Blue Lake Biotechnology announced that it has received a $5 million grant from the Gates Foundation to support the addition of younger children to a Phase 1/2a clinical trial of its BLB201 nasal vaccine against RSV. According to Blue Lake, the FDA has cleared the addition of children aged 12 -18 months to the study, which previously had been enrolling children aged 18 months to 59 months.
The FDA granted Fast Track designation to BLB-201 for the prevention of RSV in children under 2 and adults over 60 in 2022. The pediatric trial was initiated in 2023, but in December 2024, the FDA clinical holds on all pediatric RSV vaccine trials, stopping dosing of all children under 2 years old and children aged 2-5 years who were RSV-negative. The agency lifted the hold on the Blue Lake trial in November 2025.
The announcement notes that the FDA clearance was based on unblinded data from 111 children enrolled in the study up to April 2026. Blue Lake says that those data indicated that BLB201 was over 70% effective in preventing symptomatic RSV infection in those children.
Blue Lake CEO Biao He commented, “This timely grant gives Blue Lake the ability to expand our ongoing clinical study of our RSV vaccine candidate with a focus on toddlers as young as 12 months old in the 2026-2027 RSV season. Besides building a larger dataset for safety and efficacy of BLB201 in preventing symptomatic RSV infection, the study will also explore the potential for BLB201 to reduce transmission of RSV between family members.”
Read the Blue Lake Biotechnology press release
