![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » Sanofi and GSK Land $2.1 Billion Operation Warp Speed Contract
Sanofi and GSK Land $2.1 Billion Operation Warp Speed Contract
August 3, 2020
Sanofi and GlaxoSmithKline (GSK) have secured a $2.1 billion U.S. government contract to develop and produce 100 million doses of their COVID-19 vaccine candidate.
The biggest vaccine deal so far under the Trump administration’s Operation Warp Speed, the funding from HHS and the Department of Defense will help pay for late-stage development, including a phase 3 trial. Sanofi plans to launch a phase 1/2 study in September, followed by a phase 3 trial by year’s end.
The deal includes an option for the government to acquire another 500 million doses. Financial terms of that option have not been set. The drugmakers are also scaling up manufacturing to produce up to 1 billion doses per year globally.
The companies partnered on development of the vaccine in April, using Sanofi’s recombinant protein-based vaccine technology and GSK’s adjuvant technology.
HHS and the Department of Defense entered into a similar deal with Pfizer and BioNTech last month for production and delivery of 100 million doses of their vaccine candidate (DID, July 23).
Also, on Friday, the European Commission announced that it has concluded exploratory talks with Sanofi and GSK to purchase 300 million doses of their vaccine on behalf of its 27 member states and said it is in “intensive discussions” with other vaccine manufacturers. — Jordan Williams
Upcoming Events
-
21Oct