Safety and Reactogenicity of the ChAdOx1 (AZD1222) COVID-19 Vaccine in Saudi Arabia

Overview

Journal Int J Infect Dis

Publisher Elsevier

Specialty Infectious Diseases

Date 2021 Jul 28

PMID 34320413

Citations 36

Authors

Salma Al Bahrani

Ali AlBarrak

Othman Ali Alghamdi

Mesfer Abdullah Alghamdi

Fatimah H Hakami

Asmaa K Al Abaadi

Sausan A Alkhrashi

Mansour Y Alghamdi

Meshael M Almershad

Mansour Moklif Alenazi

Mohamed Hany El Gezery

Arulanantham Zechariah Jebakumar

Jaffar A Al-Tawfiq

Affiliations

Soon will be listed here.

Abstract

Introduction: The Kingdom of Saudi Arabia was one of the first countries to implement a COVID-19 vaccination program. This study estimated the safety and reactogenicity of the ChAdOx1-S vaccine after the first dose administered to adults.

Methods: This cross-sectional study included 1592 randomly selected vaccinees from April to May 2021. A questionnaire was delivered to the vaccinees via phone calls 7 and 21 days after the first vaccine dose.

Results: Of the 1592 vaccinees who had the first dose, the mean age was 37.4 (± 9.6) years and 81% were males. Of all the vaccinees, 553 (34.7%) reported an adverse reaction on the first telephone call. The most common symptoms were: pain at the site of injection (485, 30.5%), musculoskeletal symptoms (438, 27.5%), skin rash (307, 19.2%), gastrointestinal symptoms (379, 23.8%) and fever (498, 31.3%). Men were more likely to report fever (76.9% vs. 23.1%; P = 0.005), skin rash (81.1% vs. 18.9%, P = 0.005) and pain at the injection site (77.3% vs. 22.7%, P < 0.0001). Post-vaccine COVID-19 infection was 0.5% and there were no hospitalizations.

Conclusion: This study observed no major side effects of the ChAdOx1-S vaccine and no reported breakthrough infection during the observation period.

Citing Articles

Safety and Adverse Effects Related to COVID-19 Viral Vector Vaccines: A Systematic Review.

SeyedAlinaghi S, Pashaei A, Tantuoyir M, Karimi A, Mojdeganlou H, Nazarian N Tanaffos. 2025; 23(2):102-114.

PMID: 39959793 PMC: 11825072.

Short-term side effects of COVID-19 vaccines among healthcare workers: a multicenter study in Iran.

Mirnia K, Haji Esmaeil Memar E, Kamran N, Yeganedoost S, Klashami Z, Mamishi S Sci Rep. 2024; 14(1):4086.

PMID: 38374372 PMC: 10876545. DOI: 10.1038/s41598-024-54450-w.

The Relationship Between Menstrual Cycle Irregularities and COVID-19 Vaccination.

Aljehani A, Banjar S, Alawam H, Alowais S, Aldraibi Y, BinSaif A Cureus. 2024; 15(12):e49841.

PMID: 38164312 PMC: 10758269. DOI: 10.7759/cureus.49841.

Side effects of COVID-19 vaccines in the middle eastern population.

Murished G, Dandachi I, Aljabr W Front Immunol. 2023; 14:1270187.

PMID: 38022593 PMC: 10654979. DOI: 10.3389/fimmu.2023.1270187.

COVID-19 Vaccine Hesitancy Among Pregnant Women.

Alkhalifah M, AlHusseini N, McGhee J Cureus. 2023; 15(6):e41126.

PMID: 37519564 PMC: 10382906. DOI: 10.7759/cureus.41126.

