{"id":134028,"date":"2021-06-28T13:59:41","date_gmt":"2021-06-28T10:59:41","guid":{"rendered":"https:\/\/www.btv.md\/?p=134028"},"modified":"2021-06-28T13:59:41","modified_gmt":"2021-06-28T10:59:41","slug":"cand-vaccinul-rusesc-va-putea-sa-intre-oficial-pe-piata-europeana-si-de-ce-depinde-acest-lucru","status":"publish","type":"post","link":"https:\/\/www.btv.md\/ro\/cand-vaccinul-rusesc-va-putea-sa-intre-oficial-pe-piata-europeana-si-de-ce-depinde-acest-lucru\/","title":{"rendered":"C\u00e2nd vaccinul rusesc va putea s\u0103 intre oficial pe pia\u021ba european\u0103 \u0219i de ce depinde acest lucru"},"content":{"rendered":"<div class=\"txt f-s-18 l-h-29 post-content-block\">\n<p><strong>S\u0103pt\u0103m\u00e2na trecut\u0103 Reuters a relatat, cit\u00e2nd surse proprii, c\u0103 aprobarea vaccinului Sputnik V de c\u0103tre Agen\u021bia European\u0103 a Medicamentului (EMA) va fi am\u00e2nat\u0103 p\u00e2n\u0103 \u00een septembrie \u0219i, poate chiar p\u00e2n\u0103 la sf\u00e2r\u0219itul anului. Potrivit publica\u021biei, Institutul Gamalei, unde a fost dezvoltat vaccinul, nu a furnizat datele necesare \u00een intervalul de timp specificat, relateaz\u0103 <a href=\"https:\/\/www.zdg.md\/stiri\/stiri-externe\/cand-vaccinul-rusesc-va-putea-sa-intre-oficial-pe-piata-europeana-si-de-ce-depinde-acest-lucru\/\">zdg.md<\/a>.<\/strong><\/p>\n<p><strong>Funda\u021bia de Investi\u021bii Directe din Rusia, care a depus cererea la EMA, a calificat cele relatate de Reuters drept specula\u021bii. Funda\u021bia a raportat c\u0103 toate \u201edatele privind studiile clinice ale vaccinului Sputnik V au fost furnizate, inspec\u021bia GCP (good clinical practice) a fost finalizat\u0103, \u0219i pe baza rezultatelor primite EMA a emis o incheiere pozitiv\u0103. Ei cred ca \u00een termen de dou\u0103 luni Sputnik V va primi und\u0103 verde \u00een Europa.<\/strong><\/p>\n<p>\u00cen\u021belegem \u00een ce stadiu este acum Sputnik \u0219i cum arat\u0103 procesul de \u00eenregistrare a vaccinului.<\/p>\n<p>Pentru ca vaccinul s\u0103 fie utilizat peste tot \u0219i recunoscut de toate \u021b\u0103rile UE, acesta trebuie s\u0103 primeasc\u0103 aprobarea Agen\u021biei Europene a Medicamentului. La momentul actual patru vaccinuri au o astfel de aprobare:<\/p>\n<ul>\n<li>Moderna,<\/li>\n<li>Pfizer\/BioNTech,<\/li>\n<li>AstraZeneca,<\/li>\n<li>Johnson &amp; Johnson.<\/li>\n<\/ul>\n<p>Persoanele vaccinate cu aceste vaccinuri primesc certificate verzi digitale europene, care vor facilita foarte mult circula\u021bia \u00een UE: titularii de certificate nu trebuie s\u0103 respecte autoizolarea dup\u0103 sosirea \u00eentr-o \u021bar\u0103 anume. \u00cen unele \u021b\u0103ri, certificatele digitale ofer\u0103 mai multe oportunit\u0103\u021bi \u2014 de exemplu, \u00een Letonia, pot vizita restaurantele \u0219i evenimentele \u00een mas\u0103 doar persoanele vaccinate.<\/p>\n<p>Dac\u0103 Sputnik V va primi aprobarea EMA, atunci persoanele vaccinate cu acesta vor primi cel mai probabil acelea\u0219i drepturi \u00een Europa ca \u0219i cele vaccinate cu vaccinuri europene \u0219i americane. Adic\u0103 vor putea c\u0103l\u0103tori liber. Chiar \u0219i acum exist\u0103 \u021b\u0103ri care recunosc Sputnik V, le permit ru\u0219ilor vaccina\u021bi cu acesta s\u0103 intre \u0219i nu le cer s\u0103 respecte autoizolare. Acestea sunt, de exemplu, Croa\u021bia, Grecia, Cipru \u0219i Estonia. Totu\u0219i aceste \u021b\u0103ri sunt \u00een minoritate. Majoritatea \u021b\u0103rilor, cel pu\u021bin deocamdat\u0103, inten\u021bioneaz\u0103 s\u0103 a\u0219tepte decizia EMA \u0219i declar\u0103 c\u0103\u00a0<em>se aplic\u0103 scutiri doar pentru persoanele vaccinate cu un vaccin aprobat de EMA<\/em>.