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Istituto Superiore di Sanità
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Epidemiology for public health - ISS

COVID-19 vaccination in pregnancy and breastfeeding

Concerns about receiving the vaccine among pregnant and breastfeeding women, due to a lack of conclusive data on the safety and efficacy of COVID-19 vaccines for these target populations, have been a subject of debate at the national and international levels. Most countries initially recommended that vaccination should be offered to breastfeeding mothers and pregnant women at higher risk of exposure to the virus (e.g. healthcare professionals) or at greater risk of developing a severe illness (women with pre-existing conditions, who are obese or coming from countries with high emigration rates). Recommendations included individual risk/benefit assessments, which involved meetings with healthcare professionals.


In Italy, during the first wave of the pandemic, the Italian Obstetric Surveillance System (ItOSS) of the ISS considered interim national and international recommendations, reviewed the relevant scientific evidence and produced documents that were endorsed and subscribed to by the main scientific associations in the sector (Italian Society of Gynaecology and Obstetrics, SIGO; Italian Association of Hospital Obstetricians and Gynaecologists, AOGOI; Italian Association of University Gynaecologists, AGUI; Association of Local Gynaecologists, AGITE; National Federation of Midwifery Associations, FNOPO; Italian Society of Neonatology, SIN; Italian Society of Perinatal Medicine, SIMP; Italian Society of Paediatrics, SIP; Paediatric Cultural Association, ACP; Italian Society of Anaesthesia, Analgesia, Resuscitation and Intensive Care, SIAARTI). The first interim document was published on 9 January 2021, and updated on 31 January 2021, after the AstraZeneca vaccine was put on the market.


  • The first interim document was published on 9 January 2021, and updated on 31 January 2021, after the AstraZeneca vaccine was put on the market.
  • On 22 September 2021, the ISS updated the recommendations in its original document with the aim of helping healthcare professionals and pregnant and breastfeeding mothers make informed decisions during the COVID-19 pandemic.
  • On 13 December 2021, the Istituto Superiore di Sanità (ISS) further updated the interim indications by considering and recommending the offer of a dose of mRNA vaccine, as a booster of a primary vaccination cycle – in accordance with the regulation in force – to pregnant women who are in the second and third trimester and wish to be vaccinated. The recommendation takes into account the numerous and growing evidence regarding the safety of vaccination in pregnancy, both for the fetus and for the mother; evidence relating to the increased morbidity associated with the Delta variant; of its increasing circulation in that period and of the significant lowering of the median age of infection in Italy.
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Last updated: 15 December 2021

Page created: 9 January 2021

Revised by: Serena Donati – Women’s, Children’s and Adolescents’ Health Unit, National Centre for Disease Prevention and Health Promotion (CNAPPS) - ISS.