MMWR Morb Mortal Wkly Rep. 2022 Nov 11;71(45):1436-1441. doi: 10.15585/mmwr.mm7145a2.
Four COVID-19 vaccines are currently approved for primary series vaccination in the United States under a Biologics License Application or authorized under an emergency use authorization (EUA) by the Food and Drug Administration (FDA), and recommended for primary series vaccination by the Advisory Committee on Immunization Practices (ACIP): 1) the 2- or 3-dose monovalent mRNA BNT162b2 (Pfizer-BioNTech, Comirnaty) COVID-19 vaccine; 2) the 2- or 3-dose monovalent mRNA mRNA-1273 (Moderna, Spikevax) COVID-19 vaccine; 3) the single-dose adenovirus vector-based Ad26.COV.S (Janssen [Johnson & Johnson]) COVID-19 vaccine; and 4) the 2-dose adjuvanted, protein subunit-based NVX-CoV2373 (Novavax) COVID-19 vaccine. The number of doses recommended is based on recipient age and immunocompromise status (1). For additional protection, FDA has amended EUAs to allow for COVID-19 booster doses in eligible persons (1). Because COVID-19 vaccines have demonstrated decreased effectiveness during the period when the Omicron variant (B.1.1.529) of SARS-CoV-2 predominated, bivalent booster doses (i.e., vaccine with equal components from the ancestral and Omicron strains) were considered for the express purpose of improving protection conferred by COVID-19 vaccine booster doses (2). During September-October 2022, FDA authorized bivalent mRNA vaccines for use as a booster dose in persons aged ≥5 years who completed any FDA-approved or FDA-authorized primary series and removed EUAs for monovalent COVID-19 booster doses (1). Pfizer-BioNTech and Moderna bivalent booster vaccines each contain equal amounts of spike mRNA from the ancestral and Omicron BA.4/BA.5 strains. After the EUA amendments, ACIP and CDC recommended that all persons aged ≥5 years receive 1 bivalent mRNA booster dose ≥2 months after completion of any FDA-approved or FDA-authorized monovalent primary series or monovalent booster doses.
目前,有 4 种 COVID-19 疫苗已通过生物制品许可申请(BLA)在美国获得批准,或通过美国食品药品监督管理局(FDA)的紧急使用授权(EUA)获得授权,并被免疫接种咨询委员会(ACIP)推荐用于初级系列接种:1)2 剂或 3 剂单价 mRNA BNT162b2(辉瑞-生物科技,Comirnaty)COVID-19 疫苗;2)2 剂或 3 剂单价 mRNA mRNA-1273(莫德纳,Spikevax)COVID-19 疫苗;3)单剂量腺病毒载体 Ad26.COV.S(杨森[强生])COVID-19 疫苗;4)2 剂含佐剂、蛋白亚单位的 NVX-CoV2373(诺瓦瓦克斯)COVID-19 疫苗。推荐的剂量数基于受种者年龄和免疫功能受损状态(1)。为了提供额外的保护,FDA 已修订 EUA,允许符合条件的人接种 COVID-19 加强针(1)。由于 COVID-19 疫苗在 SARS-CoV-2 奥密克戎变异株(B.1.1.529)流行期间效力降低,因此考虑使用二价加强针(即,来自原始株和奥密克戎株的等量成分的疫苗),以明确提高 COVID-19 疫苗加强针提供的保护(2)。2022 年 9 月至 10 月期间,FDA 授权二价 mRNA 疫苗用于完成任何 FDA 批准或授权的初级系列接种的≥5 岁人群的加强针,并取消了单价 COVID-19 加强针的 EUA(1)。辉瑞-生物科技和莫德纳的二价加强针疫苗均含有等量的来自原始株和奥密克戎 BA.4/BA.5 株的刺突 mRNA。EUA 修订后,ACIP 和 CDC 建议≥5 岁的所有人在完成任何 FDA 批准或授权的单价初级系列或单价加强针接种后≥2 个月接种 1 剂二价 mRNA 加强针。
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