Kamar yadda ACIP ta yi niyya ba tare da samun damar samun cikakkun bayanan gwaji ba, an riga an fara wani tsari mai ban tsoro a duniyar gaske. Yanzu, nazarin bayanan FAERS na FDA ya nuna mutuwar jarirai 37 daga cikin rahotanni 991 kawai - siginar mutuwa kusan sau biyu na sauran alluran rigakafin yau da kullun. Me yasa ba a bayyana hakan ba?
Alamar gargadi ta riga ta bayyana a cikin gwaje-gwaje na asibiti: mutuwar jarirai a cikin kungiyoyin jiyya sun ninka sau biyu a cikin makamai masu sarrafawa - siginar da ya kamata ya haifar da bincike na gaggawa. Kamar yadda aka rubuta a cikin labarin Brownstone da ya gabata, An hana wannan rashin daidaituwa mai ban tsoro daga ACIP yayin nazarinta na Yuni 2025 na Merck's RSV antibody, Clesrovimab.
Yanzu ya bayyana cewa ba wannan ne kawai jan tuta da aka ajiye daga kwamitin ba. Binciken bayanan gaskiya na duniya daga Tsarin ba da rahoto mara kyau na FDA (FAERS) ya bayyana gaskiya mai ma'ana: tun daga Sanofi's Beyfortus (nirsevimab), wanda aka yarda kuma aka ƙara shi cikin jadawalin rigakafi na jarirai na Amurka a cikin 2023, an sami rahotannin abubuwan da ba su dace ba 1,012 - gami da mutuwar jarirai 37, wani taro da ba a taɓa gani a bayanan lafiyar lafiyar yara na yara.
Rarraba Rarraba Na Mutuwa
Tun daga ranar 29 ga Satumba, 2025, bayanan FAERS sun lissafta rahotanni mara kyau na Beyfortus 1,012, gami da munanan lokuta 684 da mutuwar jarirai 37 (duba Hoto 1). Wannan yana nuna adadin mutuwar da aka ruwaito na 3.6% - sama da ƙa'idodin tarihi. Cikakken CDC binciken sa ido (1991-2001) ya gano cewa mace-mace yawanci ta ƙunshi 1.4% zuwa 2.3% na duk rahotannin VAERS na yara. A 2023 nazari na ainihi sama da shekaru 30 na bayanan VAERS an gano cewa mace-mace ta kai kashi 1.0 cikin ɗari na duk rahotanni a duk ƙungiyoyin shekaru, tare da mafi yawan shekaru suna zama ƙasa da kashi 2%, kuma keɓancewar tsiro a farkon 1990s ya wuce wannan matakin. Dangane da wannan yanayin, adadin shari'o'in Beyfortus da aka ruwaito da suka shafi mutuwar jarirai ya kusan ninka matsakaicin matsakaicin tarihi.
Gabaɗaya babban bayanin martaba daidai yake. Daga cikin jimillar rahotannin Beyfortus guda 1,012 a cikin FAERS, 684 (67.4%) an ware su azaman munanan al'amuran da suka faru - wanda aka ayyana azaman asibiti, yanayin barazanar rai, nakasa, ko mutuwa. Kamar yadda cikakken bayani a sama, wannan ya haɗa da mutuwar jarirai 37 (3.6%). Sauran lokuta masu tsanani sun haɗa da asibiti 415 (40.9%) da kuma 46 abubuwan da ke barazanar rai (4.5%). Don kwatanta, iri ɗaya Nazarin CDC An gano cewa kawai 14.2% na rahotannin an rarraba su da mahimmanci, yayin da 2023 nazari na ainihi an ba da rahoton adadin asibiti na 5.8% kawai da abubuwan da ke barazanar rayuwa a 1.4% na duk rahotanni. Waɗannan ma'auni suna nuna yadda rashin daidaituwa ya kasance mai tsanani ga Beyfortus.
Hoto 1: Bayanan amincin bayanan tallace-tallace akan Beyfortus, kamar yadda aka ruwaito ga FAERS (an shiga Satumba 29, 2025). Tare da mutuwar jarirai 37 da 684 munanan al'amura masu banƙyama a tsakanin rahotannin aukuwa mara kyau guda 1,012, ba a gabatar da wannan siginar ga ACIP ba yayin shawarwarin ta na Yuni 2025.
