{"id":21225,"date":"2022-02-22T05:24:00","date_gmt":"2022-02-21T21:24:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=21225"},"modified":"2022-02-22T05:45:33","modified_gmt":"2022-02-21T21:45:33","slug":"nejm%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a%e5%8d%95%e5%89%82%e8%85%ba%e7%97%85%e6%af%92%e7%96%ab%e8%8b%97ad26-cov2-s%e7%9a%84%e6%95%88%e6%9e%9c%e5%8f%8a%e5%ae%89%e5%85%a8%e6%80%a7%ef%bc%9a","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=21225","title":{"rendered":"[NEJM\u53d1\u8868\u8bba\u6587]\uff1a\u5355\u5242\u817a\u75c5\u6bd2\u75ab\u82d7Ad26.COV2.S\u7684\u6548\u679c\u53ca\u5b89\u5168\u6027\uff1a\u6700\u540e\u5206\u6790"},"content":{"rendered":"\n

ORIGINAL ARTICLE<\/a><\/p>\n\n\n\n

Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S<\/h1>\n\n\n\n

Jerald Sadoff, Glenda Gray, An Vandebosch,\u00a0et al<\/h3>\n\n\n\n

N Engl J Med February 9, 2022
DOI: 10.1056\/NEJMoa2117608<\/h3>\n\n\n\n

Abstract<\/h2>\n\n\n\n

BACKGROUND<\/h2>\n\n\n\n

The Ad26.COV2.S vaccine was highly effective against severe\u2013critical coronavirus disease 2019 (Covid-19), hospitalization, and death in the primary phase 3 efficacy analysis.<\/p>\n\n\n\n

METHODS<\/h2>\n\n\n\n

We conducted the final analysis in the double-blind phase of our multinational, randomized, placebo-controlled trial, in which adults were assigned in a 1:1 ratio to receive single-dose Ad26.COV2.S (5\u00d71010<\/sup> viral particles) or placebo. The primary end points were vaccine efficacy against moderate to severe\u2013critical Covid-19 with onset at least 14 days after administration and at least 28 days after administration in the per-protocol population. Safety and key secondary and exploratory end points were also assessed.<\/p>\n\n\n\n

RESULTS<\/h2>\n\n\n\n

Median follow-up in this analysis was 4 months; 8940 participants had at least 6 months of follow-up. In the per-protocol population (39,185 participants), vaccine efficacy against moderate to severe\u2013critical Covid-19 at least 14 days after administration was 56.3% (95% confidence interval [CI], 51.3 to 60.8; 484 cases in the vaccine group vs. 1067 in the placebo group); at least 28 days after administration, vaccine efficacy was 52.9% (95% CI, 47.1 to 58.1; 433 cases in the vaccine group vs. 883 in the placebo group). Efficacy in the United States, primarily against the reference strain (B.1.D614G) and the B.1.1.7 (alpha) variant, was 69.7% (95% CI, 60.7 to 76.9); efficacy was reduced elsewhere against the P.1 (gamma), C.37 (lambda), and B.1.621 (mu) variants. Efficacy was 74.6% (95% CI, 64.7 to 82.1) against severe\u2013critical Covid-19 (with only 4 severe\u2013critical cases caused by the B.1.617.2 [delta] variant), 75.6% (95% CI, 54.3 to 88.0) against Covid-19 leading to medical intervention (including hospitalization), and 82.8% (95% CI, 40.5 to 96.8) against Covid-19\u2013related death, with protection lasting 6 months or longer. Efficacy against any severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was 41.7% (95% CI, 36.3 to 46.7). Ad26.COV2.S was associated with mainly mild-to-moderate adverse events, and no new safety concerns were identified.<\/p>\n\n\n\n

\"\"\/<\/figure>\n\n\n\n
\"\"\/<\/figure>\n\n\n\n
\"\"\/<\/figure>\n\n\n\n
\"\"\/<\/figure>\n\n\n\n
\"\"\/<\/figure>\n\n\n\n

CONCLUSIONS<\/h2>\n\n\n\n

A single dose of Ad26.COV2.S provided 52.9% protection against moderate to severe\u2013critical Covid-19. Protection varied according to variant; higher protection was observed against severe Covid-19, medical intervention, and death than against other end points and lasted for 6 months or longer. (Funded by Janssen Research and Development and others; ENSEMBLE ClinicalTrials.gov number, NCT04505722. opens in new tab<\/a>.)<\/p>\n","protected":false},"excerpt":{"rendered":"

ORIGINAL ARTICLE Final Analysis of Efficacy and Safety […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/21225"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=21225"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/21225\/revisions"}],"predecessor-version":[{"id":21226,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/21225\/revisions\/21226"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=21225"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21225"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21225"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}