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Ma lalo o ka malu o ka maʻi maʻi Covid-19, ke kū nei ke olakino lehulehu o ka honua i nā pilikia i ʻike ʻole ʻia. Eia nō naʻe, i loko o kahi pilikia i hōʻike ʻia e ka ʻepekema a me ka ʻenehana i ko lākou mana nui a me ka mana. Mai ka puka ʻana mai o ka maʻi ahulau, ua hui pū ke kaiāulu ʻepekema honua a me nā aupuni e hāpai i ka hoʻomohala wikiwiki ʻana a me ka hoʻolaha ʻana i nā lāʻau lapaʻau, e loaʻa ana nā hopena kupaianaha. Eia nō naʻe, ʻo nā pilikia e like me ka hāʻawi like ʻole ʻana o nā kano a me ka lawa ʻole o ka makemake o ka lehulehu e loaʻa i nā lāʻau lapaʻau e hoʻopilikia mau nei i ka hakakā honua i ka maʻi maʻi.

Ma mua o ka maʻi maʻi maʻi Covid-19, ʻo ka maʻi maʻi maʻi 1918 ka maʻi maʻi maʻi ʻino loa i ka mōʻaukala US, a ʻo ka nui o ka make i hoʻokumu ʻia e kēia maʻi maʻi Covid-19 ua aneane ʻelua ʻelua o ka maʻi maʻi 1918. Ua alakaʻi ka maʻi maʻi maʻi Covid-19 i ka holomua maikaʻi loa ma ke kahua o nā kano, e hāʻawi ana i nā lāʻau lapaʻau palekana a maikaʻi hoʻi no ke kanaka a me ka hōʻike ʻana i ka hiki o ke kaiāulu olakino e pane koke i nā pilikia nui i mua o nā pono olakino olakino. E pili ana i kahi moku'āina palupalu i ka ʻāina āpau a me ka honua āpau, me nā pilikia e pili ana i ka hāʻawi ʻana a me ka hoʻokele. ʻO ke kolu o ka ʻike he mea koʻikoʻi ka pilina ma waena o nā ʻoihana pilikino, nā aupuni, a me nā kula no ka hoʻolaha ʻana i ka hoʻomohala wikiwiki ʻana o ka maʻi kanulau mua o Covid-19. Ma muli o kēia mau haʻawina i aʻo ʻia, ke ʻimi nei ka Biomedical Advanced Research and Development Authority (BARDA) i ke kākoʻo no ka hoʻomohala ʻana i kahi hanauna hou o nā kano i hoʻomaikaʻi ʻia.

ʻO ka papahana NextGen he $ 5 biliona kālā i hoʻokumu ʻia e ke Keʻena ʻOihana Ola a me nā lawelawe kanaka i manaʻo ʻia e hoʻomohala i ka hanauna hou o nā ʻōnaehana olakino no Covid-19. E kākoʻo kēia hoʻolālā i nā hoʻāʻo ʻelua makapō, hoʻokele ikaika i ka Phase 2b e loiloi i ka palekana, ka pono, a me ka immunogenicity o nā lāʻau lapaʻau hoʻokolohua e pili ana i nā lāʻau lapaʻau i ʻae ʻia i nā lāhui like ʻole a me ka lāhui. Manaʻo mākou e pili kēia mau kahua kano i nā maʻi maʻi maʻi ʻē aʻe, e hiki ai iā lākou ke pane koke i nā hoʻoweliweli olakino a me ka palekana. E pili ana kēia mau hoʻokolohua i nā manaʻo he nui.

