{"id":27510,"date":"2021-08-26T08:37:54","date_gmt":"2021-08-26T05:37:54","guid":{"rendered":"https:\/\/aluksne.lv\/?p=27510"},"modified":"2021-08-26T08:37:54","modified_gmt":"2021-08-26T05:37:54","slug":"zva-atgadina-covid-19-vakcinas-nav-eksperimentalas-bet-registretas-atbilstosi-stingram-prasibam","status":"publish","type":"post","link":"https:\/\/aluksne.lv\/index.php\/2021\/08\/26\/zva-atgadina-covid-19-vakcinas-nav-eksperimentalas-bet-registretas-atbilstosi-stingram-prasibam\/","title":{"rendered":"ZVA atg\u0101dina: Covid-19 vakc\u012bnas nav eksperiment\u0101las, bet re\u0123istr\u0113tas atbilsto\u0161i stingr\u0101m pras\u012bb\u0101m"},"content":{"rendered":"

Vis\u0101m l\u012bdz \u0161im re\u0123istr\u0113taj\u0101m Covid-19 vakc\u012bn\u0101m ir veikti nepiecie\u0161amie tre\u0161\u0101s f\u0101zes kl\u012bniskie p\u0113t\u012bjumi par dro\u0161umu, iedarb\u012bbu un kvalit\u0101ti, kuru rezult\u0101tus ir izv\u0113rt\u0113jusi Eiropas Z\u0101\u013cu a\u0123ent\u016bra (EZA) pirms \u0161o\u00a0 vakc\u012bnu\u00a0 re\u0123istr\u0101cijas, jo t\u0101\u00a0 ir oblig\u0101ta pras\u012bba.<\/strong><\/p>\n

L\u012bdz ar to vakc\u012bnas pret Covid-19 nav eksperiment\u0101las, jo ir izg\u0101ju\u0161as re\u0123istr\u0101cijas procesu – \u00a0vakc\u012bnas re\u0123istr\u0101cijai ieteikusi EZA un ES ties\u012bbu aktos noteikt\u0101 k\u0101rt\u012bb\u0101 t\u0101s apstiprin\u0101jusi ar\u012b Eiropas Komisija.<\/p>\n

Balstoties uz Saeimas Aizsardz\u012bbas, iek\u0161lietu un korupcijas\u00a0 nov\u0113ro\u0161anas s\u0113d\u0113 atsevi\u0161\u0137u deput\u0101tu paustajiem maldino\u0161ajiem apgalvojumiem par vakc\u012bnu dro\u0161umu, ZVA atg\u0101dina un aicina iepaz\u012bties ar aktu\u0101lo inform\u0101ciju par vakc\u012bnu re\u0123istr\u0101ciju un izv\u0113rt\u0113\u0161anu.<\/p>\n

#1 Nek\u0101das atk\u0101pes no re\u0123istr\u0101cijas pras\u012bb\u0101m un standartiem nav pie\u013cautas<\/strong><\/p>\n

Vakc\u012bnas pret Covid-19 ES ir re\u0123istr\u0113jusi Eiropas Komisija p\u0113c EZA veikt\u0101s zin\u0101tnisk\u0101s izv\u0113rt\u0113\u0161anas un izsniegtas rekomend\u0101cijas \u0161o vakc\u012bnu re\u0123istr\u0113\u0161anai.<\/p>\n

 <\/p>\n

Vakc\u012bnas tiek re\u0123istr\u0113tas tikai tad, ja EZA sa\u0146em uzticamus un p\u0101rliecino\u0161us zin\u0101tniskus pier\u0101d\u012bjumus, ka t\u0101s atbilst Eirop\u0101 past\u0101vo\u0161aj\u0101m stingraj\u0101m pras\u012bb\u0101m par iedarb\u012bgumu, dro\u0161umu un kvalit\u0101ti, tai skait\u0101, ja ir apstiprin\u0101ts veids, k\u0101 Covid-19 vakc\u012bnas tiek ra\u017eotas, un ra\u017eotnes atbilst farmaceitiskajiem standartiem.<\/p>\n

