Anan akwai babban bita na kwangilar masana'antu tsakanin US DOD da Moderna.
Allurar Moderna, mRNA-1273 mallaki ne tare da Gwamnatin Amurka, saboda kamfanin yana samun tallafi daga tallafin bincike na tsaro na tsawon shekaru kuma ya sami musayar ikon mallakar fasaha daga Gwamnatin Amurka, baya ga aikin bincike na asali da na asibiti da Cibiyar Bincike ta NIH ta gudanar don Moderna. NIH da Moderna kowanne yana da sabon lambar Bincike na daban don wannan samfurin.
Moderna ya shiga nau'ikan kwangiloli guda biyu tare da Gwamnatin Amurka don allurar Spikevax:
- Kwangilar "Alurar rigakafi" da gyare-gyare waɗanda ke ƙayyadaddun ayyukan R&D waɗanda Gwamnatin Amurka ta ba da umarni kuma ta biya su. Lura cewa a cikin yanayin Pfizer babu wani ayyukan R&D da Gwamnatin Amurka ta ba da umarnin ko ta biya su, saboda an cire waɗannan daga iyakokin kwangilar.
- Kwangilar (s) "Masana'antu" wanda ya ba da umarnin masana'anta mai girma. Wannan ya bambanta da kwangilar masana'anta na Pfizer kamar yadda ba a amfani da kalmomin "nunawa" da "samfurin" ba. Na yi imani wannan saboda dole ne kwangilar OTA ya kasance na samfuri amma kwangilar FAR ba dole ba ne.
Bayanan kula akan sakewa. A cikin kwangilar Moderna da Pfizer da yawa an sake gyara wuraren da ke nuna dalilin sakewa - "lambobin sakewa." An ba da abubuwan da aka sake gyara lambobin b (4) da b (6), suna tsaye ga:
(b) (4) Bayyana bayanan da zasu shafi aikace-aikacen fasahar ci gaba a cikin tsarin makaman Amurka,
da kuma
(b) (6) Bayyana bayanai, gami da bayanan gwamnatocin kasashen waje, da za su haifar da mummunar illa ga dangantaka tsakanin Amurka da gwamnatin ketare ko kuma ayyukan diflomasiyya da ke gudana. na Amurka.
Akwai nau'ikan kwangila da yawa akwai, da gyare-gyare. An sanya hannu a sigar farko a ranar 9 ga Agusta, 2020 kuma sigar ƙarshe da ake samu ita ce 15 ga Yuni, 2021. A ɗaya daga cikinsu an canza sunan mai sa hannun a gefen Moderna da (b)(6). A cikin wani sigar ba a gyara shi ba - ya kasance Hamilton Bennett, babban darektan samun damar rigakafin rigakafi da haɗin gwiwa.
Wannan mace mai shekaru 35 da haihuwa da alama ba ta cancanta ba, musamman don "injiniya maganin rigakafi" kamar yadda aka bayyana rawar ta a cikin manema labarai. Tarihin Moderna sananne ne ga manyan abubuwan tashi na ƙwararrun mutane da gogaggun mutane. Dangane da rahotannin manema labarai da asusun masu ciki, al'adun sarrafa guba na Stephan Bancel ya haifar da tashi daga ƙwararrun masana kimiyya da suka haɗa da shugabannin R&D, Oncology, Cardiovascular, Chemistry, Rare Diseases, har ma da alluran rigakafi (daidai lokacin da kamfanin ya fara yin alluran rigakafi a cikin 2016). Rashin iya aiki na ƙarshe sharadi ne na zamba ta ƙarshe.
Ba kamar na Pfizer's da sauran kwangilolin covid ba, kwangilar Moderna baya ƙarƙashin Sauran Ma'amaloli (OTA) amma FAR 43.103 (a) (3) da "Yarjejeniyar Mutual na Ƙungiyoyi." Wannan yana da ɗan bambanci game da abin alhaki na samfur kuma gabaɗaya yana watsi da ƙa'idodin magunguna, kamar yadda aka bayyana a ƙasa.
Adadin farkon kwangilar ya kasance dala biliyan 1.5, kuma an ƙara wannan zuwa daidai dala 8,145,591,662.60 daga baya. gyara. Sittin cents - masu laifi suna samun maki don salo da hankali ga daki-daki! Lura cewa wannan ƙari ne ga kwangilar R&D dala biliyan 1 don ɗimbin karatun da ba su da mahimmanci waɗanda na tattauna a cikin Sashe na 1.
