A cikin Yuni 2025, Kwamitin Shawarwari kan Ayyukan rigakafi (ACIP) ya gudanar da nasa taro na farko A karkashin sabon jagorancin da Sakataren Lafiya Robert F. Kennedy, Jr. Ya nada, tsammanin jama'a ya bayyana a fili: cewa wannan sabon kwamitin da aka nada zai mayar da hankali, 'yancin kai, da kuma nazarin shaida mai mahimmanci kafin ya ba da shawarar yin amfani da sababbin kayayyakin magunguna na yau da kullum.
Ɗaya daga cikin muhimman abubuwan da ke cikin ajanda shine ko a ba da shawarar Merck sabon RSV monoclonal antibody, Clesrovimab, don amfani da yau da kullum ga jarirai masu lafiya. Ko da yake an sayar da shi azaman sabon samfuri, yana kusan kama da tsari da aiki zuwa Sanofi – AstraZeneca's nirsevimab, amince a 2023.
Daga karshe kwamitin ya kada kuri’a 5 zuwa 2 na amincewa da shawarar. Wannan kuri'ar ta biyo bayan CDC gabatar, wanda ya tsara bayanan aminci a matsayin mai kwantar da hankali, wanda ya jagoranci yawancin membobin don kammala cewa babu wani fitattun damuwa na tsaro.
Amma wannan tabbacin ya dace? Kuma a kan menene ainihin tushensa?
Siginar Kamewa, da Yadda Aka Gabatar da shi
A yayin taronta na Yuni 2025, an nuna wa mambobin ACIP tsaro slide daga CDC's Vaccine Safety Datalink (VSD), mai da hankali kan kame bayan gudanar da nirsevimab. An raba bayanan zuwa ƙungiyoyin shekaru biyu: jarirai masu shekaru 0-37 kwanaki da waɗanda shekaru 38 kwanaki zuwa ƙasa da watanni 8. Kowane rukuni ya nuna haɓakar ƙimar haɗari don kamewa (3.50 da 4.38, bi da bi), amma duka biyun an lakafta su "ba mahimmanci." Ba a nuna cikakken bincike ba.
Duk da haka, kamar yadda Dr. Maryanne Demasi daga baya ruwaito, Haɗa ƙungiyoyin biyu a cikin ƙungiya ɗaya yana haifar da hoto daban-daban: kusan kusan ninki huɗu a cikin haɗarin haɗari (RR 3.93, 95% CI 1.21-12.79, p = 0.02), sakamakon da ke da mahimmanci. Ba a taɓa gabatar da wannan ƙaƙƙarfan siginar ga kwamitin ba.
Shawarar daidaitawa a cikin kwanaki 38 - daidai ma'anar jadawalin Amurka lokacin da aka fara allurar rigakafin jarirai na yau da kullun - ba shi da takamaiman hujjar ilimin halitta, kuma ta hanyar tarwatsa siginar a cikin ƙananan ƙungiyoyi biyu, ya kawar da mahimmancin ƙididdiga.
Zaɓin ƙira na biyu ya ƙara matsalar. Binciken CDC ya yi amfani da tazarar haɗari mai kamun kai tare da kwanaki 7 na farko da aka keɓe a matsayin "haɗari" da kwanakin 8-21 da aka yi la'akari da matsayin lokacin "sarrafawa". Duk wani kame da ke faruwa a rana ta 8 ko kuma daga baya an ƙidaya shi da ƙimar baya, kodayake irin wannan lokacin na iya bayyana tasiri mai alaƙa da samfur. Daidaitaccen aikin kula da magunguna yana kira don gwada tagogi da yawa, ba ƙunƙuntaccen yanke ba.
Waɗannan yanke shawara na nazari sun dace. Kuri'ar don ba da shawarar clesrovimab ta ci 5-2. Da a ce an nuna wa membobin haɗarin kama kama tare da daidaiton matakan gwaji a cikin al'amuran tsarin juyayi, canza kuri'u biyu kawai zai canza sakamakon.