ʻO ka hopena nui o ka Phase 2b hoʻokolohua lapaʻau i manaʻo ʻia he hoʻomaikaʻi maikaʻi ʻana o ka lāʻau lapaʻau ma mua o 30% ma luna o kahi manawa nānā 12 mau mahina i hoʻohālikelike ʻia me nā kano i ʻae ʻia. E loiloi ka poʻe noiʻi i ka maikaʻi o ke kano hou e pili ana i kona hopena pale e kū'ē i ka maʻi Covid-19; Eia kekahi, ma ke ʻano he hope lua, e hoʻāʻo pono nā mea komo me nā swabs ihu i kēlā me kēia pule e loaʻa ai ka ʻikepili no nā maʻi asymptomatic. Hoʻokumu ʻia nā lāʻau lapaʻau i kēia manawa ma ʻAmelika i nā spike protein antigens a lawelawe ʻia ma o ka intramuscular injection, aʻo ka hanauna e hiki mai ana o nā kano moho e hilinaʻi i kahi kahua ʻē aʻe, me nā spike protein genes a me nā wahi i mālama ʻia o ka genome virus, e like me nā genes encoding nucleocapsid, membrane, a i ʻole nā ​​​​protein kino ʻole. Hiki i ke kahua hou ke hoʻokomo i nā lāʻau lapaʻau viral recombinant e hoʻohana ana i nā vectors me / ʻaʻole hiki ke hana hou a loaʻa i nā ʻano genes e hoʻopili ana i ka SARS-CoV-2 structural and non structural proteins. ʻO ka lāʻau lapaʻau mRNA (samRNA) o ka lua o ka hanauna he ʻano ʻenehana wikiwiki e hiki ke loiloi ʻia ma ke ʻano he hopena ʻē aʻe. Hoʻopili ka lāʻau lapaʻau samRNA i nā replika e lawe ana i nā kaʻina immunogenic i koho ʻia i loko o nā nanoparticles lipid e hoʻoulu i nā pane kūlohelohe kūpono. ʻO nā mea maikaʻi loa o kēia kahua e loaʻa i nā kaila RNA haʻahaʻa (hiki ke hōʻemi i ka hoʻoulu ʻana), ʻoi aku ka lōʻihi o ka pane ʻana i ka pale ʻana, a ʻoi aku ka paʻa o nā lāʻau lapaʻau paʻa i nā wela o ka friji.

ʻO ka wehewehe ʻana o ka correlation of protection (CoP) he mea hoʻohālikelike adaptive humoral a me ka cellular immune pane e hiki ke hāʻawi i ka pale mai ka maʻi a i ʻole ka hoʻopili hou ʻana me nā pathogens kikoʻī. E loiloi ka hoʻāʻo ʻana o ka Phase 2b i nā CoPs o ke kano Covid-19. No nā maʻi he nui, me nā coronaviruses, he paʻakikī mau ka hoʻoholo ʻana i ka CoP no ka mea e hana pū ana nā ʻāpana he nui o ka pane immune e hoʻopau i ka maʻi, me ka neutralizing a me ka non neutralizing antibodies (e like me ka agglutination antibodies, precipitation antibodies, a i ʻole hoʻohui i nā antibodies fixation), isotype antibodies, CD4+ a me CD8+T cell, antibody Fc effector function, a me nā cell memory. ʻOi aku ka paʻakikī, ʻokoʻa ke kuleana o kēia mau ʻāpana i ke kūʻē ʻana iā SARS-CoV-2 ma muli o ka pūnaewele anatomical (e like me ka circulation, tissue, a i ʻole respiratory mucosal surface) a me ka hopena i manaʻo ʻia (e like me ka maʻi asymptomatic, maʻi hōʻailona, ​​a i ʻole maʻi koʻikoʻi).

ʻOiai ke paʻakikī nei ka ʻike ʻana i ka CoP, hiki i nā hopena o nā hoʻāʻo kano ma mua o ka ʻae ʻia ke kōkua i ka helu ʻana i ka pilina ma waena o ka neʻe ʻana i nā pae antibody a me ka maikaʻi o ke kano. E ʻike i kekahi mau pono o CoP. Hiki i kahi CoP piha ke hana i nā haʻawina hoʻopalekana pale ʻana ma nā kahua kano hou i ʻoi aku ka wikiwiki a ʻoi aku ka maikaʻi ma mua o nā hoʻāʻo ʻana i ka placebo-controlled, a kōkua i ka loiloi i ka hiki ke pale i ka maʻi kano o nā heluna kanaka ʻaʻole i hoʻokomo ʻia i nā hoʻāʻo ʻana i ka pono o ka lāʻau lapaʻau, e like me nā keiki. ʻO ka hoʻoholo ʻana i ka CoP hiki ke loiloi i ka lōʻihi o ka pale ʻana ma hope o ka maʻi me nā maʻi hou a i ʻole ka hoʻopaʻa ʻana i nā maʻi hou, a kōkua i ka hoʻoholo ʻana i ka wā e pono ai nā pana hoʻoikaika.

