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Today, Sanofi Canada has announced that they have completed the acquisition of Nuvaxovid market authorization from Novavax and that Nuvaxovid will be available to Canadians in the fall.

“Nuvaxovid will be made available in Canada by Sanofi for the fall 2026-2027 season”
“Provincial and territorial availability will be confirmed pending ongoing discussions and provincial assessments”

> With the launch of Nuvaxovid, a non-mRNA protein-based COVID-19 vaccine, Sanofi is now able to offer Canadians greater choice when it comes to COVID-19 protection. The availability of Nuvaxovid means that every Canadian will have the opportunity to access their personal COVID-19 vaccine choice. Canadians have clearly expressed a need for a non-mRNA option when it comes to COVID-19 protection. With this transfer, Sanofi can now respond to that need.

Delphine Lansac, General Manager, Canada, Vaccines at Sanofi.

Press release: https://www.newswire.ca/news-releases/sanofi-becomes-market-authorization-holder-for-nuvaxovid-r-in-canada-expanding-covid-19-vaccine-choices-for-canadians-867181632.html

Sanofi appears to have created a webpage for the Canadian product here, which includes the current product monograph: https://www.sanofi.com/en/canada/your-health/vaccines-products/nuvaxovid

Press release: https://investors.invivyd.com/news-releases/news-release-details/invivyd-announces-revolution-program-progress-and-advancement

Highlights:

The number of COVID-19 events accumulated in the DECLARATION trial can already provide sufficient statistical power to support the high end of anticipated VYD2311 efficacy.
The study is being upsized anyway, by ~500 patients, to act as a buffer. This slightly shifts the timeline for when study results will be available, from “mid-year” to Q3 2026.
Invivyd and the FDA have aligned on a pediatric trial design, “DRUMMER”, to asses safety and immunobridging in pediatric populations to support potential BLA approval for ages 0-11.

Prior discussions on VYD2311 and DECLARATION:

March 5th, 2026: Enrollment in DECLARATION is complete
December 23rd, 2025: Initiation of declaration trial - includes all prior history, as well
January 20th, 2026: SPEAR study group announces plans for phase 2 study of VYD2311 for treatment of Long COVID

Sanofi Canada: The market authorization transfer of Nuvaxovid is complete, and Nuvaxovid will be available in Canada in the fall.

Update on VYD2311, Invivyd’s intramuscular mAb candidate for the prevention of COVID: Sufficient statistical power already achieved in DECLARATION, the ongoing trial supporting FDA approval, but trial upsized by ~500 enrollees. Results Q3 2026. FDA has aligned on a pediatric trial, “DRUMMER”