A ƙarshe, kamar yadda Demasi ya jaddada, damuwar ba ta iyakance ga alama ɗaya ba. Ganin irin kamanceceniya tsakanin nirsevimab da clesrovimab, haɗarin kamuwa da cutar na iya zama tasiri a aji. Wannan yana nufin tsallake binciken da aka tattara bai ɓoye bayanan ƙididdiga kawai ba. Ya riƙe bayanai tare da tasirin kai tsaye ga kowane RSV monoclonal antibody yanzu da ake amfani da shi.
Waɗannan binciken sun fito ne kawai ta hanyar sake nazari mai zaman kansa. Ba tare da aikin Dokta Demasi ba, watakila ba a san su ba - ba ga jama'a ba, har ma da mambobin ACIP da ke kada kuri'unsu.
Hoton Mutuwar ACIP Bai Auna Ba
Gabatarwar CDC ga ACIP bai haɗa da wani haɗaɗɗen bita na bayanan mace-mace daga gwajin asibiti na ko dai RSV monoclonal ba - ba Merck's clesrovimab ba, kuma ba Sanofi-AstraZeneca's nirsevimab ba. Wannan tsallake yana da ban sha'awa, idan aka ba da cewa a duk layin samfuran biyu, sakamakon gwaji yana nuna daidaitaccen daidaituwa kuma sananne a cikin mace-mace tsakanin jiyya da makamai masu sarrafawa.
Nirseimab: Mutuwar hannu
FDA Haɗe-haɗe Review don nirsevimab a sarari ya nuna "rashin daidaituwa" a cikin mace-mace da aka gani a cikin gwajin yara. Bayanan sun kasance kamar haka (Shafi na 49, shafi na 117):
- Gwaji 03: 2 sun mutu a cikin 968 masu karɓar nirsevimab; 3 daga cikin 479 sarrafawa.
- Gwaji 04 (MELODY): 4 sun mutu a cikin 1,998 masu karɓar nirsevimab; 0 daga cikin 996 placebo.
- Gwaji 05 (MEDLEY): 5 mutuwar tsakanin 613 nirsevimab masu karɓar; 1 daga cikin 304 da aka ba palivizumab.
- Gwaji 08: 1 mutuwa tsakanin 60 nirsevimab masu karɓa; babu hannun sarrafa lokaci guda.
A cikin duka: 12 mutuwar tsakanin 3,710 nirseimab masu karɓa tare da mutuwar 4 a cikin sarrafawar 1,797 - adadin mace-mace na 0.32% a cikin makamai na magani idan aka kwatanta da 0.22% a cikin makamai masu sarrafawa. Rashin ma'auni na iya zama ƙanƙanta a cikakkiyar ma'ana, amma ya kasance ba zato ba tsammani, kuma yana tafiya akai-akai a hanya ɗaya.
Clesrovimab: Mutuwar hannu
FDA ta 2025 nazarin hadarin don clesrovimab - samfurin da ke ƙarƙashin ACIP - yana nuna irin wannan yanayin a cikin manyan gwaje-gwajensa guda biyu:
- MAI KYAU (MK-1654-004): 7 mutuwar tsakanin 2,409 masu karɓar clesrovimab; 3 daga cikin 1,202 placebo.
- SMART (MK-1654-007): 8 mutuwar tsakanin kusan 500 masu karɓar clesrovimab; 4 daga cikin kusan 500 suna karɓar palivizumab.
Tsakanin karatun biyu: 15 mutuwar a cikin magani hannun riga 7 a cikin sarrafawa.
Yayin da masu bitar FDA ba su danganta mutuwar ga clesrovimab ba bayan nazarin shari'ar, sun yarda da rashin daidaituwar lambobi.
A cikin 2023 update zuwa gwajin MELODY, rubutun da aka buga a cikin New England Journal of Medicine ya bayar da rahoton mutuwar hudu a hannun nirsevimab da Zero a cikin hannun placebo, yana gamawa da cewa samfurin ya kasance mai aminci saboda an yanke hukuncin mutuwar waɗanda ba su da alaƙa da magani.
Amma duban tsanaki akan shari'ar Karin Ƙarin ya ba da labari na daban. Ƙarƙashin zane mai gudana na CONSORT, bayanin kula yana rubuta mutuwa ta biyar a hannun nirsevimab. Bayanin ya bayyana cewa an haɗa mutuwar hudu har zuwa ranar 361 a cikin binciken aminci, yayin da aka cire ƙarin mutuwa a ranar 440.
