Karimi Mehran, Zarei Tahereh, Haghpanah Sezaneh, Azarkeivan Azita, Naderi Maryam, Matin Sara, Bazrafshan Asghar, Zahedi Zohreh, Shirkavand Afshan, Pishdad Parisa, De Sanctis Vincenzo
Hematology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
Zafar Adult Thalassemia Clinic, Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran.
Mediterr J Hematol Infect Dis. 2022 Mar 1;14(1):e2022026. doi: 10.4084/MJHID.2022.026. eCollection 2022.
The ongoing COVID-19 pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has led to high morbidity and mortality worldwide. Vaccination against SARS-CoV-2 is a leading strategy to change the course of the COVID-19 pandemic.
Our aim was to investigate the efficacy and side effects of the Sinopharm vaccine in patients with hemoglobinopathies in Iran and the frequency of breakthrough infection after a full course of vaccination.
A multicenter cross-sectional study of 434 patients with hemoglobinopathies (303 β-thalassemia major, 118 β-thalassemia intermedia, and 13 sickle-thalassemia) were conducted from March to July 2021 in IRAN. All patients have received the first dose of the China Sinopharm vaccine and received the second dose of the vaccine 28 days apar.
Detection of immunity after vaccination was evaluated by commercial enzyme-linked immunosorbent assay (Pishtazteb ELISA commercial kit), including a surrogate virus neutralization test (sVNT), for detection of SARS-CoV-2 immunoglobulins (IgA, IgM, IgG), total neutralizing antibody (NAb).
The mean age of patients was 35.0 ± 8.5 (from 18 to 70) years, and 55.6% were positive for the antibody. Overall, 48.2% of the studied population had at least one side effect after vaccination. The most frequent side effects were fever and chills, dizziness, and body pain. A total of 90 (20.7%) vaccinated patients developed breakthrough infections after two doses of Sinopharm vaccination. Disease severity was recorded, and it was classified as mild in 77.8%, moderate in 13.6%, and severe in 7.4% of patients. One 28-year-old woman with β-thalassemia major died eight days after diagnosing a breakthrough SARS-CoV-2 infection.
No safety concerns were identified in patients who received two doses of the Sinopharm vaccine. Its efficacy was not optimal due to the lack of effect on new variations of the virus. However, our data show that it seems to be protective against the severity of COVID-19 infection in patients with hemoglobinopathies. The frequency of breakthrough infections after two doses of Sinopharm vaccination supports the evolving dynamic of SARS-CoV-2 variants requiring special challenge since such infection may represent a risk for vulnerable patients.
由严重急性呼吸综合征冠状病毒2（SARS-CoV-2）引起的新冠疫情在全球范围内导致了高发病率和高死亡率。接种针对SARS-CoV-2的疫苗是改变新冠疫情发展进程的主要策略。
我们的目的是调查国药疫苗在伊朗血红蛋白病患者中的疗效和副作用，以及全程接种疫苗后突破性感染的发生率。
2021年3月至7月在伊朗对434例血红蛋白病患者（303例重型β地中海贫血、118例中间型β地中海贫血和13例镰状细胞-地中海贫血）进行了一项多中心横断面研究。所有患者均接种了第一剂中国国药疫苗，并在28天后接种了第二剂疫苗。
通过商业酶联免疫吸附测定（Pishtazteb ELISA商业试剂盒）评估接种疫苗后的免疫情况，包括替代病毒中和试验（sVNT），用于检测SARS-CoV-2免疫球蛋白（IgA、IgM、IgG）、总中和抗体（NAb）。
患者的平均年龄为35.0±8.5（18至70岁）岁，55.6%的患者抗体呈阳性。总体而言，48.2%的研究人群在接种疫苗后至少出现一种副作用。最常见的副作用是发热、寒战、头晕和身体疼痛。在接种两剂国药疫苗后，共有90例（20.7%）接种疫苗的患者发生了突破性感染。记录了疾病严重程度，77.8%的患者为轻症，13.6%为中症，7.4%为重症。一名28岁的重型β地中海贫血女性在诊断为突破性SARS-CoV-2感染八天后死亡。
在接种两剂国药疫苗的患者中未发现安全问题。由于对病毒新变种缺乏效果，其疗效并不理想。然而，我们的数据表明，它似乎对血红蛋白病患者的新冠感染严重程度具有保护作用。两剂国药疫苗接种后突破性感染的发生率支持了SARS-CoV-2变种不断演变的动态，因为这种感染可能对脆弱患者构成风险，需要特别应对。