<\/p>\n<p>Serviciul de pres\u0103 al EMA a declarat pentru\u00a0<em>Novaya Gazeta<\/em>\u00a0c\u0103 vaccinul rusesc se afl\u0103 acum \u00een etapa examin\u0103rii treptate, care a \u00eenceput pe 4 martie. Conform regulilor EMA, \u00een aceast\u0103 etap\u0103 se poate afla un vaccin, \u00een privin\u021ba c\u0103ruia nu s-au finalizat studiile clinice \u2014 datele pot fi transmise treptat spre EMA, pe m\u0103sur\u0103 ce devin disponibile. Dup\u0103 ce prime\u0219te aprobarea preliminar\u0103 \u00een aceast\u0103 etap\u0103, produc\u0103torul vaccinului depune o cerere oficial\u0103 de autorizare a medicamentului.<\/p>\n<p>Apoi \u00eencepe a doua etap\u0103 \u2013 evaluarea cererii oficiale. De obicei, perioada de examinare dureaz\u0103 p\u00e2n\u0103 la 210 zile, iar \u00een cazul vaccinurilor contra coronavirusului, este \u00een vigoare un protocol accelerat \u2014 p\u00e2n\u0103 la 150 de zile. \u00cen acela\u0219i timp, serviciul de pres\u0103 al EMA a declarat pentru Novaya Gazeta c\u0103 nu au primit \u00eenc\u0103 o cerere de autorizare din partea Rusiei, transmite\u00a0Novaya Gazeta.<\/p>\n<p><em>\u201eEMA va putea spune mai multe despre termenii posibili de autorizare a Sputnik V dup\u0103 primirea cererii oficiale de autorizare, atunci va fi posibil s\u0103 se evalueze mai bine corectitudinea datelor disponibile\u201d,<\/em>\u00a0a explicat agen\u021bia.<\/p>\n<p>Serviciul de pres\u0103 a men\u021bionat, de asemenea, c\u0103 nu poate comenta datele privind vaccinul, care trece printr-o etap\u0103 de examinare treptat\u0103. Pozi\u021bia public\u0103 a EMA privind Sputnik V va fi exprimat\u0103 dup\u0103 a doua etap\u0103 \u2013 evaluarea cererii de autorizare.<\/p>\n<p>Criteriile prin care vaccinul este testat \u00een aceast\u0103 etap\u0103 sunt cunoscute \u2014 acestea sunt publicate pe\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/other\/ema-considerations-covid-19-vaccine-approval_en.pdf\">situl<\/a>\u00a0EMA.<\/p>\n<p>\u00cen primul r\u00e2nd, este eficacitatea, care este dovedit\u0103 \u00een a treia etap\u0103 a studiilor clinice \u2013 de preferin\u021b\u0103 cel pu\u021bin 50%. \u00cen al doilea r\u00e2nd, siguran\u021ba vaccinului: pentru a o evalua, sunt necesare c\u00e2teva mii de voluntari, care vor fi monitoriza\u021bi \u00een privin\u021ba efectelor secundare cel pu\u021bin timp de \u0219ase s\u0103pt\u0103m\u00e2ni dup\u0103 administrarea vaccinului. \u00cen acela\u0219i timp, EMA recomand\u0103 cu t\u0103rie monitorizarea st\u0103rii de s\u0103n\u0103tate a voluntarilor \u00eenc\u0103 un an dup\u0103 vaccinare pentru a \u00een\u021belege efectul pe termen lung al medicamentului asupra organismului.<\/p>\n<p><em>Deoarece cererea oficial\u0103 de autorizare nu a fost \u00eenc\u0103 depus\u0103, evaluarea acesteia nu a \u00eenceput.<\/em><\/p>\n<p>Probabil, acest lucru se datoreaz\u0103 \u00eent\u00e2rzierii, care este men\u021bionat\u0103 de interlocutorii Reuters.<\/p>\n<p>\u00cen paralel, vaccinul rusesc este studiat de Organiza\u021bia Mondial\u0103 a S\u0103n\u0103t\u0103\u021bii (OMS) ca parte a a\u0219a-numitei proceduri EUL \u2013 includerea \u00een registrul fondurilor destinate utiliz\u0103rii \u00een situa\u021bii de urgen\u021b\u0103. Aceast\u0103 procedur\u0103 func\u021bioneaz\u0103 atunci c\u00e2nd exist\u0103 o amenin\u021bare semnificativ\u0103 pentru s\u0103n\u0103tatea public\u0103 (de exemplu, o epidemie, a\u0219a cum este acum) \u0219i presupune posibilitatea evalu\u0103rii medicamentelor care sunt \u00eenc\u0103 \u00een curs de dezvoltare. Aprobarea OMS nu \u00eenseamn\u0103 c\u0103 toate \u021b\u0103rile vor recunoa\u0219te vaccinul, dar pentru multe guverne na\u021bionale acesta este un criteriu important.<\/p>\n<p>\u00cen prezent, pe lista vaccinurilor aprobate de OMS sunt:<\/p>\n<ul>\n<li>Moderna,<\/li>\n<li>Pfizer,<\/li>\n<li>Johnson &amp; Johnson,<\/li>\n<li>AstraZeneca,<\/li>\n<\/ul>\n<p>\u0219i, de asemenea, vaccinul indian<\/p>\n<ul>\n<li>Covishield<\/li>\n<\/ul>\n<p>\u0219i chineze\u0219ti<\/p>\n<ul>\n<li>Sinovac<\/li>\n<li>Sinopharm.