Yayin da rahotannin VAERS ba su tabbatar da dalilin ba, ana amfani da su da yawa daga masu gudanarwa don gano sigina. Mahimmanci, har ma da kafaffen tsarin sa ido kamar VAERS kiyasta don kama kashi 1-10% na ainihin abubuwan da ba su dace ba. Wadannan alamu, ko da na farko, sun cancanci bincike na gaggawa, ba korarwa ba.
Siffar Mutuwar Zamani ta Boye Daga Masu Bita
A kallo na farko, mutum na iya ba da shawarar cewa karuwar adadin masu mutuwa yana nuna haɓakar amfani da Beyfortus kawai. Amma duk da haka tsarin lokaci yana ba da labari mai ban sha'awa - wanda ke bayyana sigina mai girma da rashin daidaituwa, tun ma kafin cikakken ɗauka.
Kafin yin nazarin yanayin yanayi daki-daki, yana da mahimmanci a fahimci ma'auni na ɗauka. A lokacin lokacin RSV na 2023-2024 - farkon lokacin da ko dai nirsevimab ko maganin RSV na uwa ya kasance - Bayanan CDC ya nuna cewa kashi 29% na jariran da suka cancanta ne kawai aka yi musu rigakafi ta kowace hanya. Matsayin matakin jiha ya bambanta daga 11% zuwa 53% (CDC, 2024). Wannan ƙayyadaddun tallafi yana da mahimmancin mahallin: idan munanan abubuwan da suka faru sun riga sun kunno kai a mafi girman ɗaukar hoto, menene zai faru yayin da ake faɗaɗa amfani?
Jadawalin mutuwar kowace shekara yana ba da bambanci mai koyarwa:
- 2023: Beyfortus ya an yi birgima kawai a watan Oktoba, tare da iyakataccen taga na watanni uku kafin lokacin ya ƙare - kuma a tsakiyar karancin kasa baki daya wanda ya hana samun dama ga jarirai masu haɗari. Kawai 2 mutuwar an ba da rahoton wannan shekarar.
- 2024: Tare da mayar da wadata, an ba da maganin a cikin cikakken lokacin RSV - watanni shida a jimlar (Janairu-Maris, sannan kuma Oktoba-Disamba). Rahotanni sun kai ga 15 mutuwar.
- 2025: Zuwa Satumba, bayan watanni uku na farkon lokacin ɗaukar hoto na wannan shekarar. Mutuwar jarirai 20 An riga an ba da rahoto - wanda ya zarce adadin shekarar da ta gabata, tun ma kafin fara kakar 2025-2026.
Wannan tsarin yana ɓata ra'ayi cewa siginar kayan aiki ne kawai na amfani mai faɗi. Idan ƙarin watanni da ƙarin allurai sune kawai bayani, adadin mutuwar da aka ruwaito ya kamata ya yi girma a hankali. Madadin haka, bayanan suna nuna haɓaka mai ƙarfi - ko da lokacin da aka ba Beyfortus na 'yan watanni. Kuma waccan tagar da aka matsa amfani da ita ita kanta tana faɗi: Beyfortus ba maganin gargajiya ba ne amma monoclonal antibody wanda ke raguwa bayan watanni biyar zuwa shida, shi ya sa ake gudanar da shi kawai lokacin RSV (Oktoba-Maris).
A wasu kalmomin, kawo yanzu dai an samu rahoton mutuwar mutane 37 sun taru a ciki kasa da cikakken yanayi biyu na amfani - maida hankali wanda ya sa rashin daidaituwa ya fi wuya a watsar.
Bugu da ƙari, ba kawai adadin adadin mutuwar jarirai da aka ruwaito yana ƙaruwa ba, amma haka ma adadin mutuwar da aka ruwaito a cikin jimillar rahotannin da suka faru. Kamar yadda aka nuna a hoto na 1:
- a 2023, FAERS sun rubuta mutuwar jarirai 2 a cikin rahotanni 122 (1.6%);
- a 2024, 15 sun mutu daga cikin rahotanni 352 (4.3%);
- Kuma zuwa Satumba 2025, 20 sun mutu a cikin rahotanni 538 (3.7%) - duk da cewa lokacin 2025-2026 RSV bai fara ba tukuna.
Matsakaicin adadin rahotannin mutuwa da aka lura a cikin 2024 da 2025 sun bayyana musamman sama da tsarin VAERS na tarihi na wannan rukunin, yana ƙara damuwa cewa yanayin ba wai kawai yana nuna ƙarar ƙarar rahoto ba, amma na iya sigina takamaiman batun aminci na samfur wanda ke buƙatar ƙarin bincike.