Iyakar kwangilar shine "ƙirƙirar har zuwa 500M allurai"
Ma'aikatar Tsaro da Lafiya da Ayyukan Dan Adam (HHS) na buƙatar samar da manyan allurai na alluran rigakafi don tallafawa martanin gaggawa na ƙasa ga Cutar Coronavirus 2019 (COVID-19) ga Gwamnatin Amurka (USG) da jama'ar Amurka.
Lura wannan don “ƙira” ne ba nuni ko samfuri ba.
Manufofin
Wannan yana da ban sha'awa. Wannan sakin layi ya haɗa da kalmomin sauti masu daɗi waɗanda ke rufe ainihin niyya: don ayyana yaƙin sinadarai-sunadarai da makaman nukiliya mara iyaka akan Amurkawa, juyar da kariyar mabukaci a ƙarƙashin “amsar annoba.” Ka lura da kalmomin “dukkan ƙoƙarin al’umma:”
Harshen “Dukkanin al’umma” na iya nufin haɗa al’umma a lokacin yaƙi. A cikin wannan amfani, don bayyananniya yaƙi ne tare da ayyana maƙiyi na waje. Duk da haka, a cikin sabon zamanin yaƙi na ƙarni na 5 mara iyaka, ana amfani da wannan harshe don nuna alamar mamaye ƙasar gaba ɗaya ta hanyar dakaru na soja, yawanci ta hanyar nuna wani rikicin da aka ƙirƙira, kuma yawanci daga ciki.
Na sami nassoshi da yawa game da wannan ƙamus a cikin manema labarai da suka koma shekaru da yawa, a cikin Amurka da suka shafi abubuwan soja kamar yakin cyber, amma kuma a cikin Sinanci, Singaporean, da Australian danna. Wani bayani mai ban sha'awa kuma cikakke na "Dukkanin Nation Chimera" a cikin tushen Philippine tare da bayyana irin wannan tsarin da gwamnatin sojan ta yi amfani da ita wajen kwace dukkan sassan gwamnati, da kuma daukacin kungiyoyin fararen hula. A wasu kalmomi, yana kwatanta shigar da tsarin fasisti / kamala. Ina ba da shawarar masu karatu sosai da su ziyarci hanyar haɗi zuwa labarin Philippine da aka buga a cikin Maris 2019 a sama, saboda abin mamaki, yaren da ake amfani da shi yana da kama da kalaman gwamnatin Amurka da ke da alaƙa da “amsar cutar ta covid” da Operation Warp Speed. Shin marubutan gwamnatin Amurka sun yi wa Duerte zage-zage ne ko kuwa globo-mafia da aka kama sun yi ishara ga juna da manyansu ta haka?
"Dukkan al'umma" yana da alaƙa da "duk gwamnatiDukansu an gabatar da su a matsayin ra'ayoyi masu kyau a cikin rubutu a sarari, amma a zahiri waɗannan kalmomi suna nuna alamar cin zarafi ta hannun reshen zartarwa na gwamnati.
PL 115-92 yana nufin Dokar Jama'a kuma an tattauna a kasa. Hanya ce ta juyar da ka'idojin FDA ta hanyar sanya shi don hidimar manufofin DOD ta hanyar Yarjejeniyar Interagency da aka ambata. Yanzu dole ne su bi umarnin DOD da karya-yarda da wanda ba a yarda da shi ba akan umarni da kan jadawalin.
A ƙarshe, a bayyane yake cewa gwaje-gwajen asibiti ba su da alaƙa da amincewar alluran da FDA ta yi, saboda manyan masana'antar waɗannan abubuwan ba su dogara da su ba. Ana yin shi a layi daya da waɗannan atisayen bogi waɗanda aka yi niyya don yaudarar jama'a.
Yarda da ka'idodin magunguna da Kyawawan Ayyukan Masana'antu (cGMP)
Kwangilar ta ambaci dokokin cGMP. Duk da haka yana cikin wani sashe "Takardu masu aiki" - yana nufin wannan a matsayin takarda, ba doka ba.
Kuma ƙari, a cikin Kwaskwarimar 1 kwangilar ta ce: "CGMP masana'anta na allurai miliyan 100, dangane da kowane keɓantawa da aka kafa ta ko ikon tilastawa na FDA." Saboda haka, idan FDA ta yanke shawarar cewa babu cGMP ya zama dole, to ba lallai ba ne.
