key: cord-0998881-lbmx6yuy
authors: Chouchana, Laurent; Canouï, Etienne; Batista, Rui; Contejean, Adrien; Cariou, Alain; Treluyer, Jean Marc; Charlier, Caroline
title: Balancing the reactogenicity of the ChAdOx1 nCov-19 vaccine against SARS-CoV-2 and the urgent need of a large immunization in healthcare workers
date: 2021-07-27
journal: Therapie
DOI: 10.1016/j.therap.2021.07.004
sha: 22ee7dd4d950ff728687b7b9e468b090208c6596
doc_id: 998881
cord_uid: lbmx6yuy

nan

Vaccine; COVID-19; SARS-CoV-2; Healthcare workers; Reactogenicity; Adverse drug reaction Abbreviations COVID: coronavirus disease SARS-CoV-2: severe acute respiratory syndrome coronavirus 2

Among the anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine arsenal, ChAdOx1 nCov-19 vaccine relies on a replication-deficient chimpanzee adenovirus vector containing the SARS-CoV-2 structural surface spike glycoprotein. The vaccine, administered as two intramuscular injections with a 4-12 week interval, has been approved in the UK on 30 December 2020, and across the European union on 29 January 2021 [1, 2] .

Safety and efficacy have been demonstrated across four clinical trials among adult population [3, 4] . In an interim analysis, adverse events and especially serious ones were balanced between groups. Among the vaccinated population, authors report two cases of transverse myelitis, including one possibly related to the vaccine, and one case of high fever (above 40°C) that recovered spontaneously [3] . However, local and systemic transient reactogenicity was very common, with fatigue reported in more than 50% of participants, and headache and malaise in up to 40% [5] . In the European product information, the most frequently noted symptoms included injection site tenderness or pain (respectively 64 and 54%), headache (53%), fatigue (53%), myalgia (44%), pyrexia (including feverishness [34%] and fever >38°C

[8%]), chills (32%) and arthralgia (26%) [2] . We report here our preliminary experience on For instance, fever was reported in 47% of the healthcare workers receiving the AZD1222 vaccine, compared to 8.6% with a first dose of mRNA vaccine, in a population-based study [8] . Foremost, in our cohort, such systemic reactogenicity led to sick leave in more than one third of the vaccinated. This issue should be taken into account to address the paramount needing of rapidly protecting our professionals while maintaining the operation of high-demand services as the pandemic continues to unfold. 

Oxford University/AstraZeneca COVID-19 vaccine approved. GOVUK

EMA recommends COVID-19 Vvaccine AstraZeneca for authorisation in the EU

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

Efficacy of COVID-19 vaccines: From clinical trials to real life

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

French organization for the pharmacovigilance of COVID-19 vaccines: A major challenge

Point de situation sur la surveillance des vaccins contre la COVID-19 -ANSM : Agence nationale de sécurité du médicament et des produits de santé

Reactogenicity following receipt of mRNA-based COVID-19 vaccines

* Comorbidities included: type 2 diabetes (N = 2), and hypertension, cardiac disease, and pituitary adenoma (N = 1, each)

± Comorbidities included: hypothyroidism (N = 2), including one with obesity, hypertension, past history of preeclampsia, asthma (N = 1, each)

‡ Comorbidities included: hypertension, past history of preeclampsia, and asthma (N = 1, each)

§ Comorbidities included: hypothyroidism (N = 2)

Other symptoms included tachycardia, paresthesia, neck stiffness, hallucinations and dizziness (N = 1, each)

The authors would like to thanks to all the healthcare workers and the French Pharmacovigilance Network involved in large immunization campaign and in its safety monitoring [6] .

LC and CC designed the study, performed statistical analysis and drafted the paper. EC and ACo collected the data. RB, Aca and JMT critically reviewed the paper. All the authors approved the final version of the paper. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

This research was found to be in conformity with the French regulations by the local Ethical Review Committee and has been approved under the number 2021-08009. In line with the French law, these individual case safety reports have been reported anonymously to the National Pharmacovigilance Database.