Sanofi and GlaxoSmithKline (GSK) will be awarded up to $2.1 billion by the U.S. Departments of Health and Human Services (HHS) and Defense (DoD) toward development and manufacturing of the recombinant protein-based COVID-19 vaccine being produced by the companies, they and the U.S. government said.
HHS and DoD are providing the funding as part of Operation Warp Speed—the program through which President Donald Trump’s administration has committed the nation to delivering 300 million vaccine doses protecting against SARS-CoV-2 by January 2021.
“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,” HHS Secretary Alex Azar II stated.
Operation Warp Speed funds and coordinates development of vaccines, drugs, and diagnostics across agencies of DoD and HHS—the latter agency including the FDA, the NIH, the Centers for Disease Control and Prevention (CDC), and the Biomedical Advanced Research and Development Authority (BARDA).
BARDA partnered with the DoD Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense and the Army Contracting Command to furnish the funding—which Sanofi said will secure the scale-up of Sanofi’s and GSK’s manufacturing capabilities in the United States for the vaccine, resulting in a significant increase in capacity.
“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,” said Roger Connor, president of GSK Vaccines.
The Sanofi-GSK vaccine combines Sanofi’s S-protein COVID-19 antigen, which is based on recombinant DNA technology, and GSK’s pandemic AS03 adjuvant. The vaccine is among 17 “Front Runner” programs among nearly 280 COVID-19 therapeutics included in GEN’s updated “COVID-19 Drug & Vaccine Candidate Tracker.”
“With our partner GSK, we expect our Phase I/II study for the recombinant adjuvanted approach to start in September,” added Thomas Triomphe, executive vice president and global head of Sanofi’s vaccine business Sanofi Pasteur.
Phase III by year’s end
The Phase I/II trial will be followed by a Phase III trial by the end of 2020, Sanofi said—with the companies planning to request U.S. regulatory approval in the first half of 2021 should the data prove positive.
Sanofi will receive the majority of the U.S. government funding, more than half of which is intended to support late-stage development of the vaccine, including a large-scale Phase III efficacy trial and other clinical studies, with the rest to be used toward manufacturing scale-up and delivery of an initial 100 million doses of the vaccine.
The companies have agreed to carry out fill-finish manufacturing in the United States so that vaccine doses are packaged and ready to ship immediately if clinical trials are successful and FDA authorizes use.
While clinical trials are underway, HHS said, manufacturing efforts would begin with a demonstration project—a parallel effort intended to speed up vaccine development.
The vaccine “would be available to the American people at no cost,” HHS stated, if the doses are used in a COVID-19 vaccination campaign. However, the agency cautioned that healthcare professionals could charge for the cost of administering the vaccine “as is customary with government-purchased vaccines.”
Lower actual dose price
One analyst expects Sanofi/GSK’s actual dose price for their vaccine to be lower than that of the COVID-19 RNA-based vaccines being developed by other front-runners—namely Pfizer and BioNTech (BNT162b2) and Moderna (mRNA-1273).
“A significant portion of the funding is earmarked for clinical trials, manufacturing, scale-up, and delivery, implying that the actual dose price could be lower than the previous bar for the United States set by PFE/BNTX ($19.50/dose),” Mani Foroohar, MD, managing director and senior research analyst, genetic medicines with SVB Leerink, wrote in an investor note. “For mRNA-1273, we currently model pandemic-level pricing similar to PFE/BNTX at $20/dose ($40/course), and see pricing materially above this level as challenging in the pandemic period.”
The U.S. government has a further option for the supply of an additional 500 million doses.
Sanofi and GSK added that they are scaling up manufacturing of the antigen and adjuvant to produce up to one billion doses per year globally. To that end, the companies announced on Wednesday that they agreed to supply up to 60 million doses of their COVID-19 vaccine to the U.K. government.
The companies added that they are in “active” ongoing discussions with the European Commission and various global organizations. Representatives of France and Italy are on the European Union’s negotiation team for supplying European countries from Sanofi’s and GSK’s European industrial network with the vaccine, Sanofi added.
Accelerating worldwide supply
In addition, GSK and Sanofi plan to provide a “significant” portion of their total worldwide available supply capacity in 2021 and 2022 to “Access to COVID‐19 Tools (ACT) Accelerator,” a global collaboration designed to accelerate development, production, and equitable access to COVID-19 tests, treatments, and vaccines. ACT partners include leaders of governments, global health organizations, businesses, and philanthropies.
The World Health Organization is among global organizations participating in the ACT accelerator effort, along with the Bill & Melinda Gates Foundation; the Coalition for Epidemic Preparedness Innovations (CEPI); the Foundation for Innovative New Diagnostics (FIND); Gavi, The Vaccine Alliance; The Global Fund; Unitaid; Wellcome; The World Bank; and the World-Bank-supported Global Financing Facility.
GSK has launched partnerships to create adjuvanted COVID-19 vaccines with Sanofi among several other partners, which include Clover Biopharmaceuticals, Medicago, the University of Queensland, Vir Biotechnology, Xiamen Innovax Biotech, and Xiamen University.
Sanofi is partnering with Translate Bio to develop an mRNA vaccine for COVID-19, through a partnership that expanded in June to include the disease among infectious diseases targeted, with the phama giant nearly tripling to more than $2.3 billion its potential payout to the Lexington, MA, biotech.
The companies aim to launch a first-in-human clinical trial of the COVID-19 vaccine in the fourth quarter—and have increased from five to seven the maximum number of vaccines they plan to develop. Translate Bio has established mRNA manufacturing capacity and Sanofi said it expects to be able to supply annual capacity of 90 to 360 million doses.