Perspectives on administration of COVID-19 vaccine to pregnant and lactating women: a challenge for low- and middle-income countries

Duarte, Geraldo; Coutinho, Conrado Milani; Rolnik, Daniel Lorber; Quintana, Silvana Maria; e Silva, Ana Cláudia Rabelo; Poon, Liona C.; da Silva Costa, Fabrício

Women in the pregnancy-puerperal cycle or those who are lactating have been deliberately excluded from participating in COVID-19 vaccine clinical trials that aimed to evaluate either the efficacy in inducing the formation of neutralizing antibodies or the investigational products’ safety profile. Exclusion of pregnant and lactating women from such studies still certainly inequitably deny these women access to COVID-19 vaccines since these products’ availability became increasingly available to non-pregnant people and even during pregnancy in high-income settings. In this clinical opinion article, we discuss aspects of the prolonged pandemic, the emergence of viral variants, the risks of severe complications of COVID-19 in pregnant women, and the disproportionate impact on low- and middle-income countries. We argue that the decision to receive the COVID-19 vaccine should be a joint decision between the pregnant or lactating women and the healthcare providers while considering the available data on vaccine efficacy, safety, the risks of SARS-CoV-2 infection in pregnant women, and the woman's individual risk for infection and serious illness. The various types of vaccines already in use and their safety and effectiveness, and the potential risks and benefits of their administration to pregnant or lactating women are reviewed.