Capitalizing on the Opportunity to Collect Timely Data on the Use of M72/AS01E in Breastfeeding Populations
8 January 2025
On 13 December 2024, TB advocates from nine countries, who were among the authors of the Washington, D.C. Community Consensus on the Earlier Inclusion of Pregnant Women and Persons in TB Research, wrote an open letter to the sponsors of the M72/AS01E TB vaccine trial — the Bill & Melinda Gates Medical Research Institute and Wellcome Trust — to express their grave concern that the study (which is currently enrolling) excludes breastfeeding individuals.
The advocates called on the trial sponsors to rapidly develop, initiate, fund, and conduct a dedicated study evaluating the safety of M72/AS01E in breastfeeding individuals.
The advocates requested a response to the letter by 22 January 2025.
Download the open letter here.