{"id":21223,"date":"2022-02-20T05:18:00","date_gmt":"2022-02-19T21:18:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=21223"},"modified":"2022-02-20T07:54:52","modified_gmt":"2022-02-19T23:54:52","slug":"nejm%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a%e6%96%b0%e5%86%a0%e7%97%85%e6%af%92%e8%85%ba%e7%97%85%e6%af%92%e7%96%ab%e8%8b%97nvx-cov2373%e5%af%b9%e7%be%8e%e5%9b%bd%e5%92%8c%e5%a2%a8%e8%a5%bf","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=21223","title":{"rendered":"[NEJM\u53d1\u8868\u8bba\u6587]\uff1a\u65b0\u51a0\u75c5\u6bd2\u817a\u75c5\u6bd2\u75ab\u82d7NVX-CoV2373\u5bf9\u7f8e\u56fd\u548c\u58a8\u897f\u54e5\u6210\u5e74\u4eba\u7684\u6548\u679c\u53ca\u5b89\u5168\u6027"},"content":{"rendered":"\n

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

Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico<\/h1>\n\n\n\n

Lisa M. Dunkle, Karen L. Kotloff, Cynthia L. Gay,\u00a0et al<\/h3>\n\n\n\n

N Engl J Med 2022; 386:531-543
DOI: 10.1056\/NEJMoa2116185<\/h3>\n\n\n\n

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

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

NVX-CoV2373 is an adjuvanted, recombinant spike protein nanoparticle vaccine that was shown to have clinical efficacy for the prevention of coronavirus disease 2019 (Covid-19) in phase 2b\u20133 trials in the United Kingdom and South Africa, but its efficacy had not yet been tested in North America.<\/p>\n\n\n\n

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

We conducted a phase 3, randomized, observer-blinded, placebo-controlled trial in the United States and Mexico during the first half of 2021 to evaluate the efficacy and safety of NVX-CoV2373 in adults (\u226518 years of age) who had not had severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Participants were randomly assigned in a 2:1 ratio to receive two doses of NVX-CoV2373 or placebo 21 days apart. The primary objective was to determine vaccine efficacy against reverse-transcriptase\u2013polymerase-chain-reaction\u2013confirmed Covid-19 occurring at least 7 days after the second dose. Vaccine efficacy against moderate-to-severe disease and against different variants was also assessed.<\/a><\/p>\n\n\n\n

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

Of the 29,949 participants who underwent randomization between December 27, 2020, and February 18, 2021, a total of 29,582 (median age, 47 years; 12.6% \u226565 years of age) received at least one dose: 19,714 received vaccine and 9868 placebo. Over a period of 3 months, 77 cases of Covid-19 were noted \u2014 14 among vaccine recipients and 63 among placebo recipients (vaccine efficacy, 90.4%; 95% confidence interval [CI], 82.9 to 94.6; P<0.001). Ten moderate and 4 severe cases occurred, all in placebo recipients, yielding vaccine efficacy against moderate-to-severe disease of 100% (95% CI, 87.0 to 100). Most sequenced viral genomes (48 of 61, 79%) were variants of concern or interest \u2014 largely B.1.1.7 (alpha) (31 of the 35 genomes for variants of concern, 89%). Vaccine efficacy against any variant of concern or interest was 92.6% (95% CI, 83.6 to 96.7). Reactogenicity was mostly mild to moderate and transient but was more frequent among NVX-CoV2373 recipients than among placebo recipients and was more frequent after the second dose than after the first dose.<\/p>\n\n\n\n

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

NVX-CoV2373 was safe and effective for the prevention of Covid-19. Most breakthrough cases were caused by contemporary variant strains. (Funded by Novavax and others; PREVENT-19 ClinicalTrials.gov number, NCT04611802. opens in new tab<\/a>.)<\/p>\n","protected":false},"excerpt":{"rendered":"

ORIGINAL ARTICLE Efficacy and Safety of NVX-CoV2373 in […]<\/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\/21223"}],"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=21223"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/21223\/revisions"}],"predecessor-version":[{"id":21224,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/21223\/revisions\/21224"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=21223"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21223"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21223"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}