Breastfeeding women are routinely excluded from clinical studies; it also refers to the research into COVID-19 vaccine. The only data on the safety of vaccination during lactation period come from post-marketing or spontaneous notifications of suspected adverse events. Lack of current clinical data raises a lot of doubts as regards the safety and risk of the vaccination in this group during SARS-CoV-2 pandemic.
The aim of the study is urgent counteraction against adverse consequences of this situation, which are shortening of the breastfeeding period or rejection of vaccination in the lactation period. The project will fill in the niche in the knowledge regarding the effectiveness and safety of pharmacotherapy in the breastfeeding period through delivery of a tool assessing vaccination complications in the lactation period.
We will make use of the experience of the Institute for Women’s Health, UCL, in London in the application of the Delphi procedure for achieving a group consensus among experts worldwide on the scale of adverse events of medical interventions, including vaccination, in the lactation period and their effects on the mother and child in perinatal period. An interdisciplinary panel of experts representing entities supporting breastfeeding and research institutions will work in order to exchange experience regarding safety of pharmacotherapy, so as adverse events of medicines applied during lactation are clearly defined. Moreover, a study regarding the supervision over COVID-19 vaccine will be conducted in 100 breastfeeding women in Poland. There will be prepared a register of the vaccinated breastfeeding women based on the clinical data compiled and proposal of terminology regarding adverse events during lactation will be evaluated and validated.