Novavax, Inc. kajeno e phatlalalitse liphetho tsa pele ho tsoa tekong ea kliniki ea Mokhahlelo oa 1/2 oa Ente ea Motsoako oa Mokokotlo oa COVID-Influenza (CIC). CIC e kopanya ente ea Novavax 'COVID-19, NVX-CoV2373, le moemeli oa eona oa ente ea ntaramane ea quadrivalent. Teko ea CIC e bonts'itse hore ho etsa ente e kopaneng hoa khoneha, ho mamellehe hantle ebile ho na le immunogenic.
"Re ntse re tsoela pele ho lekola boemo bo matla ba bophelo bo botle ba sechaba mme re lumela hore ho ka ba le tlhokahalo ea li-boost ho loants'a COVID-19 le feberu ea selemo," ho boletse Gregory M. Glenn, MD, Mopresidente oa Lipatlisiso le Nts'etsopele, Novavax. "Re khothatsoa ke lintlha tsena le tsela e ka tlang pele bakeng sa ente e kopaneng ea COVID-19-ntaramane hammoho le liente tse ikemetseng tsa ntaramane le COVID-19."
Boemo ba polokeho le mamello ea ente e kopaneng e ne e lumellana le e ikemetseng ea NVX-CoV2373 le quadrivalent nanoparticle influenza reference formulations tekong. Moento oa motsoako o fumanoe ka kakaretso o mamelloa hantle. Mathata a tebileng a ne a sa tloaeleha 'me ha ho tse ileng tsa hlahlojoa hore li amana le ente.
Phuputso e sebelisitse lintlha tse hlalosang, ho lekola polokeho le likarabelo tsa sesole sa 'mele tsa mefuta e fapaneng ea ente ea CIC. Ho ile ha sebelisoa Moetso oa Moetso oa Liteko (DOE) ho rala teko, e nolofalletsang tokiso e matla haholoanyane ea khetho ea litekanyetso tsa li-antigen tsa COVID-19 le ntaramane bakeng sa nts'etsopele e eketsehileng ha e bapisoa le mekhoa ea khale. Liphetho tsa liteko tsa pele li fumane hore litlhare tse fapaneng tsa ente ea CIC li susumelitse karabelo ea 'mele ea ho itšireletsa mafung ho barupeluoa ho bapisoa le litšupiso tsa ntaramane e ikemetseng le liente tse ikemetseng tsa COVID-19 (bakeng sa li-antigen tsa H1N1, H3N2, B-Victoria HA le SARS-CoV-2 rS) . Liphetho tsa mohlala li boetse li bonts'a hore sebopeho se kopaneng se na le monyetla oa ho fokotsa palo eohle ea li-antigen ho fihlela ho 50% ka kakaretso, ho ntlafatsa tlhahiso le phano.
Ka bobeli liente tse thehiloeng ho protheine tse sebelisitsoeng tekong li entsoe ka sehlahisoa sa saponin-based sa Matrix-M™ se nang le tokelo ea molao ho matlafatsa karabelo ea 'mele ea ho itšireletsa mafung le ho susumetsa maemo a phahameng a li-antibodies. Lintlha tsena li tšehetsa tsoelo-pele ea teko ea netefatso ea Mokhahlelo oa 2, e lebelletsoeng ho qala mafelong a 2022.
Lintlha tse tsoang tekong li hlahisitsoe ho World Vaccine Congress (WVC) Washington, DC.
Influenza Program Update
Ho WVC, Novavax e boetse e lekola liphuputso tsa bohlokoa ho tsoa tekong ea Mokhahlelo oa 3 ea mokhethoa oa eona a le mong oa feberu, eo pele e neng e bitsoa NanoFlu, e ileng ea fihlela pheletso ea eona ea mantlha ea immunogenicity. Liphetho tsena li se li phatlalalitsoe ho The Lancet.
Ho fana ka tumello ho US
Leha e le NVX-CoV2373 kapa moemeli oa ente ea ntaramane ha aa lumelloa kapa a amohetsoe hore a sebelisoe US ke Tsamaiso ea Lijo le Lithethefatsi ea US.
Lintlha tsa Bohlokoa tsa Tšireletseho bakeng sa NVX-CoV2373
• NVX-CoV2373 e hanyetsanoa ho batho ba nang le hypersensitivity ho ntho e sebetsang, kapa ho leha e le efe ea li-excipients.
• Liketsahalo tsa anaphylaxis li tlalehiloe mabapi le tsamaiso ea liente tsa COVID-19. Kalafo le tlhokomelo e nepahetseng e lokela ho ba teng haeba ho ka ba le karabelo ea anaphylactic ka mor'a ho tsamaisoa ha ente. Ho khothaletsoa tlhokomeliso e haufi bonyane metsotso e 15 mme tekanyetso ea bobeli ea ente ha ea lokela ho fuoa ba nang le phihlelo ea anaphylaxis ho tekanyo ea pele ea NVX-CoV2373.
• Boitšoaro bo amanang le ho tšoenyeha, ho akarelletsa le vasovagal reactions (syncope), hyperventilation, kapa khatello ea kelello e amanang le maikutlo e ka 'na ea etsahala hammoho le ente e le karabo ea psychogenic ho ente ea nale. Ke habohlokoa hore ho be le mehato ea ho itšireletsa ho qoba kotsi ea ho akheha.
• Ho entoa ho lokela ho chechisoa ho batho ba tšoeroeng ke lefu le matla la febrile kapa tšoaetso e matla. Ho ba teng ha tšoaetso e nyane le / kapa feberu e tlase ha ea lokela ho lieha ho entoa.
• NVX-CoV2373 e lokela ho fanoa ka tlhokomeliso ho batho ba fumanang kalafo ea anticoagulant kapa ba nang le thrombocytopenia kapa lefu leha e le lefe la coagulation (joaloka haemophilia) hobane ho tsoa mali kapa matetetso a ka hlaha ka mor'a tsamaiso ea intramuscular ho batho bana.
• Ho sebetsa hantle ha NVX-CoV2373 ho ka ba tlase ho batho ba nang le immunosuppressed.
• Tsamaiso ea NVX-CoV2373 nakong ea bokhachane e lokela ho nahanoa feela ha melemo e ka bang teng e feta likotsi tse ka bang teng bakeng sa mme le lesea.
• Liphello tsa NVX-CoV2373 li ka ama ka nakoana bokhoni ba ho khanna kapa ho sebelisa mechini.
• Batho ba ka 'na ba se sireletsehe ka ho feletseng ho fihlela matsatsi a 7 ka mor'a tekanyo ea bona ea bobeli. Joalo ka liente tsohle, ente ea NVX-CoV2373 e kanna ea se sireletse bohle ba amohelang ente.
• Litlamorao tse atileng haholo tse ileng tsa bonoa nakong ea lithuto tsa bongaka e ne e le hlooho, ho nyekeloa ke pelo kapa ho hlatsa, myalgia, arthralgia, bonolo/bohloko sebakeng sa ente, mokhathala, le malaise.
SEO U LOKELANG HO SE NKA HO SEHLOOHO ENA:
- Close observation for at least 15 minutes is recommended and a second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of NVX-CoV2373.
- The safety and tolerability profile of the combination vaccine was consistent with the stand-alone NVX-CoV2373 and quadrivalent nanoparticle influenza vaccine reference formulations in the trial.
- Neither NVX-CoV2373 or the influenza vaccine candidate have been authorized or approved for use in the U.
