Sağlık Çalışanlarında İnaktif Bir Koronavirüs-19 Aşısının Alınmasından Sonra Advers Olaylar: Kesitsel Bir Çalışma
Öz
Amaç: Sinovac tarafından üretilen aşı Türkiye’de acil kullanım onayı programına göre ruhsatlandırılmıştır. Doğal olarak bu ürünün güvenlik sorunlarıyla ilgili birçok eksikliği vardır. Amaç aşının potansiyel yan etkilerini araştırmaktı.
Gereç ve Yöntemler: Kendi kendine uygulanan 24 maddelik bir anket aracılığıyla sağlık çalışanları üzerinde retrospektif kesitsel bir çalışma yapıldı.
Bulgular: Yüz otuz üç kişiden 51’i (%38) aşının ilk dozundan sonra yan etkiler yaşadı. En yaygın yan etkiler yorgunluk, baş ağrısı, ishal ve ateşti. Deneklerin yüzde doksan beşi (n=126) ikinci aşı dozunu aldı ve sadece 43 denek (%26) advers olaylar tanımladı. Bu olaylar, ilk dozdan sonra görülenlere benzerdi. Bir kişide, akut hipertansiyon yükselmesi ciddi bir yan etki olarak kabul edildi. Yan etkilerin sıklığına ilişkin bir kadın baskınlığı, yalnızca ilk doz uygulamasından sonra tespit edildi.
Sonuç: Aşıya yanıt olarak önemli miktarda yan etki olmasına rağmen, bunlar ciddi olaylar olarak tanımlanamaz. Bu nedenle, bu aşı 2019 koronavirüs hastalığı tehdidi altındakiler için yeterince güvenli görünüyor.
Anahtar Kelimeler
advers ilaç olayı COVID-19 aşısı SARS-COv-2 virüsü güvenlilik
Kaynakça
- Ciotti M, Angeletti S, Minieri M, Giovannetti M, Benvenuto D, Pascarella S et al. COVID-19 Outbreak: An Overview. Chemotherapy. 2019; 64(5-6):215-223.
- Sun P, Lu X, Xu C, Sun W, Pan B. Understanding of COVID-19 based on current evidence. J Med Virol. 2020; 92(6):548-551.
- Zhang Y, Zeng G, Pan H, Li C, Hu Y, Chu K 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.
- World Health Organization: Safety of medicines: A guide to detecting and reporting adverse drug reactions-why health professionals need to take action. Geneva 2002.
- Ergün Y, Ergün TB, Toker E, Ünal E, Akben M. Knowledge attitude and practice of Turkish health professionals towards pharmacovigilance in a university hospital. Int Health. 2019;11(3):177-184.
- Jefferson T, Rudin M, Di Pietrantonj C. Adverse events after immunisation with aluminium-containing DTP vaccines: systematic review of the evidence. Lancet Infect Dis. 2004;4(2):84-90.
- Tanriover MD, Doğanay HL, Akova M, Güner HR, Azap A, Akhan S et al. Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): İnterim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey. Lancet. 2021;398(10296):213-222.
- Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Published: November 27, 2017 U.S. Department of Health and Human Services
- Uppsala Monitoring Center. Website: https://www.who-umc.org/global-pharmacovigilance/publications/glossary/ Access date: 08.09.2021
- Zucker I, Prendergast BJ. Sex differences in pharmacokinetics predict adverse drug reactions in women. Biol Sex Differ. 2020;11(1):32-46.
- Watson S, Caster O, Rochon PA, den Ruijter H. Reported adverse drug reactions in women and men: Aggregated evidence from globally collected individual case reports during half a century. EClinicalMedicine. 2019;17:100188.
- Davies EA, O'Mahony MS. Adverse drug reactions in special populations-the elderly. Br J Clin Pharmacol. 2015;80(4):796-807.
- Alhawassi TM, Krass I, Bajorek BV, Pont LG. A systematic review of the prevalence and risk factors for adverse drug reactions in the elderly in the acute care setting. Clin Interv Aging. 2014;9:2079-2086.
