A cikin wani yanke shawara mai kunya na tarihi, FDA kwanan nan ta zama ita kaɗai mai kula da tsarin ƙasa da ƙasa ba da izinin amfani da rigakafin mRNA daga Moderna da Pfizer na yara masu watanni shida zuwa shekaru biyar.
Ga mafi rinjayen ƙanana da yara ƙanana, da alama babu hujja ko buƙatar wannan game da izini.
Suna cikin ƙarancin haɗari na rikice-rikice masu tsanani daga COVID, ma'ana cewa lissafin fa'idar haɗarin yana da haɗari a mafi kyau, kuma mai yuwuwa mara kyau a mafi muni.
Hakanan shaida ce ga yadda hukumomin Amurka suka yi nasara a siyasance wanda a zahiri babu wata ƙasa da ake mutuntawa a duniya a duk faɗin duniya da ta yanke wannan shawara mai ruɗani.
Sweden, alal misali, yana da ya dakatar da shirin na allurar Moderna ga duk wanda ke ƙarƙashin 30.
Ba 18. Ba 12. Ba 5. 30.
A yanzu Amurka za ta yi wa yara ‘yan kasa da watanni shida allurar rigakafi iri daya da Sweden ta haramta amfani da shi ga duk wanda bai kai shekaru 30 ba, yana mai nuni da illolin da ke karkatar da lambobin fa’ida.
Duk da wannan game da bambance-bambancen ra'ayi, Shugaban Ma'aikatan Fadar White House/Mukaddashin Shugaban kasa Ronald Klain cikin rudani ya yi bikin sanarwar:
Abin sha'awa, The New York Times link Klain tweeted ya kawo wani kuma game da yanayin aiwatar da izini, yana buƙatar bincika takaddun FDA da maganganun da suka gabata.
Na farko ban sha'awa bit na bayanai daga dogon saki FDA shine kimanta tasirinsu na tasirin rigakafin ga ƙungiyoyin tsofaffi.
Lambobin ba su da kyau:
Ƙididdigar da aka lura da tasirin maganin alurar riga kafi akan cututtukan cututtuka saboda bambancin Omicron sun haɗa da: 8.8% (95% CI, 7.0 zuwa 10.5) a 25 ko fiye da makonni tun lokacin rigakafin farko a cikin manya; 59.5% tsakanin matasa 12 zuwa 15 shekaru 2 zuwa 4 makonni bayan kashi 2, 16.6% a cikin watan 2 bayan kashi na biyu, da 9.6% a cikin wata 3 bayan kashi na biyu.
8.8% tasiri a kan alamun bayyanar cututtuka bayan watanni ~ 6 tsakanin manya.
A cikin kawai biyu watannin allurar rigakafi, tasiri a kan cututtukan cututtuka a tsakanin yara masu shekaru 12 zuwa 15 ya ragu zuwa 16.6%, da 9.6% a wata na uku. Ba su fayyace tasiri daga baya ba, mai yiwuwa saboda ya ragu zuwa kashi sifili ko ma ya zama mara kyau.
Bugu da ƙari kuma, ƙididdigarsu na tasirin maganin alurar riga kafi game da asibiti da ziyartar sashen gaggawa sun yi ƙasa da 95-100% na ƙimar da "ƙwararrun masana" suka yi amfani da su don tabbatar da nuna bambanci da kira mai ban tsoro don ware "marasa rigakafi" daga kulawar likita:
Ƙididdiga da aka lura na tasirin rigakafin mRNA na farko game da asibiti saboda bambancin Omicron a cikin manya an ba da rahoton a 41% -57% a watanni 6-9 ko fiye bayan kashi na biyu.
A cikin binciken daya lura tsakanin matasa masu shekaru 12 zuwa 18 (tsakiyar tsaka-tsakin tun lokacin rigakafin, kwanaki 162) a lokacin Omicron-mafi rinjaye, tasirin rigakafin farko shine 40% (95% CI, 9 zuwa 60) akan asibiti don COVID-19
Ƙididdiga da aka lura na tasirin rigakafin mRNA na farko a kan sashen gaggawa / ziyarar kulawa na gaggawa saboda bambancin Omicron a cikin manya an ba da rahoton tsakanin 31% -38% a watanni 6-9 ko fiye bayan kashi na biyu.
