A key development in our campaign:
Pemgarda (Pemivibart), the monoclonal antibody designed to protect immunocompromised individuals from COVID-19, has completed its Phase 3 immune-bridging trial—now published in Clinical Infectious Diseases.
Read the study: https://doi.org/10.1093/cid/ciaf265
Key findings:
• The trial demonstrated robust neutralizing antibody responses
• Pemgarda was well-tolerated, with a safety profile similar to placebo
• The data formed the basis for its Emergency Use Authorization by the U.S. FDA
Immune-bridging is a recognized regulatory pathway used during public health emergencies. It allows for faster access when large-scale efficacy trials are impractical—especially for rare or vulnerable populations.
We’ll now be following up with Health Canada to:
• Request formal guidance on immune-bridging acceptance
• Advocate for Pemgarda’s authorization based on existing data
• Reiterate the urgent unmet need among immunocompromised Canadians
Thank you for continuing to push with us. Your voice is making a difference.
Let’s keep the pressure on.
In solidarity,
Rowan
#MAbsForCanadaNOW | #ProtectImmunocompromised |#COVID19IsNotOver
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