An binne a cikin FDA's takardar bayani don taron Kwamitin Ba da Shawarwari na Magunguna da Abubuwan Halittu (VRBPAC) ranar 10 ga Disamba, 2020, don rigakafin Pfizer-BioNTech COVID-19- akwai bayanai masu ban tsoro da batun da ya kamata a magance.
Da farko, yana da kyau a nuna cewa Pfizer ya yi amfani da 'dakin gwaje-gwaje na tsakiya' (duba shafi na 13 na takaddar) zaɓin ta, don tabbatar da shari'o'in COVID-19 ta amfani da gwajin PCR. Idan, a kowane lokaci, ɗan takara ya kamu da rashin lafiya mai tsanani na numfashi, ziyarar rashin lafiya na faruwa. Gwaje-gwaje don ziyarar rashin lafiya sun haɗa da swab na hanci (tsakiyar turbinate), wanda aka gwada a dakin gwaje-gwaje na tsakiya ta amfani da gwajin juzu'i-polymerase chain reaction (RT-PCR).'
A baya na rubuta rahoton bincike mai zurfi a kan Gwajin PCR. Ƙimar sake zagayowar (CT) da aka yi amfani da ita, tana tasiri sosai ga sakamakon gwaji.
A cewar wani karatun Jaafar et al., marubutan sun gano cewa lokacin gudanar da gwaje-gwaje na PCR tare da hawan keke na 35 ko fiye - daidaito ya ragu zuwa 3%, ma'ana har zuwa 97 % na sakamako masu kyau na iya zama alamun ƙarya.
Babu wani bayani da aka bayar kan ƙimar CT da aka yi amfani da ita a wannan 'ɗakunan gwaje-gwaje na tsakiya'.
Idan aka ba da abin da muka sani, babban gwajin asibiti na Pfizer gaskiya ne, wanda ba a rufe shi ba - an bayyana jagororin su a fili a cikin ka'idar binciken nasu kuma ga yuwuwar shari'ar COVID-19, nan da nan ma'aikatan wurin gwajin ba su makanta. Wannan yana nufin, ma'aikatan gwaji sun san ko wani ɗan takara na musamman yana da placebo ko maganin.
Adadin ingancin allurar rigakafin Pfizer da aka fi sani da kashi 95%, ya taso ne daga sakamakon gwajin PCR da aka samar daga wannan dakin bincike na tsakiya. Rashin makantar gwaje-gwajen asibiti yana haifar da tsananin son zuciya da asarar amincin bayanai, don haka yuwuwar CTs ɗin za a iya haɓakawa ga mahalarta marasa alurar riga kafi (placebo) waɗanda ake zargi da samun COVID-19, wanda ke haifar da kusan garantin ingantaccen sakamako na Covid. Ga waɗanda ke da maganin alurar riga kafi, ƙimar CT da aka yi amfani da ita na iya zama ƙasa da ƙasa, yana sa ya fi haifar da mummunan sakamako.
A shafi na 24 na takardar, ana iya samun sakamakon da ke nuna 95% VE (tasirin maganin alurar riga kafi) a ƙasa.
95% VE (tasirin maganin rigakafi) ya taso daga 8 tabbatar da shari'o'in Covid daga rukunin da aka yi wa allurar (daga akalla kwanaki 7 bayan kashi 2) daura da 162 daga rukunin placebo. Wadannan bayanan guda biyu sune ainihin abin da Pfizer ya rataya hular su don tabbatar da nasarar rigakafin su.
Wannan ita ce bayanan da FDA da sauran hukumomin gudanarwa a duniya suka dogara da su don ba da EUA (Izinin Amfani da Gaggawa) don rigakafin Pfizer-BioNTech COVID-19 da kuma biliyoyin allurai da za a jigilar su a duk duniya tare da wasu ƙasashe suna aiwatar da umarnin rigakafin draconian mai cike da cece-kuce.
Wani mahimmin sashe da aka binne a cikin wannan takarda, wanda ke yin ishara da yuwuwar ainihin VE a wancan lokacin, shine bayanan tsinuwa masu zuwa a ƙasa (aka samo a shafi na 42).
Waɗannan mutane ne da ke nuna ainihin alamun. Idan ka ƙididdige VE daga waɗannan lambobi, yana da ƙanƙanta 12%. Ana ƙididdige VE ta hanyar rarraba bambanci tsakanin lambobi a cikin placebo da ƙungiyoyin rigakafi, ta lambar shari'ar a cikin rukunin placebo x 100 = VE na 12%
Wannan babban hawa ne daga 95% VE wanda aka samar ta hanyar gwajin PCR da aka sarrafa cikin sauƙi, wanda Pfizer ya zaɓa. Abin da ya fi ban tsoro, shi ne cewa an san wannan bayanan kusan shekara guda da rabi da suka wuce, ta FDA da kansu.
An sake buga shi daga Mayarwa
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Sonia Iliya tana da kwarewa a fannin Tattalin Arziki. Tsohuwar mai binciken BBC ce kuma yanzu tana aikin jarida mai bincike.
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