<\/li>\n<\/ul>\n<p>Pe\u00a0situl\u00a0organiza\u021biei se poate vedea la ce etap\u0103 fiecare vaccin este evaluat de OMS, aceste informa\u021bii sunt actualizate periodic.<\/p>\n<p>Astfel, Rusia a depus o cerere preliminar\u0103 \u2013 un document necesar pentru a \u00eencepe procesul de evaluare. Etapa de verificare a rezultatelor studiilor clinice \u0219i controlul producerii vaccinului a \u00eenceput. \u00cen acela\u0219i timp, OMS a\u0219teapt\u0103 c\u00e2teva date suplimentare din Rusia \u0219i efectueaz\u0103 o inspec\u021bie a \u00eentreprinderilor, \u00een care se produce vaccinul.<\/p>\n<p>Majoritatea pozi\u021biilor privind aprobarea Sputnik sunt marcate cu cuvintele \u2013 \u201ea\u0219tept\u0103m date suplimentare\u201d. Sursa: site-ul OMS<\/p>\n<p>Anume \u00een aceast\u0103 s\u0103pt\u0103m\u00e2n\u0103,\u00a0<em>exper\u021bii OMS au dezv\u0103luit \u00een timpul inspec\u021biei \u00eenc\u0103lc\u0103ri la Farmstandart-UfaVITA \u2014 una dintre \u00eentreprinderile\u00a0\u00een care se produce vaccinul.<\/em><\/p>\n<p><u>Comentariile<\/u>\u00a0inspectorilor se refer\u0103 la mai multe aspecte, acestea sunt: integritatea datelor \u0219i a rezultatelor testelor \u00een timpul monitoriz\u0103rii microbiologice, efectuarea unei monitoriz\u0103ri adecvate ecologice \u00een timpul producerii, posibilitatea urm\u0103ririi \u0219i identific\u0103rii complete a loturilor, men\u021binerea nivelului necesar de sterilitate. OMS raporteaz\u0103 c\u0103 toate comentariile au fost transmise conducerii companiei \u00een speran\u021ba c\u0103 situa\u021bia va fi corectat\u0103 c\u00e2t mai cur\u00e2nd posibil.<\/p>\n<p>Foto: zdg.md.<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>S\u0103pt\u0103m\u00e2na trecut\u0103 Reuters a relatat, cit\u00e2nd surse proprii, c\u0103 aprobarea vaccinului Sputnik V de c\u0103tre Agen\u021bia European\u0103 a Medicamentului (EMA) va fi am\u00e2nat\u0103 p\u00e2n\u0103 \u00een septembrie \u0219i, poate chiar p\u00e2n\u0103 la sf\u00e2r\u0219itul anului. Potrivit publica\u021biei, Institutul Gamalei, unde a fost dezvoltat vaccinul, nu a furnizat datele necesare \u00een intervalul de timp specificat, relateaz\u0103 zdg.md. Funda\u021bia [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":134029,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6349],"tags":[26997],"class_list":["post-134028","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-social","tag-cand-vaccinul-rusesc-va-putea-sa-intre-oficial-pe-piata-europeana-si-de-ce-depinde-acest-lucru"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>C\u00e2nd vaccinul rusesc va putea s\u0103 intre oficial pe pia\u021ba european\u0103 \u0219i de ce depinde acest lucru - BTV<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.btv.md\/ro\/cand-vaccinul-rusesc-va-putea-sa-intre-oficial-pe-piata-europeana-si-de-ce-depinde-acest-lucru\/\" \/>\n<meta property=\"og:locale\" content=\"ro_RO\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"C\u00e2nd vaccinul rusesc va putea s\u0103 intre oficial pe pia\u021ba european\u0103 \u0219i de ce depinde acest lucru - BTV\" \/>\n<meta property=\"og:description\" content=\"S\u0103pt\u0103m\u00e2na trecut\u0103 Reuters a relatat, cit\u00e2nd surse proprii, c\u0103 aprobarea vaccinului Sputnik V de c\u0103tre Agen\u021bia European\u0103 a Medicamentului (EMA) va fi am\u00e2nat\u0103 p\u00e2n\u0103 \u00een septembrie \u0219i, poate chiar p\u00e2n\u0103 la sf\u00e2r\u0219itul anului. 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Potrivit publica\u021biei, Institutul Gamalei, unde a fost dezvoltat vaccinul, nu a furnizat datele necesare \u00een intervalul de timp specificat, relateaz\u0103 zdg.md. 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