J 2021

Safety of ChAdOx1 nCoV-19 Vaccine: Independent Evidence from Two EU States

RIAD, Abanoub, Andrea POKORNÁ, Mohamed MEKHEMAR, Jonas CONRAD, Jitka KLUGAROVÁ et. al.

Basic information

Original name

Safety of ChAdOx1 nCoV-19 Vaccine: Independent Evidence from Two EU States

Authors

RIAD, Abanoub (818 Egypt, guarantor, belonging to the institution), Andrea POKORNÁ (203 Czech Republic, belonging to the institution), Mohamed MEKHEMAR, Jonas CONRAD, Jitka KLUGAROVÁ (203 Czech Republic, belonging to the institution), Michal KOŠČÍK (203 Czech Republic, belonging to the institution), Miloslav KLUGAR (203 Czech Republic, belonging to the institution) and Sameh ATTIA

Edition

Vaccines, Basel, MDPI, 2021, 2076-393X

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30102 Immunology

Country of publisher

Switzerland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

Impact factor

Impact factor: 4.961

RIV identification code

RIV/00216224:14110/21:00121806

Organization unit

Faculty of Medicine

UT WoS

000666000500001

Keywords in English

AZD1222; ChAdOx1 nCoV-19; COVID-19; Czech Republic; drug-related side effects and adverse reactions; Germany; health personnel; mass vaccination; Oxford–AstraZeneca vaccine

Tags

International impact, Reviewed
Změněno: 8/2/2022 10:32, Mgr. Tereza Miškechová

Abstract

V originále

Recent reports of thrombosis following AstraZeneca COVID-19 vaccine in young females (<55 years-old) led to temporary suspension and urgent investigation by the European Medicines Agency (EMA) that concluded that vaccine benefits still outweigh its side effects (SEs). Therefore, this study aims to provide early independent evidence on the vaccine SEs’ prevalence and their potential risk factors; a cross-sectional survey-based study was carried out between February and March 2021 in Germany and Czech Republic among healthcare workers who recently received the AstraZeneca COVID-19 vaccine. The study used a validated self-administered questionnaire composed of twenty-eight multiple-choice items covering demographic variables, medical anamneses, and local, systemic, oral, and skin related SEs of the vaccine. Out of the ninety-two included participants, 77.2% were females and 79.3% were from Germany. Their mean age was 35.37 ± 12.62 (19–64) years-old, 15.2% had chronic illnesses and 22.8% were receiving medical treatments. Overall, 94.6% of the participants reported at least one SE. The most common local SE was injection site pain (72.8%), and the most common systemic SEs were fatigue (73.9%), muscle pain (55.4%), chills (48.9%), feeling unwell (46.7%), nausea (45.7%), and headache (29.3%). The vast majority (91.9%) resolved within 1–3 days, and the below 35 years-old group was the least affected age group. The SEs’ frequency was insignificantly higher in females and previously infected participants; the vaccine safety for the elderly was supported by the early findings of this study. Chronic illnesses and medical treatments were not associated with an increased risk of SE incidence and frequency. No blood disorder SEs were reported in our sample. Further independent studies are highly required to evaluate the safety of the AstraZeneca vaccine and to explore whether gender or previous infection could be associated with the vaccine SEs.

Links

CZ.02.1.01/0.0/0.0/16_013/0001826, interní kód MU
(CEP code: EF16_013/0001826)
Name: CZECRIN_PRO PACIENTY - zavádění inovativních moderních terapií
Investor: Ministry of Education, Youth and Sports of the CR, Priority axis 1: Strengthening capacities for high-quality research
LTC20031, research and development project
Name: Towards an International Network for Evidence-based Research in Clinical Health Research in the Czech Republic
Investor: Ministry of Education, Youth and Sports of the CR, INTER-COST
MUNI/A/1608/2020, interní kód MU
Name: Prohlubování znalostí v oblasti zdravotních rizik a benefitů výživy, prostředí a životního stylu III
Investor: Masaryk University
MUNI/IGA/1543/2020, interní kód MU
Name: Evidence-based Practice of Healthcare Professionals and Students in the Czech Republic (Acronym: Evidence-Based Practice in Czechia)
Investor: Masaryk University
90128, large research infrastructures
Name: CZECRIN III