Press Release N° 3/2021-COVID-19 vaccines, pregnancy and breast-feeding. Guidance of the Italian National Institute of Health

ISS per COVID-19

Published 25/10/2020 - Edited 31/12/2020

Il 9 gennaio 2020 l'Organizzazione Mondiale della Sanità (OMS) ha dichiarato che le autorità sanitarie cinesi hanno individuato un nuovo ceppo di coronavirus mai identificato prima nell'uomo, provvisoriamente chiamato 2019-nCoV e classificato in seguito ufficialmente con il nome di SARS-CoV-2. Il virus è associato a un focolaio di casi di polmonite registrati a partire dal 31 dicembre 2019 nella città di Wuhan, nella Cina centrale. L'11 febbraio, l'OMS ha annunciato che la malattia respiratoria causata dal nuovo coronavirus è stata chiamata COVID-19. Il 30 gennaio, l'Istituto Superiore di Sanità (ISS) ha confermato i primi due casi di infezione da COVID-19 in Italia e il 21 febbraio ha confermato il primo caso autoctono in Italia.

L’ISS dal 28 febbraio coordina un sistema di sorveglianza che integra a livello individuale i dati microbiologici ed epidemiologici forniti dalle Regioni e Provincie Autonome (PA) e dal Laboratorio nazionale di riferimento per SARS-CoV-2 dell’ISS. Ogni giorno un’infografica dedicata riporta – con grafici, mappe e tabelle - una descrizione della diffusione nel tempo e nello spazio dell’epidemia di COVID-19 in Italia e una descrizione delle caratteristiche delle persone affette.

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Back Press Release N° 3/2021-COVID-19 vaccines, pregnancy and breast-feeding. Guidance of the Italian National Institute of Health

Published 09/01/2021 - Edited 29/12/2021

Rome, 09 January 2021

Although no data are available to evaluate the effects of COVID-19 vaccines in pregnancy and breastfeeding, vaccination is not contraindicated. Women at high risk of contracting the disease in severe form should discuss the potential benefits and risks of vaccination with the healthcare professional who assists them, while if a woman discovers she is pregnant after the first or second dose there is no reason to terminate the pregnancy. These are the main indications of the interim document on "Vaccination against COVID-19 during pregnancy and breastfeeding" drawn up by the Italian Obstetric Surveillance System (ItOSS) of the Italian National Institute of Health (ISS), agreed upon and signed by the main scientific societies in the sector (SIGO, AOGOI , AGUI, AGITE, FNOPO, SIMP, SIN, SIP, ACP and SIAARTI).

The document reviews the main indications adopted at the international and national level, as well as the scientific evidence that has emerged so far on the subject. “In Italy – the document points out - pregnant and breastfeeding women are offered the possibility of choosing, with the support of health professionals, whether or not to undergo vaccination after an individual assessment of the risk-benefit profile. The choice of not excluding vaccination during pregnancy concerns women who have a high risk of exposure to the SARS-CoV-2 virus and / or whose health conditions would expose them to a risk of serious maternal and / or foetus / neonatal morbidity if they were to become infected. In these selected cases, women are invited to individually discuss the potential benefits and risks with the healthcare professional who assists them, in order to make an informed decision with full awareness”.

These are the main indications:

Pregnant and breastfeeding women were not included in the Pfizer-BioNtech mRNA (Comirnaty) and Moderna vaccine evaluation trials so there are no safety and efficacy data for these women.
The studies carried out so far have neither highlighted nor suggested biological mechanisms associating mRNA vaccines with adverse effects in pregnancy, and the laboratory evidence on animals suggests the absence of vaccination risk.

Currently pregnant and breastfeeding women are not a priority target of the COVID-19 vaccination offer which, to date, is not routinely recommended for these women.
The data of the ItOSS study – which refers to the first pandemic wave in Italy - shows that pregnant women do not present an increased risk of infection compared to the general population. Previous comorbidities (hypertension, obesity) and non-Italian citizenship are significantly associated with a higher risk of serious complications from COVID-19 which, overall, concern a minority of mothers and newborn babies.
Vaccination should be considered for pregnant women who are at high risk for serious complications from COVID19. Women with these conditions must evaluate the potential benefits and risks with the healthcare professionals who assist them and the choice must be made on a case-by-case basis.
If a vaccinated woman discovers that she is pregnant soon after being vaccinated, there is no evidence suggesting that pregnancy should be terminated.
If a woman discovers that she is pregnant between the first and second doses of the vaccine, she can postpone the second dose until pregnancy runs its course, except for women at high risk.
Breastfeeding women can be included in the vaccination offer without the need to interrupt breastfeeding.