar halitta, wakili na yaƙin halitta, makamin halitta, ko bioweapon) shine kwayar cuta, virus, protozoan, m, naman gwari, ko guba wanda za a iya amfani da shi da gangan a matsayin makami a ciki bio ta'addanci or yakin rayuwa (BW).
Akan Wane Tushen Shari'a aka Bayar da EUA don rigakafin Covid mRNA?
Zai yi kama, dangane da dokokin EUA, cewa babu ɗaya daga cikin yanayi huɗu masu yuwuwar da aka bayyana a cikin doka da za a iya amfani da su ga samfurin da aka yi niyya don hana ko magance wata cuta da ke haifar da cuta ta zahiri.
Koyaya, an yi amfani da wannan dokar don ba da izini ga rigakafin mRNA Covid.
Idan aka ba da zaɓaɓɓu huɗu da aka jera a cikin dokar EUA, wanda aka yi amfani da shi don “maganganun rigakafi” na Covid.
C) yanke hukunci ta hanyar Sakataren cewa akwai wani gaggawar lafiyar jama'a, ko wata muhimmiyar yuwuwar ga gaggawar lafiyar jama'a, wanda ke shafar, ko kuma yana da babban yuwuwar tasiri, tsaron ƙasa ko lafiya da tsaro na United Amirka 'yan ƙasa da ke zaune a ƙasashen waje, kuma wanda ya haɗa da wani nau'in halitta, sinadarai, rediyo, ko wakili na nukiliya ko wakilai, ko cuta ko yanayin da zai iya kasancewa ga irin wannan wakili ko wakilai.
A lokacin da musamman ga Covid, ga yadda aka ce:
Sakataren Ma'aikatar Kiwon Lafiya da Ayyukan Jama'a (HHS) ya ƙaddara cewa akwai gaggawar lafiyar jama'a da ke da muhimmiyar damar yin tasiri ga tsaron ƙasa ko lafiya da amincin 'yan ƙasar Amurka da ke zaune a ƙasashen waje, kuma hakan ya haɗa da kwayar cutar da ke haifar da Cutar Coronavirus 2019 (COVID-19)…
Babu shakka a nan cewa "kwayar da ke haifar da COVID-19" ana ɗaukarta daidai da "wakilin halitta, sinadarai, rediyo, ko wakili na nukiliya."
Hakanan yana da mahimmanci a lura cewa EUA "ƙaddamar da gaggawar lafiyar jama'a" ta bambanta da, kuma ba ta kowace hanya ta dogara da, duk wasu sanarwar gaggawa ta lafiyar jama'a, kamar waɗanda WHO, gwamnatin Amurka, da shugaban ƙasa suka yi a farkon cutar ta Covid-19.
Don haka ko da WHO, gwamnatin Amurka, da Shugaban kasa suka ba da sanarwar cewa cutar ta ƙare, har yanzu ana iya samun izinin amfani da gaggawa idan Sakataren HHS ya ci gaba da da'awar cewa yanayin da aka bayyana a sashe na C) ya wanzu.
Kallo duk EUA don ɗaruruwan samfuran likitancin da ke da alaƙa da Covid, Yana da matukar wahala a ga yadda sakataren HHS zai iya ba da hujjar da'awar cewa "akwai wani gaggawar lafiyar jama'a wanda ke da tasiri mai mahimmanci don tasiri ga tsaron kasa ko lafiya da lafiyar 'yan Amurka da ke zaune a kasashen waje" a mafi yawan, idan ba duka ba, na waɗannan lokuta.
Ƙarin "Sharuɗɗan Dokoki" don FDA don Ba da izini na Amfani da Gaggawa
Da zarar Sakataren HHS ya ba da sanarwar cewa akwai gaggawar lafiyar jama'a da ke ba da garantin EUA, dangane da ɗayan yanayi huɗu da aka jera a cikin doka, akwai ƙarin “sharuɗɗan doka” guda huɗu waɗanda dole ne a cika su don FDA ta ba da EUA. Ga yadda FDA ke bayanin waɗannan buƙatun:
- Mummunan cuta ko Lalacewa Mai Barazanar Rayuwa
Don FDA ta fitar da EUA, wakilin (s) na CBRN da ake magana a kai a cikin sanarwar EUA na Sakatariyar HHS dole ne su kasance masu iya haifar da mummuna ko cuta ko yanayi mai haɗari.
