By David E. Hubler
Contributor, In Homeland Security
The U.S. Department of Health and Human Services (HHS) will pay pharmaceutical company Novavax $1.6 billion to develop 100 million doses of a safe, effective vaccine for COVID-19 by the beginning of 2021, according to the New York Times.
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The HHS announcement comes as the number of new coronavirus infections during the first six days of July approached 300,000 with more states and cities re-imposing shutdown orders, according to The Washington Post.
Government Places Significant Bet on Company That Has Never Brought a Product to Market
“The deal is the largest that the Trump administration has made so far with a company as part of Operation Warp Speed, the sprawling federal effort to make coronavirus vaccines and treatments available to the American public as quickly as possible,” The New York Times said. “In doing so, the government has placed a significant bet on Novavax, a company based in Maryland that has never brought a product to market.”
“It speaks to the confidence that they have in our platform to be able to develop a vaccine,” Stanley Erck, Novavax’s president and CEO, said.
As HHS Secretary Alex Azar explained, “Operation Warp Speed is creating a portfolio of vaccines to increase the odds that we will have at least one safe, effective vaccine as soon as the end of this year….Depending on success in clinical trials, today’s $1.6 billion investment supports our latest vaccine candidate, being developed by Novavax, all the way through clinical trials and manufacturing 100 million doses for the American people.”
Operation Warp Speed a Partnership among Components of HHS, CDC, FDA and Others
Operation Warp Speed is a partnership among components of HHS, including the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Biomedical Advanced Research and Development Authority (BARDA), and the Department of Defense (DoD).
“OWS engages 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,” the HHS fact sheet added.
The vaccine development plan is as follows, subject to change as work proceeds:
- Fourteen promising candidates have been chosen from the 100+ vaccine candidates currently in development—some of them are already in clinical trials with U.S. government support.
- The 14 vaccine candidates are being narrowed down to about seven candidates, representing the most promising candidates from a range of technology options, which will go through further testing in early-stage clinical trials.
- Large-scale randomized trials for the demonstration of safety and efficacy will proceed for the most promising candidates.
HHS plans for a tiered approach to vaccine distribution, which will build on allocation methodology developed as part of pandemic flu planning and be adjusted based on experience during the first wave of the COVID-19 response, data on the virus and its impact on populations and the performance of each vaccine, and the needs of the essential workforce.
OWS will expand domestic manufacturing and supplies of specialized materials and resources, such as glass vials, that can be necessary for distribution. DoD’s involvement will enable faster distribution and administration than would have otherwise been possible.
Dr. Francis Collins, the director of the U.S. National Institutes of Health, explained that there is a “need for speed,” and the older approach takes “considerably longer” to develop.
“We have no time to waste,” Dr. Francis Collins told CNN.
However, some scientists worry that “Operation Warp Speed is missing out on tried and true vaccine technologies that have over and over again resulted in proven winners,” according to CNN.
Saad Omer, a Yale University infectious disease expert who has helped develop several vaccines, told CNN that Operation Warp Speed needs to widen its portfolio to include the older technologies.”New technologies are good, and they could perform well, but we should really be hedging our bets,” Omer said.
Dr. Paul Offit, a University of Pennsylvania professor who developed a vaccine against rotavirus, agreed. “Just because it’s new doesn’t mean it’s better,” he said.
But Dr. Francis Collins, the director of the National Institutes of Health, told CNN that there is a “need for speed,” and the older approach takes “considerably longer” to develop. “We have no time to waste,” he said.