Idan waɗannan abubuwan da suka faru sun faru a lokacin gwamnatin shugaban ƙasa na ƙarshe, za a yi la'akari da yawa daga manyan muryoyin likitanci na ilimi. Maimakon haka, shirun yana damewa. Yi la'akari da tsarin lokaci na masu haɓakawa, babban Matsi na Fadar White House bayan masu haɓakawa, da buɗaɗɗen tambayar aminci:
A farkon Afrilu 2021, an nakalto Albert Bourla, Shugaba na Pfizer yana cewa masu ƙarfafawa za su zama dole a cikin watanni 12.
Nan da nan aka koma baya daga Fauci, da sauran jami'an gwamnati cewa ana buƙatar shaida kafin irin wannan sanarwar.
A cikin Yuli 2021, Bourla ya bayyana cewa kamfaninsa zai nemi izinin FDA don masu haɓakawa a cikin Agusta.
akwai sake samun koma baya daga manyan jami'ai, kuma bayan 'yan kwanaki, an yi ganawar sirri tsakanin shugabannin Pfizer da manyan masana kimiyya na gwamnati.
Jim kadan bayan haka, Fadar White House ta kaddamar da wani kamfen na yada labarai na tura masu kara kuzari. (Dukkanmu mun tuna ranar Lahadi show bonanza). Fadar White House ta yanke shawarar wa'adin zai kasance 20 ga Satumba.
A ranar 1 ga Satumba, 2021, an ba da rahoton cewa Marion Gruber da Philip Krause, jami'ai biyu na dogon lokaci a ofishin kayayyakin rigakafin na FDA, da Darakta da Mataimakin Darakta, zai yi murabus .
Kafofin yada labarai da yawa sun ba da rahoton cewa wannan shawarar, bayan shekaru da yawa tana aiki a FDA, ya kasance saboda gaskiyar cewa gidan farar fata ya ƙaddamar da kamfen na kafofin watsa labaru wanda ke yin alƙawarin ƙarfafa Amurkawa ga kowa a ƙarshen wata.
Wannan shawarar ta tilastawa ma'aikatan FDA waɗanda ba za su iya yin la'akari da aikace-aikacen ba tare da nuna son kai ba, saboda sun fuskanci matsin lamba na siyasa don ba da izini.
Manyan masanan kimiyyar FDA guda biyu sun haɗu da wasu a cikin takardar Lancet suna ba da hujjar dalilin da yasa ba a tallafawa masu haɓaka da ingantaccen kimiyya, wanda Fauci ke da mahimmanci.
Amma duk da haka, dangane da wannan takaddama, an shawarci Fadar White House da ta dawo da shirinsu na masu haɓakawa.
Ana gudanar da kwamitin ba da shawara ga FDA, amma kwamitin bai sa Fadar White House ba. Suna jefa ƙuri'a don ƙaramin shawara na ƙarfafawa a cikin tsofaffi kuma suna zaɓar yawan haɗarin haɗari - ba masu haɓakawa ga duk Amurkawa ba.
FDA na iya ba da izini masu haɓakawa, amma ACIP na CDC yana ba da ƙarin shawarwarin da aka keɓance. Wannan rukunin ya yi jinkirin ba da shawarar ƙarfafawa ga matasa - har ma da waɗanda ke cikin haɗari mai yawa saboda sana'a. (Lura: wannan saboda yayin da kake ƙarami kuma mafi koshin lafiya, ma'aunin fa'ida / cutarwa ya fi rashin tabbas, ƙari a ƙasa)
Duk da haka, darektan CDC, wanda aka nada a Fadar White House, ya soke wannan shawarar!
A cikin Nuwamba 2021, FDA, ba tare da tasirin Gruber da Krause ba, sun ƙaura don amincewa da masu haɓakawa ga duka> 18 ba tare da kwamitin shawara ba.
A ranar 19 ga Nuwamba, CDC ta gudanar da taron shawarwari na ACIP don daidaita shawarwari da:
Paul Offit (wani memba na kwamitin ba da shawara na rigakafi na FDA, amma ba ACIP ba) da kuma, Marion Gruber da Philip Krause (jami'an biyu da suka yi murabus) sun rubuta tsawatarwa a cikin Washington Post, suna masu sukar shawarar.
A cikin Disamba, wannan lokacin ba tare da wani kwamitin shawarwari ba (ba VRBAC ko ACIP ba), FDA ta sake faɗaɗa masu haɓakawa zuwa 16 da 17 masu shekaru tare da ƙarancin bayanai.
Philip Krause (Mataimakin Darakta mai murabus) da Luciana Boro (tsohuwar babban masanin kimiya na FDA) sun rubuta op-ed mai ban tsoro a cikin WaPo.
A halin yanzu, yayin da wannan ke faruwa:
- Shaidu masu tasowa sun nuna cewa myocarditis ya fi kowa fiye da yadda ake tunani a farko.
- Ƙididdiga daga Ontario, Kanada, Isra'ila da sauran wurare suna nuna ƙima kamar 1 cikin 3 zuwa 6k. FDA ta tabbatar da hakan tare da binciken Optum.