 <\/p>\n

Lai vakc\u012bnas pand\u0113mijas laik\u0101 b\u016btu pieejamas \u0101tr\u0101k, t\u0101s re\u0123istr\u0113tas, izmantojot pa\u0101trin\u0101t\u0101s re\u0123istr\u0101cijas meh\u0101nismu \u2013 re\u0123istr\u0101ciju ar nosac\u012bjumiem. EZA mobiliz\u0113ja lielu augsti kvalific\u0113tu zin\u0101tnieku un ekspertu grupu, lai nodro\u0161in\u0101tu kvalitat\u012bvu un profesion\u0101lu vakc\u012bnu izv\u0113rt\u0113\u0161anas procesu iesp\u0113jami \u012bs\u0101 laik\u0101 atbilsto\u0161i nemain\u012bgi stingr\u0101m regulator\u0101m pras\u012bb\u0101m. EZA <\/strong>veica da\u017e\u0101du datu un p\u0113t\u012bjumu rezult\u0101tu da\u013cu pak\u0101penisku v\u0113rt\u0113\u0161anu, kam\u0113r vakc\u012bnu izstr\u0101d\u0101t\u0101ji paral\u0113li ieguva p\u0101r\u0113jos nepiecie\u0161amos datus. Parast\u0101 situ\u0101cij\u0101 vakc\u012bnu izstr\u0101d\u0101t\u0101jiem vispirms j\u0101apkopo visi dati, un tikai p\u0113c tam tiek s\u0101kta pieteikuma izv\u0113rt\u0113\u0161ana EZA, kas aiz\u0146em ilgu laiku.<\/p>\n

Re\u0123istr\u0101cija ar nosac\u012bjumiem jaun\u0101m z\u0101l\u0113m, ne tikai vakc\u012bn\u0101m pret Covid-19, tiek izmantota \u013coti bie\u017ei. Piem\u0113ram, no 39 jaun\u0101m z\u0101\u013cu viel\u0101m, kuras 2020. gad\u0101 tika re\u0123istr\u0113tas Eirop\u0101, 13 gad\u012bjumos veikta re\u0123istr\u0101cija ar nosac\u012bjumiem.<\/p>\n

Covid-19 vakc\u012bnu izstr\u0101d\u0113 ir izmantotas gan jau zin\u0101mas un ilgsto\u0161i vakc\u012bnu izstr\u0101d\u0113 lietotas, gan inovat\u012bvas metodes. P\u0113tnieki jau vair\u0101k nek\u0101 10 gadus ir p\u0113t\u012bju\u0161i potenci\u0101l\u0101s SARS un MERS v\u012brusa vakc\u012bnas. \u0160ie iepriek\u0161 veiktie ilgsto\u0161ie p\u0113t\u012bjumi kalpoju\u0161i par pamatu \u0101tr\u0101kai vakc\u012bnu kandid\u0101tu izstr\u0101dei \u0161aj\u0101 pand\u0113mij\u0101.<\/strong><\/p>\n

#2 Vakc\u012bnas nav iesp\u0113jams re\u0123istr\u0113t bez izv\u0113rt\u0113tiem un Eiropas Z\u0101\u013cu a\u0123ent\u016br\u0101 apstiprin\u0101tiem tre\u0161\u0101s f\u0101zes kl\u012bnisko p\u0113t\u012bjumu rezult\u0101tiem<\/strong><\/p>\n

