"Kamohelo ea FDA ea Spikevax ke mohato oa bohlokoa toants'ong ea seoa sa COVID-19, e tšoaeang ente ea bobeli e amohetsoeng ho thibela COVID-19. Sechaba se ka tiisetsoa hore Spikevax e kopana le litekanyetso tse phahameng tsa FDA bakeng sa polokeho, katleho le boleng ba tlhahiso bo hlokehang ho ente efe kapa efe e lumelletsoeng ho sebelisoa United States," ho boletse Mokhomishenara oa FDA Janet Woodcock, MD "Le ha limilione tse makholo tsa litekanyetso tsa Moderna COVID. -19 Ente e fuoe batho ba tlas'a tumello ea ts'ebeliso ea tšohanyetso, rea utloisisa hore ho batho ba bang, tumello ea FDA ea ente ena e ka kenya ts'epo e eketsehileng ea ho etsa qeto ea ho entoa. ”
Spikevax e na le sebopeho se ts'oanang le sa Ente ea EUA Moderna COVID-19 mme e tsamaisoa e le letoto la mantlha la litekanyetso tse peli, khoeli e le 'ngoe e arohane. Spikevax e ka sebelisoa ka mokhoa o ts'oanang le Ente ea EUA Moderna COVID-19 ho fana ka letoto la ente ea COVID-19. Ente ea Moderna COVID-19 e ntse e fumaneha tlasa EUA e le letoto la litekanyetso tse peli bakeng sa batho ba lilemo tse 18 ho ea holimo, e le letoto la boraro la letoto la letoto la batho ba lilemo li 18 ho ea holimo ba ikemiselitseng ho ba le mefuta e itseng ea immunocompromise, hape e le tekanyo e le 'ngoe ea booster bakeng sa batho ba lilemo li 18 le ho feta bonyane likhoeli tse hlano ka mor'a ho qeta letoto la mantlha la ente. E boetse e lumelletsoe ho sebelisoa e le "heterologous" (kapa "kopanya u bapise") lethal dose le le leng la booster bakeng sa batho ba lilemo tse 18 ho ea holimo kamora ho phethoa ha ente ea mantlha ka ente e fapaneng e fumanehang ea COVID-19.
"Litsebi tsa bongaka le tsa mahlale tsa FDA li entse tlhahlobo e phethahetseng ea datha ea mahlale le tlhaiso-leseling e kenyellelitsoeng ts'ebelisong e amanang le polokeho, katleho le boleng ba tlhahiso ea Spikevax. Sena se kenyelletsa netefatso e ikemetseng ea litlhahlobo tse fanoeng ke k'hamphani, litlhahlobo tsa rona tsa data, hammoho le tlhahlobo e felletseng ea lits'ebetso tsa tlhahiso, mekhoa ea liteko le lits'ebetso tsa tlhahiso, "ho boletse Peter Marks, MD, Ph.D. Setsi sa FDA sa Tlhahlobo le Lipatlisiso tsa Biologics. "Liente tse sireletsehileng le tse sebetsang ke ts'ireletso ea rona e ntle ka ho fetisisa khahlanong le seoa sa COVID-19, ho kenyelletsa le mefuta e fapaneng e ntseng e potoloha. Sechaba se ka tiisetsoa hore ente ena e amohetsoe ho latela litekanyetso tse thata tsa mahlale tsa FDA.”
Tekolo ea FDA ea Lintlha tsa Katleho bakeng sa Kamohelo bakeng sa Batho ba Lilemo Tse 18 le Ho feta
Kopo ea laesense ea Spikevax biologics (BLA) e thehile holim'a datha le tlhaiso-leseling e tšehelitseng EUA, joalo ka data ea pele ho kliniki le ea bongaka, hammoho le lintlha tsa ts'ebetso ea tlhahiso le libaka tseo ente e etsoang ho tsona. FDA e ea hlahloba le ho etsa litlhahlobo tsa eona tsa datha ho bona hore na polokeho le katleho ea ente li bontšitsoe le ho fihlela maemo a tumello, le hore na tlhahiso le lintlha tsa setsi li netefatsa boleng le botsitso ba ente.
Kamohelo ea Spikevax e ipapisitse le tlhahlobo le tlhahlobo ea FDA ea tlhaiso-leseling ea ts'ireletso le katleho ho tsoa tekong ea bongaka e sa sebetseng, e laoloang ke placebo, e foufalitsoeng e ts'ehelitseng EUA ea Pherekhong 2020 bakeng sa Vaccine ea Moderna COVID-19 le tlhaiso-leseling e tsoang kamora EUA. boiphihlelo ba ho tsebisa polokeho le katleho.
