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

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


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.

Publication types

  • Review

MeSH terms

  • 2019-nCoV Vaccine mRNA-1273 / therapeutic use
  • Adolescent
  • Adult
  • BNT162 Vaccine / therapeutic use
  • Breast Feeding
  • COVID-19 / prevention & control*
  • COVID-19 Vaccines / therapeutic use*
  • ChAdOx1 nCoV-19 / therapeutic use
  • Child
  • Child, Preschool
  • Europe
  • Female
  • Humans
  • Hypersensitivity*
  • Immunocompromised Host*
  • Infant
  • Practice Guidelines as Topic
  • Pregnancy
  • Pregnancy Complications, Infectious / prevention & control*
  • SARS-CoV-2


  • COVID-19 Vaccines
  • ChAdOx1 nCoV-19
  • 2019-nCoV Vaccine mRNA-1273
  • BNT162 Vaccine