Ikigo cya Leta zunze ubumwe za Amerika Gishinzwe ibiribwa n’imiti, US FDA, cyemeje bidasubirwaho urukingo rwakozwe na Pfizer Inc. na BioNTech SE mu gukingira COVID-19 abantu barengeje imyaka 16, rukazajya rukoreshwa ku izina rya Comirnaty.
Ni icyemezo cyitezweho guha icyizere abantu bakemangaga izi nkingo zakozwe ndetse zikemezwa ngo zikoreshwe bwangu mu bihe bidasanzwe, uruhushya ruzwi nka Emergency use authorization (EUA).
US FDA kuri uyu wa Mbere yatanze icyemezo kidasubirwaho, ko urukingo rwa Pfizer rwemerewe gukoreshwa mu gukingira COVID-19 abantu barengeje imyaka 16 muri rusange, aho kuba gusa ibihe bidasanzwe.
Ni icyemezo cyafashwe nyuma y’uko rwagaragaje ubushobozi buhagije mu gukumira ko umuntu yandura COVID-19 akagaragaza ibimenyetso byayo, ari nabyo byatuma aremba.
Gusa FDA yavuze ko ku bafite hagati y’imyaka 12 na 15, uru rukingo rukomeza gukoreshwa ku burenganzira butangwa mu bihe bidasanzwe. Ni kimwe no ku gutanga urukingo rwa gatatu ku bakeneye kongererwa ubwirinzi kurushaho.
Ku barengeje imyaka 16, icyemezo cya nyuma gifashwe mu mezi atarenga ane uhereye igihe Pfizer yatangiriye urugendo rwo gusaba kwemererwa burundu.
Ubusanzwe byafataga igihe kigera mu mezi icumi.
Komiseri w’agateganyo wa US FDA, Janet Woodcock, yavuze ko kwemeza uru rukingo ari intambwe ikomeye mu guhangana n’icyorezo cya COVID-19.
Ati “Mu gihe uru rukingo n’izindi zuzuje ibisabwa bya gihanga ngo zikoreshwe mu bihe bidasanzwe, nk’urukingo rwa mbere rwemejwe na FDA, abaturage bakwiye kwizera badashidikanya ko rwujuje ibisabwa byose haba mu mutekano w’uwaruhawe, uburyo rukora n’ubuziranenge rwakoranywe, bisabwa na FDA kugira ngo ikintu cyemezwe.”
Urukingo rwa Pfizer-BioNTech rwatangiye gukoreshwa mu buryo bw’ibihe bidasanzwe guhera ku wa 11 Ukuboza 2020, hakingirwa abarengeje imyaka 16.
Ku wa 10 Gisurasi 2021 byemewe ko rushobora no guhabwa abafite imyaka hagati ya 12 na 15.
Pfizer iteganya gusaba igenzura riganisha mu kwemererwa mu buryo ntakuka no kuri ibyo byiciro, hashingiwe ku bipimo bizakusanywa mu gihe cy’amezi atandatu.
Kugira ngo iki cyemezo gitangwe, FDA yatangaje ko yakoze isesengura ry’ibipimo bisaga 40,000 by’abantu barengeje imyaka 16, batigeze bagira ikimenyetso cy’uko banduye COVID-19 nyuma yo guhabwa urukingo rwa kabiri.
Ibyavuye mu isuzuma byerekanye ko Comirnaty ikora ku gipimo cya 91% mu gukumira COVID-19.
Kuva icyorezo cya COVID-19 cyatangira mu mpera z’umwaka wa 2019, Ishami ry’Umuryango w’Abibumbye ryita ku buzima, WHO, rimaze kwemeza ikoreshwa ryo mu bihe bidasanzwe inkingo esheshatu za Pfizer-BioNTech, Johnson & Johnson, AstraZeneca, Moderna, Sinovac na Sinopharm.
Ikusanyamakuru rikomeje ku rukingo rwa karindwi arirwo Sputnik V, rukorerwa mu Burusiya.