Tsarin damuwa ya wuce iyakokin Amurka. Mai zaman kansa ainihin bayanan duniya daga Faransa sun ba da shawarar haɗin gwiwa mai ban sha'awa na ɗan lokaci tsakanin lokacin ƙaddamar da nirseimab na ƙasa baki ɗaya da kuma yanayin mace-macen jarirai. A lokacin kaka na 2023, yayin da nirsevimab ya zama ko'ina, Faransa ta yi rikodin ƙididdiga masu yawa a cikin mace-mace tsakanin jarirai masu shekaru 2-6: mutuwar 55 a cikin Satumba da 62 a cikin Oktoba. A watan Nuwamba, lokacin da aka taƙaita rarrabawar na ɗan lokaci, mace-mace ta ragu sosai zuwa 26. Yayin da aka ci gaba da samun shiga, mutuwar ta sake karuwa - ta kai 50 a cikin Disamba da 52 a cikin Janairu. Duk da yake waɗannan alkaluman ba su tabbatar da dalilin ba, tsarin maimaitawa wanda ya yi daidai da samuwa yana jaddada buƙatar gaggawa na kula da harhada magunguna na ƙasa da ƙasa da cikakken fayyace daga masu sarrafawa da masana'antun.
Gwaje-gwajen Asibiti da Bayanan Duniya na Gaskiya suna Ba da Labari iri ɗaya
Daidaituwa yana da ban mamaki. Rashin daidaituwa iri ɗaya wanda ya fara bayyana a cikin gwaje-gwajen - inda mutuwar jarirai a cikin hannun jiyya ya kusan ninki biyu na waɗanda ke cikin ƙungiyoyin sarrafawa - a yanzu an sake bayyana a cikin sa ido na gaske. A cikin saituna guda biyu, siginar ba ta yaɗuwa ko shubuha ba, amma tana mai da hankali ne kuma ana iya aunawa. Gwaje-gwajen sun nuna nauyin mace-macen da bai dace ba a cikin mutanen da ake son amfana; FAERS yanzu ya nuna cewa da zarar an fitar da samfurin gabaɗaya, tsarin ya ci gaba. A dunkule, waɗannan layukan shaida guda biyu sun samar da gargaɗi mai ma'ana - wanda masu mulki da kwamitocin shawarwari suka zaɓi kada su fuskanci.
Wannan gazawar don magance madaidaiciyar siginar aminci da za a iya aunawa yana da damuwa musamman dangane da yadda tsarin bita ya gudana. Kamata ya yi wannan ya zama lokacin da za a yi cikakken bayyana gaskiya, musamman ganin cewa ACIP ita ce ta rage yawan jiki da ke da alhakin bitar aminci. Lokacin da aka ƙaddamar da clesrovimab na Merck don amincewa, ya ƙetare kwamitin shawarwarin aminci na FDA (VRBPAC). A cikin takaddun amincewarta, FDA ta ba da hujjar wannan shawarar ta la'akari cewa clesrovimab "ba shine farkon ajinsa ba," don haka baya buƙatar ƙarin bita na shawarwari. Wannan ya bar ACIP a matsayin wurin bincike na ƙarshe kafin ƙaddamar da ƙasa.
Duk da haka maimakon samun cikakken hoto, an kare kwamitin daga mahimman bayanai na aminci - duka rashin daidaituwa na mace-mace a cikin gwaje-gwajen da kuma bayyanar siginar gaske na duniya. Ba za a iya tsammanin ƙungiyoyin masu ba da shawara za su yanke shawarar tushen shaida ba lokacin da aka hana mahimman bayanan aminci daga nazarin su. Lokacin da mutuwar jarirai 37 ya faru a cikin ƙasa da yanayi biyu na amfani - a saman ninka yawan mace-mace a cikin ƙungiyar sa baki idan aka kwatanta da sarrafawa a cikin gwaje-gwajen asibiti - jama'a sun cancanci amsa, ba shiru ba. Duk wani abu da bai wuce cikakkiyar fayyace ba, da kuma niyyar fuskantar waɗannan siginonin aminci kai tsaye, ya ƙunshi gazawar amincin kimiyya da aikin kare jarirai da wannan samfurin ya yi niyya don hidima.
Dangane da tara tutocin jajayen, tsallakewa, da sigina da aka danne da ke fitowa a yanzu, ba zai yuwu ga kowane samfurin ya kasance da kariya daga cikakken bincike ba. Dukansu nirsevimab (Beyfortus) da clesrovimab suna ba da garantin cikakken kimantawa ta ACIP - wannan lokacin tare da cikakkun bayanai akan tebur.
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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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