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

Nicoletta Luxi, Alexia Giovanazzi, Annalisa Capuano, Salvatore Crisafulli, Paola Maria Cutroneo, Maria Pia Fantini, Carmen Ferrajolo, Ugo Moretti, Elisabetta Poluzzi, Emanuel Raschi, Claudia Ravaldi, Chiara Reno, Marco Tuccori, Alfredo Vannacci, Giovanna Zanoni and Gianluca Trifirò ()
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Nicoletta Luxi: University of Verona
Alexia Giovanazzi: University of Verona
Annalisa Capuano: University of Campania “Luigi Vanvitelli”
Salvatore Crisafulli: University of Messina
Paola Maria Cutroneo: University Hospital of Messina
Maria Pia Fantini: University of Bologna
Carmen Ferrajolo: University of Campania “Luigi Vanvitelli”
Ugo Moretti: University of Verona
Elisabetta Poluzzi: University of Bologna
Emanuel Raschi: University of Bologna
Claudia Ravaldi: University of Florence and CiaoLapo Foundation for Perinatal Health
Chiara Reno: University of Bologna
Marco Tuccori: University Hospital of Pisa
Alfredo Vannacci: University of Florence and CiaoLapo Foundation for Perinatal Health
Giovanna Zanoni: University Hospital
Gianluca Trifirò: University of Verona

Drug Safety, 2021, vol. 44, issue 12, No 2, 1247-1269

Abstract: 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.

Date: 2021
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DOI: 10.1007/s40264-021-01131-6

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