ZF-UZ-VAC2001 vaktsinasi klinik tadqiqotlarida 29 000 nafar kishi ishtirok etgan

Bugun ijtimoiy tarmoqlarda Xorazm viloyatida Xitoy-Oʻzbek vaktsinasi olgandan keyin ahvoli ogʻirlashgan fuqaro haqida video lavha tarqaldi.

Sogʻliqni saqlash vazirligi zudlik bilan ushbu vaziyat nazoratga olinganligi, bemorning ahvolini oʻrganish va bu holat nima sababdan yuz berganiga aniqlik kiritish maqsadida mamlakatimizning tajribali infetsionist, reanematolog, oftalmolog, virusolog, immunolog, nevropatolog, psixolog kabi mutaxassislaridan iborat tezkor guruh tuzilganligi haqida xabar berdi.

Xoʻsh, Xitoy-Oʻzbek vaktsinasi atrofidagi shov-shuvlar va bu vaktsinaga ishonchsiz qarayotgan ayrim yurtdoshlarimizning fikrlari qay darajada asosli?

Farmatsevtika tarmogʻini rivojlantirish agentligi mazkur mavzu yuzasidan quyidagilarni maʼlum qiladi:

2020 yilning 19 noyabr kuni Innovatsion rivojlanish vazirligining Ilgʻor texnologiyalar markazi tomonidan Farmatsevtika tarmogʻini rivojlantirish agentligi huzuridagi Davlat markaziga Xitoy-Oʻzbek vaktsinasining sifat nazorati tekshiruvlarini oʻtkazish uchun vaktsina, platsebo namunalari va tegishli standartlar hamda reagentlar taqdim qilingan edi.

“Dori vositalari, tibbiy buyumlar va tibbiy texnika ekspertizasi va standartlashtirish davlat markazi” DUK tomonidan belgilangan tartibda mazkur vaktsinaning barcha xavfsizlik koʻrsatkichlari sinovdan oʻtkazildi va uning ijobiy natijalari shuningdek, Etika qoʻmitasining vaktsinani klinik tadqiqotlari oʻtkazishning etika jihatidan asoslanganligi toʻgʻrisidagi xulosalari asosida aholi orasida uchinchi bosqich klinik sinovlarga yoʻnaltirildi.

Zhifei Longcom Biopharmaceutical Co. Ltd kompaniyasi koronavirusga qarshi vaktsinani yaratishda Oʻzbekistonning hissasi va caʼy-harakatlarini inobatga olib, ZF 2001 vaktsinani birga yaratgan hammuallif mamlakat sifatida belgiladi.

Ushbu yangi vaktsinani ZF-UZ-VAC 2001 nomi bilan birgalikda ishlab chiqarish va foydalanilishga kelishilgani bildirildi.

Joriy yilning 1 mart sanasida ZF-UZ-VAC 2001 koronavirusning yangi tipiga qarshi rekombinant (CHO cell) vaktsina tibbiyot amaliyotida qoʻllash uchun tegishli tartibda Farmatsevtika tarmogʻini rivojlantirish agentligi huzuridagi Davlat markazig tomonidan davlat roʻyxatidan oʻtkazildi. (Roʻyxat raqami – DV/X 08646/03/21)

Maʼlumot uchun: Oʻzbekiston Respublikasining 2016 yil 4 yanvarda tasdiqlangan “Dori vositalari va farmatsevtika faoliyati toʻgʻrisida”gi Qonunning 12-moddasiga koʻra dori vositalari, tibbiy buyumlar va tibbiy texnikaning tibbiyot amaliyotida qoʻllanilishiga, qoida tariqasida, ular davlat roʻyxatidan oʻtkazilganidan keyin ruxsat etiladi.

Kecha 27-avgust, Xitoylik hamkorlar tomonidan Koronavirusga qarshi ZF-UZ-VAC2001 vaktsinasining 3-faza klinik sinovlari vaktsina barcha shtammlar uchun umumiy 81,76% samaradorlikni koʻrsatganligi eʼlon qilindi.

Qayd etilishicha, 3-dozadan soʻng vaktsinaning samaradorligi barcha shtammlar uchun umumiy 81,76%, «britancha» shtammga qarshi esa 92,93% tashkil etdi. Oʻlim va ogʻir xolatlarga qarshi 100% samaradorligini koʻrsatdi. JSST talablariga koʻra vaktsina kamida 50%dan yuqori samara berishi lozim.

Shuni alohida qayd qilish kerakki, Jahon sogʻliqni saqlash tashkiloti protokoliga koʻra 3-faza sinovlarini ochiqlash hamda statistik tahlillar oʻtkazish uchun toʻliq vaktsinadan soʻng kamida 156 holda kasallik aniqlanishi kerak. ZF-UZ-VAC2001 vaktsinasining 3 faza klinik sinovlari natijasi 221 nafar kasallik aniqlangan ishtirokchilardagi tahlilga koʻra aniqlandi va bu sinov natijasini yanada aniqroq boʻlishini taʼminlaydi.

Aytish joiz, ushbu xalkaro miqyosdagi ZF-UZ-VAC2001 vaktsinasining III faza koʻpmarkazli klinik tadqiqotlari 2020 yilning 10 dekabridan boshlangan boʻlib, sinovlarda 18 yoshdan katta boʻlgan jami 29 000 nafar kishini qamrab olindi. Mazkur tadqiqotlar Xitoyning Xunan viloyatida, shuningdek Oʻzbekiston, Indoneziya, Pokiston va Ekvador davlatlarida oʻtkazildi. Oʻzbekistonda klinik tadqiqotlar Zhifei Longcom Biopharmaceutical Co.Ltd kompaniyasining 8 nafar mutaxassislari, Innovatsion rivojlanish vazirligi huzuridagi Ilgʻor texnologiyalar markazining 30 nafar olimlari, Sogʻliqni saqlash vazirligi huzuridagi Virusologiya ilmiy-tadqiqot instituti va boshqa tibbiyot muassasalarining 112 nafar tibbiyot xodimlari tomonidan oʻtkazilmoqda. Koll-markazda 32 nafar xodim faoliyat yuritib, klinik sinovlarida ishtirok etgan koʻngillilardan har kuni telefon orqali xabar olib turildi.

Klinik tadqiqotlarda Oʻzbekistondan jami 6966 nafar koʻngilli ishtirok etdi, ulardan 214 nafari 60 yoshdan katta kishilardir. Tadqiqotlar davomida har bir koʻngilli ishtirokchi 28 kun oraligʻi bilan 3 ta dozada «vaktsina/platsebo» sxemasida emlandi. Ulardan 13 kishida oʻrta darajadagi nojoʻya taʼsir aniqlangan boʻlib, 0,002 foizdan kam koʻrsatkichdir. Alohida ajratilgan guruhlarda 95% holatlarda yetarli darajada antitanalar ishlab chiqarilgani aniqlandi.

Xulosa oʻrnida barcha yurtdoshlarimizdan shuni iltimos qilardikki, Xorazmda yuz bergan holat boʻyicha vaziyatni toʻliq oʻrganmasdan turli oʻrinsiz, asoslanmagan xabarlarni tarqatmaslikka chaqiramiz.

Zero Oʻzbekistonda amalga oshirilayotgan ommaviy vaktsinatsiya orqali COVID’19ni yurtimizda keng tarqalishini oldini olishimiz mumkin

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