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AZ '코로나19백신 임상재개'에 美NIH ”안전성 우려” - 바이오스펙테이터

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AZ '코로나19백신 임상재개'에 美NIH ”안전성 우려”

입력 2020-09-18 11:02 수정 2020-09-21 07:31

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이 기사는 '프리미엄 뉴스서비스 BioS+' 기사입니다.
미국에선 AZD1222 임상중단 지속, 재개시점 미정.."백신과 발생한 부작용의 정확한 인과관계 확인 못해"…임상정보 공개 투명성 우려 지적도

▲아스트라제네카 이미지 라이브러리 자료

아스트라제네카(Astrazeneca)와 옥스포드대가 공동개발하는 코로나19(COVID-19) 백신 ‘AZD1222’의 임상 재개에 대해 미국 국립보건원(NIH)이 우려를 표명한 것으로 알려졌다.

캘리포니아 비영리 언론사 카이저헬스뉴스(Kaiser Health News)는 지난 14일(현지시간) “미국 NIH가 아스트라제네카의 코로나19 백신 임상 재개에 우려하고 있다”고 밝혔다.

아스트라제네카는 코로나19 백신 AZD1222의 임상3상에서 환자 1명이 횡단 척수염(Transverse Myelitis) 증상을 보여 임상을 중단했다가 6일만에 재개했다. 아스트라제네카는 독립적인 안전위원회와 영국 규제당국이 안전성 문제를 확인할 수 있도록 임상을 자발적으로 중단했고, 이후 영국 의약품건강관리제품규제청(MHRA)으로부터 백신의 안전성에 문제가 없다는 것을 확인받아 영국에서 임상을 재개했다고 설명했다.

이같은 아스트라제네카의 행보에 미국 국립보건원이 우려를 제기하고 나선 것이다. NIH는 아스트라제네카, 옥스포드대, 영국 의약품건강관리제품규제청이 내린 결론에 대한 정확한 규명 필요하다는 입장이다. 이번에 발생한 횡단 척수염이 드물지만 백신에 의해서도 유발할 수 있다고 보기 때문. 신경학자들의 의견에 따르면 횡단 척수염이 주로 바이러스 감염에 따른 면역반응으로 일어나지만 백신 투여가 매우 낮은 빈도로 유발할 수 있다는 설명이다....

'프리미엄 뉴스서비스 BioS+'는 독자들에게 가치(value)있는 기사를 제공합니다.
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