Wannan keɓancewar bai dace da na gwajin ba Yarjejeniya, wanda ya ƙayyadad da bin diddigin aminci na kusan kwanaki 510s bayan dosing. Ta wannan ma'anar, mutuwar da ke faruwa a ranar 440 ta faɗi ciki taga aminci da aka nufa.
Irin wannan shubuha ya bayyana a cikin Merck's Gwajin CLEVER. An ba da rahoton mutuwar bakwai a hannun clesrovimab da uku a cikin hannun placebo a cikin lokacin lura na kwanaki 365, duk an kore su a matsayin "marasa alaƙa."
Duk da haka bayyanar CDC Hakanan ya haɗa da bayanin ƙasa game da ƙarin mutuwa a ranar 487, bayan jaririn ya daina shiga cikin umarnin likita a hukumance. Har yanzu dai ba a sani ba ko an kirga wannan shari'ar a cikin mutane bakwai ko kuma an bi da su daban.
Kasancewar wannan shari'ar ba ta taga an bayyana dalla-dalla, yayin da aka gabatar da mace-macen a cikin taga guda bakwai kawai ba tare da fayyace dalili ko lokaci ba, yana nuna hanyar da za a bi don bayyana gaskiya. Irin waɗannan ayyukan bayar da rahoto suna hana masu dubawa masu zaman kansu tantance ko yanayin mace-mace ya kasance a bayyane saboda kwatsam ko kuma an ba da garantin bincike na kusa.
Ana sake ganin irin wannan tsari a gwaji na SMART na Merck. A can, an sami mutuwar mutane takwas a tsakanin masu karɓar clesrovimab da huɗu a cikin jarirai da aka ba palivizumab. Har yanzu, masu binciken sun yanke shawarar cewa babu ɗayan mutuwar da ke “da alaƙa,” kuma ba a bayar da cikakken bayani game da lokaci ko sanadi ba.
Babban batu a nan ba dalili ba ne amma gaskiya. Masu karatu da masu ba da shawara ya kamata su iya ganin kowane mutuwa a cikin babban bayanan bayanai lokacin da jimlar ta yi ƙanƙanta. Maimakon haka, labarin da aka buga ya ba da rahoton lamba ɗaya, yayin da ƙarin kayan ya bayyana wani.
Wannan zaɓin rahoton yana barin masu ba da shawara ba tare da ikon tantance haɗarin mace-mace ba. Kuma lokacin da aka yi la'akari da duk gwaje-gwajen tare, daidaiton damuwa yana bayyana. Babu ɗayan gwajin da aka yi don gano bambance-bambance a cikin mace-mace, kuma jimillar lambobi kaɗan ne. Duk da haka, lokacin da kwatancen bazuwar masu zaman kansu guda huɗu - a cikin samfuran guda biyu da mahalli da yawa - duk suna nuna ƙarin mutuwar a cikin makamai na magani fiye da sarrafawa, daidaito yana da wuya a yi watsi da shi.
A matsayin Farfesa Retsef Levi, daya daga cikin mambobin ACIP guda biyu da suka kada kuri'ar kin amincewa. nuna: "Gwajiyoyi daban-daban guda hudu duk sun nuna cewa mace-mace na tafiya hanya daya."
Don samfurin da aka yi niyya don gudanarwa na yau da kullun a cikin lafiyayyen jarirai na cikakken lokaci, ko da madaidaicin siginar aminci yakamata ya haifar da binciken kusa. Hakan bai faru ba a wannan yanayin, kuma ba a taɓa sanya cikakken hoton mace-mace akan tebur ba.