Duk abin da ake da'awar ingancin ingancin ya kasance pre-Omicron, waɗannan kashi sun ragu sosai idan aka kwatanta da tsammanin.
Kasa da kashi 41% don ingancin rigakafin rigakafin kamuwa da asibiti ga manya watanni 6-9 ko fiye bayan kashi na biyu.
Sashen gaggawa ko kulawar gaggawa kamar ƙasa da 31%. 40% tare da tazarar amincewa na 9-60% ga matasa masu shekaru 12-18.
Wannan kuma wani dalili ne da ya sa umarni bisa allurar rigakafin gaba ɗaya ba za a iya karewa ba:
Waɗannan lambobin ba su da ƙarfi sosai kuma ba za su gaza ba asali 50% manufa cewa FDA ta saita don ba da izinin gaggawa na rigakafin COVID.
Ka tuna abin da ya shafi ɓangaren da na ambata a baya game da tsari na yara ƙanana?
Ba wai kawai ƙimar tasiri ba ta kai ga 50% kofa a cikin manya ba, ga yara, kawai sun fitar da wannan ma'auni.
Don ba da izinin maganin alurar riga kafi ga ƙananan shekaru, FDA ta ƙididdige ingancin rigakafin ta hanyar "immunobridgeing" da kwatanta tsararrun ƙwayoyin cuta daga ƙungiyoyin tsofaffi:
An yi amfani da tasirin rigakafin ta hanyar rigakafi dangane da kwatancen abubuwan ƙarshen immunogenicity (SARS-CoV-2 neutralizing antibody geometric mean focuss (GMTs) da seroresponse rate 1 month after Dose 3) tsakanin mahalarta 6-23 watanni masu shekaru daga binciken C4591007 (n=146) da mahalarta 16 shekaru 25 da shekaru 4591001 na binciken.
Mahimmanci, kodayake halittar antibody a fili bai isa ya hana kamuwa da cuta ba, ko cimma ainihin kiyasin kashi 95%, FDA ta nuna tasirin rigakafin a tsakanin jarirai da yara kanana bisa kwatancen tsararrun rigakafin.
A wannan lokacin, ya riga ya bayyana dalilin da ya sa Amurka za ta zama ƙasa ɗaya ta Yamma da za ta fara rigakafin mRNA ga yara wannan ƙarami.
Matsin lamba na siyasa daga Mukaddashin Shugaban Kasa Klain, masu fafutuka kamar Ashish Jha, Jeremy Faust, Jerome Adams da sauran su na da hadari babu shakka.
Wannan na iya yuwuwar bayyana dalilin da yasa FDA ta canza manufar daga ingancin 50% zuwa tsararrun antibody - don mika wuya ga matsin lamba na siyasa daga Fadar White House da abokansu a cikin kafofin watsa labarai da al'ummar “gwani”.
A watan da ya gabata, Vinay Prasad yayi cikakken bayani game da rashin fahimtar wannan shawarar:
Har ila yau, ya ambaci cewa 50% manufa da aka ƙaddara da farko shine "masu sabani" kuma maras kyau.
Tasirin allurar rigakafi a kan asibiti a lokacin Omicron ga waɗanda ke da "cikakken alurar riga kafi" shine. m fiye da haka, kuma sun yi la'akari da inganci a tsakanin yara ƙanana dangane da ƙarni na antibody a cikin ƙungiyoyin shekaru iri ɗaya.
A takaice, sun jefar da manufarsu ta sabani, wadda ta riga ta yi ƙasa kaɗan, sannan kuma aka ƙididdige ingancin aiki bisa ga ƙarshen ƙarshen (ƙararrun antibody) waɗanda muka riga muka gani baya aiki sosai a kan bambance-bambancen yanzu.
Don haka tabbas, wannan yana da matukar damuwa da takaici, amma hey, aƙalla Ron Klain yana farin ciki.
