Nyowani Spikevax COVID-19 Vaccine Inowana Mvumo kubva kuUS FDA

"Kubvumidzwa kweFDA kweSpikevax inhanho yakakosha mukurwisa denda reCCIDID-19, ichimaka mushonga wechipiri wakabvumidzwa kudzivirira COVID-19. Veruzhinji vanogona kuvimbiswa kuti Spikevax inosangana neiyo FDA yakakwirira mwero yekuchengetedza, kushanda nesimba uye kugadzira mhando inodiwa kune chero yekudzivirira yakabvumidzwa kushandiswa muUnited States," akadaro Acting FDA Commissioner Janet Woodcock, MD "Kunyange mazana emamiriyoni emadhora eModerna COVID. -19 Vaccine yakapihwa kune vanhu vari pasi pemvumo yekushandiswa kwechimbichimbi, tinonzwisisa kuti kune vamwe vanhu, mvumo yeFDA yejekiseni iyi inogona kuwedzera chivimbo mukuita sarudzo yekubaiwa."

Spikevax ine dhizaini yakafanana neEUA Moderna COVID-19 Vaccine uye inopihwa seyekutanga nhevedzano yemadhizi maviri, mwedzi mumwe chete. Spikevax inogona kushandiswa zvakachinjika neEUA Moderna COVID-19 Vaccine kupa iyo COVID-19 yekudzivirira yakatevedzana. Moderna COVID-19 Vaccine inoramba iripo pasi peEUA seyechipiri-dosi yepuraimari yakatevedzana kune vanhu vane makore gumi nemasere ekuberekwa zvichienda mberi, seyechitatu yepakati pekutanga dosi kune vanhu vane makore gumi nemasere ekuberekwa zvichikwira avo vakatemerwa kuve nemamwe marudzi e immunocompromise, uye semushonga umwechete webooster kuvanhu vane makore 18 ekuberekwa zvichikwira angangoita mwedzi mishanu mushure mekunge vapedza chirongwa chekutanga chejekiseni. Iyo zvakare inotenderwa kushandiswa senge heterologous (kana "kusanganisa uye mechi") imwechete booster dosi kune vanhu vane makore gumi nemasere ekuberekwa zvichikwira zvichitevera kupedzwa kwekutanga nhomba nemushonga unowanikwa weCOVID-18.

"Nyanzvi dzeFDA dzezvekurapa nesainzi dzakaita ongororo yakakwana yedata resainzi uye ruzivo rwakasanganisirwa mukushandisa zvine chekuita nekuchengetedzeka, kushanda nesimba uye kugadzira mhando yeSpikevax. Izvi zvinosanganisira iyo agency yakazvimiririra yekuongorora yakaunzwa nekambani, yedu ongororo yedata, pamwe nekuongorora kwakadzama kwemaitiro ekugadzira, nzira dzekuyedza uye zvivakwa zvekugadzira, "akadaro Peter Marks, MD, Ph.D., director we iyo FDA's Center yeBiologics Evaluation uye Tsvagiridzo. “Majekiseni akachengeteka uye anoshanda ndiwo dziviriro yedu yakanakisa padenda reCCIDID-19, kusanganisira akasiyana arikutenderera. Veruzhinji vanogona kuvimbiswa kuti jekiseni iri rakatenderwa zvichifambirana nehurongwa hwesainzi hweFDA. "

FDA Kuongorora kweKushanda kweData Yemvumo yeVanhu vane 18 Makore Ezera uye Vakuru.

Iyo Spikevax biologics rezinesi application (BLA) inovaka pamusoro pedata uye ruzivo rwaitsigira EUA, senge preclinical uye data yekiriniki, pamwe neruzivo rwemagadzirirwo ekugadzira uye masaiti panogadzirwa jekiseni. Iyo FDA inoongorora nekuita ongororo yayo yedata kuti ione kana kuchengetedzeka uye kushanda kwejekiseni kwaratidzwa uye kunosangana nechiyero chekubvumidzwa, uye kana ruzivo rwekugadzira uye nzvimbo inovimbisa mhando yekudzivirira uye kuenderana. 

Mvumo yeSpikevax yakavakirwa pakuongorora kweFDA uye kuongororwa kwekutevera kuchengetedzeka uye kushanda kwedata kubva kune inoenderera mberi, yakadzorwa-inodzorwa-inodzorwa, yakapofumadzwa kiriniki kuyedza yakatsigira iyo Zvita 2020 EUA yeModerna COVID-19 Vaccine uye ruzivo kubva post EUA. ruzivo rwekuwedzera kuzivisa kuchengetedza uye kushanda. 