Vakc\u012bnu un jebkuru citu z\u0101\u013cu re\u0123istr\u0101cija parasti nav iesp\u0113jama bez tre\u0161\u0101s f\u0101zes kl\u012bnisko p\u0113t\u012bjumu rezult\u0101tu izv\u0113rt\u0113\u0161anas EZA, jo t\u0101 ir viena no pamatpras\u012bb\u0101m re\u0123istr\u0101cijai. Vien\u012bgie iz\u0146\u0113mumi var\u0113tu b\u016bt retas un \u013coti smagas saslim\u0161anas, kad pasaul\u0113 ir \u013coti mazs pacientu skaits un nav pieejamas \u0101rst\u0113\u0161anas metodes, ta\u010du pat \u0161\u0101du terapiju apstiprin\u0101\u0161anai visbie\u017e\u0101k nepiecie\u0161ami tre\u0161\u0101s f\u0101zes p\u0113t\u012bjumi.<\/p>\n

Ar vis\u0101m \u010detr\u0101m jau <\/strong>re\u0123istr\u0113taj\u0101m vakc\u012bn\u0101m pret Covid-19 ir veikti tre\u0161\u0101s f\u0101zes kl\u012bniskie p\u0113t\u012bjumi, kuru rezult\u0101ti ir izv\u0113rt\u0113ti un apstiprin\u0101ti EZA. <\/strong><\/p>\n

Veiktajos kl\u012bniskajos p\u0113t\u012bjumos piedal\u012bj\u0101s vair\u0101ki desmiti t\u016bksto\u0161i cilv\u0113ku. Kl\u012bniskajos p\u0113t\u012bjumos ar Pfizer-BionTech izstr\u0101d\u0101to vakc\u012bnu \u201cComirnaty\u201d kopum\u0101 piedal\u012bj\u0101s aptuveni 44 000 cilv\u0113ku, savuk\u0101rt \u201cModerna\u201d vakc\u012bnas \u201cSpikevax\u201d kl\u012bniskajos p\u0113t\u012bjumos piedal\u012bj\u0101s aptuveni 30 000 cilv\u0113ku. Kl\u012bniskajos p\u0113t\u012bjumos ar \u201cAstraZeneca\u201d vakc\u012bnu \u201cVaxzevria\u201d piedal\u012bj\u0101s aptuveni 24 000 cilv\u0113ku, bet \u201cCovid-19 Vaccine Janssen\u201d p\u0113t\u012bjumos \u2013\u00a0aptuveni 21\u00a0900 cilv\u0113ku.<\/p>\n

Covid-19 vakc\u012bnu kl\u012bniskajos p\u0113t\u012bjumos zin\u0101tniekiem un farm\u0101cijas uz\u0146\u0113mumiem neilg\u0101 laika posm\u0101 izdev\u0101s iesaist\u012bt lielu dal\u012bbnieku skaitu. Dal\u012bbnieku \u0101tra iesaiste parasti ir \u0161\u0137\u0113rslis daudzu z\u0101\u013cu p\u0113t\u012bjumu veik\u0161an\u0101, kad vienlaikus pasaul\u0113 ar vienu slim\u012bbu neslimo tik daudz cilv\u0113ku, k\u0101 tas bija Covid-19 gad\u012bjum\u0101. \u0160ajos z\u0101\u013cu un vakc\u012bnu p\u0113t\u012bjumos ilgus gadus aiz\u0146em tie\u0161i kl\u012bnisko p\u0113t\u012bjumu norise tikai t\u0101d\u0113\u013c, ka nepietiek kl\u012bnisko p\u0113t\u012bjumu dal\u012bbnieku un ir gr\u016bti un laikietilp\u012bgi \u0161os dal\u012bbniekus iesaist\u012bt kl\u012bniskos p\u0113t\u012bjumos. Ta\u010du Covid-19 vakc\u012bnu gad\u012bjum\u0101 uz\u0146\u0113mumiem \u013coti \u0101tri izdev\u0101s piesaist\u012bt lielu apjomu kl\u012bnisko p\u0113t\u012bjumu dal\u012bbnieku un t\u0101d\u0113j\u0101di ar\u012b vi\u0146i var\u0113ja \u0101tri ieg\u016bt kl\u012bnisko p\u0113t\u012bjumu rezult\u0101tus.\u00a0 <\/strong><\/p>\n