Litlhahlobo tse nchafalitsoeng ho bona katleho ea Spikevax li kenyelletsa baamoheli ba ente ba 14,287 le baamoheli ba placebo ba 14,164 ba lilemo tse 18 le ho feta ba neng ba sena bopaki ba ts'oaetso ea SARS-CoV-2 pele ba fuoa tekanyetso ea pele. Lintlha tse sebelisitsoeng bakeng sa litlhahlobo li ile tsa bokelloa pele ho hlaha mofuta oa Omicron. Lintlha tsena li bonts'itse hore Spikevax e ne e sebetsa ka 93% ho thibela COVID-19, ha linyeoe tse 55 tsa COVID-19 li le sehlopheng sa ente le linyeoe tse 744 tsa COVID-19 sehlopheng sa placebo. Ente e boetse e sebetsa ka 98% ho thibela mafu a matla.
Tekolo ea FDA ea Lintlha tsa Tšireletseho bakeng sa Kamohelo bakeng sa Batho ba Lilemo Tse 18 le ho Feta
Tlhahlobo ea polokeho ea FDA ea Spikevax e kenyelelitse baamoheli ba ente ba ka bang 15,184 le baamoheli ba placebo ba 15,162 ba lilemo tse 18 le ho feta, ho feta halofo ea barupeluoa bana e ile ea lateloa bakeng sa sephetho sa polokeho bonyane likhoeli tse nne kamora tekanyetso ea bobeli. Hoo e ka bang barupeluoa ba 7,500 ba neng ba abetsoe ho amohela Spikevax nakong ea teko ea tleliniki ba qetileng ho latela ts'ireletso bonyane likhoeli tse 6 kamora tekanyo ea bobeli.
Litla-morao tse atisang ho tlalehoa ke barupeluoa ba liteko tsa tleliniki e ne e le bohloko, bofubelu le ho ruruha sebakeng sa ente, mokhathala, hlooho, bohloko ba mesifa kapa manonyeletso, ho tsieleha, ho nyekeloa ke pelo / ho hlatsa, lymph nodes tse ruruhileng tlas'a letsoho le feberu.
Ntle le moo, FDA e entse tlhahlobo e matla ea tlhaiso-leseling ea polokeho ea kamora tumello e amanang le myocarditis (ho ruruha ha mesifa ea pelo) le pericarditis (ho ruruha ha lisele tse potolohileng pelo) kamora ho entoa ka Vaccine ea Moderna COVID-19 mme e entse qeto ea hore Lintlha li bonts'a likotsi tse eketsehang haholo nakong ea matsatsi a supileng kamora tekanyetso ea bobeli, 'me kotsi e bonoang e le holimo ho banna ba lilemo tse 18 ho isa ho tse 24. Lintlha tse fumanehang ho tsoa ho latela nako e khuts'oane li fana ka maikutlo a hore batho ba bangata ba bile le tharollo ea matšoao. Leha ho le joalo, batho ba bang ba ne ba hloka thuso ea tlhokomelo e matla. Boitsebiso ha bo so fumanehe mabapi le liphello tsa bophelo bo botle ba nako e telele. The Spikevax Prescribing Information e kenyelletsa temoso mabapi le likotsi tsena.
FDA e entse tlhahlobo ea eona ea kotsi ea melemo e sebelisa mohlala ho bolela esale pele hore na ke linyeoe tse kae tse nang le matšoao a COVID-19, lipetlele, ba amoheloang setsing sa tlhokomelo e matla (ICU) le lefu le tsoang ho COVID-19 ente ho batho ba lilemo tse 18 ho ea holimo e ka thibelang khahlano le ts'oaetso. palo ea linyeoe tse ka bang teng tsa myocarditis/pericarditis, ho kena sepetlele, ho amoheloa ICU le lefu le ka amahanngoang le ente. FDA e entse qeto ea hore melemo ea ente e feta kotsi ea myocarditis le pericarditis ho batho ba lilemo tse 18 ho ea holimo.
FDA e hloka hore k'hamphani e etse lithuto tsa postmarketing ho tsoela pele ho lekola likotsi tsa myocarditis le pericarditis kamora ho entoa ka Spikevax. Lithuto tsena li tla kenyelletsa tlhahlobo ea liphetho tsa nako e telele har'a batho ba nang le myocarditis kamora ho entoa ka Spikevax. Ntle le moo, leha e se litlhoko tsa FDA, k'hamphani e ikemiselitse ho etsa lithuto tse ling tsa polokeho ea kamora 'maraka, ho kenyelletsa le ho etsa boithuto ba ngoliso ea bakhachane ho lekola boimana le liphetho tsa masea kamora ho fumana Spikevax nakong ea kemolo.
FDA e file kopo ena Tlhahlobo ea Bohlokoa. Tumello e fuoe ModernaTX, Inc.