Kariya ta Halitta
FDA a cikin hikimar su mara iyaka kuma sun yi watsi da kimanta na CDC, wanda ya bayyana cewa kashi 75% na yara sun riga sun sami COVID:
Tabbas, babu wanda ke da hannu a cikin wannan tsarin yanke shawara da ke shirye ya yarda cewa kashi 75% na yara sun kamu da cutar ta COVID duk da rufe fuska, rufe makarantu da sauran "sama baki" da aka tsara don hana ko "jinkirin" yaduwar cutar. Amma na digress.
Kariya na halitta yana iya zama mafi kariya daga kamuwa da cuta a nan gaba fiye da allurar rigakafi, kamar yadda wannan Tracy Høeg tweet yayi bayani dangane da bayanai daga binciken New England Journal of Medicine:
FDA ta yi tsere don ba da izinin allurar rigakafin ga yara ƙanana dangane da martanin rigakafin mutum maimakon ƙididdige ƙimar inganci yayin yin watsi da cewa kashi 75% na yara ƙanana sun riga sun sami mafi kyawun kariya.
Clinic ne a cikin abin da ba za a yi ba.
Haƙiƙanin Ƙimar Inganci
FDA ta samar da wasu ƙididdiga masu inganci na alluran shekaru biyu na watanni 6-23 da shekaru 2-4 kuma alkaluman da suka isa sun nuna dalilin da ya sa dole ne su yi amfani da martanin rigakafin cutar maimakon ainihin tabbatar da raguwa.
Mahalarta 6-23 watanni
Binciken ingantaccen bayani na farko na shari'o'in COVID-19 da ke faruwa aƙalla kwanaki 7 bayan- Kashi na 3 tsakanin mahalarta 6-23 watanni a cikin kashi 3 ingantaccen ingancin yawan adadin ya haɗa da jimlar 3 da aka tabbatar sun taru a cikin mahalarta tare da kuma ba tare da shaidar kamuwa da cutar SARS-CoV-2 na farko ba har zuwa bayanan yankewar yawan jama'a na Afrilu 29, 2022. Mahalarta 3 bazuwar zuwa BNT376b162 da mahalarta 2 bazuwar zuwa placebo. Ƙididdigar VE a cikin wannan bincike na farko shine 75.6% (95% CI: -369.1%, 99.6%), tare da shari'ar 1 COVID-19 a cikin ƙungiyar BNT162b2 idan aka kwatanta da 2 a cikin rukunin placebo (2: 1 bazuwar BNT162b2 zuwa placebo).
Kara jaddadawa
Akwai shari'ar 1 a cikin rukunin rigakafin da 2 a cikin rukunin placebo. Shi ke nan.
Wannan shine yadda zaku sami tazarar amincewa na -369.1% zuwa 99.6%. Alurar riga kafi na iya samun kusan kashi 400% mara inganci ga jarirai, ko kuma yana iya zama ɗaya daga cikin manyan alluran rigakafin da aka taɓa ƙirƙira tare da kusan cikakkiyar tasiri. Wa ya sani! Tabbas ba FDA ta dogara da jimlar 3 na COVID a cikin wannan rukunin shekarun ba.
Amma kada ku damu, sun tattara bayanai da yawa don ƙungiyar masu shekaru 2-4.
Saitin bayanan yana da jimillar shari'o'i 7:
Mahalarta 2-4 shekaru
Binciken ingantaccen bayanin farko na shari'o'in COVID-19 da ke faruwa aƙalla kwanaki 7 bayan-Kashi na 3 tsakanin mahalarta 2-4 shekaru a cikin ƙimar ƙimar inganci na 3 ya haɗa da jimlar 7 da aka tabbatar da taru a cikin mahalarta tare da ko ba tare da shaidar da ta gabata ba.
