European Medicines Agency inoti Janssen vaccine yakachengeteka kushandisa - kunyangwe isingawanzo kuitika yekugwamba kweropa

Pamusangano wayo wa20 Kubvumbi 2021, EMA's Safety committee (PRAC) akagumisa kuti yambiro pamusoro pemagwamba eropa asina kujairika ane maplatelet eropa akaderera anofanira kuwedzerwa kune ruzivo rwechigadzirwa yeCOVID-19 Vaccine Janssen. PRAC akagumisawo kuti zviitiko izvi zvinofanirwa kunyorwa sezvisingawanzo mhedzisiro yejekiseni.

Pakusvika pakuguma kwayo, Komiti yakafunga nezvehumwe humbowo huripo huripo hunosanganisira mishumo masere kubva kuUnited States yezviitiko zvakakomba zveropa risina kujairika rine chokuita neropa rakaderera replatelet, rimwe rayo raiva nemigumisiro inouraya. Kubva musi wa13 Kubvumbi 2021, vanhu vanopfuura mamirioni manomwe vakagamuchira mushonga waJanssen muUnited States.

Mhosva dzese dzakaitika kune vanhu vari pasi pemakore makumi matanhatu ezera mukati memavhiki matatu mushure mekudzivirira, ruzhinji muvakadzi. Kubva pane humbowo huripo huripo, zvimwe zvinhu zvengozi hazvina kusimbiswa.

PRAC akacherechedza kuti kugwamba kweropa kwainyanya kuitika panzvimbo dzisina kujairika dzakadai semutsinga dziri muuropi (cerebral venous sinus thrombosis, CVST) uye dumbu (splanchnic vein thrombosis) uye mutsinga, pamwe nekuderera kwemaplatelet eropa uye dzimwe nguva kubuda ropa. Mhosva dzakaongororwa dzaive dzakafanana nenyaya dzakaitika neCCIDID-19 yekudzivirira yakagadziriswa neAstraZeneca, Vaxzevria.

Vanamazvikokota vezvehutano uye vanhu vachawana jekiseni vanofanira kuziva nezve mukana wezviitiko zvisingawanzoitiki zvemagwamba eropa akasanganiswa nekuderera kwemaplatelet eropa anoitika mukati memavhiki matatu ejekiseni.

COVID-19 yakabatana nenjodzi yekuiswa muchipatara uye kufa. Iko kutaurwa kusanganiswa kwemagwamba eropa uye kuderera kweplatelet eropa kushoma, uye mabhenefiti ese eCCIDID-19 Vaccine Janssen mukudzivirira COVID-19 anodarika njodzi dzemhedzisiro.

Ongororo yesainzi yeEMA inosimbisa kushandiswa kwakachengeteka uye kunoshanda kwemishonga yekudzivirira yeCOVID-19. Kushandiswa kwejekiseni panguva yekurwisa majekiseni padanho renyika kuchatarisa mamiriro edenda uye kuwanikwa kwejekiseni muNyika dzeNhengo.

Imwe tsananguro inonzwisisika yekubatanidzwa kweropa rekuvhara ropa uye kuderera kweplatelet yeropa ndeyekupindura kwemuviri, zvichiita kuti kuve nemamiriro akafanana neanoonekwa dzimwe nguva kune varwere vanobatwa neheparin inonzi heparin induced thrombocytopenia, HIT.

PRAC inosimbisa kukosha kwekukasika kurapwa kwenyanzvi. Nokuziva zviratidzo zvokugwamba kweropa uye kuderera kwe<em>platelet eropa ndokuzvirapa nokukurumidza, nyanzvi dzezvoutano dzinogona kubatsira vaya vanenge vawirwa nedambudziko pakupora uye kudzivisa matambudziko. Thrombosis yakabatana ne thrombocytopenia inoda nyanzvi yekiriniki manejimendi. Vanamazvikokota vezvehutano vanofanirwa kubvunza nhungamiro inoshanda uye/kana kubvunza vanamazvikokota (semuenzaniso, vehematologists, mazvikokota mukugwinya) kuti vaongorore uye varape chirwere ichi.

Kana ari majekiseni ese, EMA icharamba ichitarisa kuchengetedzeka nekushanda kwejekiseni uye kupa veruzhinji ruzivo rwechizvino-zvino.