NOTE: Wannan ma'auni yana maimaita ƙayyadaddun takamaiman wakilin CBRN, wanda doka ta bayyana a matsayin makamin da ake amfani da shi wajen aikata laifi.
- Shaidar Tasiri
Kayayyakin likitanci waɗanda za a iya la'akari da su don EUA su ne waɗanda “za su yi tasiri” don hanawa, tantancewa, ko magance cututtuka masu haɗari ko masu barazana ga rayuwa ko yanayin da wani wakili (s) na CBRN zai iya haifar da su a cikin sanarwar gaggawa ko barazanar gaggawa ta Sakataren HHS a ƙarƙashin sashe na 564(b).
Ma'auni na "na iya zama mai tasiri" don EUAs yana ba da ƙananan shaidar shaida fiye da ma'auni na "tasiri" wanda FDA ke amfani da shi don amincewar samfur. FDA ta yi niyya don tantance yuwuwar tasiri na yuwuwar samfurin EUA akan kowane hali ta hanyar amfani da bincike mai fa'ida, kamar yadda aka bayyana a ƙasa.
[FUSKA FUSKA]
TAMBAYA TA DOKA: Ta yaya kowa zai iya da'awar doka cewa samfurin da aka ba da izini a ƙarƙashin EUA yana "lafiya kuma mai tasiri" idan ƙa'idar doka don EUA "zai iya zama tasiri" kuma FDA ta bayyana cewa wannan "ƙananan matakin shaida" fiye da ma'aunin da aka yi amfani da shi don amincewar samfur na yau da kullum?
- Binciken Risk-Amfani
Ana iya la'akari da samfur don EUA idan Kwamishinan ya ƙaddara cewa sananne da yuwuwar fa'idodin samfurin, lokacin da aka yi amfani da shi don tantancewa, hanawa, ko magance cutar da aka gano ko yanayin, ya fi sananne da yuwuwar haɗarin samfurin.
A cikin ƙayyadaddun ko sananne da yuwuwar fa'idodin samfurin sun fi sananne da haɗarin haɗari, FDA yayi niyyar duba a jimlar shaidar kimiyya don yin ƙayyadaddun ƙayyadaddun fa'idar haɗari gabaɗaya. Irin wannan shaida, wanda zai iya tashi daga tushe iri-iri, iya haɗawa (amma ba'a iyakance shi ba): sakamakon gwaji na gida da na waje, in vivo ingantattun bayanai daga ƙirar dabba, da bayanan in vitro, samuwa ga FDA la'akari. FDA kuma za ta tantance inganci da adadin akwai shaida, idan aka yi la'akari da yanayin ilimin kimiyya na yanzu.
[FUSKA FUSKA]
NOTE NA DOKA: Babu ma'auni na shari'a kuma babu ma'anar doka don abin da ake nufi da "sananan fa'idodi da fa'idodi" don wuce "sananan hadura da yuwuwar haɗari." Hakanan babu wani ma'anar doka mai ƙima ko ƙididdigewa ga abin da ya ƙunshi "samuwa shaida" wanda aka dogara akan binciken fa'idar haɗarin "zai iya kasancewa". Za a iya samun ainihin shaidar sifili, amma imani cewa samfurin yana da fa'ida mai yawa kuma ba haɗari mai yawa ba, kuma hakan zai gamsar da wannan "buƙatun doka."
- Babu Madadi
Don FDA ta fitar da EUA, dole ne babu isassun, yarda, da samuwa madadin samfurin ɗan takara don bincikar, hanawa, ko magance cutar ko yanayin. Za a iya la'akari da yuwuwar madadin samfurin "babu" idan babu isassun kayayyaki na madadin da aka amince da shi don cika buƙatar gaggawa.
