The Trump administration’s Operation Warp Speed (OWS) is aiming to deliver 300 million doses of a safe and effective vaccine for coronavirus by January 2021, according to senior administration officials on Tuesday.
“We are already seeing vaccine development proceeding at a record-setting pace,” a senior administration official said on a conference call with reporters.
Officials said the administration has chosen 14 “promising candidates” for a vaccine, down from more than 100 candidates. Some of the 14 are already in clinical trials, with government support. The 14 candidates will be narrowed further down to about seven most promising candidates. All successful vaccines will be approved by the Food and Drug Administration (FDA).
Officials said they anticipate that anyone who wants a vaccine dose but cannot afford one will be provided one for free, and they expect most insurance companies to cover vaccinations as they have with other coronavirus-related services without a co-pay.
Distribution will be on a tiered system, with higher priority for the elderly, those with preexisting conditions, and people performing essential services, officials said.
OWS is part of the administration’s plans to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics — collectively known as “countermeasures.”
The operation is a partnership among the FDA, Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Biomedical Advanced Research and Development Authority (BARDA), and the Department of Defense (DOD).
The operation is also working with private firms and other federal agencies, including the Departments of Agriculture, Energy, and Veterans Affairs, and will coordinate existing HHS-wide efforts.
In terms of vaccine development, OWS is overseeing protocols for clinical trials, which will allow them to proceed more quickly, as opposed to more traditional public-private partnerships, where pharmaceutical companies decide on their own protocols.
So far, HHS has announced $456 million in funds for Johnson & Johnson’s candidate vaccine, with Phase 1 clinical trials set to begin this summer. HHS has also made up to $483 million in support available for Moderna’s candidate vaccine, which began Phase 1 trials on March 16 and received a fast-track designation from the FDA.
HHS has announced up to $1.2 billion in support for AstraZeneca’s candidate vaccine, developed in conjunction with the University of Oxford. HHS and AstraZeneca have an agreement to make available at least 300 million doses of the vaccine for the U.S., with Phase 3 clinical studies beginning this summer with approximately 30,000 volunteers in the U.S., and the first doses to be delivered as early as October 2020.
In terms of manufacturing, OWS is investing in the manufacturing capacity needed to distribute the successful vaccines.
In addition to investments in AstraZeneca, Moderna, and Johnson & Johnson’s manufacturing capabilities, HHS also announced a task order with Emergent BioSolutions to advance domestic manufacturing capabilities and capacity for a potential vaccine and therapeutics worth approximately $628 million.
HHS has also announced a $138 million contract with ApiJect for more than 100 million pre-filled syringes for distribution across the United States by year-end 2020, as well as the development of manufacturing capacity for the ultimate production goal of over 500 million pre-filled syringes in 2021.
HHS and DOD have announced a joint effort to increase domestic manufacturing capacity for vials that may be needed for vaccines and treatments, which includes $204 million to Corning to expand the domestic manufacturing capacity to produce an additional 164 million Valor Glass vials each year if needed, and $143 million to SiO2 Materials Science to ramp up capacity to produce the company’s glass-coated plastic container, which can be used for drugs and vaccines.
In terms of distribution, DOD will help distribute and administer the vaccines faster than would have otherwise been possible, officials said.
“We are working these details, every single one, day and night, 24/7, to ensure we can achieve the goals of Operation Warp Speed,” the senior administration official said.
OWS is being led by HHS Secretary Alex Azar and Defense Secretary Mark Esper, with Dr. Moncef Slaoui designated as chief adviser and Gen. Gustave F. Perna nominated to be chief operating officer.
Congress has authorized almost $10 billion to OWS through supplemental funding, including the CARES Act.