SARS-CoV-2 kamuwa da cuta har zuwa data yanke na Afrilu 29, 2022. The Dose 3 evaluable ingancin yawan jama'a tare da kuma ba tare da shaida na kafin SARS CoV-2 kamuwa da cuta hada 589 mahalarta bazuwar zuwa BNT162b2 da 271 mahalarta bazuwar zuwa placebo. Ƙididdigar VE a cikin wannan bincike na farko shine 82.4% (95% CI: -7.6%, 98.3%), tare da 2 COVID-19 lokuta a cikin ƙungiyar BNT162b2 idan aka kwatanta da 5 a cikin rukunin placebo (2: 1 bazuwar BNT162b2 zuwa placebo). Wata shari'ar da aka tabbatar a cikin rukunin placebo ta faru ne a cikin ɗan takara tare da shaidar kamuwa da cutar SARS-CoV-2 kafin kwanaki 7 bayan kashi 3.
Da kyau aƙalla mun yi ƙasa zuwa yiwuwar 8% rashin inganci a cikin tazarar amincewa!
Amma kuma, kar ku damu, FDA tana sane da wannan iyakancewar, da ƙari da yawa ban da:
A cikin nazarin haɗin gwiwar ƙungiyoyin shekaru biyu, VE ya kasance 80.4% (95% CI: 14.1%, 96.7%) tare da lokuta 3 a cikin ƙungiyar BNT162b2 da lokuta 7 a cikin rukunin placebo. Fassarar bayanan ingancin bayan-Dose 3 ga ƙungiyoyin shekaru biyu, kuma ga rukunin shekaru na watanni 6 zuwa shekaru 4 gabaɗaya, an iyakance shi saboda dalilai masu zuwa:
- Ba za a iya ƙididdige ƙimar ingancin allurar bayan kashi na 3 ba saboda ƙarancin adadin lokuta da aka tara yayin bin makanta, kamar yadda aka nuna a cikin ɗimbin tazarar amincewa da ke da alaƙa da kimomi.
- Waɗannan bayanan ingantattun bayanai na farko ne, kamar yadda ka'ida ta kayyade lokuta 21 ba a cimma ba tukuna.
- Akwai tsaka-tsakin tsaka-tsaki mai ma'ana tsakanin allurai 2 da 3, tare da tsaka-tsakin tsaka-tsaki na 112 (kewayon 56 zuwa 245) kwanaki tsakanin mahalarta watanni 6-23 na shekaru da 77 (kewaye 42 zuwa 239) kwanaki tsakanin mahalarta 2-4 shekaru masu shekaru a cikin Kashi na 3 ƙimar ingancin ingancin yawan.
- Matsakaicin makantar makantar lokaci mai zuwa bayan Dose 3 a cikin nazarin shine kwanaki 35 kawai don mahalarta 6-23 watanni da kwanaki 40 don mahalarta 2-4 shekaru.
Yarjejeniyar da aka ayyana lokuta 21 ba a cimma ba. Amma sun ba da izinin allurar ta wata hanya!
Daga cikin rukunin masu shekaru 2-4, akwai adadi mafi girma na lamuran da suka “cika ka'idojin COVID-19 mai tsanani" a cikin rukunin da suka karɓi maganin:
Laifukan bakwai a cikin mahalarta 2-4 shekaru sun cika ka'idojin COVID-19 mai tsanani: 6 a cikin rukunin BNT162b2, wanda shari'o'in 2 suka faru bayan rashin makanta, kuma 1 a cikin rukunin placebo.
Wannan baya nufin cewa wadanda aka yiwa alurar riga kafi sune Kara mai yuwuwa ya sami mummunan shari'ar COVID, amma ya sake jaddada matsalar irin waɗannan ƙananan samfuran samfuran da yin watsi da maƙasudin asali.
Kuma ya kamata a lura da cewa an yanke shawarar cewa ba za su kasance "mahimmancin asibiti ba:"
Dukkanin wanda mai binciken ya yi la'akari da su a matsayin ba su da mahimmanci a asibiti bisa gwaji a ziyarar rashin lafiya da kuma gudummawar yanayi irin su mahalarta kuka yayin jarrabawa.
The Data Tables
FDA ta san cewa yawancin Amurkawa ba za su taɓa kallon teburin bayanai ba, musamman waɗanda ke cikin kafofin watsa labarai da aji na “gwani” na Twitter.
