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Warp Speed’s $2.1B commitment to Sanofi-GSK COVID-19 program brings total to $8.3B across seven vaccines

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A preclinical vaccine from Sanofi and GSK may be months behind other COVID-19 vaccines in development, but the U.S. government has made its largest financial commitment yet to its development and manufacturing, pledging up to $2.1 billion as part of Operation Warp Speed.

That brings the U.S. government’s total commitment to about $8.3 billion across seven vaccine programs that use four different modalities, most of which are already in the clinic (see “COVID-19 Vaccines with U.S. Government Funding”).

The majority of the new cash will go to Sanofi (Euronext:SAN; NASDAQ:SNY). More than half is earmarked for the vaccine’s development, including clinical testing that is due to start in September. The balance will go toward manufacturing and delivery of the first 100 million doses; the U.S. has an option for the supply of an additional 500 million.

The two companies have historically been competitors in the vaccine sector, but are collaborating on the COVID-19 product. The vaccine uses an antigen from Sanofi, based on the recombinant protein technology used in the company’s flu vaccine, along with an adjuvant from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).

It is due to enter a Phase I/II trial in September, with a Phase III trial to follow by year-end.

Operation Warp Speed is aiming to secure many millions of doses of a safe and effective COVID-19 vaccine. The first Emergency Use Authorization could arrive by year-end, with others to follow in 2021. Five other vaccines that have received Operation Warp Speed funding are already in the clinic, with three in late-stage testing.

Figure: COVID-19 vaccines with U.S. government funding

A GSK spokesperson told BioCentury it is too early to report any preclinical data from the vaccine. The companies expect a two-dose schedule, but are also testing a single-dose administration.

The partners plan to commit a portion of the doses to the Access to COVID-19 Tools (ACT) Accelerator, and have begun conversations with the COVID-19 Vaccine Global Access Facility (COVAX) to ensure global access (see “WHO Seeks $18B for Vaccines Advanced Market Commitments”).

Launched this year by global public health and private sector organizations, the ACT Accelerator created COVAX as a global purchasing pool to provide priority populations around the world with access to vaccines.

The Warp Speed arrangement comes two days after the U.K. government reached a supply agreement with Sanofi and GSK to provide 60 million doses of the vaccine (see “Locking Down Access”).

Elizabeth S. Eaton contributed to this report.

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