Jau min\u0113ts, ka Covid-19<\/strong> vakc\u012bnu efektivit\u0101tes jeb iedarb\u012bguma un dro\u0161uma kl\u012bnisko p\u0113t\u012bjumu rezult\u0101tu izv\u0113rt\u0113\u0161ana un apstiprin\u0101\u0161ana Eiropas Z\u0101\u013cu a\u0123ent\u016br\u0101 pirms \u0161o vakc\u012bnu re\u0123istr\u0113\u0161anas ir oblig\u0101ta pamatpras\u012bba, lai \u0161\u012bs Covid-19 vakc\u012bnas tiktu re\u0123istr\u0113tas.<\/strong> Tas noz\u012bm\u0113, ka \u0161\u012b kl\u012bnisko p\u0113t\u012bjumu da\u013ca ir nosl\u0113gta un piln\u012bb\u0101 izv\u0113rt\u0113ta.<\/strong> K\u0101di p\u0113t\u012bjumu aspekti turpin\u0101s? L\u012bdz 2022. gadam ra\u017eot\u0101jiem j\u0101turpina veikt p\u0113t\u012bjumi par pavisam citiem t\u0101diem aspektiem k\u0101 vakc\u012bnu aizsardz\u012bbas ilgums, transmisijas samazin\u0101\u0161ana un vakc\u012bnu piem\u0113rot\u012bba b\u0113rniem, kuri jaun\u0101ki par 12 gadu vecumu.<\/p>\n

\u00a0<\/strong><\/p>\n

#3 Vakc\u012bnas nav eksperiment\u0101las<\/strong><\/p>\n

L\u012bdz ar to visas Covid-19 vakc\u012bnas, kuras ir sa\u0146\u0113mu\u0161as re\u0123istr\u0101cijas at\u013cauju, ir p\u0101rbaud\u012btas, ar t\u0101m ir veikti visi nepiecie\u0161amie kl\u012bniskie p\u0113t\u012bjumi par dro\u0161umu un efektivit\u0101ti, kuru rezult\u0101tus ir izv\u0113rt\u0113jusi un apstiprin\u0101jusi EZA, un \u0161\u012bs vakc\u012bnas nek\u0101d\u0101 veid\u0101 nav eksperiment\u0101las, jo ir izg\u0101ju\u0161as pilnu re\u0123istr\u0101ciju kompetentaj\u0101 iest\u0101d\u0113, ko ties\u012bbu aktos noteiktaj\u0101 k\u0101rt\u012bb\u0101 ir atzinusi ar\u012b Eiropas Komisija. <\/strong><\/p>\n

Par eksperiment\u0101l\u0101m uzskat\u0101mas tikai t\u0101s vakc\u012bnas, kas v\u0113l nav re\u0123istr\u0113tas un ar kur\u0101m veic pirmsre\u0123istr\u0101cijas kl\u012bniskos p\u0113t\u012bjumus, bet ne Eirop\u0101 jau re\u0123istr\u0113t\u0101s \u010detras Covid-19 vakc\u012bnas.\u00a0<\/p>\n

J\u0113dziens \u201ceksperiment\u0101l\u0101s z\u0101les\u201d jeb saska\u0146\u0101 ar visp\u0101rpie\u0146emto terminolo\u0123iju \u201cp\u0113t\u0101m\u0101s z\u0101les\u201d ir attiecin\u0101ms tikai uz z\u0101l\u0113m (ar\u012b vakc\u012bn\u0101m), ko izmanto kl\u012bniskajos p\u0113t\u012bjumos, kas ir atsevi\u0161\u0137a stingri regul\u0113ta joma. Latvijas teritorij\u0101 nav noticis un ar\u012b pa\u0161laik nenotiek neviens Covdid-19 vakc\u012bnu kl\u012bniskais p\u0113t\u012bjums.<\/p>\n

