Friday, December 4, 2020

This Week in Operation Warp Speed - Dec. 4, 2020

 Dec. 4, 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:

Recommendations were adopted by the Centers for Disease Control and Prevention to vaccinate both health care personnel and residents of long-term care facilities during the initial phases of COVID-19 vaccine availability. The CDC’s Advisory Committee on Immunization Practices voted on the matter during an emergency meeting Dec. 1.  

Moderna applied for Emergency Use Authorization for its COVID-19 vaccine Monday, Nov. 30. The company also reported that complete data demonstrated the vaccine was 94.1% effective in a trial with more than 30,000 participants.

Pfizer’s COVID-19 vaccine achieved its first authorization on the world stage when the United Kingdom granted a temporary authorization for emergency use. Distribution across the U.K. will be prioritized according to the populations identified in guidance from the Joint Committee on Vaccination and Immunisation. 

THERAPEUTICS DEVELOPMENT:

The U.S. government purchased an additional 650,000 doses of bamlanivimab for delivery in December and January for treatment of non-hospitalized COVID-19 patients. The U.S. Department of Health and Human Services announced the contract with Eli Lilly and Company for its investigational monoclonal antibody therapeutic. The latest purchase brings the combined total to 950,000 doses.

MANUFACTURING, DISTRIBUTION AND ADMINISTRATION:

Pfizer published details about the specially designed, temperature-controlled shippers which can maintain its vaccine at recommended storage conditions (-70°C ±10°C) for extended periods of time without any additional equipment except dry ice. The company noted the shipper can maintain temperature for 10 days unopened, which allows for global distribution. Once open, a vaccination center may use the specially designed shippers as a temporary storage solution to maintain the recommended storage conditions up to 30 days, with re-icing every five days in accordance with the handling instructions. If requested with the order, dry ice and a dry ice supply kit will be provided by Operation Warp Speed through McKesson’s contract with UPS Health, within 24 hours of vaccine delivery to refill the thermal shipping container for the first re-ice. Subsequent dry ice refreshes will be required by the administration site

KEY ENGAGEMENTS/OUTREACH:

Operation Warp Speed co-leaders Dr. Moncef Slaoui and Gen. Gus Perna visited partner organizations including Catalent, AmerisourceBergen and a UPS freezer farm in Louisville, Kentucky, this week solidifying distribution solutions and the mission’s whole-of-America approach.

Brig. Gen. Michael “Mac” McCurry, Operation Warp Speed’s Director of Security and Assurance, conducted multiple engagements with interagency partners to enhance security of the “last tactical mile” of vaccine distribution.  McCurry previously updated the regional directors within the Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency to build a common perspective on vaccine distribution efforts. This week, McCurry was joined by the U.S. Marshal Service in addressing more than 1,500 state, local and municipal law enforcement agencies on a call hosted by the FBI Office of Partner Engagement.  Operation Warp Speed will continue to engage with law enforcement at all levels to facilitate vaccine distribution.

Marion Whicker, Operation Warp Speed’s Deputy Chief for Supply, Production and Distribution, provided a COVID-19 vaccine distribution update during a call with about 100 Tribal Leaders and Native American Community members.

Dr. Gary Disbrow, Deputy Assistant Secretary for Preparedness and Response and Director of the Biomedical Advanced Research and Development Authority (BARDA), spoke with members of the Vaccine Consultation Panel this week to provide an update on vaccine development and distribution. The panel includes broad and diverse healthcare professionals from national healthcare organizations, think tanks and tribal health officials.

Dr. Moncef Slaoui, Operation Warp Speed Chief Science Advisor, spoke on Washington Post Live about the science behind the COVID-19 vaccines.

Operation Warp Speed held its third weekly press briefing with plans for a fourth, tentatively set for Wednesday, Dec. 9. Credentialed media may call in to ask questions and the briefing is broadcast live on HHS and DOD sites.

SENIOR LEADER QUOTES:

“Don't allow one headline to determine what you're going to do. There is so much available information. I encourage everybody, as individuals, to inform themselves and then make the decision that is best for you and your family.” ~Operation Warp Speed Chief Operating Officer Gen. Gus Perna

“The data we are seeing from Pfizer and Moderna are clear, transparent and demonstrated safe and effective.” ~Dr. Moncef Slaoui, Operation Warp Speed Chief Science Advisor

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.

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