{"id":23548,"date":"2023-03-24T04:33:00","date_gmt":"2023-03-23T20:33:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=23548"},"modified":"2023-03-24T05:37:52","modified_gmt":"2023-03-23T21:37:52","slug":"nejm%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a5%e5%b2%81%e4%bb%a5%e4%b8%8b%e5%84%bf%e7%ab%a5%e6%8e%a5%e7%a7%8d%e8%be%89%e7%91%9e%e6%96%b0%e5%86%a0%e7%97%85%e6%af%92mrna%e7%96%ab%e8%8b%97%e7%9a%84","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=23548","title":{"rendered":"[NEJM\u53d1\u8868\u8bba\u6587]\uff1a5\u5c81\u4ee5\u4e0b\u513f\u7ae5\u63a5\u79cd\u8f89\u745e\u65b0\u51a0\u75c5\u6bd2mRNA\u75ab\u82d7\u7684\u8bc4\u4f30"},"content":{"rendered":"\n

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

Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age<\/h1>\n\n\n\n

Flor M. Mu\u00f1oz, Lawrence D. Sher, Charu Sabharwal,\u00a0et al<\/h3>\n\n\n\n

N Engl J Med 2023; 388:621-634
DOI: 10.1056\/NEJMoa2211031<\/h3>\n\n\n\n

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

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

Safe and effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in young children.<\/p>\n\n\n\n

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

<\/p>\n\n\n\n

We conducted a phase 1 dose-finding study and are conducting an ongoing phase 2\u20133 safety, immunogenicity, and efficacy trial of the BNT162b2 vaccine in healthy children 6 months to 11 years of age. We present results for children 6 months to less than 2 years of age and those 2 to 4 years of age through the data-cutoff dates (April 29, 2022, for safety and immunogenicity and June 17, 2022, for efficacy). In the phase 2\u20133 trial, participants were randomly assigned (in a 2:1 ratio) to receive two 3-\u03bcg doses of BNT162b2 or placebo. On the basis of preliminary immunogenicity results, a third 3-\u03bcg dose (\u22658 weeks after dose 2) was administered starting in January 2022, which coincided with the emergence of the B.1.1.529 (omicron) variant. Immune responses at 1 month after doses 2 and 3 in children 6 months to less than 2 years of age and those 2 to 4 years of age were immunologically bridged to responses after dose 2 in persons 16 to 25 years of age who received 30 \u03bcg of BNT162b2 in the pivotal trial.<\/a><\/p>\n\n\n\n

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

During the phase 1 dose-finding study, two doses of BNT162b2 were administered 21 days apart to 16 children 6 months to less than 2 years of age (3-\u03bcg dose) and 48 children 2 to 4 years of age (3-\u03bcg or 10-\u03bcg dose). The 3-\u03bcg dose level was selected for the phase 2\u20133 trial; 1178 children 6 months to less than 2 years of age and 1835 children 2 to 4 years of age received BNT162b2, and 598 and 915, respectively, received placebo. Immunobridging success criteria for the geometric mean ratio and seroresponse at 1 month after dose 3 were met in both age groups. BNT162b2 reactogenicity events were mostly mild to moderate, with no grade 4 events. Low, similar incidences of fever were reported after receipt of BNT162b2 (7% among children 6 months to <2 years of age and 5% among those 2 to 4 years of age) and placebo (6 to 7% among children 6 months to <2 years of age and 4 to 5% among those 2 to 4 years of age). The observed overall vaccine efficacy against symptomatic Covid-19 in children 6 months to 4 years of age was 73.2% (95% confidence interval, 43.8 to 87.6) from 7 days after dose 3 (on the basis of 34 cases).<\/p>\n\n\n\n

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

A three-dose primary series of 3-\u03bcg BNT162b2 was safe, immunogenic, and efficacious in children 6 months to 4 years of age. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04816643. opens in new tab<\/a>.)<\/p>\n","protected":false},"excerpt":{"rendered":"

ORIGINAL ARTICLE Evaluation of BNT162b2 Covid-19 Vaccin […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/23548"}],"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=23548"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/23548\/revisions"}],"predecessor-version":[{"id":23549,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/23548\/revisions\/23549"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=23548"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=23548"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=23548"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}