A kufanana kwechiratidzo chekuongorora kwakapedzwa nguva pfupi yapfuura kune imwe yekudzivirira yeCOVID-19, Vaxzevria (yaimbova COVID-19 Vaccine AstraZeneca).

Ruzivo kune veruzhinji

• Mhosva dzeasina kujairika ropa clots ane akaderera maplatelet akaitika muvanhu vakagamuchira Janssen's COVID-19 yekudzivirira muUnited States.
• Ngozi yekuva nechirwere ichi yakadzikira zvakanyanya, asi vanhu vanozowana vaccine vanofanirwa kuramba vachiziva zviratidzo kuitira kuti vawane kurapwa nekukurumidza kubatsira kupora uye kudzivirira matambudziko.
• Vanhu vanofanirwa kutsvaga kurapwa nekukurumidza kana vaine chero chezvinotevera zviratidzo mumavhiki matatu mushure mekubaiwa neCOVID-19 Vaccine Janssen:
  • Kufema kwekufema;
  • kurwadziwa muchipfuva;
  • gumbo kuzvimba;
  • marwadzo anoramba ari mudumbu (mudumbu);
  • zviratidzo zvetsinga, zvakadai semusoro wakaoma uye unoramba uripo kana kusaona, uye;
  • madiki madiki eropa pasi peganda kunze kwenzvimbo yejekiseni.
• Taura nenyanzvi yako yezvehutano kana taura nevakuru vezvehutano munyika kana uine mibvunzo nezvejekiseni rako.

Ruzivo rwevashandi vehutano

• EMA yakaongorora nyaya sere dze thrombosis pamwe chete nethrombocytopenia muvanhu vakawana Janssen's COVID-19 vaccine muUnited States.

• Aya marudzi asingawanzowaniki ethrombosis (ane thrombocytopenia) aisanganisira venous thrombosis kazhinji munzvimbo dzisina kujairika dzakadai secerebral venous sinus thrombosis uye splanchnic vein thrombosis, pamwe ne arterial thrombosis, uye mhedzisiro inouraya mune imwe nyaya. Mhosva dzese dzakaitika muvanhu vari pasi pemakore makumi matanhatu ekuberekwa, uye vazhinji vaive muvakadzi, mukati memavhiki matatu munhu ange abaiwa.
• Mhosva dzakaongororwa dzaive dzakafanana nenyaya dzakaitika neCCIDID-19 yekudzivirira yakagadziriswa neAstraZeneca, Vaxzevria.
• Kana iri iyo michina, inofungidzirwa kuti yekudzivirira inogona kukonzeresa mhinduro yekudzivirira inotungamira kune heparin-induced-thrombocytopenia senge kusagadzikana. Panguva ino, maitiro epathophysiological haasati asimbiswa, uye iye zvino hazvigoneki kuziva zvakananga zvinokonzera njodzi.
• Vashandi vezvehutano vanofanirwa kuve vakangwarira kune zviratidzo uye zviratidzo zve thromboembolism uye thrombocytopenia kuitira kuti vagone kukurumidza kurapa vanhu vanobatwa zvinoenderana nezviripo. zvekutevedzera.
• Thrombosis pamwe chete ne thrombocytopenia inoda nyanzvi yekiriniki manejimendi. Vanamazvikokota vezvehutano vanofanirwa kubvunza nhungamiro inoshanda uye/kana kubvunza vanamazvikokota (semuenzaniso, vehematologists, mazvikokota mukugwinya) kuti vaongorore uye varape chirwere ichi.
• Vashandi vezvehutano vanofanirwa kuudza vanhu vanotambira jekiseni kuti vanofanirwa kutsvaga kurapwa kana vakakura:
  • zviratidzo zvemagwamba eropa sekupfupika kwekufema, kurwadziwa muchipfuva, kuzvimba gumbo, kurwadziwa kwemudumbu kunoramba kuripo.
  • neurological zviratidzo zvakadai semusoro wakakomba uye unoramba uripo uye kusaona
  • petechiae kupfuura nzvimbo yekudzivirira mushure memazuva mashoma.
• Mabhenefiti ejekiseni anoenderera mberi achipfuura njodzi kune vanhu vanougamuchira. Mushonga wekudzivirira unoshanda mukudzivirira COVID-19 uye kuderedza kuchipatara uye kufa.

