Pfizer da Moderna suna da matsala. Harbin su na mRNA Covid-19 ba ya dakatar da kamuwa da cuta, watsawa, asibiti, ko mutuwa daga kwayar cutar SARS-CoV-2. Sama da rabin biliyan allurai an yi allurar a cikin Amurkawa a cikin watanni 17 da suka gabata kuma waɗannan harbe-harbe ba su yi wani tasiri na musamman kan yanayin cutar ba. Fiye da Amurkawa sun mutu sakamakon cutar coronavirus tun lokacin da aka gabatar da harbe-harbe fiye da yadda aka gabatar da su.
Pfizer da Moderna suna yin game $ 50 biliyan shekara guda a kan waɗannan harbe-harbe kuma suna son hakan ya ci gaba. Don haka suna buƙatar sake fasalin. Watakila niyya wani sabon bambance-bambancen, watakila canza wasu kayan aikin - wanda ya sani, waɗannan hotunan sun yi takaici don haka ba a bayyana abin da zai ɗauka don samun aiki ba.
Wannan matsala ce saboda sake fasalin harbe-harbe yana nufin sabbin gwaje-gwaje na asibiti da sabon bita na tsari ta FDA. Akwai kyakkyawan zarafi cewa duk wani harbin da aka sake fasalin zai iya kasa sabon gwajin asibiti, kuma jama'a na da matukar shakku game da wadannan harbe-harbe, don haka binciken zai yi tsanani.
Don haka Pfizer da Moderna sun gano hanyar da za su yi amfani da kame ka'ida don samun amincewa da sake fasalin nasu na Covid-19 BA TARE da ƙarin gwaji na asibiti ba. Ana kiran tsarin nasu "Tsarin Gaba" kuma Kwamitin Ba da Shawarar Magungunan Magunguna da Magungunan Halittu na FDA (VRBPAC) zai zaɓe shi. Yuni 28.
Kwayoyin cuta sun bambanta da yanki. A kowane lokaci, nau'in mura da ke yawo a Ingila ya bambanta da yadda yake a Thailand, Amurka, ko Afirka ta Kudu. Koyaya, kamfanonin harhada magunguna sun gwammace su ƙirƙiri nau'i-nau'i-nau'i-nau'i-nau'i-nau'i don rage farashin masana'antu da kuma haɓaka riba. Don haka WHO da hukumomin kiwon lafiyar jama'a a duniya (ciki har da FDA da CDC) sun ƙirƙiri "cibiyar sa ido kan mura" da ke gano nau'o'in mura daban-daban a wurare dabam dabam.
Daga nan sai suka gudanar da wani gagarumin wasan kwaikwayo mai suna "Tsarin zabar nau'in cutar mura" inda suka zabo nau'in cutar mura guda hudu da za su shiga cikin maganin mura a wannan shekarar (akwai maganin mura guda daya ga dukkan kasashen da ke Arewacin Hemisphere da mura daya ga dukkan kasashen Kudancin Hemisphere, shi ke nan).
Wannan tsari na choreographed a hankali yana haifar da gazawa sau da yawa fiye da a'a. Wannan ba abin mamaki ba ne - ta yin amfani da hanyar allurar rigakafi guda ɗaya don hana ƙwayar cuta mai saurin tasowa wacce ta bambanta ta yanki da wuya ta yi aiki. Lisa Grohskopf daga Sashen mura na CDC rahotanni cewa a bara harbin mura ya kasance a wani wuri tsakanin 8% zuwa 14% mai tasiri (bisa bayanai daga shafuka bakwai da ke shiga cikin Cibiyar Taimakon Cutar Murar Amurka).
Amma a idan akwai nazarin na barkewar cutar mura a Jami'ar Michigan tsakanin Oktoba da Nuwamba 2021 ya gano cewa tasirin maganin mura bai kai komai ba.
- VE na farko: 0% CI: -25% zuwa 20%)
A cikin shekaru talatin da suka gabata, gwamnatin tarayya ta biya ƙarin diyya ga abubuwan da ba su dace ba dangane da allurar mura fiye da kowane alluran rigakafi - don haka mun san cewa harbin yana zuwa da babban adadin lahani da ake tsammani. Ganin cewa allurar mura ba ta dakatar da ɗimbin yawancin cututtukan mura ba, ƙila illolin sun fi kowane fa'ida.
A cikin duniyar mai hankali, WHO, FDA, da CDC za su yarda cewa sun yi kuskuren dabaru a cikin martanin da suka yi ga SARS-CoV-2 sannan su canza hanya don ganowa. mafi kyawun hanyoyi don tallafawa tsarin rigakafi na ɗan adam. Amma ba ma rayuwa a cikin duniya mai hankali. Madadin haka, FDA tana ba da shawarar ɗaukar tsarin zaɓin nau'in cutar mura da kuma amfani da shi zuwa harbin Covid-19 na gaba.
