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Hemoglobinopathies,, Sinopharm vaccine, efficacy, safety, adverse events, breakthrough SARS-CoV-2 infection
Background: 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.
Aims of study: Our aim was to investigate the efficacy and side effects of Sinopharm vaccine in patients with hemoglobinopathies in Iran, and the frequency of breakthrough infection after a full course of vaccination.
Methods: 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 China Sinopharm vaccine and received the second dose of the vaccine 28 days apart.
Antibody testing: 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).
Results: The mean age of patients was 35.0± 8.5 (from 18 to 70) years and 55.6% were positive for 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 full 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 the diagnosis of breakthrough SARS-CoV-2 infection.
Discussion: No safety concerns were identified in patients who received two doses of Sinopharm vaccine. Its efficacy was not optimal which might be due to lack of its effect on new variations of virus. However, our data show that it can prevent from severity of COVID-19 infection in patients with hemoglobinopathies. The frequency of breakthrough infections after full Sinopharm vaccination support the evolving dynamic of SARS-CoV-2 variants requiring special challenge, since such infection may represent a risk for vulnerable patients.
2. Lai CC, Shih TP, Ko WC, Tang H-J, Hsueh PR. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and coronavirus disease-2019 (COVID-19): The epidemic and the challenges. Int J Antimicrob Agents. 2020; 55(3):105924.
3. World Health Organization (WHO). Coronavirus disease (COVID-19) outbreak situation. Available
at: https://www.who.int/emergencies/diseases/novel- coronavirus-2019. cited date Oct 2021.
4. Anderson EJ, Rouphael NG, Widge AT, Jackson LA, Roberts PC, Makhene M, Chappell JD, Denison MR, Stevens LJ, Pruijssers AJ, McDermott AB, Flach B, Lin BC, Doria-Rose NA, O'Dell S, Schmidt SD, Corbett KS, Swanson PA 2nd, Padilla M, Neuzil KM, Bennett H, Leav B, Makowski M, Albert J, Cross K, Edara VV, Floyd K, Suthar MS, Martinez DR, Baric R, Buchanan W, Luke CJ, Phadke VK, Rostad CA, Ledgerwood JE, Graham BS, Beigel JH; mRNA-1273 Study Group. Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults. N Engl J Med. 2020;383:2427-2438.
5. Meo SA, Bukhari IA, Akram J, Meo AS, Klonoff DC. COVID-19 vaccines: comparison of biological, pharmacological characteristics and adverse effects of Pfizer/BioNTech and Moderna Vaccines.
Eur Rev Med Pharmacol Sci. 2021; 25:1663-1669.
6. Knoll M.D., Wonodi C. Oxford-AstraZeneca COVID-19 vaccine efficacy. Lancet. 2021; 397:72–74.
7. Hotez PJ, Nuzhath T, Callaghan T, Colwell B. COVID-19 Vaccine Decisions: Considering the Choices and Opportunities. Microbes Infect. 2021; 23:104811.
8. Alishaq M, Nafady-Hego H, Jeremijenko A, Al Ajmi JA, Elgendy M, Vinoy S, Fareh SB, Veronica Plaatjies J, Nooh M, Alanzi N, Kaleeckal AH, Latif AN, Coyle P, Elgendy H, Abou-Samra AB, Butt AA. Risk factors for breakthrough SARS-CoV-2 infection in vaccinated healthcare workers. PLoS ONE.2021;16(10): e0258820.
9. Baraniuk C. What do we know about China’s covid-19 vaccines? BMJ. 2021;373: n912.
10. Al Kaabi N, Zhang Y, Xia S, Yang Y, Al Qahtani MM, Abdulrazzaq N, Al Nusair M, Hassany M, Jawad JS, Abdalla J, Hussein SE, Al Mazrouei SK, Al Karam M, Li X, Yang X, Wang W, Lai B, Chen W, Huang S, Wang Q, Yang T, Liu Y, Ma R, Hussain ZM, Khan T, Saifuddin Fasihuddin M, You W, Xie Z, Zhao Y, Jiang Z, Zhao G, Zhang Y, Mahmoud S, ElTantawy I, Xiao P, Koshy A, Zaher WA, Wang H, Duan K, Pan A, Yang X. Effect of 2 Inactivated SARS-CoV-2 Vaccines on Symptomatic COVID-19 Infection in Adults: A Randomized Clinical Trial. JAMA. 2021; 326:35-45.
11.Saeed BQ, Al-Shahrabi R, Alhaj SS, Alkokhardi ZM, Adrees AO. Side effects and perceptions following Sinopharm COVID-19 vaccination. Int J Infect Dis. 2021; 111:219-226.
12. Haghpanah S, Hosseini-Bensenjan M, Sayadi M, Karimi M. Incidence Rate of COVID-19 Infection in Hemoglobinopathies: A Systematic Review and Meta-analysis. Hemoglobin. 2021:1-9.
13. Karimi M, De Sanctis V. Implications of SARS-CoV 2 infection in thalassemias: Do patients fall into the "high clinical risk" category? Acta Biomed. 2020;91:50–56.
14. Karimi M, Haghpanah S, Azarkeivan A, Zahedi Z, Zarei T, Akhavan Tavakoli M, Bazrafshan A, Shirkavand A, De Sanctis V. Prevalence and mortality in β-thalassaemias due to outbreak of novel coronavirus disease (COVID-19): the nationwide Iranian experience. Br J Haematol. 2020;190:e137-e140.
15. Karimi M, Haghpanah S, Zarei T, Azarkeivan A, Shirkavand A, Matin S, Tavakoli MA, Zahedi Z, De Sanctis V. Prevalence and severity of Coronavirus disease 2019 (COVID-19) in Transfusion Dependent and Non-Transfusion Dependent β-thalassemia patients and effects of associated comorbidities: an Iranian nationwide study. Acta Biomed. 2020;91(3):e2020007.
16. Son KB, Lee TJ, Hwang SS. Disease severity classification and COVID-19 outcomes, Republic of Korea. Bulletin of the World Health Organization. 2021;99:62-66.
17. Okba NMA, Müller MA, Li W, Wang C, Geurtsvan Kessel CH, Corman VM, Lamers MM, Sikkema RS, de Bruin E, Chandler FD, Yazdanpanah Y, Le Hingrat Q, Descamps D, Houhou-Fidouh N, Reusken CBEM, Bosch BJ, Drosten C, Koopmans MPG, Haagmans BL. Severe Acute Respiratory Syndrome Coronavirus 2-Specific Antibody Responses in Coronavirus Disease Patients. Emerg Infect Dis. 2020; 26:1478-1488.
18. El-Shitany NA, Harakeh S, Badr-Eldin SM, Bagher AM, Eid B, Almukadi H, Alghamdi BS, Alahmadi AA, Hassan NA, Sindi N, Alghamdi SA, Almohaimeed HM, Mohammedsaleh ZM, Al-Shaikh TM, Almuhayawi MS, Ali SS, El-Hamamsy M. Minor to Moderate Side Effects of Pfizer-BioNTech COVID-19 Vaccine Among Saudi Residents: A Retrospective Cross-Sectional Study. Int J Gen Med. 2021;14:1389-1401.
19. Chapin-Bardales J, Gee J, Myers T. Reactogenicity Following Receipt of mRNA-Based COVID-19 Vaccines. JAMA. 2021;325:2201-2202.
20. Kadali RAK, Janagama R, Peruru S, Malayala SV. Side effects of BNT162b2 mRNA COVID-19 vaccine: A randomized, cross-sectional study with detailed self-reported symptoms from healthcare workers. Int J Infect Dis. 2021;106:376-381.
21. Menni C, Klaser K, May A, Polidori L, Capdevila J, Louca P, Sudre CH, Nguyen LH, Drew DA, Merino J, Hu C, Selvachandran S, Antonelli M, Murray B, Canas LS, Molteni E, Graham MS, Modat M, Joshi AD, Mangino M, Hammers A, Goodman AL, Chan AT, Wolf J, Steves CJ, Valdes AM, Ourselin S, Spector TD. Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the COVID Symptom Study app in the UK: a prospective observational study. Lancet Infect Dis. 2021;21:939-949.
22. Jayadevan R, Shenoy RS, Anithadevi T. Survey of symptoms following COVID-19 vaccination in India. medRxiv. 2021.02.08.21251366
23. Hatmal MM, Al-Hatamleh MAI, Olaimat AN, Hatmal M, Alhaj-Qasem DM, Olaimat TM, Mohamud R. Side Effects and Perceptions Following COVID-19 Vaccination in Jordan: A Randomized, Cross-Sectional Study Implementing Machine Learning for Predicting Severity of Side Effects. Vaccines (Basel). 2021; 9 (6) :556.
24. Zahid MN, Moosa MS, Perna S, Buti EB. A review on COVID-19 vaccines: stages of clinical trials, mode of actions and efficacy. Arab J Basic Appl Sci. 2021;28:225-33.
25. Xia S, Zhang Y, Wang Y, Wang H, Yang Y, Gao GF, Tan W, Wu G, Xu M, Lou Z, Huang W, Xu W, Huang B, Wang H, Wang W, Zhang W, Li N, Xie Z, Ding L, You W, Zhao Y, Yang X, Liu Y, Wang Q, Huang L, Yang Y, Xu G, Luo B, Wang W, Liu P, Guo W, Yang X. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial. Lancet Infect Dis. 2021;21:39-351.
26. Jahromi M, Al Sheikh MH. Partial protection of Sinopharm vaccine against SARS COV2 during recent outbreak in Bahrain. Microb Pathog. 2021;158:105086.
27. Benger M, Williams O, Siddiqui J, Sztriha L. Intracerebral haemorrhage and COVID-19: Clinical characteristics from a case series. Brain Behav Immun. 2020;88:940-4.
28. Ronaldson PT, Davis TP. Mechanisms of Endothelial Injury and Blood–Brain Barrier Dysfunction in Stroke. Primer on Cerebrovascular Diseases. 2nd Ed., Elsevier; 2017; 220-6.
29. Divani AA, Andalib S, Di Napoli M, Lattanzi S, Hussain MS, Biller J, McCullough LD, Azarpazhooh MR, Seletska A, Mayer SA, Torbey M. Coronavirus Disease 2019 and Stroke: Clinical Manifestations and Pathophysiological Insights. J Stroke Cerebrovasc Dis. 2020;29(8):104941.
30. Jia Z, Gong W. Will Mutations in the Spike Protein of SARS-CoV-2 Lead to the Failure of COVID-19 Vaccines? J Korean Med Sci. 2021 May 10;36(18):e124.