This is a compilation of initiatives, actions and accomplishments across Operation Warp Speed (OWS)’s primary efforts in the past week provided by the Department of Health and Human Services (HHS) and Department of Defense (DOD),
Pfizer submitted a request Friday for Emergency Use Authorization from the Food and Drug Administration. This came days after the company announced the conclusion of its Phase 3 study and reported its vaccine candidate met all primary efficacy end points, noting its efficacy was consistent across age, gender, race and ethnicity, with more than 94% observed in adults over 65.
Moderna announced intent to submit for an Emergency Use Authorization in the coming weeks, following its vaccine candidate showing 94.5% efficacy in its first interim analysis. Preliminary analysis from a Phase 3 study with more than 30,000 participants suggests a broadly consistent safety and efficacy profile across all evaluated subgroups.
The VA issued a PSA and announced its nationwide effort to recruit volunteers to test vaccines and treatments for COVID-19 at more than 50 VA facilities. VA’s volunteer list is open to veterans and non-veterans, 18 years old or older. Participation in any research study is strictly voluntary. Vaccines being studied at VA sites include candidates developed by Moderna, AstraZeneca, Pfizer and Janssen. VA’s trials for COVID-19 treatments include remdesivir, monoclonal antibodies, Tocilizumab and others.
As of Thursday, the government has allocated more than 100,000 treatment courses (vials) of bamlanivimab with about 40,000 courses currently being prepared for distribution. The first allocation began Nov. 10. A jurisdiction-by-jurisdiction dashboard of allocations can be found here, and is updated each Wednesday at 11 a.m. ET.
MANUFACTURING, DISTRIBUTION AND ADMINISTRATION:
Operation Warp Speed will distribute vaccines alongside ancillary kits with all the required supplies to administer them, such as needles, syringes, alcohol pads and limited personal protective equipment. Currently, more than 1 million standard kits, which would cover 100 million vaccine doses, are assembled. Each standard kit, which support Moderna’s vaccine candidate, includes supplies to administer 100 doses. More than 20,000 Pfizer kits, which would cover 20 million vaccine doses, are assembled, with more in production every day. Each of the Pfizer kits, which also include the diluent required, include supplies to administer 975 doses.
Operation Warp Speed announced Nov. 13 that COVID-19 vaccines will be allocated pro-rata, in proportion to population.
With distribution of safe and effective COVID-19 vaccines approaching, Operation Warp Speed is refining plans to deliver vaccine doses across the country. Operation Warp Speed’s Director of Supply, Production and Distribution Paul Ostrowski discusses the strategy with video clips available for use by the media.
Operation Warp Speed Chief Operating Officer Gen. Gus Perna joined Vice President Mike Pence and members of the COVID-19 Task Force for a live update from the White House on Thursday.
Operation Warp Speed leaders held the first of several planned routine briefings for media Wednesday. View the session here. The next event is tentatively scheduled for Tuesday, Nov. 24. For notification of this and other upcoming events, register here.
Governors received an Operation Warp Speed overview Monday on a call with HHS Secretary Alex Azar, OWS Director of Supply, Production and Distribution Paul Ostrowski and the Centers for Disease Control and Prevention Director Dr. Robert Redfield. Discussion included the importance of provider enrollment in the CDC Vaccine Tracking System (VTrcks).
House and Senate members took a call with Operation Warp Speed leaders Chief Operating Officer Gen. Gus Perna and Chief Advisor Dr. Moncef Slaoui who provided an update on the pro-rata allocation and distribution plan and the close coordination with all 64 jurisdictions to ensure the COVID-19 vaccine gets first to those Americans who need it most.
Gen. Gus Perna visited Pfizer and Walgreens this week to exchange information on planning efforts, logistical infrastructure and next steps as vaccine distribution is imminent. Photos and b-roll from the Walgreen’s visit are available here.
U.S. Army Surgeon General Lt. Gen. R. Scott Dingle visited Operation Warp Speed this week to meet with Gen. Perna and to thank the dozens of Army medical officers who are supporting the mission.
SENIOR LEADER QUOTES:
“My message is hope and help are on the way. Operation Warp Speed is already delivering, and it’s going to keep delivering in the days and weeks ahead.” ~HHS Secretary Alex Azar
“At Operation Warp Speed, innovation toward our end state is our only concern. This is not about egos or credit. It is about how to solve this complex problem.” ~GEN Gus Perna, Operation Warp Speed Chief Operating Officer
“I’ve used the metaphor that the cavalry is on the way. If you’re fighting a battle and the cavalry is on the way, you don’t stop shooting. You keep going until the cavalry gets here.” ~ Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases
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.