- Myocarditis yana shafar maza> mata
- Mafi girman shekarun haɗari shine 12-40 tare da 16-24 mafi girman alƙaluma
- Moderna yana da haɗari mafi girma fiye da Pfizer
- Yawancin ƙasashen Turai sun dakatar da Moderna a cikin matasa
- Bayanai daga Ontario sun nuna cewa mafi girman lokaci tsakanin yana da alaƙa da ƙarancin myocarditis
- Masana harkokin tsaro, irin su Walid Gelad, suna bin wannan batu tare da ƙwararrun masana
Me ake nufi da wannan?
Babu shakka cewa haɗarin fa'idar fa'idar kashi uku mai yuwuwa zai yi kyau ga tsofaffi da waɗanda ke da cututtuka ko waɗanda ke da rigakafi. Hakanan babu tantama cewa haxarin/fa'idar bayanin martaba ba shi da tabbas a cikin matasa.
Mutum mai bakin ciki, lafiyayyen mutum mai shekaru 16 zuwa 40 ba tare da wata matsala ta likita ba yana da abin da zai samu kuma wani abu ya rasa daga shan abin kara kuzari. Amfanin fa'idar ita ce raguwa na ɗan gajeren lokaci a cikin ƙananan cututtuka (wanda aka sani da wasu kwarin gwiwa). Fa'idar da ba ta da tabbas ita ce ko an sami raguwa a cikin matsanancin covid ko asibiti a cikin wannan rukunin shekaru. A lokaci guda, akwai wani abu da za a rasa, kashi na 3 zai iya haifar da myocarditis. Myocarditis, kamar duk AEs, ya faɗi a cikin rarrabawa. Yawancin abubuwan da suka faru za su kasance masu sauƙi, kuma mafi yawan suna iya warware kansu, amma wasu ba za su kasance masu laushi ba, saboda yanayin abubuwan da ba su da kyau, kuma wasu na iya haifar da al'amurra na dogon lokaci.
A cikin kimiyyar tsari, mashaya don fara samfuran samfuran a cikin samari masu lafiya yana da girma sosai. Ba mu inganta yakin neman zabe ba tare da sanin da wasu kwarin gwiwa fa'idodin sun zarce kasada ba. A cikin annoba, yana da ma'ana a sami ma'auni mafi izini, amma ba za mu iya ba da shawarar yin rigakafin ga kowane mutum ba idan akwai lahani ga lafiyar lafiya a cikin wannan rukunin.
Ga yara maza / maza 16-40, babban rashin tabbas ko kashi na uku zai ba da fa'ida, kuma hakan bai dace da kimiyyar tsari ba. Wannan shine dalilin da ya sa manyan masana allurar rigakafi guda biyu a FDA suka yi murabus, kuma dalilin da yasa suke ci gaba da rubuta op ed.
A halin yanzu masana twitter sun shiga yakin farfaganda. Babban hanyoyin da suke yin ƙarya sune kamar haka: ba sa gabatar da bayanan myocarditis ta shekaru da jima'i, amma suna haɗuwa tare da dukan mutane (wannan yana lalata siginar aminci). Sun tabbatar da cewa kwayar cutar koyaushe tana iya haifar da myocarditis fiye da maganin alurar riga kafi (wannan karyar bayanan Burtaniya sun saba wa kashi biyu na Moderna). Ba su da alama sun fahimci cewa raguwa na sama a cikin mummunan cuta na iya raguwa tare da kowane ƙarin kashi (watau ƙasa da ƙarancin myocarditis ya isa ya daidaita fa'idar da za a iya samu.
A ƙarshe, Fadar White House ba hukuma ce mai son kai ba. Fadar White House tana fuskantar raguwar amincewar kima, batutuwan sarkar kayayyaki, da hauhawar farashin kayayyaki. Adadin COVID19 yana cutar da burinsu na siyasa, amma myocarditis baya yi. Ba su da wani matsayi don yanke hukunci wanda ya fi muni kuma inda ma'auni na ma'auni. Ko ta yaya, mun fahimci cewa bai kamata shugaban kasa ya yanke shawarar lokacin da aka amince da allurar ba. Me ya sa yake da wuya a fahimci cewa bai kamata wannan shugaban ya yanke shawara lokacin da aka ba da umarni masu ƙarfafawa ba?
Tsoro magani ne mai ƙarfi, kuma yana ɓata hangen nesa. Idan kun ji tsoro, ba za ku iya gani sosai ba. Amincewa da tsarin rigakafin da ya zama, a matsakaita, cutar da yara maza ko maza na wasu shekaru zai zama babban kuskure. Amincewa da allurar rigakafi za ta kai sabon matsayi, kuma alluran rigakafi a matsayin batun yaƙin al'ada zai ƙaru. Amurka ba za ta tsira ba. Jami'an biyu sun yi daidai da yin murabus. Ba zan so wannan akan agogona ba.
An sake bugawa daga shafin marubucin.
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Vinay Prasad MD MPH masanin ilmin jini-oncologist ne kuma Mataimakin Farfesa a Sashen Cutar cututtuka da Biostatistics a Jami'ar California San Francisco. Yana gudanar da dakin gwaje-gwaje na VKPrasad a UCSF, wanda ke nazarin magungunan ciwon daji, manufofin kiwon lafiya, gwajin asibiti da mafi kyawun yanke shawara. Shi marubucin sama da labaran ilimi 300, da kuma littattafan Ƙarshen Juyawar Likitanci (2015), da Malignant (2020).
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