“Na damu da cewa, idan muka ce eh, jihohi za su ba da umarnin gudanar da wannan rigakafin ga yara don zuwa makaranta, kuma ban yarda da hakan ba.”—H. Cody Meissner, Farfesa na Likitan Yara, Makarantar Magunguna ta Jami'ar Tufts, kuma memba na Kwamitin Ba da Shawarwari na Magunguna da Abubuwan Halittu na Hukumar Abinci da Magunguna ta Amurka, gabanin jefa ƙuri'a a ranar 26 ga Oktoba ko a ba da shawarar tsawaita Izinin Amfani da Gaggawa na rigakafin Covid-19 na Pfizer Inc. ga yara.1
Sukace eh.
FDA ta fuskanci Ad-Com tare da tambayar e-ko-a, sama-ko-ƙasa. "A'a" da zai hana allurar ga duk yara masu shekaru 5 zuwa 11, gami da yara masu haɗari na musamman, kamar waɗanda ba su da ƙarfi, masu kiba, masu fama da cututtukan huhu, ko dogaro da ciyarwar bututu. Don haka "e" wanda ya kusan gama ɗaya.2
FDA ta tsawaita EUA washegari.
Idan ana son sanarwa ta yarda cewa buƙatar wannan rigakafin ta bambanta a cikin yawan yaran yara, to dole ne ta fito daga Cibiyar Kula da Cututtuka da Cututtuka. Amma mako mai zuwa anan shine Rochelle Walensky, Daraktar CDC: "Yanzu muna fadada shawarwarin rigakafin ga yara sama da miliyan 28 a Amurka."3
Babu nuance da yawa a can. Miliyan ashirin da takwas za su kasance… kowa da kowa-duk yara 5-11.
Shin umarni na gaba?
Peter Marks, wanda ke shugabantar sashin FDA da ke sa ido kan sake duban rigakafin, ya ba wa Ad-Com wannan tabbacin: "Akwai wasu gwamnonin da suka riga sun ba da sanarwar ba za su yi wani umarni ba har sai an sami izini sabanin izinin Amfani da Gaggawa."
Akwai kyakkyawan dalili da zai sa Dr. Marks ya tsallake siyasar rigakafin. A cikin tashin hankalin da gwamnatin Biden ta yi, FDA ta karɓi maganganun 143,499 daga jama'a da ke rarrabuwar kawuna kan wannan rigakafin sabon salo ga kimiyyar likita. Amma duk da haka batun ba umarni ba ne gabanin amincewar rigakafi ta hukuma ta FDA. Abin da gwamnonin za su yi ke nan bayan haka. Gavin Newsom a California ya riga ya ba da sanarwar cewa kowane ɗan makaranta a jihar dole ne ya sami jab.4 Kathy Hochul a New York ta ce za ta "za ta kiyaye dukkan zabuka a kan tebur tabbas."5
Har yanzu yana da kyau a tambaya, Menene gaggawar? Menene gaggawa, aƙalla, ga yara masu lafiya? Yawan kamuwa da cutar Covid mai tsanani a cikin yara ba wani abu bane kamar na manya. Adadin mace-mace a cikin yara masu lafiya ya yi ƙasa sosai don yana da wahalar aunawa.6
Yi la'akari da yadda Pfizer ya tsara wannan sabuwar gwaji idan kamfanin zai cika ƙaƙƙarfan ƙayyadaddun ƙayyadaddun abin da Covid tsoro da rawar jiki suka ƙarfafa. Gwajin ya shigar da yara 4,647.7 Idan aka yi la'akari da yawan adadin wannan girman, idan aka yi la'akari da buƙatun saurin gudu, babu wata dama ta nuna raguwar cututtuka masu tsanani, musamman ma yawancin yara suna da lafiya. Da ma rashin daidaiton ya bambanta da a ce gwajin ya mayar da hankali kan yara da ke cikin haɗari mai yawa, amma hakan bai faru ba.
Yara nawa, to, a cikin ko dai allurar ko rukunin placebo, suka mutu daga Covid? Sifili. Nawa ne suka sauko da rashin lafiya mai tsanani? Sifili. A cikin binciken farko na Pfizer na manyan yara, masu shekaru 12 zuwa 15, nawa ne suka mutu ko suka kamu da rashin lafiya? Sifili da sifili.8
Don haka mayar da hankali kan ƙwayoyin rigakafin da allurar ta haifar. Wannan shine farkon ƙarshen ƙarshen (gwajin farko na inganci) don ƙungiyar 5-11. Fahimtar cewa FDA ta bayyana a cikin taƙaitaccen bayaninta ga Ad-Com cewa "… babu takamaiman maganin antibody titer," titer wanda ke nuna matakin rigakafin, "an kafa shi don hasashen kariya daga Covid-19…" Akwai wata hanya ta gaba, kodayake: rigakafi.