TAMBAYA TA SHARI'A: Baya ga mummunar tozarta / haramta wasu hanyoyin maganin Covid-19 kamar ivermectin da hydroxychloroquine, a wane lokaci ne aka sami wata hanyar da aka amince da ita don "hana Covid-19" (abin da kawai aka sayi rigakafin mRNA don yi) - Paxlovid, alal misali - wanda zai ba da doka ta EUAs?
Anan ga yadda duk waɗannan “sharuɗɗan doka” suka gamsu a zahiri Izinin Amfani na Gaggawa don rigakafin mRNA na BioNTech/Pfizer Covid:
Na gama da cewa amfani da gaggawa na Pfizer-BioNTech COVID-19 Vaccine don rigakafin COVID-19 lokacin da aka gudanar da shi kamar yadda aka bayyana a cikin Iyalin Izini (Sashe na II) ya cika ka'idojin bayar da izini a ƙarƙashin sashe na 564(c) na Dokar, saboda:
- SARS-CoV-2 na iya haifar da mummuna ko cuta mai barazana ga rayuwa ko yanayi, gami da matsanancin rashin lafiya na numfashi, ga mutanen da suka kamu da wannan cutar;
- Dangane da jimillar shaidar kimiyya da ke akwai ga FDA, yana da kyau a yarda cewa Pfizer-BioNTech COVID-19 Vaccine na iya yin tasiri wajen hana COVID-19, da kuma cewa, lokacin da aka yi amfani da su a ƙarƙashin sharuɗɗan da aka bayyana a cikin wannan izini, sananne da fa'idodin fa'idodin Pfizer-BioNTech COVID-19 lokacin amfani da shi don rigakafin COVID-19 ya zarce haɗarin da aka sani da shi; kuma
- Babu isassun, yarda, da samuwa madadin amfani da gaggawa na Pfizer-BioNTech COVID-19 Vaccine don rigakafin COVID-19.
[FUSKA FUSKA]
NOTE: Iyakar mahallin da FDA ta auna yuwuwar fa'idodi da haɗarin maganin, kuma a cikin abin da FDA ta ƙaddara cewa "zai iya zama tasiri" shine. a cikin rigakafin Covid-19.
Babu wani la'akari, babu wata shaida ta ainihin fa'ida ko yuwuwar fa'ida, kuma babu ƙayyadaddun cewa akwai yuwuwar tasirin maganin don yin wani abu dabam, gami da: rage haɗarin kamuwa da cuta mai tsanani, rage haɗarin asibiti, rage haɗarin mutuwa, rage haɗarin kowane yanayi a zahiri ko yuwuwar alaƙa da Covid-19.
DON HAKA, mutum na iya yin tambaya da halaccin sahihancin duk wani iƙirari na cewa allurar "lafiya ce kuma mai tasiri" a cikin mahallin wani abu ban da "lokacin da aka yi amfani da shi don hana COVID-19" - wanda aka san cewa ba a yi ba da daɗewa ba bayan an gabatar da su.
Idan aka gaya wa mutane cewa allurar rigakafin mRNA na BioNTech/Pfizer suna da "lafiya kuma masu tasiri" a wani abu banda hana Covid-19, kuma idan an yi musu barazanar da wani sakamako na rashin ɗaukar maganin ga wani abu banda hana Covid-19, shin za su iya samun hujja ta halal cewa an tilasta musu ba bisa ka'ida ba don ɗaukar samfurin da ba a yarda da shi ba a ƙarƙashin da'awar yaudara?
Bukatun mataki na uku don EUA don samfuran da ba a yarda da su ba
Da zarar muna da ƙayyadaddun sanarwar gaggawa ta EUA, kuma da zarar FDA ta bayyana cewa samfurin na iya zama mai tasiri kuma duk abin da shaida ke samuwa (daga sifili zuwa mara iyaka) ya nuna cewa fa'idodinsa sun fi haɗarinsa (kamar yadda aka ƙaddara ta duk abin da FDA ke tunanin waɗannan na iya zama), akwai ƙarin Layer na rashin aminci, ƙa'idodin da ba su da inganci.
