📢Some small progress updates on Hummingbird, Novavax’s large phase 2b/3 trial to study the safety and immunogenicity of Nuvaxovid in children aged 6 months to 12 years:
1. On April 29th, the FDA updated its postmarketing commitment database (which it does quarterly), and in that update, they reported that:
• Novavax/Sanofi had requested an extension for Hummingbird on December 4th, which was granted by FDA on January 15th
• As such, the projected date for the final report submission shifted from March 4th to May 22nd
2. The Hummingbird trial listing on
ClinicalTrials.gov was indeed updated on that same projected date (May 22nd), for the first time since 2024, to shift from “Active, not recruiting” to “Completed”.
Finally looks like some real progress, to me.
Keep in mind that this trial alone was originally deemed good enough by the FDA to support an expansion of the label to pediatric populations, before FDA commissioner Makary and CBER director Prasad put in place a requirement for an additional immunogenicity study. Those guys are long gone now, and the rumor on the street is that RFK Jr. might not be far behind.
FDA PMC database:
accessdata.fda.gov/scripts/c…
Trial listing:
clinicaltrials.gov/study/NCT…