Rashin Bayyanar Abubuwan Da Ke Kashe Mutuwa
Cikakkun bayanai masu ma'ana ga ACIP yakamata ya haɗa da ba wai kawai kirga adadin mutuwa ta hannun gwaji ba har ma da tsarin tebur wanda ke jera dalilin mutuwa, lokaci, da aikin hannu na kowane harka. Wannan matakin daki-daki yana da mahimmanci bisa ga ka'idoji da ka'idoji na yanzu. The CONSORT Harms 2022 tsawo (wanda ke haɗawa cikin babban jerin abubuwan dubawa na CONSORT) yana jaddada buƙatar cikakken, ƙayyadaddun rahoton lahani a cikin gwaje-gwajen asibiti bazuwar. Hakazalika, da ICH E9(R1) jagora ya jaddada muhimmancin ayyana kimantawa (a zahiri: ainihin sakamakon da gwajin ya yi iƙirarin aunawa) da kuma gudanar da bincike na gaskiya wanda ke ba da damar bincike mai zaman kansa, maimakon dogaro da hukunce-hukuncen labari kawai.
Duk da haka, taƙaitawar jama'a na FDA ya dogara ne akan maganganun ba da labari cewa mutuwar ba ta da alaƙa," ba tare da gabatar da rugujewar matakin hannu ba wanda zai ba da damar masu bita masu zaman kansu su bincika tari ta lokaci, ciwo, ko rashin lafiya. Babu CDC ko masu tallafawa samfurin ba su ba ACIP irin wannan lissafin gefe-da-gefe ba.
Wannan gibin ba shi ne ka'ida ba. A cikin gwajin lokaci na 2b na nirsevimab, alal misali, mutuwar biyu a cikin hannun jiyya an danganta su zuwa gastroenteritis a cikin in ba haka ba jarirai masu lafiya - daya a ranar 143 da wani a ranar 338. Irin wannan sakamakon yana da wuya. Ba tare da bayyanannen tebur matakin hannu na sanadi da lokaci ba, haɗe da ko da ainihin ƙididdigar ƙididdiga na rashin daidaituwa gabaɗaya, an bar masu ba da shawara ba su iya yanke hukunci ko waɗannan mutuwar suna nuna bazuwar bazuwar ko siginar aminci mai ma'ana da ke ba da garantin ƙarin bincike.
Tushen Sa ido ɗaya, Babu Triangulation
A taronta na Yuni 2025, bayanin lafiyar CDC ga ACIP ya zana musamman akan Datalink Safety Datalink (VSD), tsarin sa ido mai aiki da ke haɗa bayanan lafiyar lantarki a cikin tsarin kiwon lafiyar Amurka 13. Ba a nuna daidaitaccen bincike daga VAERS ya da FDA MedWatch, kodayake jagorancin tarayya A bayyane yake raba rahoto don RSV monoclonals: lokacin da aka ba da maganin rigakafi kadai, za a ba da rahoton abubuwan da ba su da kyau MedWatch; idan aka ba shi tare da alluran rigakafi, rahotanni sun tafi VAERS.
Ta hanyar iyakance bincikenta zuwa tushe guda ɗaya, CDC ta gabatar da ACIP tare da tsarin tsari guda ɗaya na aminci. Wannan kunkuntar ruwan tabarau yana da haɗarin yin watsi da sigina waɗanda za su iya fitowa da farko a cikin wani rafi na sa ido, daidai dalilin da yasa ake ɗaukar triangulation a cikin tsarin a matsayin tushen tushe a cikin farmako.
Wannan zaɓin ya wuce iyakar Amurka. Mai zaman kansa ainihin bayanan duniya daga Faransa, wanda mai bincike Hélène Banoun ta gabatar, ya ƙara jaddada mahimmancin ra'ayi mai mahimmanci. A yayin fidda nirseimab na farko a duk faɗin ƙasar a cikin kaka 2023, mace-mace da ke faruwa a jarirai masu shekaru 2-6 kwanaki sun nuna yanayin ɗan lokaci:
- Satumba 2023: Mutuwar 55 (ƙididdigar ƙididdiga ta haɓaka)
- Oktoba 2023: Mutuwar 62 (ƙididdigar ƙididdiga ta haɓaka)
Lokacin da aka iyakance rarraba kuma aka samar da wadatar a cikin Nuwamba 2023, adadin masu mutuwa ya ragu sosai zuwa 26. Daga baya, yayin da aka dawo da rarrabawa, mace-mace ta sake tashi zuwa 50 a cikin Disamba da 52 a cikin Janairu 2024, duka suna wakiltar kololuwar kididdiga.