Adverse Events After Receipt of an Inactive Coronavirus Disease-19 Vaccine in Healthcare Professionals: A Cross-Sectional Study
Öz
Objective: The vaccine manufactured by Sinovac has been licensed according to the emergency use authorization program in Turkey. Inherently, this product has many shortcomings regarding safety issues. The aim was to explore the potential adverse reactions of the vaccine.
Materials and Methods: A retrospective cross-sectional study via a 24-item self-administered questionnaire was conducted among healthcare professionals.
Results: Of 133 persons, 51 subjects (38%) experienced adverse events after the first dose of the vaccine. The most common adverse events were fatigue, headache, diarrhea, and fever. Ninety five percent of the subjects (n=126) had the second dose of the vaccine and only 43 subjects (26%) described adverse events. These events were similar to those seen after the first dose. In one person, acute hypertension elevation was considered to be a serious adverse event. A female dominance regarding the frequency of adverse events was, solely, detected after the first dose administration.
Conclusion: Although there is a significant amount of adverse events in response to the vaccine, these cannot be identified as serious events. Therefore, this vaccine seems to be safe enough for those under the threat of the coronavirus disease 2019.
Anahtar Kelimeler
Kaynakça
- Ciotti M, Angeletti S, Minieri M, Giovannetti M, Benvenuto D, Pascarella S et al. COVID-19 Outbreak: An Overview. Chemotherapy. 2019; 64(5-6):215-223.
- Sun P, Lu X, Xu C, Sun W, Pan B. Understanding of COVID-19 based on current evidence. J Med Virol. 2020; 92(6):548-551.
- Zhang Y, Zeng G, Pan H, Li C, Hu Y, Chu K 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.
- World Health Organization: Safety of medicines: A guide to detecting and reporting adverse drug reactions-why health professionals need to take action. Geneva 2002.
- Ergün Y, Ergün TB, Toker E, Ünal E, Akben M. Knowledge attitude and practice of Turkish health professionals towards pharmacovigilance in a university hospital. Int Health. 2019;11(3):177-184.
- Jefferson T, Rudin M, Di Pietrantonj C. Adverse events after immunisation with aluminium-containing DTP vaccines: systematic review of the evidence. Lancet Infect Dis. 2004;4(2):84-90.
- Tanriover MD, Doğanay HL, Akova M, Güner HR, Azap A, Akhan S et al. Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): İnterim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey. Lancet. 2021;398(10296):213-222.
- Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Published: November 27, 2017 U.S. Department of Health and Human Services
- Uppsala Monitoring Center. Website: https://www.who-umc.org/global-pharmacovigilance/publications/glossary/ Access date: 08.09.2021
- Zucker I, Prendergast BJ. Sex differences in pharmacokinetics predict adverse drug reactions in women. Biol Sex Differ. 2020;11(1):32-46.
- Watson S, Caster O, Rochon PA, den Ruijter H. Reported adverse drug reactions in women and men: Aggregated evidence from globally collected individual case reports during half a century. EClinicalMedicine. 2019;17:100188.
- Davies EA, O'Mahony MS. Adverse drug reactions in special populations-the elderly. Br J Clin Pharmacol. 2015;80(4):796-807.
- Alhawassi TM, Krass I, Bajorek BV, Pont LG. A systematic review of the prevalence and risk factors for adverse drug reactions in the elderly in the acute care setting. Clin Interv Aging. 2014;9:2079-2086.
Ayrıntılar
| Birincil Dil | İngilizce |
|---|---|
| Konular | Sağlık Kurumları Yönetimi |
| Bölüm | Araştırma Makaleleri |
| Yazarlar | |
| Yayımlanma Tarihi | 16 Mart 2023 |
| Gönderilme Tarihi | 16 Aralık 2021 |
| Kabul Tarihi | 24 Şubat 2022 |
| Yayımlandığı Sayı | Yıl 2023 Cilt: 18 Sayı: 1 |
