Below is a compilation of initiatives, actions and accomplishments across Operation Warp Speed (OWS)’s primary efforts in the past week. To learn more about OWS, visit the Department of Health and Human Services (HHS) website and Department of Defense (DOD) website.
Pfizer announced its vaccine candidate demonstrated an efficacy rate above 90% based on the first interim efficacy analysis conducted Nov. 8 by an external, independent Data Monitoring Committee. Pfizer said the news means they are a significant step closer to provide a much needed breakthrough in ending the global health crisis.
Moderna reached case accrual for the first interim analysis of its vaccine candidate with 53 COVID-19 cases identified in its ongoing Phase 3 trial. The data is being prepared for submission to the independent Data Safety Monitoring Board for analysis and recommendation.
Operation Warp Speed posted clips from an interview with Dr. Moncef Slaoui who discusses several aspects of vaccine development and the accelerated process to find a safe and effective COVID-19 vaccine. The nearly nine-minute video covers vaccine safety, Pfizer’s recent efficacy announcement, Operation Warp Speed’s approach and vaccine confidence. The video is posted and available for download on the Defense Visual Information Distribution Service (DVIDS) and is considered in the public domain.
Eli Lilly’s investigational Monoclonal Antibody therapeutic bamlanivimab received emergency use authorization for the treatment of mild to moderate COVID-19 outpatients who are at high risk of progressing to severe COVID-19 or hospitalization.
HHS announced its allocation plan for initial doses of bamlanivimab to state and territorial health departments, which in turn, will determine which healthcare facilities will receive the infusion drug. Eighty thousand doses were shipped to locations determined by states and patients have already begun receiving the therapeutic.
MANUFACTURING, DISTRIBUTION AND ADMINISTRATION:
HHS announced the government’s partnership with large chain pharmacies and networks that represent independent pharmacies and regional chains to increase access to a COVID-19 vaccine once authorized for distribution. The partnership brings about 60% of the nation’s pharmacies into the federal pharmacy program. The move is another way to reach people where they live, since it is estimated that most Americans live within five miles of a pharmacy.
Photos and b-roll of the ongoing work at Operation Warp Speed, including the Vaccine Operations Center, are being posted on the Defense Visual Information Distribution Service (DVIDS). All content is available for download and considered in the public domain.
Secretary Alex Azar joined CBS This Morning to discuss this week’s developments on Operation Warp Speed, including the positive news on the Pfizer vaccine and the emergency use authorization granted for Eli Lilly’s antibody therapeutic.
Operation Warp Speed Chief Scientific Advisor Dr. Moncef Slaoui visited two clinical trial sites in Atlanta including one at the VA Medical Center Thursday, Nov. 12. Dr. Slaoui has praised clinical trial employees and volunteers for their critical role in the effort to develop a safe and effective COVID-19 vaccine. In partnership with the Department of Veterans Affairs, Janssen is enrolling volunteers for Phase 3 trials at 17 VA sites nationwide. The VA population allows the trials to expand their age and race diversity.
Operation Warp Speed Chief Operating Officer Gen. Gus Perna visited public health officials and Centers for Disease Control and Prevention leaders during a trip to Atlanta Thursday, Nov. 12.
SENIOR LEADER QUOTES:
“Ensuring access and affordability of the COVID-19 vaccine for all Americans is a top priority for the Trump Administration. We are leveraging the existing private sector infrastructure to get safe and effective vaccines supported by Operation Warp Speed into communities and into arms as quickly as possible with no out-of-pocket costs.” ~HHS Secretary Alex Azar
“I believe that the mission we have – to develop, manufacture, and deliver safe and effective vaccines – is moving in the right direction. And I am just going to keep my head down and drive to that end.” ~GEN Gus Perna, Operation Warp Speed Chief Operating Officer
“No department or agency was ever structured to manage and distribute six vaccine candidates in the middle of a pandemic. But this is what DOD does. We’re planners, we’re enablers and we provide the bandwidth – that’s the power of Operation Warp Speed.” ~Mr. Paul Ostrowski, Operation Warp Speed Director of Supply, Production and Distribution.
Operation Warp Speed is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics and diagnostics.