Safety and efficacy of COVID-19 vaccines in pregnant and lactating women: a comprehensive review.

Breastfeeding plays a critical role in providing essential nutrients and antibodies that enhance the health of new-borns and infants, supporting their immune systems and overall growth and development. Healthcare professionals, universally recommend breastfeeding for the first six months of an infant's life, in conjunction with an appropriate complementary diet. However, the COVID-19 pandemic has understandably raised concerns among lactating mothers and pregnant women regarding the risks of infection and vaccine safety. Therefore, it is essential to carefully evaluate the potential dangers of COVID-19 transmission within this vulnerable population especially when considering vaccination for pregnant and breastfeeding women. Encouragingly, the United States Food and Drug Administration has granted approval for the use of two COVID-19 vaccines namely, Pfizer-BioNTech COVID-19 and Moderna COVID-19 to contain the spread of the COVID-19 virus. Both vaccines have been approved for administration in pregnant and breastfeeding women, providing much-needed reassurance to those with concerns about vaccine safety. It is important to recognize that the benefits of vaccination for both the mother and the infant far outweigh the risks associated with COVID-19 infection. Therefore, lactating mothers should view vaccination as a vital measure to protect themselves and their infants from the virus. In addition to elaborating on the successes of safety and effectiveness, this review is unique that it also includes current and newly updated evidence published between 2020 and 2025, comprehensively discussing on several newer vaccine platforms together with recent viral variants. Furthermore, it synthesizes information on the transfer of transplacental and a breast-milk antibody that outlines a clear evidence-gap that may direct further research within pregnant and lactating populations.