Press Release No. 68/2022 Pregnancy and Breastfeeding: Update of ISS Guidance for COVID-19 Vaccination

ISS, 7 October 2022

The Italian Obstetric Surveillance System (ItOSS) of the Istituto Superiore di Sanità has updated its guidance on COVID-19 vaccination for pregnant and breastfeeding women following the new vaccines available and in light of the second booster (fourth dose) also for this category of individuals. Here are the main indications in support of the provisions set out in the Circular Letter of the Ministry of Health dated 7 September 2022.

Pregnant women

• Primary vaccination against COVID-19 and booster doses (third and fourth doses) with mRNA vaccines are recommended for all pregnant women at any stage of pregnancy, especially if there is an increased risk of developing severe COVID-19 disease (women with risk factors such as age ≥30 years, BMI >30 kg/m², comorbidities, being a citizen of a Country with high emigration flows).
• The booster dose with the bivalent formulation of Comirnaty Original/Omicron and Spikevax Original/Omicron mRNA vaccines (fourth dose) is recommended in pregnant women at the dosages authorized for the purpose.
• An interval of at least 120 days must have elapsed between the previous dose of an anti-COVID-19 vaccine or previous SARS-CoV-2 infection and the administration of the booster dose.

• The primary vaccination course and booster doses (third and fourth doses) can be administered concomitantly with the recommended vaccinations against influenza and pertussis during pregnancy.

Breastfeeding women

• Primary vaccination against COVID-19 and booster doses (third and fourth dose) with mRNA vaccines are recommended for all breastfeeding women, without the need to interrupt breastfeeding.
• The booster dose with the bivalent formulation of Comirnaty Original/Omicron and Spikevax Original/Omicron mRNA vaccines (fourth dose) is recommended for breastfeeding women at the dosages authorized for the purpose.
• An interval of at least 120 days must have elapsed between the previous dose of an anti-COVID-19 vaccine or previous SARS-CoV-2 infection and the administration of the booster dose.
• Primary vaccination and the booster doses (third and fourth dose) with mRNA vaccines do not expose infants to risks and indeed allow them to acquire antibodies against SARS-CoV-2 through the mother’s milk.
• The vaccination calendar of a newborn breastfed by a vaccinated mother does not entail any changes.

“As with the general population, also for pregnant women, the mRNA vaccines have been particularly effective in preventing severe COVID-19 disease. Thanks to the current availability of large amounts of data - the authors recall - international public health agencies claim that vaccination, with the primary cycle and boosters (third and fourth doses), is the safest and most effective way to protect pregnant women and their children against COVID-19 disease”.