Bambance-bambancen samfur da abubuwan da ba a bayyana ba
PO ya ƙunshi abubuwa da yawa ban da allurar mRNA-1273 (Spikevax), kuma dukkansu an gyara su gaba ɗaya tare da (b)(4) - watau "Bayyana bayanan da za su lalata aikace-aikacen fasahar zamani a cikin tsarin makamin Amurka."
A daya daga cikin gyare-gyaren, an kara da cewa: H.19 Bambance-bambancen samfur (Hukumar FAR 43.103(a)(3), Yarjejeniyar Mutual na Jam'iyyun), kuma an sake gyara gaba daya tare da sake fasalin "makamai", gami da kalmar "Bambance-bambance." Wannan na iya nufin bambancin guba na batches daban-daban, amma wannan hasashe ne kawai a ɓangarena:
Dokar Jama'a PL 115-92
Ƙarƙashin "Ƙa'ida" kawai abin da aka ayyana shi ne Moderna shine mai ɗaukar nauyin samfurin, IND da BLA. Sa'an nan kuma ya ce DOD za ta yi amfani da wannan doka don samfurin: "DoD Medical Product Priority. PL 115-92 yana ba da damar DoD don buƙatar, da kuma FDA don samar da, taimako don haɓaka haɓaka samfurori don ganowa, bi da, ko hana cututtuka masu haɗari ko haɗari ko kuma yanayin da ke fuskantar ma'aikatan sojan Amurka. Mai kwangila ya gane cewa DoD kawai zai iya amfani da PL115 92. "
A bayyane yake, sojojin Amurka sun yi kira ga dokar mashaya 115-92 (wataƙila ma'auni don hanzarta matakan magance hare-haren soji, amma wanda a aikace shine DoD ke jagorantar masu kula da magunguna [FDA]) a cikin kwangilar biliyan biliyan w/Pfizer don samar da biowepon.
Anan ga rubutun da ya dace na doka, wanda kai tsaye ya juyar da FDA kuma yana aiki a sabis na ƙare DOD. Yana da matukar matsala a faɗi aƙalla, musamman idan aka yi amfani da shi (kamar yadda lamarin ya kasance w/covid) fiye da yadda doka ta tanada (watau kare jami'an soji daga hare-hare), amma a maimakon haka ana amfani da su don tura asirce, fasahar amfani da dual, ba tare da ingantacciyar gwajin mabukaci da kariya kan fararen hular da ba su ji ba. Mai karatu ne ya samar da hoton dokar:
Maganar Dokar PREP
Wannan sashe yana ayyana ɗan kwangilar ba tare da wani abin alhaki ba sannan ya bayyana abubuwa da fasaha a matsayin aikace-aikacen farar hula da na soja, watau makamai:
Mahimman fifikon tsaro
Tsaro An ƙara ƙimar fifiko ta hanyar gyara a ranar 11 ga Satumba, 2020. Ƙara fifikon Abubuwan Kiwon Lafiya da Tsarin Rabawa (HRPAS) fifiko na DO-HR ga wannan kwangilar. Ƙara fifikon fifiko na Tsaro da Tsarin Raba (DPAS) na DO-C9 zuwa wannan kwangilar don yin daidai da ƙimar fifikon HRPAS na DO-HR. Ƙara FAR 52.211-15, fifikon Tsaro da Buƙatun Rarraba Wannan oda ce da aka ƙware don tsaro na ƙasa, shirye-shiryen gaggawa, da amfani da shirin makamashi, kuma ɗan kwangilar zai bi duk buƙatun Filayen Tsaro da Tsarin Tsarin Rabawa (15 CFR 700).
Bayanin oda mai ƙima a cikin abin da aka makala wanda Janar Perna COO na OWS ya sanya wa hannu:
An sake bugawa daga marubucin Mayarwa
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Sasha Latypova tsohuwar jami'ar R&D ce ta magunguna. Ta yi aiki a cikin masana'antar har tsawon shekaru 25, kuma a ƙarshe ta mallaki da sarrafa ƙungiyoyin bincike na kwangila da yawa waɗanda ke aiki akan gwaji na asibiti don kamfanonin 60 + kantin magani, gami da Pfizer, AstraZeneca, J & J, GSK, Novartis da sauran su. Ta yi aiki shekaru da yawa a cikin kimanta lafiyar zuciya da jijiyoyin jini kuma ta yi hulɗa tare da FDA da sauran hukumomin gudanarwa kan waɗannan al'amura a madadin abokan cinikinta kuma a matsayin wani ɓangare na Ƙungiyar Binciken Kare Lafiyar Zuciya ta FDA.
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