One of the top concerns around the COVID-19 coronavirus is knowing when a safe and effective vaccine will be developed and distributed, and on Tuesday, the Department of Health and Human Services said that January 2021 is a likely timeframe for when that might happen.
The projection is based on the current efforts of HHS' Operation Warp Speed, an initiative that aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by the peak of the next flu season. It's part of a broader strategy to accelerate the development, manufacture and distribution of coronavirus vaccines, therapeutics and diagnostics – collectively referred to by HHS as "countermeasures."
OWS intends to achieve this goal by investing in and coordinating countermeasure development, in part by partnering with components of HHS, including the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institutes of Health, and the Biomedical Advanced Research and Development Authority, and also the Department of Defense.
OWS is also engaging with private firms and other federal agencies, including the Department of Agriculture, the Department of Energy and the Department of Veterans Affairs. It will coordinate existing HHS-wide efforts, including the NIH's Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, NIH's Rapid Acceleration of Diagnostics (RADx) initiative, and work by BARDA.
Congress has directed almost $10 billion to this effort through supplemental funding, including the CARES Act. Congress has also appropriated other flexible funding. The almost $10 billion specifically directed includes more than $6.5 billion designated for countermeasure development through BARDA and $3 billion for NIH research.
HHS Secretary Alex Azar and Defense Secretary Mark Esper oversee OWS, with Dr. Moncef Slaoui designated as chief advisor and General Gustave F. Perna nominated to be chief operating officer. To allow these OWS leaders to focus on operational work, in the near future the program will be announcing separate points of contact for communication with Congress and the public.
WHAT'S THE IMPACT?
While Dr. Matt Hepburn, joint project lead, CBRN Defense Enabling Biotechnologies, said the situation was "dynamic," he expects to be able to meet the self-imposed January 2021 deadline so long as the process for narrowing down top vaccine candidates goes smoothly.
"We anticipate that as some vaccines work better than others we may shift in our priority," said Hepburn.
Currently, OWS is eyeing 14 potential vaccine candidates and expects it will be whittling that list down to about seven depending on the results of development and clinical trials. Protocols for the demonstration of safety and efficacy are now being crafted, which HHS said 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.
Large-scale randomized trials for the demonstration of safety and efficacy will proceed for the most promising candidates.
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.
Paul Mango, deputy chief of staff for policy in HHS' Office of the Secretary, said the OWS efforts will likely justify the financial risk since stay-at-home and other social-distancing orders have cost the country an estimated $25 billion per day, while the opportunity to develop an effective and scalable vaccine is potentially worth trillions.
"We cannot promise a 100% chance of success, but we've maximized the probability of success," said Mango.
For vulnerable Americans who may not be able to afford a vaccine, Mango said the vaccine would be provided for free, and OWS is working with insurers who have already expressed an eagerness to cover them without copays, much as they have done with other COVID-19 services.
"There's nothing definitive but we fully anticipate that commercial insurers will do what they have done for previous COVID services, and that's to cover these for their members," he said.
MANUFACTURING AND DISTRIBUTION
In terms of manufacturing, the federal government is making investments in the necessary manufacturing capacity at its own risk, ostensibly to give firms confidence that they can invest aggressively in development and more quickly distribute 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 will be used for whatever vaccine is eventually successful, regardless of which firms have developed the capacity.
Before the countermeasures are approved or authorized, the program intends to build the necessary plans and infrastructure for distribution.
HHS plans for a tiered approach to vaccine distribution.
"The tiered approach for distribution is based on methodology used for pandemic and influenza planning for decades, as well as what we've learned during the COVID-19 pandemic," said Hepburn.
He said that older Americans and front-line healthcare workers will be among those prioritized in the first tier, since they are at the greatest risk. "That will depend on the results of clinical trials," he said.
OWS will expand domestic manufacturing and supplies of specialized materials and resources, such as glass vials, that can be necessary for distribution. The Department of Defense's involvement will enable faster distribution and administration than would have otherwise been possible, HHS said.
THE LARGER TREND
Actions to support OWS' efforts began even before the unveiling of OWS itself.
On March 30, for instance, HHS announced $456 million in funds for Johnson and Johnson's candidate vaccine, with Phase 1 clinical trials set to begin this summer, while on April 16 it 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.
On 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 U.S., with the first doses delivered as early as October 2020, and Phase 3 clinical studies beginning this summer with about 30,000 volunteers.
The government has also made moves to support manufacturing: The May 21, April 16, and March 30 HHS agreements with AstraZeneca, Moderna, and Johnson and Johnson, respectively, include investments in manufacturing capabilities, and on 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 about $628 million.
On the distribution front, on May 12 DoD and HHS announced a $138 million contract with ApiJect for more than 100 million prefilled syringes for distribution by year-end 2020, as well as the development of manufacturing capacity for the ultimate production goal of more than 500 million prefilled syringes in 2021.
On June 9, HHS and DoD announced a joint effort to increase domestic manufacturing capacity for vials that may be needed for vaccines and treatments, including $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.