Invivyd reports VYD2311 topline safety edge over mRNA COVID vaccine in LIBERTY trial

Invivyd, Inc. announced on September 29, 2026 that its Phase 3 LIBERTY study met its co-primary and key secondary endpoints, with VYD2311 demonstrating safety and tolerability that the company said was clinically and statistically superior to an mRNA-based COVID-19 vaccine.¹

The trial recruited 210 healthy adults aged 18-49 and randomized them 1:1:1 to a single intramuscular dose of either 250mg VYD2311, COMIRNATY, or the combination of both.¹

On the first co-primary endpoint, measuring adverse events over six days, 56.5% of VYD2311 subjects experienced a TEAE, ISR, or hypersensitivity reaction versus 91.4% on the mRNA vaccine (p<0.0001), while the combination arm showed 78.9% versus 91.4% (p=0.057).¹ On the second co-primary endpoint for systemic adverse events, VYD2311 showed 44.1% versus 68.1% for the vaccine (p=0.008), and the combination arm showed 50.0% versus 68.1% (p=0.023).¹ Over 56 days, VYD2311 showed 60.9% versus 91.4% for the vaccine (p<0.0001), with the combination arm at 83.1% versus 91.4% (p=0.21).¹ The company noted that no VYD2311-related adverse events exceeded Grade 2, and no hypersensitivity or anaphylaxis occurred in any arm.¹

On immune interference, VYD2311 added to the vaccine increased neutralizing titers by approximately 2.5 times over the vaccine alone across the 56-day study,¹ and titers from VYD2311-depleted combination samples matched those from the vaccine-only arm, confirming no interference.¹

Regarding regulatory plans, Invivyd said it intends to submit a BLA under the Accelerated Approval Program pending results from the ongoing DECLARATION pivotal study,¹ following a Type C meeting with FDA in September. The company said DECLARATION topline data on safety and immunogenicity to support the submission are now expected in October.¹ Under the plan, Invivyd would continue accumulating PCR-positive symptomatic COVID-19 events in a post-approval confirmatory cohort, targeting a 70%-90% relative risk reduction versus placebo.¹

Invivyd held an investor call on the results at 8:30 am ET on September 29, 2026.