Ua ʻike ʻia ka ʻano ʻano Omicron mua i Nowemapa 2021. Ke hoʻohālikelike ʻia me ke kānana kumu, aia ma kahi o 30 mau waikawa amino i pani ʻia (me 15 mau amino acids i loko o ka protein spike), a no laila ua koho ʻia ʻo ia he ʻano o ka hopohopo. I ka maʻi maʻi ma mua i hoʻokumu ʻia e nā ʻano like ʻole COVID-19 e like me alpha, beta, delta a me kappa, ua hōʻemi ʻia ka hana neutralizing o nā antibodies i hana ʻia e ka maʻi a i ʻole ka hoʻopaʻa ʻana i ka ʻano Omikjon, kahi i hoʻololi ai ʻo Omikjon i ka virus delta ma ka honua i loko o kekahi mau pule. ʻOiai ua emi ka mana o ka replication o Omicron i nā ʻōpū hanu haʻahaʻa i hoʻohālikelike ʻia i nā maʻi mua, ua alakaʻi mua ia i ka piʻi nui o ka maʻi maʻi. ʻO ka hoʻololi hou ʻana o ka ʻano ʻano Omicron i hoʻonui mālie i kona hiki ke pale aku i nā antibodies neutralizing i kēia manawa, a ua hoʻonui pū ʻia kāna hana hoʻopaʻa ʻana i ka angiotensin converting enzyme 2 (ACE2) receptors, e alakaʻi ana i ka piʻi ʻana o ka hoʻouna ʻana. Eia naʻe, he haʻahaʻa loa ka haʻahaʻa o ke kaumaha o kēia mau maʻi (me nā keiki JN.1 o BA.2.86). ʻO ka palekana non humoral paha ke kumu o ka haʻahaʻa haʻahaʻa o ka maʻi i hoʻohālikelike ʻia me nā hoʻouna mua. ʻO ke ola ʻana o nā maʻi maʻi Covid-19 ʻaʻole i hana i nā antibodies neutralizing (e like me ka poʻe me ka mālama ʻana i ka hemahema B-cell) e hōʻike hou ana i ke koʻikoʻi o ka palekana cellular.

Hōʻike kēia mau ʻike i ka liʻiliʻi o ka hoʻomanaʻo antigen-specific cell T e ka spike protein escape mutations i nā ʻano mutant i hoʻohālikelike ʻia me nā antibodies. Me he mea lā hiki i nā pūnaewele T hoʻomanaʻo ke hoʻomaopopo i nā epitopes peptide i mālama nui ʻia ma nā kāʻei hoʻopaʻa hoʻopaʻa hoʻopaʻa protein spike a me nā mea ʻē aʻe i hoʻopaʻa ʻia i ka hoʻopaʻa ʻana a me nā protein ʻole. Hiki i kēia ʻike ke wehewehe i ke kumu o ka pili ʻana o nā ʻano mutant me ka haʻahaʻa haʻahaʻa i nā antibodies neutralizing i kēia manawa me ka maʻi ʻoi aku ka maʻalahi, a kuhikuhi i ka pono o ka hoʻomaikaʻi ʻana i ka ʻike ʻana o nā pane pale pale T cell-mediated.

ʻO ka ʻūhā o luna ka wahi mua o ka hoʻopili ʻana a me ke komo ʻana no nā maʻi hanu e like me nā coronaviruses (ua waiwai ka epithelium ihu i nā mea hoʻokipa ACE2), kahi i loaʻa ai nā pane kūlohelohe kūlohelohe a adaptive. ʻO nā lāʻau lapaʻau intramuscular i loaʻa i kēia manawa he palena liʻiliʻi ka hiki ke hoʻoulu i nā pane immune mucosal ikaika. I nā heluna kanaka me ka nui o ka lā'au lapa'au, hiki i ka ho'omau 'ia 'ana o ka ma'i 'oko'a ke ho'oikaika i ke ko'iko'i ma luna o ka 'ano like 'ole, e ho'onui ana i ka hiki 'ole o ka pakele. Hiki i nā lāʻau lapaʻau mucosal ke hoʻoulu i nā pane immune mucosal respiratory kūloko a me nā pane immune systemic, e kaupalena ana i ka hoʻouna ʻana i ke kaiāulu a hoʻolilo iā lākou i kano kūpono. ʻO nā ala ʻē aʻe o ka lāʻau lapaʻau ʻo ia ka intradermal (microarray patch), waha (papa), intranasal (spray or drop), a i ʻole inhalation (aerosol). ʻO ka puka ʻana mai o nā lāʻau lapaʻau pono ʻole hiki ke hōʻemi i ka kānalua i nā lāʻau lapaʻau a hoʻonui i ko lākou ʻae ʻana. Ma waho o ke ala i hana ʻia, ʻo ka hoʻomaʻamaʻa maʻalahi e hōʻemi i ke kaumaha o nā limahana mālama olakino, ma laila e hoʻomaikaʻi ai i ka loaʻa ʻana o ka maʻi kano a me ka hoʻomaʻamaʻa ʻana i nā hana pane maʻi maʻi e hiki mai ana, ʻoiai inā pono e hoʻokō i nā papahana lapaʻau nui. E loiloi ʻia ka maikaʻi o nā lāʻau lapaʻau hoʻoikaika kino hoʻokahi me ka hoʻohana ʻana i ka enteric coated, nā papa lāʻau lapaʻau paʻa wela a me nā lāʻau lapaʻau intranasal ma ka loiloi ʻana i nā pane IgA antigen-specific i loko o ka ʻōpū a me ka hanu.

