FDA Inobvumidza Chekutanga COVID-19 Kurapwa kweVana Vadiki

Nhasi, US Food and Drug Administration yakawedzera kubvumidzwa kweCCIDID-19 kurapwa Veklury (remdesivir) kuti isanganise varwere vevana vane mazuva makumi maviri nemasere ekuberekwa zvichikwira vanorema makirogiramu matatu (anenge makirogiramu manomwe) nemhedzisiro yakananga SARS-CoV- 28 hutachiona hwekuongorora, avo vari:    

• Muchipatara, kana

• Haasi muchipatara uye ane COVID-19 iri pakati nepakati uye vari panjodzi huru yekuenda kuCOVID-19, kusanganisira kuchipatara kana kufa.

Chiito ichi chinoita kuti Veklury ive yekutanga kubvumidzwa kurapwa kweCOVID-19 kuvana vari pasi pemakore gumi nemaviri. Nekuda kwechiito chemvumo chanhasi, sangano iri rakadzorawo mvumo yekushandiswa kwechimbichimbi yeVeklury iyo yakambovhara huwandu hwevana.

Parizvino, Veklury yaingotenderwa kurapa vamwe vanhu vakuru uye varwere vevana (makore gumi nemaviri ezera zvichikwira vanorema makirogiramu makumi mana, angangoita makumi masere nemasere mapaundi) neCOVID-12.

"Sezvo COVID-19 ichigona kukonzera kurwara kwakanyanya muvana, vamwe vacho pari zvino vasina nzira yekudzivirira, pari kuramba paine kudiwa kwemaitiro akachengeteka uye anoshanda eCCIDID-19 ekurapa vanhu ava," akadaro Patrizia Cavazzoni, MD, director. yeFDA's Center for Drug Evaluation uye Tsvagiridzo. "Nhasi kubvumidzwa kwekutanga kweCCIDID-19 kurapwa kwevagari ava kunoratidza kuzvipira kwesangano kune icho chinodikanwa."

Veklury haisi inotsiva yekudzivirira muvanhu vanokurudzirwa vaccination yeCOVID-19 uye booster doses. Iyo FDA yakabvumidza majekiseni maviri, uye matatu ekudzivirira aripo ekushandiswa kwechimbichimbi, kudzivirira COVID-19 uye zvakakomba zvekiriniki zvakabatana neCCIDID-19, kusanganisira kuchipatara uye kufa. Iyo FDA inokurudzira veruzhinji kuti vabaiwe uye vagamuchire booster kana vakakodzera. Dzidza zvakawanda nezve FDA-yakatenderwa uye yakatenderwa COVID-19 vaccine.

Tichifunga nezve nzira yakafanana yechirwere cheCCIDID-19 muvakuru uye varwere vevana, kubvumidzwa kwanhasi kweVeklury mune vamwe varwere vevana kunotsigirwa nemhedzisiro yemhedzisiro kubva muchikamu chechitatu chekiriniki miedzo muvakuru. Ruzivo rwezviyedzo muvakuru runogona kuwanikwa muFDA-yakatenderwa zvinodhaka zvakanyorwa zveVeklury. Mvumo iyi inotsigirwawo nechikamu 3/2, single-arm, open-label clinical study yevarwere vevana makumi mashanu nevatatu vangangoita mazuva makumi maviri nemasere ekuzvarwa uye vanorema makirogiramu matatu (anenge makirogiramu manomwe) nehutachiona hweSARS-CoV-3. uye yakapfava, iri pakati nepakati kana yakaoma COVID-53. Varwere vari muchikamu ichi chevana 28/3 kuyedzwa vakagamuchira Veklury kwemazuva anosvika gumi. Kuchengetedzwa uye pharmacokinetic mhedzisiro kubva muchikamu 7/2 kudzidza mune zvevana zvidzidzo zvakafanana neizvo zvevakuru.

Iyo chete yakatenderwa dosage fomu ndeyeVeklury yejekiseni. 

Zvinogoneka zvinokonzerwa nekushandisa Veklury zvinosanganisira kuwedzera kwemazinga echiropa enzymes, iyo inogona kuva chiratidzo chekukuvara kwechiropa; uye kusawirirana kweropa, izvo zvinogona kusanganisira kuchinja kweropa uye kurova kwemwoyo, kuderera kweokisijeni muropa, fivha, kutadza kufema, kufema, kuzvimba (semuenzaniso, miromo, kumativi ose, pasi peganda), kuputika, kusvotwa, kudikitira kana kudedera.

Iyo FDA yakapa mvumo kuGiriyedhi Sayenzi Inc.