Warp Speed for Coronavirus Disease 2019 (COVID-19) Vaccines: Why Are Children Stuck in Neutral?

Warp Speed for Coronavirus Disease 2019 (COVID-19) Vaccines: Why Are Children Stuck in Neutral?
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DOI:
10.1093/cid/ciaa1425
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发表时间:
2021-07-15
期刊:
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
影响因子:
--
通讯作者:
Spearman P
Spearman P
中科院分区:
其他
文献类型:
--
作者:
Anderson EJ;Campbell JD;Creech CB;Frenck R;Kamidani S;Munoz FM;Nachman S;Spearman P

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虽然2019冠状病毒病(COVID-19)疫苗的成人临床试验已迅速进入3期临床试验,但美国尚未开始在儿童中进行临床试验。COVID-19对儿童的直接影响大于我们目前拥有有效儿科疫苗的许多其他病原体所观察到的影响。此外,儿童在严重急性呼吸综合征冠状病毒2 (SARS-CoV-2)传播中的作用显然被低估了。精心开展的2期临床试验可以充分解决潜在的COVID-19疫苗安全问题。推迟儿童2期疫苗临床试验将推迟我们从COVID-19中恢复过来的时间,并不必要地延长其对儿童教育、健康和情感福祉以及公平获得发展和社会成功机会的影响。鉴于儿童疫苗接种的潜在直接和间接益处,现在应开始实施COVID-19疫苗的二期临床试验。虽然COVID-19疫苗已迅速进入成人3期临床试验,但在美国尚未开始在儿童中进行临床试验。鉴于潜在的直接和间接益处,现在应该开始实施儿童COVID-19 II期疫苗临床试验。
While adult clinical trials of coronavirus disease 2019 (COVID-19) vaccines have moved quickly into phase 3 clinical trials, clinical trials have not started in children in the United States. The direct COVID-19 impact upon children is greater than that observed for a number of other pathogens for which we now have effective pediatric vaccines. Additionally, the role of children in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission has clearly been underappreciated. Carefully conducted phase 2 clinical trials can adequately address potential COVID-19 vaccine safety concerns. Delaying phase 2 vaccine clinical trials in children will delay our recovery from COVID-19 and unnecessarily prolong its impact upon children’s education, health, and emotional well-being, and equitable access to opportunities for development and social success. Given the potential direct and indirect benefits of pediatric vaccination, implementation of phase 2 clinical trials for COVID-19 vaccines should begin now. While COVID-19 vaccines have moved quickly into adult Phase 3 clinical trials, clinical trials have not started in children in the US. Given potential direct and indirect benefits, implementation of pediatric COVID-19 Phase II vaccine clinical trials should begin now.
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