This Week in Operation Warp Speed - Oct. 30, 2020

 Oct. 30, 2020

---

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. 

VACCINE DEVELOPMENT: 

Pfizer announced more than 42,000 participants are enrolled in its late stage trial for a COVID-19 vaccine, with nearly 36,000 having received their second dose as of Oct. 26. Pfizer expects to apply for an Emergency Use Authorization with the Food and Drug Administration next month.

AstraZeneca announced clinical trials on its AZD1222 coronavirus vaccine resumed after the FDA and an independent safety review board completed an examination of safety data. The company voluntarily paused its trial Sept. 6, as part of the standard review process for clinical trial safety events. AstraZeneca will continue to provide information to regulators, study investigators and participants according to clinical trial and regulatory standards.

Novavax, announced plans to begin Phase 3 clinical trials in the United States and Mexico by the end of November. The trials could enroll up to 30,000 people. It also reported it made significant progress in large-scale manufacturing with some delay from the original timeline. The company already has more than 5,500 participants enrolled in the United Kingdom trial, which it expanded to 15,000 volunteers. 
 
THERAPEUTICS DEVELOPMENT:

HHS and DOD announced an agreement with Eli Lilly to purchase up to nearly a million doses of the company’s investigational monoclonal antibody therapeutic bamlanivimab. An initial agreement would supply the government with 300,000 doses within the first two months following a potential FDA Emergency Use Authorization for the therapeutic. The government could purchase up to 650,000 additional doses through the end of June 2021. The New England Journal of Medicine provided an interim analysis of the Phase 2 trial for the company’s monoclonal antibody treatment.

Regeneron announced positive prospective results from ongoing Phase 2/3 trials in the COVID-19 outpatient setting. The company reports it has shared results with the FDA, which is reviewing an Emergency Use Authorization for the REGN-COV2 low dose in adults with mild to moderate COVID-19, who are at high risk for poor outcomes.  

MANUFACTURING, DISTRIBUTION AND ADMINISTRATION:

The Centers for Medicare & Medicaid Services released a plan to remove regulatory barriers and ensure consistent coverage and payment for eventual COVID-19 vaccines. CMS released a set of toolkits for providers, states and insurers to help prepare to swiftly administer the vaccine when it is available. CMS is also taking action to increase reimbursement for any new COVID-19 treatments that are approved and authorized by the FDA. 

In support of OWS, the Administration is preparing to provide ancillary supply kits to help healthcare workers who will be administering COVID-19 vaccines. The U.S. Department of Health and Human Services (HHS) recently contracted with McKesson Corporation to produce, store and distribute these vaccine ancillary supply kits on behalf of the Strategic National Stockpile.

Maj. Gen. Chris Sharpsten, deputy director of Supply, Production and Distribution, detailed logistics plans in a column published by American Shipper. 

KEY ENGAGEMENTS:

Operation Warp Speed Chief Operating Officer Gen. Gus Perna and Vaccine Development Lead Dr. Matt Hepburn participated in a discussion Oct. 27 with The Heritage Foundation on “The Fight to get a COVID-19 Vaccine.” In case you missed it, the video is located here: 
https://www.defense.gov/Watch/Video/dvpcc/false/?dvpTag=warp%20speed#DVIDSVideoPlayer581

Deputy U.S. Secretary of Health and Human Services Eric Hargan and U.S. Surgeon General Jerome Adams visited University Hospitals (UH) of Cleveland to meet with their leadership for a discussion about the COVID-19 response and to provide an update on Operation Warp Speed. This week, UH announced they will take part in conducting Phase 3 clinical trials for AstraZeneca’s COVID—19 vaccine candidate. 

SENIOR LEADER QUOTES:

“It would just be shameful if we get a vaccine out to the American people - and people don’t take it because there is doubt or concern. What we stand behind is the safety and the efficacy of the vaccine that will be delivered to the American people.” ~GEN Gus Perna, Operation Warp Speed Chief Operating Officer

“While the pandemic stresses both people and systems, the expertise and technology tools provide a disciplined and deliberate approach to prioritize vaccine delivery and ease the burden of public health officials throughout the nation.” ~Deacon Maddox, Operation Warp Speed Chief of Plans, Operations and Analytics

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.