STAT+: Invivyd’s pursuit of a Covid vaccine alternative gets a lift, but an FDA hurdle may await

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This story first appeared in Adam’s Biotech Scorecard, a STAT newsletter. Sign up here to get it delivered to your inbox. And subscribe to STAT+ to get an unabridged version, with exclusive content.

An update on Invivyd, the small biotech company developing an injectable, low-dose monoclonal antibody to protect against Covid-19 infection like a vaccine does, but without the real or perceived limitations of vaccines. I last wrote about Invivyd in this newsletter in August 2025.

On Tuesday, Invivyd reported the results from a Phase 3 study called LIBERTY that demonstrated the superior safety and tolerability of its antibody candidate, VYD2311, compared against Comirnaty, the established mRNA-based Covid vaccine marketed by Pfizer. After six days, 57% of study participants who had VYD2311 injected into the muscle of their upper arm reported headaches, chills, fatigue or pain at the injection site — the typical side effects associated with vaccinations. In the Comirnaty arm of the study, 91% of participants reported the same side effects. The difference was statistically significant. The same study showed VYD2311 was also better tolerated at 56 days, and could be combined safely with Comirnaty.

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