Re\u0123istr\u0113tu vakc\u012bnu izmanto\u0161ana vakcin\u0101cijas kampa\u0146\u0101 nav kl\u012bniskais p\u0113t\u012bjums, un, pret\u0113ji sabiedr\u012bb\u0101 pla\u0161i izplat\u012btajam k\u013c\u016bdainajam pie\u0146\u0113mumam, vakcin\u0113t\u0101s personas netiek pret savu gribu iek\u013cautas nek\u0101dos eksperimentos.<\/p>\n

J\u0101piebilst, ka atsevi\u0161\u0137as valstis, piem\u0113ram, ASV un Lielbrit\u0101nija, 2021.gada nogal\u0113 izsniedza \u0101rk\u0101rtas at\u013cauju Covid-19 vakc\u012bnu lieto\u0161anai uz laiku, savuk\u0101rt ES EZA izv\u0113l\u0113j\u0101s citu daudz stingr\u0101ku r\u012bc\u012bbu \u2013 Covid-19 vakc\u012bnu re\u0123istr\u0101ciju ar nosac\u012bjumiem. T\u0101 ir viena no re\u0123istr\u0101cijas pamatproced\u016br\u0101m, un taj\u0101 nav atk\u0101pju no ierastaj\u0101m re\u0123istr\u0101cijas pras\u012bb\u0101m. L\u012bdz ar to ES Covid-19 vakc\u012bn\u0101m nav izsniegta \u0101rk\u0101rtas at\u013cauja, un \u0161\u012bs vakc\u012bnas nav eksperiment\u0101las.<\/p>\n

\u00a0<\/strong><\/p>\n

#4 Ar nosac\u012bjumiem re\u0123istr\u0113tas vakc\u012bnas tiek uzraudz\u012btas v\u0113l r\u016bp\u012bg\u0101k nek\u0101 citas z\u0101les<\/strong><\/p>\n

Ra\u017eot\u0101jiem, kuru vakc\u012bnas vai citas z\u0101les ir sa\u0146\u0113mu\u0161as at\u013cauju re\u0123istr\u0101cijai ar nosac\u012bjumu, ir noteikts oblig\u0101ts pien\u0101kums noteikt\u0101 laik\u0101 sniegt papildu datus, piem\u0113ram, par ilgtermi\u0146a iedarb\u012bbu vai lieto\u0161anu specifisk\u0101m iedz\u012bvot\u0101ju grup\u0101m, par kur\u0101m iepriek\u0161 dati nebija pieejami un kur\u0101m lieto\u0161ana pirms tam nav bijusi p\u0113t\u012bta.<\/p>\n

\u0160\u0101da re\u0123istr\u0101cijas ar nosac\u012bjumiem proced\u016bra nodro\u0161ina to, ka ES iedz\u012bvot\u0101jiem ir \u0101tri pieejamas dro\u0161as un efekt\u012bvas z\u0101les, vienlaikus nosakot, ka tiek iev\u0101kti papildus dati, kas papla\u0161ina zin\u0101\u0161anas par jaunaj\u0101m z\u0101l\u0113m. Tas ne tikai nodro\u0161ina dro\u0161u un efekt\u012bvu terapiju pieejam\u012bbu, bet ar\u012b \u013cauj zin\u0101tniekiem un regulatoriem att\u012bst\u012bt un re\u0123istr\u0113t jaun\u0101kas un modern\u0101kas terapijas.<\/p>\n

\u00a0<\/strong><\/p>\n

#5 Valsts iest\u0101des sniedz uzticamu, p\u0101rbaud\u012btu un zin\u0101tn\u0113 balst\u012btu inform\u0101ciju<\/strong><\/p>\n

