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COVID-19 Vaccination in Pregnancy, Paediatrics, Immunocompromised Patients, and Persons with History of Allergy or Prior SARS-CoV-2 Infection: Overview of Current Recommendations and Pre- and Post-Marketing Evidence for Vaccine Efficacy and Safety.

Section of Pharmacology, Department of Diagnostics and Public Health, University of Verona, Piazzale L.A. Scuro 10, 37134, Verona, Italy. Section of Pharmacology "L. Donatelli", Department of Experimental Medicine, Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, University of Campania "Luigi Vanvitelli", Naples, Italy. Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy. Sicilian Regional Pharmacovigilance Centre, University Hospital of Messina, Messina, Italy. Department of Biomedical and Neuromotor Sciences, Alma Mater Studiorum, University of Bologna, Bologna, Italy. Department of Medical and Surgical Science, Alma Mater Studiorum, University of Bologna, Bologna, Italy. PeaRL-Perinatal Research Laboratory, NEUROFARBA Department, University of Florence and CiaoLapo Foundation for Perinatal Health, Florence, Italy. Unit of Adverse Drug Reactions Monitoring, University Hospital of Pisa, Pisa, Italy. Immunology Unit, University Hospital, Verona, Italy. Section of Pharmacology, Department of Diagnostics and Public Health, University of Verona, Piazzale L.A. Scuro 10, 37134, Verona, Italy. gianluca.trifiro@univr.it.

Drug safety. 2021;(12):1247-1269
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Abstract

To date, four vaccines have been authorised for emergency use and under conditional approval by the European Medicines Agency to prevent COVID-19: Comirnaty, COVID-19 Vaccine Janssen, Spikevax (previously COVID-19 Vaccine Moderna) and Vaxzevria (previously COVID-19 Vaccine AstraZeneca). Although the benefit-risk profile of these vaccines was proven to be largely favourable in the general population, evidence in special cohorts initially excluded from the pivotal trials, such as pregnant and breastfeeding women, children/adolescents, immunocompromised people and persons with a history of allergy or previous SARS-CoV-2 infection, is still limited. In this narrative review, we critically overview pre- and post-marketing evidence on the potential benefits and risks of marketed COVID-19 vaccines in the above-mentioned special cohorts. In addition, we summarise the recommendations of the scientific societies and regulatory agencies about COVID-19 primary prevention in the same vaccinee categories.

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Publication Type : Review

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