Question Number: 139
PDR Number: SQ22-000187
Date Submitted: 24/02/2022
Department or Body: Department of Health

To date, the Therapeutic Goods Administration (TGA) and other international regulators have not identified any safety signal for infants exposed to the breastmilk of vaccinated mothers. In Australia, and globally, vaccination against COVID-19 is recommended for breastfeeding women because of overwhelming safety evidence.

The available information indicates that it is highly unlikely for a COVID-19 vaccine to pass to a baby via breastmilk, and if it did that it would be broken down in the infant’s digestive system. Some small studies have shown trace amounts of antibodies can pass into breastmilk, but antibodies consumed orally breakdown in the stomach and intestines.

Reporting of an adverse event following vaccination to the TGA does not mean that the vaccine caused the adverse event. The TGA encourages consumers and health professionals to report suspected side effects, even if there is only a very small chance a vaccine was the cause.

The TGA analyses adverse event report data to identify patterns that indicate possible safety issues requiring investigation. If the TGA’s investigations confirm a safety issue, prompt regulatory action is taken, including communicating about the issue to health professionals and consumers.