FDA Panel Unanimously Recommends J&J Covid Booster Shot

FDA小组一致推荐J&J Covid强化注射

2021-10-16 08:00:08 RTTNews

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The advisory panel to the U.S. Food and Drug Administration has voted unanimously recommending a booster dose of Johnson & Johnson's (JNJ) vaccine at least two months after people get the first dose. Johnson & Johnson Friday announced that the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted 19-0 to recommend Emergency Use Authorization for a booster dose of its COVID-19 vaccine for adults aged 18 and older at least two months following initial vaccination with the single-shot vaccine. The panel's decision was based on by phase 3 findings showing a booster shot increased protection to 94 percent against moderate to severe/critical COVID-19 in the U.S. "Today's recommendation is based on the totality of evidence, with clinical and real-world data showing that while a single shot offers strong and long-lasting protection against COVID-19, a booster given after the single-dose primary vaccination increases protection, in particular against symptomatic COVID-19," said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. This same committee on Thursday had recommended Moderna (MRNA) booster shots to people ages 65 and older and other high-risk adults. Meanwhile, the panel's recommendation is not final and FDA will decide whether to authorize the EUA. However, the FDA usually follows the advice of the committee. J&J had received authorization for its vaccine in late February. The company had submitted a request to FDA to approve a booster shot of its one-dose vaccine for people ages 18 and older on October 5. For comments and feedback contact: editorial@rttnews.com Business News
美国食品药品监督管理局的顾问小组一致投票建议在人们接种第一剂疫苗至少两个月后,增加强生(JNJ)疫苗的剂量。 强生公司周五宣布,美国食品和药物管理局疫苗和相关生物制品咨询委员会(VRBPAC)一致以19比0的投票结果,建议对18岁及以上的成年人在首次接种单针疫苗后至少两个月的新冠肺炎疫苗的加强剂量进行紧急使用授权。 该小组的决定是基于第三阶段的发现,该发现显示,在美国,加强注射将对中度至重度/危重新冠肺炎的保护提高到94% 强生公司执行委员会副主席兼首席科学官保罗·斯托菲尔斯(Paul Stoffels)医学博士说:“今天的建议是基于全部证据,临床和现实世界的数据显示,虽然单次注射提供了对新冠肺炎病毒的强大而持久的保护,但单剂初级疫苗接种后给予的助推器增加了保护,尤其是对有症状的新冠肺炎病毒的保护。” 该委员会周四建议向65岁及以上的人和其他高危成年人注射莫德纳(MRNA)强化疫苗。 与此同时,该小组的建议不是最终的,食品和药物管理局将决定是否授权EUA。然而,食品和药物管理局通常会听从委员会的建议。 J&J在2月底获得了疫苗授权。该公司已于10月5日向美国食品和药物管理局提交了一份请求,要求批准为18岁及以上的人注射一剂疫苗。 如需评论和反馈,请联系:editorial@rttnews.com 商业新闻

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