The U.S. government’s Operation Warp Speed effort will provide up to $2.1 billion to Sanofi and GlaxoSmithKline to fund development and manufacturing of the companies’ experimental Covid-19 vaccine, the companies announced Friday.
As part of the agreement, the companies will provide the U.S. with 100 million doses of the vaccine, which will begin human trials in September. As with other vaccines in development, the Sanofi-GSK vaccine, if effective, may require two doses. The U.S. will have the option to procure up to 500 million doses; the companies say they are gearing up to be able to make 1 billion doses annually.
The Sanofi-GSK vaccine is starting trials behind vaccines of other companies with whom Operation Warp Speed is working, including Moderna — which began a pivotal Phase 3 study aimed at proving its vaccine’s efficacy on Monday — AstraZeneca, Johnson & Johnson, and Novavax. However, it is the only vaccine of the group based on technologies used in approved vaccines: the platform behind Sanofi’s Flublok flu shot, and a compound made by GSK, called an adjuvant, that is used to make vaccines more potent.
“The portfolio of vaccines being assembled for Operation Warp Speed increases the odds that we will have at least one safe, effective vaccine as soon as the end of this year,” Health and Human Services Secretary Alex Azar said in a statement released by the companies. “Today’s investment supports the Sanofi and GSK adjuvanted product all the way through clinical trials and manufacturing, with the potential to bring hundreds of millions of safe and effective doses to the American people.”
Operation Warp Speed has announced other agreements. It has invested $1.2 billion in the vaccine being developed by AstraZeneca and University of Oxford, and will receive 300 million doses; and it’s invested $1.6 billion in the Novavax vaccine, for which the U.S. will receive 100 million doses. Those agreements, like the Sanofi one, include payment for conducting clinical trials in partnership with the National Institutes of Health and grants for manufacturing.
Warp Speed has also announced it will purchase 100 million doses of the vaccine being developed by the German biotechnology firm BioNTech and the drug giant Pfizer for $1.95 billion. Those companies have chosen not to work with the NIH on clinical trials or take government grants in order to fund its work, and the deal is structured as a straight purchase of goods. The Pfizer/BioNTech vaccine, like the Moderna one, began a Phase 3 trial on Monday.
If the amounts funded were treated as purchase amounts, the Sanofi-GSK vaccine is costing $21 a dose, the Pfizer vaccine $19.95 per dose, the NovaVax vaccine $16 a dose, and the AstraZeneca-Oxford vaccine $4 per dose. But for all but the Pfizer deal, the price paid by the government is not just for doses of finished product but includes investments in technology and research.
Countries around the world, as well as a new entity created by the vaccine-purchasing nonprofit Gavi and the Coalition for Epidemic Preparedness (CEPI) in conjunction with the World Health Organization, are working to procure doses of vaccines and fund the scale-up of manufacturing before any vaccine has been proven effective because of the desperate need to slow the Covid-19 pandemic.
“The global need for a vaccine to help prevent Covid-19 is massive, and no single vaccine or company will be able to meet the global demand alone,” said Thomas Triomphe, executive vice president at Sanofi’s vaccine division, Sanofi Pasteur. Roger Connor, the president of GSK’s vaccine division, added: “We thank the U.S. government for playing a very important role in providing early, significant funding to enable the development and scale-up of this potentially important vaccine.”
The Pfizer-BioNTech and Moderna vaccines both work by using a chemical messenger called mRNA to instruct a person’s cells to make part of the virus, triggering the immune system. The J&J and AstraZeneca-Oxford vaccines use modified harmless viruses (not the coronavirus — another type of virus called an adenovirus) to do something similar. Novavax and Sanofi-GSK manufacture protein fragments of the coronavirus in insect cells and inject them directly. The addition of the GSK adjuvant further stimulates the immune system, and may allow the companies to produce more doses.
There are 25 vaccines against Covid-19 in human testing, according to the World Health Organization, and another 139 in earlier stages of research, including other, separate efforts from Sanofi and GSK.