FDA inopa mvumo nyowani yePfizer piritsi yekurapa COVID-19

Nhasi, the US Kudya neDrug Administration (FDA) yakapa mvumo yekushandisa emergency (EUA) ye Pfizer's Paxlovid (nirmatrelvir mapiritsi uye mahwendefa eritonavir, akarongedzerwa kuti ashandiswe nemuromo) kurapa zvinyoro-kusvika-zvine mwero coronavirus chirwere (COVID-19) muvakuru uye varwere vevana (makore gumi nemaviri ezera zvichikwira anorema angangoita makumi mana makirogiramu. kana makirogiramu makumi masere nemasere) ine mhedzisiro yakanaka yekuongororwa kwakananga SARS-CoV-12, uye vari panjodzi huru yekufambira mberi kune yakanyanya COVID-40, kusanganisira kuchipatara kana kufa.

Paxlovid inowanikwa nekunyorerwa chete uye inofanirwa kutangwa nekukurumidza sezvinobvira mushure mekuongororwa kweCCIDID-19 uye mukati memazuva mashanu ekutanga kwechiratidzo.

"Mvumo yanhasi inosuma kurapwa kwekutanga kweCCIDID-19 iri muchimiro chepiritsi rinotorwa nemuromo - nhanho huru mukurwisa denda repasi rose," akadaro Patrizia Cavazzoni, MD, director we. FDA's Center for Drug Evaluation uye Tsvagiridzo. "Mvumo iyi inopa chishandiso chitsva chekurwisa COVID-19 panguva yakakosha mudenda iri sezvo misiyano mitsva ichibuda uye inovimbisa kuita kuti kurapwa kwehutachiona huwanikwe kune varwere vari panjodzi huru yekuenderera kune yakanyanya COVID-19."

Pfizer's Paxlovid haina mvumo yekudzivirira-kufumurwa kana mushure-kufumurwa kweCCIDID-19 kana kutanga kurapwa mune avo vanoda kuchipatara nekuda kwekuomarara kana kunetsa COVID-19. Paxlovid haisi inotsiva yekudzivirira muvanhu vanokurudzirwa kubayiwa kweCCIDID-19 uye booster dose. Iyo FDA yakabvumidza vaccine imwe uye yakabvumidza vamwe kudzivirira COVID-19 uye zvakakomba mhedzisiro yekiriniki ine chekuita nehutachiona hweCCIDID-19, kusanganisira kuchipatara uye kufa. The FDA inokurudzira veruzhinji kuti vabaiwe nhomba uye kuti vawane chekusimudzira kana vachikodzera.

Paxlovid ine nirmatrelvir, iyo inhibisa SARS-CoV-2 protein kuti imise hutachiona kubva pakudzokorora, uye ritonavir, iyo inononotsa kuparara kwenirmatrelvir kuti ibatsire kuramba iri mumuviri kwenguva yakareba munzvimbo dzakakwirira. Paxlovid inonwiwa semapiritsi matatu (mapiritsi maviri enirmatrelvir nepiritsi rimwe reritonavir) akatorwa pamwe chete nemuromo kaviri pazuva kwemazuva mashanu, pahuwandu hwemapiritsi makumi matatu. Paxlovid haina mvumo yekushandisa kwenguva yakareba kupfuura mazuva mashanu akatevedzana.