免疫实践咨询委员会关于在 5-11 岁儿童中使用辉瑞-生物技术公司 COVID-19 疫苗的临时建议-美国，2021 年 11 月。
The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Children Aged 5-11 Years - United States, November 2021.
出版信息
MMWR Morb Mortal Wkly Rep. 2021 Nov 12;70(45):1579-1583. doi: 10.15585/mmwr.mm7045e1.
The Pfizer-BioNTech COVID-19 (BNT162b2) vaccine is a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine encoding the prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. On August 23, 2021, the Food and Drug Administration (FDA) approved a Biologics License Application (BLA) for use of the Pfizer-BioNTech COVID-19 vaccine, marketed as Comirnaty (Pfizer, Inc.), in persons aged ≥16 years (1). The Pfizer-BioNTech COVID-19 vaccine is also recommended for adolescents aged 12-15 years under an Emergency Use Authorization (EUA) (1). All persons aged ≥12 years are recommended to receive 2 doses (30 μg, 0.3 mL each), administered 3 weeks apart (2,3). As of November 2, 2021, approximately 248 million doses of the Pfizer-BioNTech COVID-19 vaccine had been administered to persons aged ≥12 years in the United States.* On October 29, 2021, FDA issued an EUA amendment for a new formulation of Pfizer-BioNTech COVID-19 vaccine for use in children aged 5-11 years, administered as 2 doses (10 μg, 0.2 mL each), 3 weeks apart (Table) (1). On November 2, 2021, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of the Pfizer-BioNTech COVID-19 vaccine in children aged 5-11 years for the prevention of COVID-19. To guide its deliberations regarding recommendations for the vaccine, ACIP used the Evidence to Recommendation (EtR) Framework and incorporated a Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. The ACIP recommendation for the use of the Pfizer-BioNTech COVID-19 vaccine in children aged 5-11 years under an EUA is interim and will be updated as additional information becomes available. The Pfizer-BioNTech COVID-19 vaccine has high efficacy (>90%) against COVID-19 in children aged 5-11 years, and ACIP determined benefits outweigh risks for vaccination. Vaccination is important to protect children against COVID-19 and reduce community transmission of SARS-CoV-2.
辉瑞-生物科技的 COVID-19（BNT162b2）疫苗是一种脂质纳米颗粒制剂，基于修饰核苷的信使 RNA 技术，编码导致 COVID-19 的 SARS-CoV-2 病毒的融合前刺突糖蛋白。2021 年 8 月 23 日，美国食品药品监督管理局（FDA）批准辉瑞-生物科技的 COVID-19 疫苗（辉瑞公司，商品名为 Comirnaty）的生物制品许可申请（BLA），用于 16 岁及以上人群（1）。根据紧急使用授权（EUA），辉瑞-生物科技的 COVID-19 疫苗也推荐用于 12-15 岁青少年（1）。所有 12 岁及以上人群建议接种 2 剂（30μg，每剂 0.3ml），间隔 3 周（2,3）。截至 2021 年 11 月 2 日，辉瑞-生物科技的 COVID-19 疫苗在美国已接种给 12 岁及以上人群约 2.48 亿剂*。2021 年 10 月 29 日，FDA 发布了辉瑞-生物科技 COVID-19 疫苗新配方的 EUA 修正案，用于 5-11 岁儿童，接种 2 剂（每剂 10μg，0.2ml），间隔 3 周（表）（1）。2021 年 11 月 2 日，免疫实践咨询委员会（ACIP）发布了一项临时建议，在 EUA 下使用辉瑞-生物科技 COVID-19 疫苗用于预防 5-11 岁儿童 COVID-19。为指导其疫苗建议的审议，ACIP 使用了证据推荐（EtR）框架，并纳入了推荐分级、评估、发展与评价（GRADE）方法。ACIP 对 5-11 岁儿童使用辉瑞-生物科技 COVID-19 疫苗的 EUA 推荐是临时的，将随着更多信息的出现而更新。辉瑞-生物科技 COVID-19 疫苗在 5-11 岁儿童中对 COVID-19 的有效性（>90%）较高，ACIP 确定接种疫苗的益处超过风险。接种疫苗对于保护儿童免受 COVID-19 侵害和减少 SARS-CoV-2 在社区中的传播非常重要。
Zotero 插件