I-FDA igunyaza u-Ervebo, umuthi wokugoma wokuqala we-Ebola

Izindaba

Ngokugunyazwa okungumlando, i-U.S. Food and Drug Administration (i-FDA) yamemezela ukunikezwa isitifiketi kuka-Ervebo, umuthi wokugoma wokuqala we-Ebola emhlabeni ukuvikela nokuvikela ezifweni zegciwane le-Ebola (EVD).

Yini i-Ebola?

I-Ebola igciwane elithelelwana kakhulu. Isatshalaliswa ngokuthintana ngqo negazi, uketshezi lomzimba, nezicubu zezilwane ezinegciwane noma abantu — futhi kungadluliselwa ngokuthintana nezindawo nezinto zokwakha (njengokulala noma okokwembatha) okungcoliswe uketshezi. Leli gciwane linenkathi yokufukamela esukela ezinsukwini ezimbili kuya kwezingu-21 (imvamisa izinsuku eziyisishiyagalombili kuya kweziyishumi). Ngemuva kwalokho, ukuqala kwezimpawu kungaba ngokuzumayo futhi kufaka umkhuhlane, ukukhathala, ubuhlungu bemisipha, ikhanda elibuhlungu nomphimbo obuhlungu. Lezi zimpawu zilandelwa ukuhlanza, uhudo, ukuqubuka, ukukhubazeka kwezinso nokusebenza kwesibindi, futhi-kwezinye izimo-ukopha ngaphakathi nangaphandle.

Isifo segciwane le-Ebola silethwe emphakathini waseMelika ngemuva kwencwadi kaRichard Preston ethengisa kakhulu, Indawo Eshisayo , yanyatheliswa ngo-1994 — ibhala umsuka nezigameko zesifo segciwane le-Ebola e-Afrika eseningizimu yeSahara. Kepha i-EVD iqinisekisile ukuthi ukuqubuka bekuhlasele abantu kusukela ngawo-1970. Ngokusho kwe-FDA, ukuqubuka eGuinea, eLiberia naseSierra Leone (okwaqala kusukela ngo-2014 kuya ku-2016) kwaholela emacaleni angaphezu kuka-28,000 we-EVD nokufa okungaphezu kuka-11,000. Njengamanje, iDemocratic Republic of the Congo (DRC) ibhekene nokuqubuka kwesibili ngobukhulu emhlabeni kwe-EVD.

Ingabe ukhona umuthi wokugomela i-Ebola?

Isifo segciwane le-Ebola yisifo esingajwayelekile kepha esibi futhi esivame ukubulala esingazi mingcele, uPeter Marks, MD, Ph.D., umqondisi we-FDA's Center for Biologics Evaluation and Research, uthi ku ukukhishwa kwezindaba . Ukugoma kubalulekile ukusiza ukuvimbela ukuqubuka nokuvimba igciwane le-Ebola ukuthi lingasabalali lapho kwenzeka ukuqubuka.

Futhi kulapho u-Ervebo engena khona. Umuthi wokugomela i-Ebola - owenziwa yinkampani eyenza imithi iMerck & Co., Inc. - uphathwa njengomjovo womthamo owodwa. Ngumuthi wokugoma ophilayo, oncishisiwe owenziwe ngokwezakhi zofuzo ukuze uqukethe amaprotheni avela ku-Zaire ebolavirus.

Ukuthuthukisa umuthi wokugoma i-Ebola

Umsebenzi womuthi wokugomela i-Ebola waqala ngonyaka we-2004, kodwa kwaze kwaqala ukuqubuka kwezifo ngonyaka we-2010 lapho inqubo yokuhlola nokwamukela u-Ervebo yayibekwe phambili kakhulu.

Ngo-2018, iWorld Health Organisation (WHO) yaqala ukusebenzisa u-Ervebo njengomuthi wokwelapha ngemuva kokuthi i-FDA inikeze igama elithi Breakthrough Therapy igama lomuthi wokugoma. Lokhu kwasiza ukuthuthukiswa kanye nokuhlolwa kwesayensi kwemithi futhi kwavumela ukuthi umuthi wokugoma usetshenziswe ngaphansi kohlelo lokufinyelela olwandisiwe ukusiza ukunciphisa ukubheduka kweDRC.

Ocwaningweni olwenziwe ngesikhathi kuqhambuka i-2014-2016 eGuinea, u-Ervebo wayezimisele ukuthi asebenze ngempumelelo ngo-100% ekuvikeleni amacala e-Ebola anezimpawu eziqhamuka ngaphezu kwezinsuku eziyishumi ngemuva kokugonywa. Ukuphepha kuka-Ervebo kwafundwa ezigulini eziyi-15,000 e-Afrika, eYurophu naseNyakatho Melika. Imiphumela emibi kunazo zonke kwaba ukusabela kwendawo yokujova, ikhanda, umkhuhlane, ubuhlungu bemisipha nokukhathala.

Kepha yazi, u-Ervebo usebenza kuphela ekulweni nohlobo lwe-Ebola lweZaire — ngokusho kukaMerck.

Futhi manje, ukugoma kuvunyelwe ukuvimbela isifo se-Ebola virus (EVD), esibangelwa yiZaire ebolavirus kubantu abaneminyaka engu-18 ubudala nangaphezulu. Ngaphambi kwalokhu kugunyazwa, umuthi wokugomela igciwane le-Ebola ungasetshenziswa kuphela ezimeni eziphuthumayo, njengokuqubuka kwamanje, kusho uDkt John Dye, oyinhloko ye-immunology yegciwane e-U.S. Army Medical Research Institute of Infectious Diseases.

Ngokuvunywa kwayo, i-Ervebo ingasetshenziswa njengendlela esebenzayo yokuvimbela ukusiza ukunqanda ukuqubuka okungenzeki, esikhundleni sokukwazi kuphela ukuphendula lapho kwenzeka.

Ukwamukelwa kwanamuhla kuyisinyathelo esibalulekile emizameni yethu eqhubekayo yokulwa ne-Ebola ngokubambisana nabalingani bethu kulo lonke uMnyango Wezempilo kanye Nezinsizakalo Zabantu e-US, kanye nabalingani bethu bamazwe omhlaba, njenge-World Health Organisation, u-Anna Abram, Iphini Likakhomishani Inqubomgomo, Umthetho, kanye Nezindaba Zamazwe Omhlaba, kusho umbiko. Le mizamo, kufaka phakathi ukuvunywa okuyingqophamlando kwanamuhla, kukhombisa ukuzinikela okungantengantengi kwe-FDA ekusebenziseni ubuchwepheshe bethu ukwenza lula ukwakhiwa nokutholakala kwemikhiqizo yezokwelapha ephephile futhi esebenzayo ukubhekana nezidingo eziphuthumayo zezempilo zomphakathi kanye nokulwa nezifo ezithathelwanayo.

Uyotholakala nini umuthi wokugomela i-Ebola?

Ngokwesitatimende sabezindaba iMerck, amanani omuthi wokugomela igciwane le-Ebola kungenzeka ukuthi abe eselungile ngasekupheleni kuka-2020. Inkampani eyenza imithi izosebenzisana neWorld Health Organisation, i-UNICEF, uhulumeni wase-US, kanye neGavi (i-Vaccine Alliance) ukuthola izindlela zokusabalalisa womuthi wokugoma.