Alamer Edrous, Alhazmi Abdulaziz, Qasir Naaif A, Alamer Rahaf, Areeshi Halima, Gohal Gassem, Qadri Marwa, Hashem Anwar M, Algaissi Abdullah
Department of Medical Laboratory Sciences, Faculty of Applied Medical Sciences, Jazan University, Jazan 45142, Saudi Arabia.
Emerging and Epidemic Infectious Diseases Research Unit, Medical Research Center, Jazan University, Jazan 45142, Saudi Arabia.
Vaccines (Basel). 2021 Nov 9;9(11):1297. doi: 10.3390/vaccines9111297.
: Massive vaccination campaigns have been undertaken globally to combat the spread of the Coronavirus Disease 2019 (COVID-19). While most COVID-19 vaccines have shown excellent efficacy and safety profiles in clinical studies, real-world monitoring of vaccine safety is still important. In this study, we aimed to investigate the early side effects of Pfizer-BioNTech (BNT162b2) mRNA vaccine in children between 12-18 years old in Saudi Arabia. : To investigate the side effects in children in this age range following the administration of either one or two doses of Pfizer-BioNTech (BNT162b2) mRNA vaccine, we conducted a retrospective, cross-sectional study using a self-administered online survey. General and demographic data were collected, and vaccine-associated side effects following vaccination were evaluated. : The study recruited a total of 965 eligible participants. Overall, 571 (60%) of the study participants reported at least one side effect following Pfizer-BioNTech (BNT162b2) mRNA vaccination. The most frequently reported side effects were pain or redness at the site of injection (90%), fatigue (67%), fever (59%), headache (55%), nausea or vomiting (21%), and chest pain and shortness of breath (20%). Joint or bone pain were reported less frequently among our participants (2%). Our data showed that more female participants reported side effects compared to male participants, with 52% and 48%, respectively. Side effects were more common after the second dose compared to the first dose in our study cohort. : While 60% of the children (12-18 years old) who received Pfizer-BioNTech (BNT162b2) mRNA vaccine reported side effects, our data showed that these side effects were not different from those that were reported in the clinical trials which lasted only for a few days. Side effects were more common after the second dose. Larger epidemiological and molecular studies are needed to evaluate the safety and the effectiveness of COVID-19 vaccine in protection of children against SARS-CoV-2 reinfections.
全球已开展大规模疫苗接种运动以抗击2019冠状病毒病（COVID-19）的传播。虽然大多数COVID-19疫苗在临床研究中显示出优异的疗效和安全性，但对疫苗安全性进行真实世界监测仍然很重要。在本研究中，我们旨在调查辉瑞-生物科技公司（BNT162b2）mRNA疫苗在沙特阿拉伯12至18岁儿童中的早期副作用。
为了调查在接种一剂或两剂辉瑞-生物科技公司（BNT162b2）mRNA疫苗后该年龄范围内儿童的副作用，我们使用自行管理的在线调查进行了一项回顾性横断面研究。收集了一般和人口统计学数据，并评估了接种疫苗后与疫苗相关的副作用。
该研究共招募了965名符合条件的参与者。总体而言，571名（60%）研究参与者报告在接种辉瑞-生物科技公司（BNT162b2）mRNA疫苗后至少出现一种副作用。最常报告的副作用是注射部位疼痛或发红（90%）、疲劳（67%）、发热（59%）、头痛（55%）、恶心或呕吐（21%）以及胸痛和呼吸急促（20%）。我们的参与者中报告关节或骨痛的频率较低（2%）。我们的数据显示，报告副作用的女性参与者比男性参与者更多，分别为52%和48%。在我们的研究队列中，与第一剂相比，第二剂后副作用更常见。
虽然60%接种辉瑞-生物科技公司（BNT162b2）mRNA疫苗的儿童（12至18岁）报告了副作用，但我们的数据显示这些副作用与仅持续几天的临床试验中报告的副作用并无不同。第二剂后副作用更常见。需要开展更大规模的流行病学和分子研究来评估COVID-19疫苗在保护儿童免受SARS-CoV-2再次感染方面的安全性和有效性。
