Umuthi wokugomela i-RSV wabesifazane abakhulelwe uyiyintshi eduze nokuvunywa ngesincomo sekomidi le-FDA

I-US Food and Drug Administration (FDA) ivotele ngoLwesine ukuncoma ukugunyazwa komgomo we-RSV we-Pfizer we-RSV. abesifazane abakhulelwe. Umuthi wokugoma manje usuyisinyathelo esisodwa sokusondela ekubeni ube owokuqala otholakalayo wokugoma komama ukuvikela izinsana egciwaneni lokuphefumula le-syncytial.

Ngemuva komhlangano womphakathi wosuku lonke obubanjwe ngenkomfa ye-inthanethi, iKomiti Yezokweluleka Yemikhiqizo Ehlobene Nezemvelo ye-FDA (VRBPAC) ivotele ngazwi linye (14-0) ukweseka ukusebenza ngempumelelo komgomo ekuvimbeleni imiphumela emibi ye-RSV ku-RSV. izingane ezifika ezinyangeni eziyisithupha ubudala lapho inikezwa abesifazane ngesikhathi sesibili noma sesithathu sokukhulelwa.

Ikomidi liphinde lavotela u-10-4 mayelana nokuphepha komgomo.

UMBIKO OMSHA UPHAKAMISA ‘UKUTHENGA NGOTHUTHUKILE’ IMITHI NGEZIGULI KANYE NABAHLINZEKI KUBANGELE UKUSHONA KWEZIDAKAMIZI

“Sikhuthazekile ngomphumela womhlangano wanamuhla we-VRBPAC, njengoba kuyigxathu elibalulekile eliya phambili emgomweni osekunesikhathi eside ufunwa wumphakathi wesayensi wokusiza ukuvimbela isifo se-RSV ezinganeni ezisanda kuzalwa phakathi nezinyanga zazo zokuqala eziyisithupha ezisengozini kakhulu,” kusho u-Annaliesa Anderson. , PhD, Iphini likamongameli omkhulu kaPfizer kanye nesikhulu sesayensi esiyinhloko socwaningo nokuthuthukiswa kokugoma, esitatimendeni sabezindaba.

Umgomo wowesifazane okhulelwe

I-US Food and Drug Administration (FDA) iphakamise ukugunyazwa komgomo we-Pfizer’s RSV kwabesifazane abakhulelwe. (iStock)

“Uma kuvunyiwe, umuntu ozogomela i-RSV unamandla okuba umuthi wokuqala wokugoma komama ongasiza ukuvikela izingane ezisanda kuzalwa lapho ziphefumula ezinyangeni zokuqala eziyisithupha zokuphila kulesi sifo esingase sibe sibi,” engeza.

“Ukuyinikeza abesifazane abakhulelwe kunikeza isivikelo esingaguquki embungwini, bese idlulela ebuntwaneni.”

Ngaphambi kokwenza isinqumo salo, ikomidi libuyekeze imiphumela yokuhlolwa komtholampilo kweSigaba 3 sikaPfizer, eyashicilelwa kuThe New England Journal of Medicine.

Nakuba izincomo ziyisinyathelo esibheke ukutholakala komgomoukugunyazwa okusemthethweni okuvela ku-FDA kusalindile.

I-ejensi kulindeleke ukuthi yenze isinqumo sayo sokugcina ngo-Agasti 2023.

Umuthi wokugoma ubonakala uthembisa, kodwa ucwaningo olwengeziwe luyadingeka, kusho udokotela

“Ngicabanga ukuthi lona umuthi wokugoma othembisayo futhi kungenzeka ukuthi uyasebenza kakhulu futhi uphephile, ikakhulukazi njengoba amashumi ezinkulungwane ezingane ezincane kakhulu ezilaliswa esibhedlela nge-RSV njalo ngonyaka,” uDkt. Marc Siegel, uprofesa wezokwelapha e-. I-NYU Langone Medical Center kanye nomnikeli wezokwelapha weFox News, utshele iFox News Digital.

Baby kudokotela

Izingane ezingaba ngu-58,000 kuya ku-80,000 ezineminyaka engu-5 nangaphansi zilaliswe esibhedlela ngokutheleleka kwe-RSV, ngokusho kwedatha evela kwa-CDC. (iStock)

“Ukuyinikeza abesifazane abakhulelwe kunikeza isivikelo esingaguquki embungwini, bese idlulela ebuntwaneni,” engeza.

Ngesonto eledlule, uSiegel uxoxisane noDkt. Paul Offit we Philadelphia, Pennsylvaniaosekomitini lokweluleka le-FDA.

CHOFOZA LAPHA UKUZE Ubhalisele IPHEPHA LETHU LEZEMPILO

“Ubenethemba elikhulu ngomgomo,” kusho uSiegel. “Kuthe uma esebona imininingwane egcwele kodwa wagcina evotele ukuthi cha [on the safety issue]ngokusobala ngenxa yokuhlotshaniswa okungenzeka nokuzalwa ngaphambi kwesikhathi.”

Kwengeza uSiegel, “Kimina, lokhu kusho ukuthi ucwaningo olwengeziwe kufanele lwenziwe. Ngiyayethemba imibono kaDkt Offit ngalokhu.”

Ingozi ye-RSV kubantwana

Kwezinye izimo, leli gciwane libeka ingozi ezinsaneni nasezinsaneni.

Izingane ezingaba ngu-58,000 kuye kwezingama-80,000 ezineminyaka engu-5 nangaphansi zilaliswe esibhedlela ngokutheleleka kwe-RSV, ngokusho kwedatha evela kuCenters for Disease Control and Prevention (CDC).

Umama osanda kuzalwa

Izinsana ezingaphansi kwezinyanga eziyisi-6 ubudala zingabonisa izimpawu ezihlanganisa ukucasuka, ukukhathala, ukuncipha kwesifiso sokudla kanye nokuma kokuphefumula. (iStock)

Ezinganeni eziningi, i-RSV ibangela ubumnene kuphela izimpawu ezinjengamakhazakodwa kwezinye izimo kungaholela ezimweni ezinzima zokuphefumula njengenyumoniya noma i-bronchiolitis, okungase kudinge ukulaliswa esibhedlela nokunakekelwa okusekelayo.

CHOFOZA LAPHA UKUZE UTHOLA UHLELO LOKUSEBENZA IZINDABA ZEZIMpungushe

Izingane ezisengozini enkulu zihlanganisa izinsana ezizalwa ngaphambi kwesikhathi, izingane ezinezinyanga eziyisithupha nangaphansi, izingane ezingaphansi kweminyaka emibili ezinesifo samaphaphu esingamahlalakhona noma isifo senhliziyo, izingane ezinokuzivikela okubuthakathaka kanye nalabo abanezinkinga ze-neuromuscular, ngokwe-CDC.

UMGOMO WE-RSV WOKUQALA OVUNYELWE YI-FDA KUBANTU ABADALA ABAneminyaka engama-60 nangaphezulu

Izinsana ezingaphansi kwezinyanga eziyisithupha ubudala zingabonisa izimpawu ezihlanganisa ukucasuka, ukukhathala, ukuncipha kwesifiso sokudla kanye nokuma kokuphefumula.

Ngasekuqaleni kwale nyanga, kubikwe ukuthi i-FDA igunyaze umgomo wokuqala we-RSV, obizwa nge-Arexy, ukuthi usetshenziswe abantu abaneminyaka engama-60 nangaphezulu ukuvimbela isifo sokuphefumula esiphansi.