EMA: miokardīts un perikardīts ir «mRNA vakcīnu blakne» galvenokārt jauniem vīriešiem

Ar mRNA tehnoloģiju radītās "Covid-19" vakcīnas. Foto: Reuters

Eiropas Zāļu aģentūra (European Medicine Agency, EMA) savā oficiālajā vietnē ir rekomendējusi miokardītu un perikardītu iekļaut divu tās reģistrēto vakcīnu –Pfizer (ASV) un BioNTech (Vācija) izstrādātās “Comirnaty un amerikāņu kompānijas “Moderna” izstrādātās  Spikevax” – blakņu sarakstā.

Pēteris Kurpnieks, īpaši InfoTOP.lv

EMA Farmakoloģisko risku novērtēšanas komiteja (Pharmacovigilance Risk Assessment Committee, PRAC) pēc īpaša izvērtējuma secinājusi, ka miokardīts un perikardīts ļoti retos gadījumos (very rare cases) tomēr var rasties pēc potēšanās ar vakcīnām, kuru pamatā ir mRNA (messenger RNA, ribonukleīnskābes matrica) tehnoloģija.

“Ievērojot to, komiteja jaunajā blakņu sarakstā rekomendēja iekļaut miokradītu un perikardītu, palielinot informētību starp veselības aprūpes speciālistiem un pacientiem, kuri potējas ar šīm vakcīnām,” teikts EMA paziņojumā.

Miokardīts un perikardīts ir sirds muskuļa iekaisuma veidi. Šīs kaites simtomi var variēties, bet parasti tiek novērota apgrūtināta elpošana, paātrināta sirdsdarbība un sāpes krūtīs. PRAC savus secinājumus izdarījusi, izpētot vairāk nekā 300 miokardīta un perikardīta gadījumu cilvēkiem, kas  Eiropā potēti ar mRNA vakcīnām.

Visbeidzot, EMA ir konstatējusi, ka šī blakne visbiežāk apdraud gados jaunus vīriešus: “Komiteja secināja, ka [miokardīta/perikardīta] gadījumi galvenokārt notika 14 dienu laikā pēc vakcinācijas, biežāk pēc otrās devas un gados jaunākiem pieaugušiem vīriešiem. Piecos EEZ [Eiropas Ekonomiskajā zonā reģistrētos] gadījumos cilvēki gāja bojā.”

Abām pārējām Eiropas Savienībā reģistrētajām kovidvakcīnām – “Janssen” (ražotājs “Johnson&Johnson”) un “Vaxzevria” (ražotājs “AstraZeneca”) konkrēto blakni EMA nav atklājusi, tomēr PRAC šo vakcīnu izplatītājiem ir pieprasījusi papildu informāciju.

www.infotop.lv/article/lv/ema-miokardits-un-perikardits-ir-mrna-vakcinu-blakne-galvenokart-jauniem-viriesiem

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