Iindaba

UGcino lwesitofu se-Covid-19

Yintoni uGonyo lwe-Covid-19?
Isitofu sokugonya se-Covid-19, esithengiswa phantsi kwegama le-brand Comirnaty, sisitofu sokugonya esisekwe kwi-mRNA kwi-Covid-19.Yenzelwe izilingo zeklinikhi kunye nokuveliswa.Isitofu sokugonya sinikezelwa ngenaliti ye-intramuscular, efuna iidosi ezimbini zinikwe ngokushiyana kweeveki ezintathu.Lolunye lwezitofu ezimbini ze-RNA ezifakwe ngokuchasene ne-Covid-19 ngo-2020, kunye nogonyo lweModerna.

Isitofu sokugonya yayisisitofu sokuqala se-COVID-19 ukugunyaziswa ngugunyaziwe olawulayo ukuba asetyenziswe ngexesha likaxakeka kwaye esokuqala savulelwa ukusetyenziswa rhoqo.NgoDisemba ka-2020, i-United Kingdom yaba lilizwe lokuqala ukugunyazisa isitofu sokugonya ngexesha likaxakeka, kungekudala yalandelwa yi-United States, i-European Union kunye namanye amazwe amaninzi kwihlabathi liphela.Kwihlabathi jikelele, iinkampani zijolise ekuveliseni malunga ne-2.5 yezigidigidi zeedosi ngo-2021. Nangona kunjalo, ukusasazwa kunye nokugcinwa kwesitofu sokugonya ngumceli mngeni wenkqubo kuba kufuneka sigcinwe kumaqondo obushushu aphantsi kakhulu.

Zeziphi izithako kuGonyo lwe-Covid-19?
Ugonyo lwe-Pfizer BioNTech Covid-19 sisitofu sokugonya i-RNA (mRNA) esinazo zombini izinto ezenziweyo, okanye eziveliswe ngokwekhemikhali, kunye nezinto ezenziwe nge-enzymatically ezivela kwizinto ezenzeka ngokwendalo ezifana neeproteni.Isitofu sokugonya asinayo nayiphi na intsholongwane ephilayo.Izithako zayo ezingasebenziyo ziquka i-potassium chloride, i-potassium monobasic, i-phosphate, i-sodium chloride, i-dibasic sodium phosphate dihydrate, kunye ne-sucrose, kunye neemali ezincinci zezinye izithako.

Ukugcinwa koGonyo lwe-Covid-19
Okwangoku, isitofu sokugonya kufuneka sigcinwe kwisikhenkcisi esisezantsi kakhulu kumaqondo obushushu aphakathi kwe -80ºC kunye ne -60ºC, apho sinokugcinwa ukuya kutsho kwiinyanga ezintandathu.Isenokuthi ifakwe efrijini ukuya kwiintsuku ezintlanu kwiqondo lokushisa eliqhelekileyo lefriji (phakathi kwe + 2⁰C kunye + 8⁰C) ngaphambi kokuxuba kunye ne-saline diluent.

Ithunyelwa kwisikhongozeli sokuhambisa esilungiselelwe ngokukodwa esinokuthi sisetyenziswe njengendawo yokugcina ixesha ukuya kwiintsuku ze-30.

Nangona kunjalo, iPfizer kunye neBioNTech zisandula ukungenisa idatha entsha kwi-US Food and Drug Administration (FDA) ebonisa ukuzinza kwesitofu sokugonya se-Covid-19 kumaqondo obushushu ashushu.Idatha entsha ibonisa ukuba inokugcinwa phakathi kwe -25 ° C ukuya -15 ° C, amaqondo obushushu axhaphake afunyanwa kwiifriji zamachiza kunye neefriji.

Ukulandela le datha, i-EU kunye ne-FDA e-USA ziphumeze ezi meko zintsha zokugcina zivumela isitofu sokugonya ngoku ukuba sigcinwe kubushushu obuqhelekileyo besikhenkcisi samayeza isithuba seeveki ezimbini zizonke.

Olu hlaziyo kwiimfuno zangoku zokugcinwa kwesitofu sokugonya se-Pfizer luya kujongana nemida ethile malunga nokusasazwa kwe-jab kwaye inokuvumela ukukhutshwa ngokulula kwesitofu sokugonya kumazwe aswele isiseko sokuxhasa amaqondo obushushu okugcina asezantsi, okwenza ukuhanjiswa kube ngaphantsi kwe inkxalabo.