Ga yadda a Rahoton Sabis na Bincike na Majalisa na 2018 akan EUA yayi bayanin haka:
FFDCA §564 tana ba da umarnin FDA don sanya wasu sharuɗɗan da ake buƙata a cikin EUA kuma suna ba da izinin ƙarin sharuɗɗan hankali idan ya dace. Sharuɗɗan da ake buƙata sun bambanta dangane da ko EUA na samfurin da ba a yarda da shi ba ko don amfanin da ba a yarda da samfurin da aka yarda ba. Don samfurin da ba a yarda da shi ba, sharuɗɗan amfani dole ne:
(1) tabbatar da cewa ƙwararrun ma'aikatan kiwon lafiya waɗanda ke gudanar da samfurin sun karɓi bayanin da ake buƙata;
(2) tabbatar da cewa mutanen da aka ba wa samfur ɗin sun karɓi bayanin da ake buƙata;
(3) bayar da kulawa da bayar da rahoto game da abubuwan da ba su da kyau da suka shafi samfurin; kuma
(4) samar da rikodi da bayar da rahoto ta masana'anta.
TAMBAYA TA SHARI'A: Menene ainihin "bayanan da ake buƙata?" Mun san cewa an sanar da mutane cewa an ba da allurar Izinin Amfani da Gaggawa. Amma an gaya musu cewa wannan yana nufin "ƙananan shaidar shaida" fiye da yadda ake buƙata don da'awar "lafiya da inganci" akan wasu samfuran likita? An sanar da su cewa akwai matakan daban-daban na "aminci da tasiri" dangane da ko samfurin yana da EUA ko wani nau'in izini?
NOTE: Doka ta bukaci a sami hanyar sa ido da bayar da rahoton munanan abubuwan da suka faru. Duk da haka, ba a bayyana wanda ke sa ido ba, menene ma'auni don bayar da rahoto, da kuma mene ne maƙasudin ɗaukar mataki bisa rahotannin.
EUA Kwatanta da Kowacce Hanyar Amincewa da Magunguna/Alurar rigakafi
A matsayin mai bincike/marubuci Sasha Latypova ya yi nuni da cewa, mutane da yawa sun ruɗe ta EUA, saboda yana da kama da EAU, wanda ke nufin “Amfani da Faɗakarwa.” Wannan wani nau'i ne na izini da aka ba wa samfurori na likita lokacin da ake buƙatar gaggawa ta wani rukuni na marasa lafiya (misali, Stage IV marasa lafiya na ciwon daji wanda aka auna tsawon rayuwarsu a cikin watanni) waɗanda ke shirye su yi haɗari da mummunan al'amura har ma da mutuwa a musayar don samun damar yin amfani da magani na gwaji.
Izinin Amfani na gaggawa ba shi da alaƙa da shi, kuma baya ɗaukar kamanni da Faɗaɗɗen Amfani.
Hanyoyi daban-daban na doka don ba da izinin samfuran likita ana gabatar dasu da kyau a cikin tebur da mai binciken shari'a ya haskaka Katarina Watt. Teburin wani bangare ne na gabatarwar 2020 don Taron Koyon Haɗin gwiwa na FDA-CDC: Sabunta Tsari akan Amfani da Ma'aunin Maganin Lafiya.
Kwatanta hanyoyin samun damar shiga
Wannan tebur yana nuna a sarari cewa tsarin EUA ba shi yiwuwa ya samar da bayanai game da ingancin samfur, ba a tsara shi don ba da shaida na aminci ba, ba zai iya samar da bayanai masu amfani don amfanar marasa lafiya na gaba ba, ba tare da tattara bayanan tsari ba, ba buƙatar sake dubawa ba, ba da izini da aka sanar, kuma babu kwamitin bita na hukuma.
Haka kuma, a cikin a Cibiyar Nazarin Magunguna ta 2009 na Buga Ilimin Kasa, Har ila yau, Watt ya haskaka, mai suna "Hanyoyin Maganin Magunguna: Ba da izini na Amfani da Gaggawa da Tsarin Wasiƙa - Takaitaccen Taron Bita" mun sami wannan sanarwa a shafi na. 28:
Yana da mahimmanci a gane cewa EU ba ta cikin hanyar ci gaba; keɓaɓɓen mahalli ne gaba ɗaya wanda ake amfani dashi lokacin yanayin gaggawa kawai kuma baya cikin tsarin amincewa da ƙwayoyi.