Akwai quadrillion x quadrillion ƙwayoyin cuta a cikin duniya (a zahiri sun fi ƙwayoyin cuta a duniya fiye da taurari a cikin duniyar da aka sani). Dari biyu ne kawai daga cikin waɗannan da alama suna da yuwuwar yin tasiri ga lafiyar ɗan adam. Amma wasu ƙwayoyin cuta suna yin mafi kyawun 'yan takara don rigakafin fiye da sauran. Kwayoyin cuta waɗanda suka daɗe da yawa, waɗanda suke da kwanciyar hankali kuma suna haɓaka sannu a hankali su ne mafi kyawun masu neman rigakafin.
Kwayoyin cuta da ke tasowa cikin sauri miyagun yan takara ne don maganin alurar riga kafi. Babu maganin alurar riga kafi don mura ko HIV saboda waɗannan ƙwayoyin cuta suna tasowa da sauri don maganin ya yi tasiri. Kwayar cutar ta SARS-CoV-2 mummunan ɗan takara ne don maganin alurar riga kafi, kamar yadda ta canza cikin sauri, wanda shine dalilin da ya sa duk ƙoƙarin da aka yi a baya na samar da rigakafin cutar sankara ya ci tura (ba su taɓa yin sa daga gwajin dabbobi ba saboda dabbobin sun mutu yayin gwajin ƙalubale ko kuma allurar sun ji rauni).
Wadanne abubuwa mara kyau ne da zasu iya faruwa lokacin da kuke yin allurar rigakafin cutar da ke tasowa cikin sauri? Zunubi na asali na antigenic, haɓaka dogaro na rigakafi, da yuwuwar haɓaka juyin halittar ƙwayar cuta ta hanyoyin da ke sanya ta. mai cutarwa (har ma sun fi juriya ga allurar rigakafi) wasu sanannun illolin da ba su da kyau.
Trevor Bedford yana da nasa dakin gwaje-gwaje a Cibiyar Cancer ta Fred Hutchinson inda ya bincika juyin halittar Covid-19. Ya ba a gabatarwa mai ban sha'awa a taron 6 ga Afrilu na taron Kwamitin Ba da Shawarwari na Magungunan Magungunan Magunguna da Magungunan Halittu na FDA, inda ya yi bayanin cewa SARS-CoV-2 na haɓaka cikin sauri. Ya yi bayanin cewa SARS-CoV-2 yana haɓaka sau biyu zuwa sau goma cikin sauri kamar kwayar cutar mura kuma waɗannan maye gurbi “na rage tasirin rigakafin. Bayan gabatar da alluran rigakafin Covid-19, juyin halittar kwayar cutar ya haɓaka.
Gabatarwar Dr. Bedford ya bayyana ya tsoratar da wasu daga cikin membobin VRBPAC saboda bayanansa sun yi kururuwa, "SARS-CoV-2 mugun dan takara ne don rigakafin!" Amma jami'an FDA kawai sun yi watsi da wasu maganganu sannan suka ci gaba da taron.
Hanya daya tilo da za a bi daga annobar ita ce janye wadannan alluran rigakafin daga kasuwa da kuma yin amfani da hanyoyin warkewa. Madadin haka, FDA tana ba da shawarar yin watsi da gwajin asibiti dangane da waɗannan alluran rigakafin gaba ɗaya.
Manufar "Tsarin nan gaba" shine a yi amfani da tsarin tsarin rigakafi na Covid-19 a cikin dawwama don goyon bayan masana'antar harhada magunguna. Idan an amince da wannan "Tsarin Gaba", duk harbe-harben Covid-19 na gaba - ba tare da la'akari da tsarin ba - za a ɗauka ta atomatik "lafiya kuma mai tasiri" ba tare da ƙarin gwajin asibiti ba, saboda ana ɗaukar su "mai kama da ilimin halitta" da harbin da ake ciki.
Idan kun canza kwayar mRNA guda ɗaya a cikin waɗannan hotunan zai canza sakamakon lafiya ta hanyoyin da babu wanda zai iya tsammani. Wannan tabbas yana buƙatar sabbin gwaji na asibiti - wanda shine abin da FDA ke ba da shawarar tsallakewa.
