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Hepburn: DOD role in Operation Warp Speed was ‘transformative’

Medical technician getting a syringe ready to give a vaccine Crystal Tyler, pharmacy technician, prepares an injection for an Operation Warp Speed patient volunteer at Brooke Army Medical Center Fort Sam Houston, Texas, November 16, 2020. BAMC is one of five Defense Health Agency military medical treatment facilities participating in the Phase III trial to evaluate the vaccine under development by AstraZeneca as part of a national initiative to accelerate the development, production and distribution of COVID-19 vaccines, therapeutics and diagnostics. (Photo by Jason Edwards, Brooke Army Medical Center.)

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The director of the Department of Defense’s Operation Warp Speed told The Society of Federal Health Professionals that he is 'incredibly proud’ of the work his team has done with the Department of Health and Human Services in finding a vaccine for COVID-19. Dr. Matthew Hepburn’s praise for DOD came during a speech to the AMSUS virtual annual meeting Dec. 8.

The DOD’s role in Operations Warp Speed (OWS) was “transformative,” said Hepburn, OWS development lead, pointing to operational planning, logistics and supply chains, which “is in our DNA” at DOD. “It comes very naturally because that is what we do…and that has made all the difference,” he told the audience of more than 1,500 online attendees.

For example, he said DOD’s expertise in obtaining contracts quickly resulted in OWS getting “a really good deal in record time that was mutually beneficial” to the six vaccine manufacturers the joint operation decided to pursue for an approved vaccine for COVID-19. Those manufacturers are Pfizer, Moderna, AstraZeneca, Janssen, Novavax, and Sanofi.

“The Department of Defense’s unique contracting experience … and other transactions have allowed us to come from where we think are the right contacts to having long-term contracts,” Hepburn said.

Pfizer and Moderna have applied for emergency use authorization from the Food and Drug Administration. Pfizer’s application will be reviewed by an FDA advisory committee of vaccine experts Dec. 10, and Moderna’s application will be reviewed a week later. The FDA usually, but not always, accepts its advisory panels’ recommendations.

The FDA announced on Dec. 8 that its review of the Pfizer vaccine found it to be safe and efficacious, meeting the requirements for emergency use authorization. The vaccine showed a strong protective effect after the first of two doses, according to the FDA.

The OWS’ chief operating officer, Army Gen. Gustave Perna, “has been very clear that we will have trucks rolling within 24 hours of approval of the first vaccine,” Hepburn said.

Once the vaccine is first available to frontline health care workers and elderly care facilities, “we need you to tell our communities that this is just one layer of a multi-level strategy” to protect against COVID-19, he stated.

He urged the health care community “to convey a message that these vaccines are safe and efficacious, and that vaccination is important” as a counterpoint to widespread misinformation in the general public about vaccines and the need for vaccination against the disease.

Clinical trials for the candidate vaccines are ongoing and represent the diversity of the general population, Hepburn said, and were done “in anticipation of trying to increase confidence” among the public. For example, at least 25% of clinical trial participants are over the age of 65, a population not normally used for clinical trials but one at greater risk from COVID-19, he noted.

The number of doses needed for immunizations is “really a moving target, which is not necessarily a bad thing,” Hepburn said. “The consistency and cadence of manufacturing improves over time, and more doses are available than we thought would be available last week.”

OWS’ project team asks for “more doses on a daily basis,” he noted.

Armed services research efforts prior to the pandemic will allow for future innovation and speed of vaccine and therapeutics development, Hepburn said.

“If we hadn’t made those investments 10 years ago, there is no way we could have achieved the speed” of going from research and development, to candidates, to clinical trials, to approval and distribution, he said.

He noted that the DOD’s “clinical research enterprise led us to be involved in the enrollment right now in the AstraZeneca clinical trials.”

He called the department’s research enterprise “an incredibly powerful tool to confront 21st century threats,” and that “this is the new standard for rapid product development, and will apply not only to pandemics but also to develop product for combat health in half the time. Imagine how fast we could go in force protection” using the new paradigm, he said.

During a question and answer session, Hepburn emphasized that the AMSUS audience “needs to remind people at the DOD and in the community at large how well DOD can work” when confronted by new viral or other national security and health care threats.

“One of the most important lessons learned is the value of military leadership” in overcoming obstacles at a rapid clip, he said, noting the DOD “didn’t take over a public health initiative, but collaborated on a project that involved not only what we’re doing for the American people but also globally.”

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