Bi tare: Idan samar da maganin rigakafi a cikin rukuni na 5-11, wace rukuni za a iya kiransa A, daidai da cewa a cikin rukuni masu shekaru 16 zuwa 25, ko B, to an yi la'akari da cewa amfanin maganin ga A zai kasance kamar wanda aka riga aka nuna a B.
Na gaba: Amfanin da za a iya tantancewa ba dole ba ne a nuna shi a cikin B musamman, amma a cikin babban rukuni wanda B ya kasance bangare, wannan rukuni na ƙarshe, C, kasancewar yawancin yawan jama'a wanda Pfizer ya gudanar da gwajin ingancinsa na farko a shekarar da ta gabata kuma a cikinsa an nuna fa'idar, wato, raguwa mai yawa a cikin cututtuka masu sauƙi zuwa matsakaici.9
Samu haka? C zuwa B zuwa A: Nuni biyu. Kada mu yi rawar jiki. Ya haɗu da ƙarshen ƙarshen.
Ƙarin bayanai dangane da ƙarshen ƙarshen “bayani” na biyu ya nuna fa'ida koda kuwa lambobi kamar yadda aka yanke bayanan taron Ad-Com ba su yi girma sosai ba don isa ga mahimmancin ƙididdiga. A cikin rukunin placebo, yara 16, ko kusan 2.1%, sun sami alamun rashin ƙarfi zuwa matsakaici; a cikin rukunin rigakafin, yara 3, ko kusan 0.2% - raguwar dangi kusan 91%. Duk yaran da ke fama da zazzabi da aka ruwaito kamar yadda alamun Covid suna cikin rukunin placebo, kodayake zazzabi ya fi zama ruwan dare a matsayin illa a rukunin rigakafin. Bugu da kari, kada mu yi rawar jiki.
Don batun yana da ƙarancin fa'ida da tasirin sakamako na ɗan gajeren lokaci fiye da haɗarin dogon lokaci. Kumburi na zuciya (myocarditis da pericarditis) yanzu ta hanyar yarjejeniya da aka dauka na gaske idan ba kasafai ba - kuma mai rikitarwa ta fahimtar cewa zai iya haifar da kamuwa da cuta. Wannan gwaji ya yi ƙanƙanta don kimanta haɗarin ko ta yaya. Don haka FDA ta ƙididdige ƙididdiga na al'amura shida: an kare mutuwar, dangane da yanayin, daga babu zuwa uku sama da watanni shida ga kowane yara miliyan da aka yi wa alurar riga kafi; kwantar da asibiti ya ragu a cikin al'amuran guda biyar kuma sama daya.
Samfuran suna, kamar yadda FDA ta ce, "masu hankali" ga abubuwan da aka shigar. Babban shigarwa ɗaya wanda ya rasa: rigakafi na halitta wanda kamuwa da cuta ke bayarwa.10 A cewar kididdigar CDC, kashi 42 cikin 5 na yara 11 zuwa 2021 sun kamu da cutar tun farkon lokacin rani na XNUMX. Wani shigarwar da zai iya wargaza duk wani tsari na yanzu zai zama ƙarin zaɓuɓɓukan warkewa, gami da magani wanda Pfizer zai nemi EUA nan ba da jimawa ba. A kowane hali, abin ƙira ba zai ƙidaya a cikin tunanin jama'a ba idan har wani cikakken alurar riga kafi da haɓaka ɗan wasan NBA ya faɗi a kotu cikin damuwa na zuciya.
Pfizer ya kira rigakafinta "harbin rayuwa."11 Harbe, a cikin jam'i, zai zama kamar ba daidai ba. Idan kariyar ko da harbi biyu ya kai gajeriyar rayuwa a cikin yara kamar na manya, harbi daya zai biyo baya har tsawon shekaru. Harbi nawa ne yaro mai shekaru biyar zai samu a karshen samartaka, don kada a ce komai a tsawon rayuwarsa? Hasashen sake yin allurai yana ƙara damuwa akan yuwuwar idan har yanzu illolin rashin lafiya ba'a iyakance ga kumburin zuciya ba.12
Lokaci yana iya faɗi ko yaran vaxxing suna yin wani abu don rage yaɗuwar kamuwa da cuta kuma ta haka cuta (ko samun rigakafi), amma ya riga ya bayyana cewa manya da aka yi wa alurar riga kafi na iya kamuwa da cuta, ɗaukar nauyin ƙwayoyin cuta masu yawa, da watsa kamuwa da cuta.13 Alurar riga kafi a matsayin rigar nagarta tana sanye da bakin ciki. Lallai babu nagarta wajen sanya yara kanana cikin kasadar kare manyansu. Ko mene ne hatsarin, ko mene ne fa’ida, wa zai yi kira kan allurar banda iyaye?