Kutheni ubushushu bogcino lwesitofu se-Covid-19 bubanda kangaka?
Isizathu sokuba isitofu sokugonya se-Covid-19 kufuneka sigcinwe sibanda kangaka kungenxa ye-mRNA ngaphakathi.Ukusetyenziswa kwetekhnoloji ye-mRNA ibe ngundoqo ekuphuhliseni isitofu sokugonya esikhuselekileyo, esisebenzayo ngokukhawuleza, kodwa i-mRNA ngokwayo ibuthathaka ngendlela emangalisayo njengoko yonakala ngokukhawuleza kwaye ngokulula.Oku kuzinziswa kuko okwenze ukuphuhlisa isitofu sokugonya esekwe kwi-mRNA kube ngumngeni kwixesha elidlulileyo.

Ngethamsanqa, umsebenzi omninzi ngoku uye ekuphuhliseni iindlela kunye netekhnoloji eyenza i-mRNA izinze ngakumbi, ngoko inokufakwa ngempumelelo kwisitofu sokugonya.Nangona kunjalo, izitofu zokuqala ze-Covid-19 mRNA zisafuna ugcino olubandayo malunga ne-80ºC ukuqinisekisa ukuba i-mRNA engaphakathi kwesitofu sokugonya ihlala izinzile, ebanda kakhulu kunoko kunokwenziwa sisikhenkcisi esisemgangathweni.La maqondo obushushu abandayo kakhulu afuneka kuphela ekugcinweni njengoko isitofu sokugonya sinyibilika phambi kokutofwa.

Iimveliso zeCarebios zoGcino lwesitofu
Izikhenkcisi zeCarebios zobushushu obuphantsi kakhulu zibonelela ngesisombululo sogcino lobushushu obuphantsi kakhulu, olulungele isitofu sokugonya se-Covid-19.Izikhenkcisi zethu zobushushu obuphantsi kakhulu, ezikwaziwa ngokuba zizikhenkcisi ze-ULT, ngokuqhelekileyo zineqondo lobushushu obuphakathi kwe -45 ° C ukuya -86 ° C kwaye zisetyenziselwa ukugcinwa kwamachiza, ii-enzymes, iikhemikhali, iibhaktheriya kunye nezinye iisampuli.

Izikhenkcezisi zethu zobushushu obuphantsi ziyafumaneka kwidizayini ezahlukeneyo kunye nobukhulu ngokuxhomekeke kubungakanani bogcino olufunekayo.Kukho iinguqulelo ezimbini ngokubanzi, isikhenkcisi esime nkqo okanye isikhenkcisi sesifuba esinokufikelela kwindawo ephezulu.Umthamo wokugcina wangaphakathi unokuqala ngokubanzi ukusuka kumthamo wangaphakathi we-128 ilitha ukuya kumthamo omkhulu we-730 ilitha.Ngokuqhelekileyo ineeshelufu ngaphakathi apho iisampulu zophando zibekwe kwaye ishelufu nganye ivalwe ngocango lwangaphakathi ukuze kugcinwe ubushushu bufana ngokusemandleni.

Uluhlu lwethu lwe -86 ° C lwezikhenkcezisi ezisezantsi kakhulu ziqinisekisa ukhuseleko oluphezulu lweesampulu ngamaxesha onke.Ukukhusela isampuli, umsebenzisi kunye nokusingqongileyo, izikhenkcisi zethu zobushushu obuphantsi zenziwa ngokwemigangatho yamazwe ngamazwe nto leyo ethetha ukuba ukusebenza ngendlela eyonga amandla okonga imali nokunceda ukugcina ukukhutshwa kokusingqongileyo kuphantsi.

Ngexabiso elingenakoyiswa lemali, uluhlu lwethu lobushushu obuphantsi lwezikhenkcisi lulungele ukugcinwa kwesampulu yexesha elide.Imiqulu ecetywayo isuka kwi-128 ukuya kwi-730L.

Izikhenkcisi eziphantsi kakhulu ziyilelwe ukhuseleko oluphezulu enkosi kuyilo olomeleleyo, olubonelela ukugcinwa lula kunye nokuthobela imithetho emitsha yokusingqongileyo ye-F-Gas.

Nxibelelana ngolwazi oluthe kratya
Ukufumana ulwazi oluthe kratya malunga nezikhenkcezisi ezinobushushu obuphantsi esizinikezelayo eCarebios okanye ukubuza malunga nesikhenkcezisi esineqondo eliphantsi kakhulu ukuze sigcine isitofu sokugonya i-Covid-19, nceda ungalibazisi ukunxibelelana nelungu leqela lethu namhlanje.


Ixesha lokuposa: Jan-21-2022