Isitofu sokugonya se-Pfizer's COVID-19 Lelokuqala ukuvunywa ngokuGqibeleleyo yi-FDA

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Ulawulo lwezoKutya kunye noLawulo lweeDrug luphawule enkulu isiganeko esibalulekileyo ngoMvulo ngokunika imvume yokugonya iPfizer-BioNTech COVID-19 yabantu abali-16 ubudala okanye ngaphezulu.Isitofu sokugonya sePfizer-BioNTech enedosi ezimbini, efumene ukukhanya okuluhlaza kugunyaziso losetyenziso olungxamisekileyo yi-FDA ngoDisemba ophelileyo, ngoku isitofu sokuqala se-coronavirus ukufumana imvume epheleleyo ngumbutho.

"Ngelixa oku nezinye izitofu zidibene nemilinganiselo engqongqo ye-FDA yokugunyazisa ukusetyenziswa ngokungxamisekileyo, njengesitofu sokuqala esigunyazisiweyo se-FDA-19 se-COVID-19, uluntu lunokuqiniseka ukuba eli chiza lihlangabezana nemigangatho ephezulu yokhuseleko, ukusebenza, kunye nokuvelisa umgangatho ofunwa yi-FDA kwimveliso evunyiweyo, utshilo uJanet Woodcock, MD, umkomishinala obambeleyo we-FDA, kwingxelo ngoMvulo. Ngelixa izigidi zabantu sele bezifumene ngokukhuselekileyo izitofu zokugonya i-COVID-19, siyaqonda ukuba kwabanye, imvume ye-FDA yesitofu sokugonya ngoku inokufaka ukuzithemba okongeziweyo ukuze ugonywe. iUS " (Eyeleleneyo: Lisebenza kangakanani isitofu sokugonya i-COVID-19)

Okwangoku, bangaphezulu kwe-170 lezigidi zabantu baseMelika abaye bagonywa ngokupheleleyo kwi-COVID-19, ngokwedatha yamva nje evela kumaZiko oLawulo lweSifo kunye noThintelo, elingana neepesenti ezingama-51.5 zabemi. Kwabo bantu abazizigidi ezili-170, ngaphezulu kwesigidi se-92 bafumene iyeza lokuthintela i-Pfizer-BioNTech, ngokwe-CDC.

Ngelixa ngaphezulu kwezigidi ezingama-64 zabantu e-US begonyelwe ngokupheleleyo iyeza lokuthintela iModerna, ngokweedatha zeCDC zamva nje, abalawuli basekwinkqubo yokujonga isicelo senkampani sokuvuma ngokupheleleyo isitofu sokugonya se-COVID-19, INew York Times uxele uMvulo. Ngaphantsi kwe-EUA - ekwasebenza kwisitofu sokugonya sikaJohnson & Johnson-i-FDA ivumela ukusetyenziswa kweemveliso zonyango ezingavunywanga ngexesha likaxakeka zempilo yoluntu (ezifana ne-COVID-19 bhubhane) ukunyanga okanye ukuthintela izigulo ezibeka ubomi esichengeni.

Ngeemeko ze-COVID-19 eziqhubeka nokunyuka kwilizwe lonke ngenxa yokosulela kakhulu kweDelta, imvume ye-FDA yesitofu sokugonya i-Pfizer-BioNTech inokukhokelela kwiimfuno zokugonya phakathi kweekholeji, imibutho kunye nezibhedlele, ngokutsho. INew York Times. Izixeko ezithile, kubandakanya neNew York, sele zifuna abasebenzi kunye nabaxhasi babonise ubungqina bogonyo ukuba bathathe inxaxheba kwimisebenzi emininzi yangaphakathi, kubandakanya ukuzonwabisa kunye nokutya.

Ukuzifihla kunye nokuziqhelanisa nokuhamba kude ekuhlaleni kubalulekile ekulweni i-COVID-19, kodwa izitofu zihlala zibhetyebhetye ekuzikhuseleni nakwabanye. Ekuvukeni kweendaba ezibuhlungu zangoMvulo ezivela kwi-FDA, mhlawumbi oku kuyakufaka ukuzithemba kogonyo kwabo banokulumkela ukufumana idosi.

Ulwazi kweli bali luchanekile ngexesha lokushicilelwa. Njengoko uhlaziyo malunga ne-coronavirus ye-COVID-19 luqhubeka nokuvela, kunokwenzeka ukuba ezinye iinkcukacha kunye nezindululo kweli bali zitshintshile ukusukela ekupapashweni kwayo. Siyakukhuthaza ukuba ujonge rhoqo ngezixhobo ezinjenge-CDC, i-WHO, kunye nesebe lezempilo likarhulumente kwindawo yakho yokufumana olona lwazi lwanamhlanje kunye neengcebiso.

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