Amma duk wanda ya bincika su nan da nan zai iya fahimtar rashin hankali na tsarin yanke shawara na FDA:
Tazarar amincewa ga kowane ƙididdige inganci guda ɗaya don mahalarta watanni 6-23 sun ragu ƙasa da sifili. Kowane guda.
Ƙididdigar gabaɗaya ita ce 14% kuma ko da hakan na iya zama ƙasa da -21.2%.
Abin dariya kawai. To, zai zama abin dariya idan ba irin wannan shawara mai mahimmanci ba.
Idan kuna son yin sadaka, aƙalla yawan ƙimar inganci ga waɗanda ke da shekaru 2 zuwa <5 ba su da tazarar amincewa mara kyau:
Ko da yake uku daga cikin manyan wuraren ƙarshe huɗu sun sami tazarar amincewa mara kyau, don haka har yanzu yana buƙatar babban adadin sadaka.
Hakanan yana da mahimmanci a lura cewa lokacin lokacin tsakanin gudanarwa na Dose 1 da Dose 2 yana da alaƙa da tasiri mara kyau a cikin ƙungiyoyin shekaru biyu.
Wataƙila wannan ya ba da gudummawa ga batutuwan bayar da rahoton bayanai yayin ƙididdige tasirin rigakafin a cikin ainihin duniya. Duk wani lamari da ya faru a wannan lokacin ana ɗaukarsa “ba a yi masa allurar rigakafi ba,” sai dai a cikin waɗannan rukunin shekaru, wanda shine lokacin da inganci ya kasance mafi ƙanƙanta.
Gaskiyar cewa FDA ta ba da izinin waɗannan alluran rigakafin ga yara dangane da wannan bayanan ba za a iya ba da izini kawai ba.
Girman samfurin ba su cika ƙayyadaddun ƙa'idodi guda 21 ba.
Ƙididdigar ingancin alluran rigakafi, har ma ban da ƙagaggun tazarar amincewa, sun yi nisa ƙasa da maƙasudin 50% na sabani da suka ƙirƙira don izinin amfani da gaggawa a tsakanin manya.
Ciki har da tazarar amincewa yana nuna yuwuwar tasiri mara kyau, wanda ko da yake ba zai yiwu ba, har yanzu yana yiwuwa idan aka ba da ƙarancin adadin lokuta a cikin duka allurar rigakafi da rukunin placebo.
Sun yi amfani da “immunobridgeing” kawai don ba da kariya dangane da tsararrun ƙwayoyin cuta, maimakon ƙayyadaddun ƙimar inganci.
Har yanzu wata alama ce mai ban tsoro game da yadda FDA ta kasance mai himma ta siyasa, da kuma yadda fafutuka ta gurbata gaskiyar hankali.
"Masana" suna da matsananciyar sha'awar ci gaba da martabarsu da kuma guje wa lakabin "anti-vaxxer" ta hanyar masu tasiri kamar Eric Feigl-Ding, Angela Rasmussen da sauransu cewa suna da alama ba su son kiran kuskure a cikin tsarin yanke shawara.
Yana da wuya a lokaci guda kuma mai sauƙi a yarda cewa wannan shine duk abin da aka ɗauka don tabbatar da rigakafin yin amfani da "gaggawa" ga ƙungiyoyi masu shekaru a cikin ƙananan haɗarin rashin lafiya mai tsanani.
Wannan shawarar da ta dace za ta zama wani dalili na ci gaba da tabarbarewar amana ga ƙwararrun masana lafiyar jama'a, abin kunya ga hukumomin Amurka da siyasa ta kama.
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Ian Miller shine marubucin "Ba a rufe ba: Kasawar Duniya na Dokokin COVID Mask." An nuna aikinsa a watsa shirye-shiryen talabijin na kasa, wallafe-wallafen labarai na kasa da na duniya da kuma ambatonsa a cikin mafi kyawun littattafan sayar da kayayyaki da suka shafi cutar. Ya rubuta wasiƙar Substack, kuma mai suna "Ba a rufe ba."
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