Yakanangana nenyanzvi yezvehutano kutaurirana (DHPC) ichatumirwa kuvashandi vehutano vanobatanidzwa mukupa jekiseni muEU. Iyo DHPC ichave zvakare rakabudiswa.

Zvakawanda nezvejekiseni

COVID-19 Vaccine Janssen ijekiseni rekudzivirira chirwere checonavirus 2019 (COVID-19) muvanhu vane makore gumi nemasere zvichikwira. COVID-18 inokonzerwa nehutachiona hweSARS-CoV-19. COVID-2 Vaccine Janssen inoumbwa nehumwe hutachiona (hwemhuri yeadenovirus) iyo yakagadziridzwa kuti ive nejena rekugadzira protein kubva kuSARS-CoV-19. COVID-2 Vaccine Janssen haina hutachiona pachayo uye haigone kukonzera COVID-19.

Iwo akajairika mhedzisiro neCCIDID-19 Vaccine Janssen anowanzo hunyoro kana pakati nepakati uye anovandudza mukati memazuva mashoma mushure mekudzivirira. Ruzivo rwakawanda zviripo.

COVID-19 Vaccine Janssen akatenderwa muEU musi wa11 Kurume 2021; kuburitswa kwejekiseni muEU kwakave kwenguva pfupi kunonoka nekambani.

Zvimwe nezve maitiro

The ongororo yezviitiko zvethromboembolic neCOVID-19 Vaccine Janssen irikuitwa muchirevo che a chengetedzo chiratidzo, pasi penguva yakakurumidza. A chengetedzo chiratidzo iruzivo rwechitsva kana chisina kunyorwa chiitiko chakashata izvo zvingangove zvichikonzerwa nemushonga uye zvinoda kuti kuongororwazve. Kuvapo kwe a chengetedzo chiratidzo hazvirevi hazvo kuti mushonga wakonzera kushumwa chiitiko chakashata. Kuongororwa kwe kuchengeteka zviratidzo inotsvaga kuona kana hukama hwechikonzero pakati pemushonga ne chiitiko chakashata zvingangoita zvine musoro.

Ongororo iyi iri kuitwa neEMA's Pharmacovigilance Risk Ongororo Komiti (PRAC), Komiti inoona nezvekuchengetedzwa kwemishonga yevanhu. Kana kuongorora kwapera, PRAC ichaita mamwe mazano sezvinodiwa kuderedza njodzi uye kuchengetedza hutano hwevarwere. Komiti yeEMA Human Medicine, CHMP, zvino ichakurumidza kuongorora chero shanduko dzinodiwa kune ruzivo rwechigadzirwa.

Ongororo yesainzi yeEMA inosimbisa kushandiswa kwakachengeteka uye kunoshanda kwemishonga yekudzivirira yeCOVID-19. Kurudziro dzeEMA ndidzo hwaro uhwo nyika dzenhengo dzeEU dzichagadzira nekuita mishandirapamwe yadzo yenyika. Izvi zvinogona kusiyana nenyika nenyika zvichienderana nezvinodiwa nenyika yavo nemamiriro ezvinhu, zvakaita sehuwandu hwehutachiona, huwandu hwevanhu vanonyanya kukoshesa, kuwanikwa kwejekiseni uye mitengo yekurapwa muchipatara.

• COVID-19 Vaccine Janssen: EPAR
• Musangano unoshamisa wePharmacovigilance Risk Assessment Committee (PRAC): 20 Kubvumbi 2021
• COVID-19 Vaccine Janssen: ongororo yezvisingawanzo kuitika zvemagwamba eropa ane akaderera maplatelet anoenderera mberi (14 / 04 / 2021)
• Mhemberero dzemusangano kubva kuPharmacovigilance Risk Assessment Committee (PRAC) 6-9 Kubvumbi 2021 (09 / 04 / 2021)
• COVID-19: zvichangobva kuitika
• COVID-19 vaccine: mvumo
• Pharmacovigilance Risk Assessment Committee (PRAC)
• Kukurukurirana kwakananga kwehutano hwehutano

Goverana ichi chinyorwa: