İnaktive Sars-Cov-2 (Coronavac) Aşısı Sonrası Nadir Görülen Yan Etkiler

Abstract

Amaç Sağlık çalışanları ve yaşlılarda Coronavac aşılamasından sonraki yan etkilerin sıklığını, tipini, başlangıç zamanını ve yoğunluğunu değerlendirmek ve ayrıca sağlık çalışanlarında aşılamadan sonra COVID-19 hastalığının oluşup oluşmadığını belirlemektir. Metod Çalışmanın kohortunu xxxxxxx Medical Park hastanesinde aşılanan sağlık çalışanları ve yaşlı kişiler oluşturmaktadır. Coronovac ile aşılanan yaşlı kişilerin verileri tıbbi kayıtlardan elde edildi. Sağlık çalışanlarına, demografik veriler, COVID-19 ile de ilişkili olan tıbbi öykü ve Coronavac aşısının yan etkilerini içeren bir anket uygulandı. Bulgular 427 anket analiz edildi. En sık görülen yan etki enjeksiyon bölgesinde ağrıydı. Birinci ve ikinci enjeksiyon sonrası ağrı insidansı sırasıyla %22.3 (102/457) ve %12,8 (52/405) idi. En sık görülen sistemik yan etki, birinci dozdan sonra %18.2 ve ikinci dozdan sonra %10.3 insidansı ile yorgunluk idi. Aşılamadan sonra sağlık çalışanlarının işe gitmesini engelleyen yan etkiler gözlenmedi. İki doz aşılamadan sonra, sadece 7 sağlık çalışanında hafif COVID-19 enfeksiyonu tespit edildi. Bir kişide ilk dozdan 7 gün sonra COVID-19 enfeksiyonu görüldü. 354 yaşlı kişiye ait tıbbi kayıtlar değerlendirildi ve bu kişilerden sadece bir tanesinde ilk dozdan sonra ürtiker tespit edildi. Sonuç Çalışmamızda Coronavac'ın iyi tolere edilen bir aşı olduğu bulunmuştur.

Keywords

• Yan etkiler, Coronavac, COVID-19 aşısı, inaktive aşı, sağlık çalışanları aşılaması, güvenlik, istenmeyen etkiler

Rare Side Effects After Inactiveted Sars-Cov-2 Vaccine (Coronavac)

Abstract

Objective To evaluate the frequency, type, onset time, and intensity of the side effects after the Coronavac vaccination in healthcare workers (HCW) and elderly people and also to determine whether COVID-19 disease occurs after vaccination in HCW. Methods HCW and elderly people who were vaccinated in XXXXXXX Medical Park were the cohorts of the study. A questionnaire was applied to HCW, and the data of elderly people were obtained from medical records. The questionnaire had demographic data, medical history also included COVID-19-related and side effects of the Coronavac vaccine. Results 427 questionnaires were analyzed. The most common adverse reaction was pain at the injection site. The incidences of pain after the first and second injections were 22.3% (102/457) and 12,8% (52/405), respectively. And most common systemic side effect was fatigue with an incidence of 18.2% and 10.3% after each dose, respectively. Side effects that kept HCW from going to work after vaccination were not observed. After the two doses of vaccination, only 7 HCW had mild COVID-19 infection. One had a COVID-19 infection after 7 days of the first dose. 354 medical records of elderly people were evaluated. Only one of them reported urticaria after the first dose. Conclusion Our study found that Coronavac is a well-tolerated vaccine.

Keywords

• Adverse reaction
• Coronavac
• COVID-19 vaccination
• inactivated vaccine
• healthcare workers vaccination
• safety
• side effects

References

1. References 1. World Health Organization; Geneva. https://worldhealthorg.shinyapps.io/covid/ (accessed, June 18, 2021).
2. 2. Guan WJ, Ni ZY, Hu Y, et al; China Medical Treatment Expert Group for Covid 19. Clinical characteristics of coronavirus disease 2019 in China. N Engl J Med. Published online February 28, 2020. doi:10.1056/NEJMoa2002032PubMed
3. 3.World Health Organization; Geneva. https://extranet.who.int/pqweb/sites/default/files/documents/Status_of_COVID-19_Vaccines_within_WHO_EUL-PQ_evaluation_process-16June2021_Final.pdf (accessed, June 18, 2021).
4. 4. World Health Organization; Geneva. https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines (accessed, June 21, 2021). 5. Sinovac Research and Development Co. Ltd. Safety and Immunogenicity Study of Inactivated Vaccine for Prophylaxis of SARS CoV-2 Infection (COVID-19). ClinicalTrials.gov. Available online: https://clinicaltrials.gov/ct2/show/NCT04352608 (accessed June 21, 2021)
5. 6. Zhang Y, Zeng G, Pan H, et al. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021;21(2):181-192. doi:10.1016/S1473-3099(20)30843-4
6. 7. Acar AB, Remziye N, Mehmet Ö. An Analysis of the Attitudes of Family Physicians Towards the COVID-19 Vaccine. Konuralp Medical Journal.13(S1):429-37.
7. 8. Zhu FC, Guan XH, Li YH, et al. Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2020;396 (10249):479–488.
8. 9. Folegatti PM, Ewer KJ, Aley PK, et al. Oxford COVID vaccine trial group. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. Lancet. 2020;396 (10249):467–478.

9. 10. Ramasamy MN, Minassian AM, Ewer KJ, et al. Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial. Lancet. 2021;396(10267):1979–1993.
10. 11.Zhang MX, Zhang TT, Shi GF, et al. Safety of an inactivated SARS-CoV-2 vaccine among healthcare workers in China [published online ahead of print, 2021 May 13]. Expert Rev Vaccines. 2021;1-8. doi:10.1080/14760584.2021.1925112.
11. 12. Serap B, Burucu R, Cantekin I, Dönmez H. Determining The Side Effects Of Covid-19 (Sinovac) Vaccination On Nurses; An Independent Descriptive Study. Konuralp Medical Journal.13(S1):479-87.
12. 13. Report on Evaluation of Safety, Efficacy and Quality of CoronaVac COVID-19 Vaccine (Vero Cell) Inactivated. Food and Health Bureau (FHB 2021.) Available online: https://www.fhb.gov.hk/download/our_work/health/201200/e_evaluation_report_ CoronaVac.pdf (accesse, June 21, 2021).