References

Xie X, Liu Y, Liu J, Zhang X, Zou J, Fontes-Garfias C . Neutralization of SARS-CoV-2 spike 69/70 deletion, E484K and N501Y variants by BNT162b2 vaccine-elicited sera. Nat Med. 2021; 27(4):620-621. DOI: 10.1038/s41591-021-01270-4. View

Al-Tawfiq J, Memish Z . COVID-19 in the Eastern Mediterranean Region and Saudi Arabia: prevention and therapeutic strategies. Int J Antimicrob Agents. 2020; 55(5):105968. PMC: 7271262. DOI: 10.1016/j.ijantimicag.2020.105968. View

Al-Tawfiq J, Sattar A, Al-Khadra H, Al-Qahtani S, Al-Mulhim M, Al-Omoush O . Incidence of COVID-19 among returning travelers in quarantine facilities: A longitudinal study and lessons learned. Travel Med Infect Dis. 2020; 38:101901. PMC: 7547317. DOI: 10.1016/j.tmaid.2020.101901. View

McDonald I, Murray S, Reynolds C, Altmann D, Boyton R . Comparative systematic review and meta-analysis of reactogenicity, immunogenicity and efficacy of vaccines against SARS-CoV-2. NPJ Vaccines. 2021; 6(1):74. PMC: 8116645. DOI: 10.1038/s41541-021-00336-1. View

Moghimi S . Allergic Reactions and Anaphylaxis to LNP-Based COVID-19 Vaccines. Mol Ther. 2021; 29(3):898-900. PMC: 7862013. DOI: 10.1016/j.ymthe.2021.01.030. View

Shaw R, Stuart A, Greenland M, Liu X, Nguyen Van-Tam J, Snape M . Heterologous prime-boost COVID-19 vaccination: initial reactogenicity data. Lancet. 2021; 397(10289):2043-2046. PMC: 8115940. DOI: 10.1016/S0140-6736(21)01115-6. View

Ramasamy M, Minassian A, Ewer K, Flaxman A, Folegatti P, Owens D . 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. 2020; 396(10267):1979-1993. PMC: 7674972. DOI: 10.1016/S0140-6736(20)32466-1. View

Assiri A, Al-Tawfiq J, Alkhalifa M, Al Duhailan H, Al Qahtani S, Dawas R . Launching COVID-19 vaccination in Saudi Arabia: Lessons learned, and the way forward. Travel Med Infect Dis. 2021; 43:102119. PMC: 8197679. DOI: 10.1016/j.tmaid.2021.102119. View

Ledgerwood J, Zephir K, Hu Z, Wei C, Chang L, Enama M . Prime-boost interval matters: a randomized phase 1 study to identify the minimum interval necessary to observe the H5 DNA influenza vaccine priming effect. J Infect Dis. 2013; 208(3):418-22. PMC: 3699006. DOI: 10.1093/infdis/jit180. View

10.

Tobaiqy M, Elkout H, MacLure K . Analysis of Thrombotic Adverse Reactions of COVID-19 AstraZeneca Vaccine Reported to EudraVigilance Database. Vaccines (Basel). 2021; 9(4). PMC: 8074142. DOI: 10.3390/vaccines9040393. View

11.

Voysey M, Clemens S, Madhi S, Weckx L, Folegatti P, Aley P . Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2020; 397(10269):99-111. PMC: 7723445. DOI: 10.1016/S0140-6736(20)32661-1. View

12.

Sadoff J, Gray G, Vandebosch A, Cardenas V, Shukarev G, Grinsztejn B . Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19. N Engl J Med. 2021; 384(23):2187-2201. PMC: 8220996. DOI: 10.1056/NEJMoa2101544. View

13.

Vergnes J . Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2021; 384(16):1577. DOI: 10.1056/NEJMc2036242. View

14.

Flanagan K, Fink A, Plebanski M, Klein S . Sex and Gender Differences in the Outcomes of Vaccination over the Life Course. Annu Rev Cell Dev Biol. 2017; 33:577-599. DOI: 10.1146/annurev-cellbio-100616-060718. View

15.

Polack F, Thomas S, Kitchin N, Absalon J, Gurtman A, Lockhart S . Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020; 383(27):2603-2615. PMC: 7745181. DOI: 10.1056/NEJMoa2034577. View

16.

Sadoff J, Le Gars M, Shukarev G, Heerwegh D, Truyers C, de Groot A . Interim Results of a Phase 1-2a Trial of Ad26.COV2.S Covid-19 Vaccine. N Engl J Med. 2021; 384(19):1824-1835. PMC: 7821985. DOI: 10.1056/NEJMoa2034201. View