STAT+: Invivyd’s pursuit of a Covid vaccine alternative gets a lift, but an FDA hurdle may await — SkimNews
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- Invivyd reported Phase 3 LIBERTY results on Tuesday showing VYD2311, its injectable low-dose monoclonal antibody designed to protect against Covid-19 like a vaccine, was significantly better tolerated than Pfizer's Comirnaty mRNA vaccine.
- After six days, 57% of VYD2311 recipients reported typical side effects (headaches, chills, fatigue, or injection-site pain) versus 91% of Comirnaty recipients — a difference the company called statistically significant.
- VYD2311 retained its tolerability advantage at 56 days, the study also showed.
- The study demonstrated VYD2311 could be combined safely with Comirnaty, according to the company.
- The article headline flags that an FDA approval hurdle may still await, even as the tolerability data gives Invivyd's vaccine-alternative approach a boost.
Why it matters: VYD2311 cut reported side effects to 57% versus 91% for Comirnaty in a Phase 3 head-to-head — a statistically significant gap that held at 56 days. If it clears the FDA, the monoclonal antibody would offer a non-mRNA alternative to Covid vaccination with a markedly better tolerability profile, though the headline itself flags that regulatory review remains the open question.
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