Warp Speed didnl;t only include payments for the development of the vaccines and promises to buy certain quantities. It also included manufacturing and distribution. Here are just a couple of sample months of activities for both:
Manufacturing
The federal government is making investments in the necessary manufacturing capacity at its own risk, giving firms confidence that they can invest aggressively in development and allowing faster distribution of an eventual vaccine. Manufacturing capacity for selected candidates will be advanced while they are still in development, rather than scaled up after approval or authorization. Manufacturing capacity developed will be used for whatever vaccine is eventually successful, if possible given the nature of the successful product, regardless of which firms have developed the capacity.
Select actions to support OWS manufacturing efforts so far include:
May
The May 21, April 16, and March 30 HHS agreements with AstraZeneca, Moderna, and Johnson & Johnson respectively include investments in manufacturing capabilities.
June
June 1: HHS announced a task order with Emergent BioSolutions to advance domestic manufacturing capabilities and capacity for a potential COVID-19 vaccine as well as therapeutics, worth approximately $628 million, using Emergent's BARDA-supported Center for Innovation in Advanced Department and Manufacturing.
July
July 27: HHS announced a task order with Texas A&M University and FUJIFILM to advance domestic manufacturing capabilities and capacity for a potential COVID-19 vaccine, worth approximately $265 million, using another BARDA-supported CIADM.
Development
To accelerate development while maintaining standards for safety and efficacy, OWS has been selecting the most promising countermeasure candidates and providing coordinated government support.
Protocols for the demonstration of safety and efficacy are being aligned, which will allow the trials to proceed more quickly, and the protocols for the trials will be overseen by the federal government, as opposed to traditional public-private partnerships, in which pharmaceutical companies decide on their own protocols. Rather than eliminating steps from traditional development timelines, steps will proceed simultaneously, such as starting manufacturing of the vaccine at industrial scale well before the demonstration of vaccine efficacy and safety as happens normally. This increases the financial risk, but not the product risk.
Select actions to support OWS vaccine and therapeutic development so far include:
March
March 30: HHS announced $456 million in funds for Johnson & Johnson's (Janssen) candidate vaccine. Phase 1 clinical trials began in Belgium on July 24th and in the U.S on July 27th. Janssen's large-scale Phase 3 clinical trial began on September 22, 2020, making them the fourth OWS candidate to enter Phase 3 clinical trials in the United States. Up to 60,000 volunteers will be enrolled in the trial at up to nearly 215 clinical research sites in the United States and internationally.
April
April 16: HHS 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 FDA. This agreement was expanded on July 26 to include an additional $472 million to support late-stage clinical development, including the expanded Phase 3 study of the company's mRNA vaccine, which began on July 27th.
May
May 21: HHS announced up to $1.2 billion in support for AstraZeneca's candidate vaccine, developed in conjunction with the University of Oxford. The agreement is to make available at least 300 million doses of the vaccine for the United States, with the first doses delivered as early as October 2020, if the product successfully receives FDA EUA or licensure. AstraZeneca's large-scale Phase 3 clinical trial began on August 31, 2020.
Distribution
OWS and our private partners are developing a plan for delivering a safe and effective product to Americans as quickly and reliably as possible. Experts from HHS are leading vaccine development, while experts from DoD are partnering with the CDC and other parts of HHS to coordinate supply, production, and distribution of vaccines.
Download the Vaccine Distribution Process - PDF*
Select actions to support OWS distribution efforts include:
May
May 12: DoD and HHS announced a $138 million contract with ApiJect for more than 100 million prefilled 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 prefilled syringes in 2021.
June
June 9: HHS and DoD announced a joint effort to increase domestic manufacturing capacity for vials that may be needed for vaccines and treatments
June 11: HHS announced $204 million in funds to Corning to expand the domestic manufacturing capacity to produce approximately 164 million Valor Glass vials per year if needed. Valor Glass provides chemical durability to minimize particulate contamination. The specialized glass allows for rapid filling and capping methods that can increase manufacturing throughput by as much as 50 percent compared with conventional filling lines, which in turn can reduce the overall manufacturing time for vaccines and therapies.
June 11: HHS announced $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. The new lines provide the capacity to produce an additional 120 million vials per year if needed.
