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Review
. 2021 Dec;44(12):1247-1269.
doi: 10.1007/s40264-021-01131-6. Epub 2021 Nov 5.

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  1 , Alexia Giovanazzi  1 , Annalisa Capuano  2 , Salvatore Crisafulli  3 , Paola Maria Cutroneo  4 , Maria Pia Fantini  5 , Carmen Ferrajolo  2 , Ugo Moretti  1 , Elisabetta Poluzzi  6 , Emanuel Raschi  6 , Claudia Ravaldi  7 , Chiara Reno  5 , Marco Tuccori  8 , Alfredo Vannacci  7 , Giovanna Zanoni  9 , Gianluca Trifirò  10 ; Ilmiovaccino COVID19 collaborating group
Collaborators, Affiliations
Review

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 et al. Drug Saf. 2021 Dec.

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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Conflict of interest statement

Gianluca Trifirò has served in the last three years on advisory boards/seminars funded by SANOFI, Eli Lilly, AstraZeneca, Abbvie, Servier, Mylan, Gilead, Amgen; he was the scientific director of a Master’s programme on pharmacovigilance, pharmacoepidemiology and real-world evidence which has received non-conditional grants from various pharmaceutical companies; he coordinated a pharmacoepidemiology team at the University of Messina until Oct 2020, which has received funding for conducting observational studies from various pharmaceutical companies (Boehringer Ingelheim, Daichii Sankyo, PTC Pharmaceuticals). He is also scientific coordinator of the academic spin-off ‘INSPIRE srl’ which has received funding for conducting observational studies from contract research organisations (RTI Health Solutions, Pharmo Institute N.V.). All the above-mentioned activities are not related to the topic of the manuscript. Carmen Ferrajolo declares that she is a member and vice-chief of academic spin-off ‘INSPIRE SRL– INnovative Solutions for medical Prediction and big data Integration in REal world setting SRL’, which has received funding for conducting observational studies from various pharmaceutical companies. The other authors have no conflicts of interest to disclose.

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