P\u0101rbaud\u012bta un zin\u0101tn\u0113 balst\u012bta inform\u0101cija par vakc\u012bn\u0101m pret Covid-19 pieejama valsts p\u0101rvaldes iest\u0101\u017eu t\u012bmek\u013cvietn\u0113s un soci\u0101lo t\u012bklu platform\u0101s. ZVA aicina izmantot uzticamus inform\u0101cijas avotus un kritiski izv\u0113rt\u0113t inform\u0101ciju, kuru internet\u0101 izplata anon\u012bmi soci\u0101lo t\u012bklu lietot\u0101ji un zin\u0101tnes noliedz\u0113ji vai kura p\u0101rpublic\u0113ta ap\u0161aub\u0101m\u0101s t\u012bmek\u013cvietn\u0113s.<\/p>\n

Zin\u0101tn\u0113 balst\u012bta inform\u0101cija par vakc\u012bnu pret Covid-19 izstr\u0101di regul\u0101ri tiek public\u0113ta ZVA t\u012bmek\u013cvietnes www.zva.gov.lv sada\u013c\u0101 \u00a0\u201cCovid-19 zi\u0146as<\/a><\/u>\u201d. Vietn\u0113 pieejama jaun\u0101k\u0101 inform\u0101cija par vakc\u012bnu izstr\u0101di, v\u0113rt\u0113\u0161anu un apstiprin\u0101\u0161anu, tai skait\u0101 par vakc\u012bnu iedarb\u012bgumu, kvalit\u0101ti un dro\u0161umu un fakti par vakc\u012bn\u0101m.<\/a> <\/u><\/p>\n

Savuk\u0101rt inform\u0101cija par vakcin\u0101cijas norisi Latvij\u0101 ir pieejama Slim\u012bbu profilakses un kontroles t\u012bmek\u013cvietn\u0113 www.spkc.gov.lv<\/a>. Lai pieteiktos vakc\u012bnas pret Covid-19 sa\u0146em\u0161anai, j\u0101piesak\u0101s vietn\u0113 www.manavakcina.lv<\/a> vai zvanot pa t\u0101lruni 8989.<\/p>\n","protected":false},"excerpt":{"rendered":"

Vis\u0101m l\u012bdz \u0161im re\u0123istr\u0113taj\u0101m Covid-19 vakc\u012bn\u0101m ir veikti nepiecie\u0161amie tre\u0161\u0101s f\u0101zes kl\u012bniskie p\u0113t\u012bjumi par dro\u0161umu, iedarb\u012bbu un kvalit\u0101ti, kuru rezult\u0101tus ir izv\u0113rt\u0113jusi Eiropas Z\u0101\u013cu a\u0123ent\u016bra (EZA) pirms \u0161o\u00a0 vakc\u012bnu\u00a0 re\u0123istr\u0101cijas, jo t\u0101\u00a0 ir oblig\u0101ta pras\u012bba. L\u012bdz ar to vakc\u012bnas pret…
Las\u012bt visu<\/a><\/p>\n","protected":false},"author":1,"featured_media":27511,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_crdt_document":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":"","_links_to":"","_links_to_target":""},"categories":[9],"tags":[],"class_list":["post-27510","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-noderiga-informacija"],"_links":{"self":[{"href":"https:\/\/aluksne.lv\/index.php\/wp-json\/wp\/v2\/posts\/27510","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/aluksne.lv\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/aluksne.lv\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/aluksne.lv\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/aluksne.lv\/index.php\/wp-json\/wp\/v2\/comments?post=27510"}],"version-history":[{"count":0,"href":"https:\/\/aluksne.lv\/index.php\/wp-json\/wp\/v2\/posts\/27510\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/aluksne.lv\/index.php\/wp-json\/wp\/v2\/media\/27511"}],"wp:attachment":[{"href":"https:\/\/aluksne.lv\/index.php\/wp-json\/wp\/v2\/media?parent=27510"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/aluksne.lv\/index.php\/wp-json\/wp\/v2\/categories?post=27510"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/aluksne.lv\/index.php\/wp-json\/wp\/v2\/tags?post=27510"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}