Landmark vaccine trial finally includes pregnant and breastfeeding women

The Tumaini trial protocol (NCT07842107) developed by the National Institute of Biomedical Research of the Democratic Republic of the Congo and partners to evaluate the efficacy of vaccines against Bundibugyo virus (BDBV) includes pregnant and lactating women. This trial represents a groundbreaking ethical and public health advance for two reasons: (1) it addresses the substantial threat of severe disease and death for pregnant women in the BDBV outbreak; and (2) it reverses a historical pattern of exclusion of pregnant and lactating women from trials of epidemic vaccines, which has led to delayed access to efficacious vaccines because pregnancy and lactation-specific evidence was unavailable.

Source: [Comment] Inclusion of pregnant and lactating women in the Tumaini vaccine efficacy trial: a landmark advance