Ma nā ho'āʻo hoʻokolohua lapaʻau 2b, ʻoi aku ka nui o ka nānā pono ʻana i ka palekana o ka poʻe komo e like me ka hoʻomaikaʻi ʻana i ka pono o ke kano. E hōʻiliʻili a kālele mākou i ka ʻikepili palekana. ʻOiai ua hōʻoia maikaʻi ʻia ka palekana o nā lāʻau lapaʻau Covid-19, hiki ke loaʻa nā hopena ʻino ma hope o ka hoʻopaʻa ʻana. Ma ka ho'āʻo NextGen, ma kahi o 10000 mau mea komo e hoʻopaʻa ʻia i ka loiloi hopena ʻino a e hāʻawi wale ʻia no ka loaʻa ʻana o ka lāʻau lapaʻau hoʻāʻo a i ʻole ka lāʻau lapaʻau laikini ma kahi ratio 1:1. ʻO ka loiloi kikoʻī o nā hopena ʻino kūloko a me ka systemic e hāʻawi i ka ʻike koʻikoʻi, me ka loaʻa ʻana o nā pilikia e like me ka myocarditis a i ʻole pericarditis.

ʻO kahi paʻakikī koʻikoʻi e kū nei e nā mea hana kano ka pono e mālama i nā hiki ke pane wikiwiki; Pono nā mea hana e hana i nā haneli miliona o nā kano i loko o 100 mau lā o ka laha, ʻo ia hoʻi kahi pahuhopu i hoʻonohonoho ʻia e ke aupuni. Ke nawaliwali nei ka maʻi maʻi a me ka hoʻokokoke ʻana o ka maʻi maʻi maʻi, e emi loa ka noi ʻana i ke kano, a e kū ana nā mea hana i nā pilikia e pili ana i ka mālama ʻana i nā kaulahao lako, nā mea kumu (enzymes, lipids, buffers, a me nucleotides), a me ka hoʻopiha a me ka hiki ke hana. I kēia manawa, ʻoi aku ka haʻahaʻa o ka noi no nā kano Covid-19 i loko o ke kaiāulu ma mua o ka noi ma 2021, akā pono e hōʻoia ʻia nā kaʻina hana e hana ana ma kahi ʻano liʻiliʻi ma mua o ka "maʻi maʻi piha piha" e hōʻoia ʻia e nā luna hoʻoponopono. Pono pū ka hoʻomohala ʻana i nā lāʻau lapaʻau i ka hōʻoia ʻana mai nā luna hoʻoponopono, e komo pū ana me nā haʻawina kūlike o waena a me nā hoʻolālā efficacy Phase 3. Inā maikaʻi nā hopena o ka hoʻokolohua Phase 2b i hoʻolālā ʻia, e hōʻemi nui ia i nā pilikia e pili ana i ka hoʻokō ʻana i nā hoʻokolohua Phase 3 a hoʻoulu i ka hoʻopukapuka pilikino i ia mau hoʻokolohua, no laila hiki ke hoʻokō i ka hoʻomohala ʻoihana.

ʻAʻole ʻike ʻia ka lōʻihi o ka hiatus maʻi maʻi i kēia manawa, akā ʻo ka ʻike hou e hōʻike nei ʻaʻole pono e hoʻopau ʻia kēia manawa. Ua hāʻawi kēia manawa iā mākou i kahi manawa e hoʻonui ai i ka ʻike o ka poʻe no ka maʻi immunology a kūkulu hou i ka hilinaʻi a me ka hilinaʻi i nā lāʻau lapaʻau no nā poʻe he nui.