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Children aged 3-17 years can take the same doses of the vaccine as adults
Published on: 2021-06-30
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Two doses of the China-made COVID-19 vaccine, CoronaVac, are safe and produce a strong antibody response among children and adolescents aged 3-17 years, according to a study published in The Lancet Infectious Diseases journal.
 

The phase 1/2 trial on 550 young people found that over 96 per cent of children and adolescents who received two doses of the vaccine, manufactured by Sinovac, developed antibodies against SARS-CoV-2, the virus that causes COVID-19.
 

Most adverse reactions were mild or moderate, with pain at the injection site the most commonly reported symptom, the researchers said.
 

The researchers conducted the phase 1/2 clinical trial of CoronaVac in healthy children and adolescents aged 3-17 years in Zanhuang County, China.
 

Between October 31 and December 2, 2020, 72 participants were enrolled in phase 1, and 480 participants enrolled in phase 2 between December 12 and December 30, 2020.
 

The vaccine -- either 1.5 microgram (g) or 3g per dose -- or a control was given by intramuscular injection in two doses, at day 0 and day 28.
 

Among the 550 participants who received at least one dose of vaccine or the control, adverse reactions within 28 days occurred in 56 (26 per cent) of 219 participants in the 1.5g group.
 

Such adverse events were reported in 63 (29 per cent) of 217 participants in the 3g group, and 27 (24 per cent) of 114 in the control group.
 

Only one serious adverse reaction -- a case of pneumonia -- was reported in the control group, however, this was unrelated to the COVID-19 vaccination, the researchers said.

In phase 1, 100 per cent of participants in both the 1.5g and 3g groups generated antibodies against SARS-CoV-2.

Stronger immune responses -- determined by the amount of antibodies produced that can neutralise the virus -- were detected among the 3g group compared with the 1.5g group.
 

In phase 2, 97 per cent of participants in the 1.5g group produced antibodies against SARS-CoV-2, compared with 100 per cent in the 3g group.
 

Participants in the 3g group again produced a stronger immune response than those in the 1.5g group.
 

The researchers noted that immune responses among children and adolescents were higher than those measured in adults aged 18-59 years and elderly aged 60 years and older.
 

No significant differences in immune response were detected in an analysis by age group.
 

More than 93 per cent of those in the 1.5g and 3g groups aged 3-5 years, 6-11 years, and 12-17 years produced antibodies against SARS-CoV-2 at day 28 after the second dose.
 

The researchers recommend two 3g doses of the vaccine for children and adolescents aged 3-17 years based on their results.
 

3-17岁孩子接种新冠疫苗剂量可与成人一样

当地时间6月28日,国际权威医学期刊《柳叶刀-感染病学》(The Lancet Infection Disease)最新在线发表新冠灭活疫苗克尔来福(CoronaVac)在健康儿童和青少年中的1/2期临床试验结果。试验初步评估表明,两剂CoronaVac疫苗用于3-17岁人群安全、可耐受,超过96%的受试者体内产生了中和抗体。
 

论文指出,“这是首次报告新冠灭活疫苗在3-17岁儿童青少年中的研究结果”。
 

根据论文介绍,这项随机、双盲、对照1/2期临床试验由科兴公司(SINOVAC)和河北省疾病预防控制中心共同领衔开展,共纳入了中国552名3-17岁健康儿童和青少年。2020年10月31日-12月2日期间,72名受试者被纳入1期临床研究;2020年12月12日至12月30日期间,480名受试者被纳入2期临床研究。受试者分别于第0天和第28天肌内注射2剂疫苗(低剂量1.5 μg/剂或中剂量3 μg/剂)或对照疫苗(氢氧化铝佐剂稀释剂)。
 

安全性结果显示,在接受至少一剂疫苗或对照疫苗的550名受试者中,1.5 μg组有26%(56/219)在28天内发生不良反应,3 μg组这一比例为29%(63/217),对照组为24%(27/114)。各组间的不良反应发生率没有显著区别。
 

大多数不良反应为轻度或中度。注射部位疼痛(13%[73/550])是最常报告的症状,1.5 μg组、3 μg组和对照组注射部位疼痛发生率分别为16%、16%和2%。仅报告了一例严重不良反应(肺炎),发生在对照组,研究者判断与疫苗接种无关。
 

论文也指出,由于研究存在一些局限性,应谨慎解释相关结果。比如,研究未评估T细胞反应,这在新冠感染中也同样起到重要的免疫保护作用;研究仅在少数受试者中进行,且均为汉族,这表明仍需在更广泛地区、更多样化人群中开展更大规模的研究。此外,目前尚无该疫苗用于儿童青少年的长期安全性和免疫反应数据,这些受试者将被随访至少1年。

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