Kwamitin ba da shawara na FDA (VRBPAC) ya hadu akan Afrilu 6, 2022 don tattauna "Tsarin nan gaba" a karon farko. Dukkan mambobin kwamitin sun yarda cewa harbin Covid-19 ba ya aiki, cewa haɓaka sau da yawa a shekara ba abu ne mai yiwuwa ba, kuma ana buƙatar sake fasalin harbe-harben. Sun kuma yarda gaba ɗaya cewa babu "madaidaicin kariya" da mutum zai iya amfani da shi don hasashen abin da matakan rigakafin zai isa don hana kamuwa da cutar ta SARS-CoV-2.
On Yuni 28, VRBPAC za ta sake haduwa don tattauna "Tsarin Gaba". Za a gabatar da shi a matsayin yarjejeniyar da aka yi saboda masana'antun suna son yanke shawara kan zaɓin nau'in rigakafin a watan Yuni don isar da allurar rigakafin alƙawarin kaka.
FDA ta ba da izinin harbin Covid-19 ga yara masu shekaru 6 zuwa shekaru 5 akan 14 da 15 ga Yuni. Don haka idan FDA ta amince da "Tsarin Gabatarwa" a ranar 28 ga Yuni, hotunan da za a ba wa yara (da Amurkawa na kowane zamani) a cikin fall zai zama hotunan da aka gyara wanda ya tsallake gwajin asibiti.
Idan ya zo ga harbin mura, FDA tana ƙoƙarin yin shinge ta hanyar sanya nau'ikan ƙwayoyin cuta guda huɗu a cikin harbi ɗaya (wanda ake kira "alurar rigakafi quadrivalent"). Wannan shine ainihin abin da suke shirin yi tare da harbin Covid-19 na gaba shima (matsa zuwa alluran rigakafi masu yawa).
Moderna yana haɓaka kewayon bivalent na Covid-19. A watan Afrilu touted harbi bivalent wanda ke niyya ga bambance-bambancen Alpha da Beta. Zuwa watan Yuni, dabarun Moderna juya zuwa harbin bivalent wanda ke yin niyya ta musamman na asalin Omicron. Amma nau'in Omicron da ya mamaye Amurka a farkon 2022 ana saurin maye gurbinsu da sabbin sauye-sauye (ciki har da BA.4 da BA.5). Yana yiwuwa gabaɗaya cewa duk wani harbin da aka sake fasalin, a lokacin da ya isa kasuwa, zai zama mummunan wasa ga wannan ƙwayar cuta mai saurin tasowa. Maimakon magance cutar, wannan hanyar na iya haɓaka haɓakar bambance-bambancen da ke guje wa alluran rigakafi. Bugu da ƙari, ta hanyar tsallake gwaji na asibiti, babu wanda zai san ko waɗannan harbe-harbe da aka sake fasalin ba su da lafiya.
Don taƙaitawa - Kwamitin Ba da Shawarar Magungunan Magunguna da Abubuwan Halittu na FDA zai haɗu akan Yuni 28 don kada kuri'a kan "Tsarin Gaba" don kimanta abin da ake kira "ƙarni na gaba" Covid-19 harbi. "Tsarin nan gaba" wani shiri ne na yin magudin tsarin tsarin rigakafi na Covid-19 a cikin dawwama.
Tsarin "Tsarin nan gaba" zai ɗauki "tsarin zaɓin yanayin mura" wanda ke kasawa kowace shekara kuma a yi amfani da shi zuwa ga harbin Covid-19 na gaba (sake fasalin). Ma'aikatan ofishin tarayya, waɗanda yawancinsu ke da rikice-rikicen kuɗi na sha'awa, za su zaɓi wane bambance-bambancen SARS-CoV-2 don haɗawa cikin harbi na shekara-shekara (ko sau biyu a shekara) Covid-19. A cikin tsari, duk harbin Covid-19 na gaba za a ɗauka ta atomatik "lafiya kuma mai tasiri" ba tare da ƙarin gwaji na asibiti ba.
"Tsarin nan gaba" rashin hankali ne. Ya nuna cewa FDA ta yi watsi da kimiyya da aikinta na doka don kare jama'a.
Asalin da aka buga a kan Mayarwa
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Toby Rogers yana da Ph.D. a cikin tattalin arzikin siyasa daga Jami'ar Sydney a Ostiraliya da kuma Jagoran Digiri na Siyasa na Jama'a daga Jami'ar California, Berkeley. Binciken nasa ya mayar da hankali kan kame ka'idoji da cin hanci da rashawa a masana'antar harhada magunguna. Dokta Rogers yana gudanar da tsarin siyasa na asali tare da ƙungiyoyin 'yanci na likita a duk faɗin ƙasar da ke aiki don dakatar da annobar cutar rashin lafiya a cikin yara. Ya yi rubutu game da tattalin arzikin siyasa na lafiyar jama'a akan Substack.
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