Ongororo yakagadziridzwa yekuona kushanda kweSpikevax yaisanganisira 14,287 vanogamuchira vaccine uye 14,164 vanogamuchira placebo vane makore gumi nemasere uye vakuru vasina humbowo hwehutachiona hweSARS-CoV-18 vasati vagamuchira dosi rekutanga. Iyo data yakashandiswa pakuongorora yakaunganidzwa isati yasiyana yeOmicron yabuda. Idzi data dzakaratidza kuti Spikevax yaive 2% inoshanda mukudzivirira COVID-93, iine makumi mashanu neshanu nyaya dzeCCIDID-19 dzichiitika muboka rekudzivirira uye makumi manomwe nemakumi mana nemana eCCIDID-55 kesi muboka replacebo. Mushonga uyu wakashandawo nechikamu che19% mukudzivirira zvirwere zvakanyanya.

FDA Ongororo Yechengetedzo Dhata Yekubvumidzwa Kune Vanhu Vane Makore 18 Ezera uye Vakuru

Ongororo yekuchengetedzwa kweFDA yeSpikevax yaisanganisira vangangosvika zviuru gumi nezvishanu nemazana mana nevaviri vanogashira vaccine uye 15,184 vanogamuchira placebo vane makore gumi nemasere zvichikwira, inopfuura hafu yevatori vechikamu iyi yakateverwa kune kuchengetedzwa kweinenge mwedzi mina mushure mepiri yechipiri. Vanenge 15,162 vatori vechikamu pakutanga vakapihwa kuti vagamuchire Spikevax muchikamu chakapofumadzwa chekiriniki kuyedzwa kwakapedza kuchengetedzeka kwekutevera kwemwedzi ingangoita 18 mushure mepiritsi yechipiri.

Migumisiro yainyanya kutaurwa nevaridzi vekiriniki yekuedza kwaiva kurwadziwa, kutsvuka uye kuzvimba panzvimbo yejekiseni, kuneta, musoro, mhasuru kana kurwadziwa kwemajoini, kupindwa nechando, kuda kurutsa/kurutsa, kuzvimba lymph nodes pasi peruoko uye fivha.

Pamusoro pezvo, iyo FDA yakaita ongororo yakasimba yeapashure-mvumo yekuchengetedza yekutarisa data ine chekuita nemyocarditis (kuzvimba kwemhasuru yemoyo) uye pericarditis (kuzvimba kwenyama yakatenderedza moyo) zvichitevera kubaiwa neModerna COVID-19 Vaccine uye yakaona kuti dhata dzinoratidza njodzi dzakawedzera kunyanya mukati memazuva manomwe zvichitevera kupihwa kwechipiri, nenjodzi inocherechedzwa yakanyanya muvarume vane makore 18 kusvika makumi maviri nemana. Inowanikwa data kubva mukutevera kwenguva pfupi inoratidza kuti vanhu vazhinji vakave nekugadziriswa kwezviratidzo. Zvisinei, vamwe vanhu vaida rubatsiro rwakanyanya. Mashoko haasati awanikwa pamusoro pezvingangoitika zvehutano zvenguva refu. Iyo Spikevax Inotsanangura Ruzivo inosanganisira yambiro nezve njodzi idzi.

Iyo FDA yakaita yayo yekubatsira-njodzi ongororo ichishandisa modhi yekufungidzira kuti vangani zviratidzo zveCCIDID-19 kesi, kuchipatara, intensive care unit (ICU) kubvumidzwa uye kufa kubva kuCOVID-19 vaccine muvanhu vane makore gumi nemasere zvichikwira vaizodzivirira kupesana ne nhamba yezvingangoitika myocarditis/pericarditis kesi, kuchipatara, ICU admissions uye kufa kungave kwakabatana nejekiseni. FDA yakaona kuti mabhenefiti ejekiseni anodarika njodzi yemyocarditis uye pericarditis muvanhu vane makore gumi nemasere zvichikwira.

Iyo FDA irikuda kuti kambani iite postmarketing zvidzidzo kuti ienderere mberi nekuongorora njodzi dzemyocarditis uye pericarditis zvichitevera kubaiwa neSpikevax. Zvidzidzo izvi zvinosanganisira ongororo yenguva refu mhedzisiro pakati pevanhu vanokura myocarditis zvichitevera kubaiwa neSpikevax. Pamusoro pezvo, kunyangwe zvisiri izvo zvinodiwa neFDA, kambani yakazvipira kuita zvimwe zvidzidzo zvekuchengetedza mushure mekushambadzira, kusanganisira kuita ongororo yekunyoresa kubata pamuviri kuti iongorore nhumbu uye mhedzisiro yevacheche mushure mekugamuchira Spikevax panguva yekuzvitakura.

Iyo FDA yakapa ichi chikumbiro Chekutanga Ongororo. Mvumo yakapihwa kuModernaTX, Inc.