CHICAGO – Pfizer Inc and BioNTech SE have started an international study with 4,000 volunteers to evaluate the safety and effectiveness of their COVID-19 vaccine in healthy pregnant women, the companies said on Thursday.
Pregnant women are at higher risk of developing severe COVID-19, and many public health officials have recommended some women in high-risk professions take coronavirus vaccines even without proof they are safe for them.
Last week, the US National Institutes of Health called for greater inclusion of pregnant and lactating women in COVID-19 vaccine research.
Bioethicists, vaccine and maternal health experts have argued for years that pregnant women should be included early in trials of pandemic vaccines so they would not need to wait until long after a successful one emerges.
Nevertheless, pregnant women were excluded from the large US trials used to obtain emergency use authorization of COVID-19 vaccines.