Shin hakan yana nufin amincewa da matakan rigakafin Covid-19 waɗanda suka dogara kan EUAs ba bisa doka ba ne? Shin yana nufin cewa babu wata hanyar doka don da'awar samfurin EUA yana da "lafiya kuma mai tasiri" saboda BA SASHE NA TSARIN YARDA DA MGUNGUN?
Kammalawa
A bayyane yake, an ba da duk bayanan da ke cikin wannan labarin, da kuma a baya part 1, cewa an ƙirƙira, kera, kuma an ba da izinin rigakafin BioNTach/Pfizer Covid mRNA a ƙarƙashin dokokin soji da aka keɓe don yanayin gaggawa da ya shafi yaƙin halittu/ta'addanci, ba cututtukan da ke faruwa a dabi'a da ke shafar al'ummar farar hula ba.
Don haka, bin ƙa'idodi da sa ido waɗanda muke tsammanin samu lokacin da aka ɗauki samfur "aminci da tasiri" ga duk farar hula ba a buƙata ta doka ba.
Za a iya amfani da wannan bincike don ƙalubalantar haƙƙin da'awar "aminci da tasiri" na jami'an gwamnati waɗanda suka san abin da EUA ya ƙunsa? Shin akwai wasu dalilai na doka?
Ina fata haka ne.
Mahimmanci, a cikin ƙalubalen shari'a ga rigakafin Covid mRNA da aka kawo ya zuwa yanzu, babu wani hukunci (wanda na sani) kan ko ana iya amfani da dokar soji, kamar OTA da EUA, ga yanayin farar hula. Sai dai, akwai wata sanarwa da alkalin kotun gundumar Michael Truncale, ya yi a cikin nasa watsi da karar mai fallasa Brook Jackson da Ventavia da Pfizer, wannan yana da mahimmanci a kiyaye.
Anan alkali ya yarda cewa yarjejeniya don rigakafin BioNTech/Pfizer mRNA na OTA ne na soja, amma ya ƙi yanke hukunci game da amfaninta ga yanayin da ba na soja ba (cutar da ke faruwa a zahiri, allurai miliyan 100 galibi ba don amfanin soja ba) a ƙarƙashinsa:
Kasancewar duka jami'an soji da fararen hula sun sami alluran bai nuna cewa samun maganin ba shi da mahimmanci wajen inganta aikin soja. Mafi mahimmanci, Ms. Jackson yana neman wannan Kotun ta soke hukuncin DoD na yin amfani da wasu Hukumance don siyan maganin Pfizer. Amma kamar yadda Kotun Koli ta Amurka ta dade tana nanata, "rikitattun shawarwari, da kwararrun yanke shawara game da abun da ke ciki, horarwa, kayan aiki, da sarrafa rundunar soji sune ainihin hukunce-hukuncen soja na kwararru." Gilligan v. Morgan, 413 US 1, 10 (1973). Don haka, yana da “wahala a yi tunanin wani yanki na ayyukan gwamnati wanda kotuna ba su da iyawa.” Id Wannan Kotu ba za ta yi watsi da hukunce-hukuncen DoD ba game da tasirin manufa a lokacin gaggawa na ƙasa.
Wannan shine ɗayan matsalolin doka da yawa waɗanda suka rage a cikin yaƙin don hana duk samfuran mRNA da aka amince da su yayin gaggawar Covid-19, da duk samfuran mRNA na gaba waɗanda amincewarsu ta dogara ne akan tsarin amincewar Covid-19.
-
Debbie Lerman, 2023 Brownstone Fellow, yana da digiri a Turanci daga Harvard. Ita marubuciyar kimiyya ce mai ritaya kuma ƙwararren mai fasaha a Philadelphia, PA.
Duba dukkan posts