Michael Nelson, wanda ke jagorantar Sashen Asthma, Allergy, da Clinical Immunology a Jami'ar Virginia, ya bayyana cewa da kansa an shafe shi da imel kafin taron Ad-Com. Kuri'arsa ta "yes" ba ita kaɗai ce ta ba da sanarwa ba: "Ina ganin wannan a matsayin dama da kuma zaɓi na sirri da kuma tambayar gaskiya," in ji shi, "kuma ba umarni ga kowa a cikin wannan rukunin shekaru ba."
A yanzu, iyaye suna da zabi. Wataƙila dole ne su yi yaƙi don kiyaye shi.
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1Duk nassoshi game da bayanan da aka gabatar a taron Ad-Com ko maganganun da aka yi a wurin ana iya samun su a cikin takardu ko bidiyon da FDA ta buga a gidan yanar gizon ta: https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-october-26ment-2021
2An kada kuri’ar ne da ci 17-0, daya kuma ya ki amincewa.
3Sanarwar kamar yadda aka yi a CBS Miami, Nuwamba 4, 2021. Kwamitin ba da shawara na CDC, Kwamitin Ba da Shawarwari kan Ayyukan rigakafi, kawai ya zaɓi 14-0 don goyon bayan rigakafin.
4Sanarwar manema labarai, Ofishin Gwamna Gavin Newsom, Oktoba 1, 2021
5WYNT, Channel 13, New York, Oktoba 24, 2021
6Bayanan mace-mace da asibiti na yawan mutanen 5-11, kafin yin lissafin duk wani ragi a cikin rahoto, kamar yadda CDC ta gabatar a taron Ad-Com: Mutuwar Covid, 94 (Janairu 1, 2020 zuwa Oktoba 16, 2021); Asibitin Covid, ma'ana duk wanda aka shigar da shi asibiti cikin makonni biyu na tabbataccen gwajin Covid wanda ƙwararrun kiwon lafiya ya ba da umarnin, 30 cikin 100,000, 68% daga cikinsu suna da alaƙa da yanayin rashin lafiya (Maris 1, 2020-Oktoba 2, 2021). Ɗaya daga cikin binciken ya gano yanayi guda uku waɗanda ke da alaƙa da mummunar cuta a cikin yara a asibiti don zama kiba, cututtukan rayuwa na yau da kullun, da dogaro da bututun ciyarwa (Maris 2020 zuwa Agusta 2021). Yawan jama'a 5-11 kusan miliyan 28 ne.
7Shari'ar ta ƙunshi ƙungiyoyi biyu. A cikin farko, an shigar da batutuwa na 2,268 don nazarin inganci da aminci, kuma kiyaye lafiyar 95% na batutuwa ya kasance akalla watanni biyu; a cikin na biyu, nazarin aminci, 2,379 batutuwa sun shiga, kuma matsakaicin matsakaici shine makonni 2.4.
8Gwajin a cikin rukunin 12-15, wanda ya yi rajistar batutuwa 2,260, ya kuma haifar da EUA. Shi ma, ya dogara da farko kan rigakafi, kodayake FDA ta ce gwajin ya ba da "shaida mai karfi kai tsaye na fa'idar asibiti ban da bayanan rigakafi." A cikin rukunin placebo, batutuwa 16 sun sami alamun Covid masu sauƙi zuwa matsakaici; a cikin rukunin rigakafin, babu.
9Na farko da mafi girma na gwajin inganci sun yi rajista kusan batutuwa 44,000 masu shekaru 16 zuwa sama, kusan dukkansu manya, kusan ɗaya cikin biyar masu shekaru 65 da haihuwa. Rage bayyanar cututtuka masu sauƙi-zuwa-matsakaici ya kasance mai mahimmanci a ƙididdiga (abin da ya faru: 0.88% a cikin rukunin placebo da 0.044% a cikin rukunin alurar rigakafi; rage haɗarin dangi, 95%). Yawan lokuta masu tsanani ba su da yawa, amma FDA ta ce rarrabuwa a cikin lokuta tsakanin placebo da kungiyoyin rigakafi "yana ba da shawarar kariya" daga cututtuka masu tsanani. Babu wanda ya mutu daga Covid a cikin kowane rukuni. An yi amfani da shi a cikin wannan rukunin, 16 zuwa sama, cewa maganin yana da amincewar samfur na yau da kullun fiye da EUA, kuma amincewar ita ce ta haifar da umarni na gwamnati da na kamfanoni.