Waɗannan sauye-sauyen sun yi daidai da tsarin jujjuyawar da ƙayyadaddun wadata - suna ba da shawarar tari na ɗan lokaci wanda, yayin da ba tabbatar da dalili ba, ya zama sigina mai ma'ana. Ya kamata a gabatar da irin waɗannan alamu na ainihi na duniya - tare da rakiyar ƙa'idodin dabaru - tare da bayanan VSD na Amurka, duk da haka an cire su daga bayanan ACIP.
A dunkule, tsallake siginar gida da na waje yana nufin an nuna wa mambobin ACIP wani yanki mai gamsarwa na shaidar da ake da su, ba cikakken hoto ba.
Wurin Makaho da aka Gina
Ba'a iyakance ga abin da ACIP ta nuna a watan Yuni ba. Matsakaicin rabe-rabe na RSV monoclonals yana haifar da ginanniyar wuri makaho a cikin rahoton amincin Amurka. Waɗannan magungunan halittu ne, duk da haka don dalilai na alhaki, an sanya su cikin jadawalin rigakafin yara, wanda ke ba masana'antun rigakafi a ƙarƙashin Shirin Rauni na Rauni na Ƙasa. Don lissafin kuɗi, ana kula da su azaman ƙwayoyi. Don rahoton aminci, an raba su: an ba su kaɗai, ana tura su zuwa MedWatch; tare da alluran rigakafi, ana tura su zuwa VAERS.
Wannan shaidar ta biyu ta haifar da abin da masana ke kira "tabo makaho mai ba da rahoto." Masu bayarwa sukan saba wa VAERS lokacin da ake jinyar jarirai, amma VAERS ba su da filin keɓe don nirsevimab ko clesrovimab. Rahotanni na iya ƙarewa a ɓarna a ƙarƙashin "nau'in rigakafin da ba a san shi ba" ko kuma a rufe su a cikin bayanan magungunan FDA, ganuwa ga manazarta amincin rigakafin rigakafin CDC. Abubuwan da ke faruwa na iya faɗuwa cikin tsage gaba ɗaya, suna lalata tsarin da ake nufi da ɗaukar faɗakarwa da wuri.
Bayan Bayanan: Amincewa a cikin ACIP
Abubuwan da aka tsallake a watan Yuni 2025 ba bayanan fasaha ba ne, amma yanke shawara waɗanda suka tsara yadda aka tsara shaida ga waɗanda ke da alhakin kiyaye lafiyar jama'a. An nuna wa membobin ACIP wani ɗan nazari wanda ya rage damuwa game da tsaro, yayin da mafi girma kuma mafi yawan tsarin damuwa ya kasance a kan tebur.
Idan kwamitin ba da shawara da aka sake ginawa bisa alkawuran 'yancin kai har yanzu ana iya gudanar da shi ta hanyar gabatar da bayanai da bai cika ba, batun ya wuce gaba ɗaya. Abin da ke tattare da shi shine ko ACIP za ta iya yin aiki daidai da matsayinta na mai zaman kanta mai zaman kanta na hatsari da fa'idodi - da kuma ko jama'a za su iya amincewa da cewa ana ba da kariya ga mafi ƙanƙanta membobinta tare da cikakken fayyace.
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Yaffa Shir-Raz, PhD, mai bincike ne na sadarwar haɗari kuma abokin koyarwa a Jami'ar Haifa da Jami'ar Reichman. Yankin bincikenta yana mai da hankali kan lafiya da sadarwa mai haɗari, gami da sadarwar Cutar Cutar Cutar Cutar (EID), kamar H1N1 da barkewar COVID-19. Ta yi nazarin ayyukan da masana'antun harhada magunguna da hukumomin kiwon lafiya da ƙungiyoyi ke amfani da su don haɓaka al'amuran kiwon lafiya da alamun jiyya, da kuma ayyukan tauhidi da ƙungiyoyi da ƙungiyoyin kiwon lafiya ke amfani da su don murkushe muryoyin da ba su dace ba a cikin maganganun kimiyya. Ita ma 'yar jarida ce ta lafiya, kuma editan Mujallar Real-Time ta Isra'ila kuma memba a babban taron PECC.
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