10Yadda za a ƙayyade adadin kamuwa da cuta na iya zama da jayayya. Wasu makonnin da suka gabata, rahotannin bayanai na yau da kullun da Hukumar Tsaron Lafiya ta Burtaniya ta fitar sun nuna cewa, yayin da kariya daga alluran rigakafi ke raguwa, adadin kamuwa da cuta (lala'i a cikin 100,000) ya girma a cikin masu cikakken rigakafin fiye da waɗanda ba a yi musu allurar ba ga duk ƙungiyoyin shekaru 30 ko sama da haka. Hukumar Kididdiga ta Ofishin ta nuna rashin amincewarta, tana mai cewa Hukumar ta dogara da alkaluman da bai dace ba kuma ta kasa yin la’akari da bambancin dabi’un kungiyoyin. Tun daga wannan lokacin Hukumar ta sanya tsawaita tsawaita bayanan zuwa bayanan kuma, musamman ga rigakafin Pfizer, ta haɓaka kwarin gwiwa kan kariyar kashi 75-85% daga kamuwa da cuta daga “ƙananan” zuwa “matsakaici.” Hukumar da Ofishin sun yarda cewa asibiti da mace-mace sun fi yawa a cikin wadanda ba a yi musu allurar ba. ("Rahoton sa ido kan rigakafin COVID-19," makonni 40 zuwa 44, Hukumar Tsaron Lafiya ta Burtaniya; Daily Mail, Nuwamba 2, 2021.)
11Dubi pfizer.com. "SABODA RAYUWA-YADDA Pfizer da BioNTech suka haɓaka da kera rigakafin COVID-19 a Lokacin Rikodi." Pfizer ya yi hasashen isar da allurai biliyan 2.3 a duk duniya a cikin 2021 da tallace-tallace na dala biliyan 36.
12 "Mu muna cikin ƙungiyar likitocin, masana kimiyya, da masu ba da shawara masu haƙuri waɗanda suka shigar da ƙarar 'Citizen Petition' tare da Hukumar Abinci da Magunguna ta Amurka (FDA), suna neman hukumar da ta jinkirta duk wani la'akari da 'cikakken yarda' na rigakafin COVID-19. Sakon kokenmu shine 'jinkiri kuma ku sami ilimin kimiyya daidai-babu wani ingantaccen dalili na gaggawa don ba da lasisi ga rigakafin coronavirus.' Mun yi imanin tushen shaidar da ke akwai-duka kafin- da kuma bayan izini-bai cika isa ba a wannan lokacin don yin cikakken hukunci ko fa'idodin asibiti sun fi haɗarin haɗari a cikin dukkan al'umma. " Baya ga dogon nazari na asibiti, masu shigar da kara sun nemi "cikakkar nazarin rarrabawar halittu… don fahimtar abubuwan da ke tattare da fassarar mRNA a cikin kyallen takarda mai nisa." (Dalilin da ya sa muka roki FDA da ta guji amincewa da duk wani maganin rigakafin cutar covid-19 a wannan shekara, British Medical Journal, Yuni 8, 2021.)
13"Alurar riga kafi ya rage haɗarin kamuwa da cutar bambance-bambancen delta kuma yana hanzarta kawar da kamuwa da cuta. Duk da haka, mutanen da ke da cikakkiyar rigakafin kamuwa da cuta suna da nauyin ƙwayar cuta mai kama da waɗanda ba a yi musu allurar rigakafi ba kuma suna iya watsa kamuwa da cuta yadda ya kamata a cikin gidajen gida, gami da cikakken allurar rigakafin." (Watsawa cikin al'umma da motsin motsin hoto na hoto na SARS-CoV-2 delta [B.1.617.2] bambance-bambancen mutane da marasa alurar riga kafi a cikin Burtaniya: mai yiwuwa, dogon lokaci, nazarin ƙungiyar, Cututtuka na Lancet cututtuka, Oktoba 29, 2021.)
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Richard Koenig shi ne marubucin Kindle Single “Babu wurin da za a je,” labarin kokarin samar da bandakuna a yayin barkewar cutar kwalara a Ghana.
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