This Week in Operation Warp Speed - Dec. 18, 2020

 Dec. 18, 2020

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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: 

The U.S. Food and Drug Administration granted Emergency Use Authorization for the Pfizer COVID-19 vaccine Dec. 11. The Vaccines and Related Biological Products Advisory Committee convened Dec. 17 to review and evaluate data concerning the safety and effectiveness and appropriate use of the Moderna vaccine candidate. The committee overwhelmingly voted to recommend Emergency Use Authorization for the vaccine. The meeting was public and related material is available for independent and public review. A recommendation from the FDA is anticipated soon.

THERAPEUTICS DEVELOPMENT:

The U.S. Department of Health and Human Services continues to publish allocations for monoclonal antibody treatments. As of this week, more than 400,000 doses of monoclonal antibodies have been allocated to the states and territories. Facilities that have utilized their allocated monoclonal antibodies can request additional patient courses through their state/territory health department. If another healthcare facility does not accept or want its allocated amount, those patient courses can be reallocated by the state to other healthcare facilities within their jurisdiction.

MANUFACTURING, DISTRIBUTION AND ADMINISTRATION:

The Advisory Committee on Immunization Practices (ACIP) issued interim considerations recommending the Pfizer vaccine for people 16 years and older. The clinical considerations are informed by FDA-submitted data, best practice guidelines and expert opinion. 

Pfizer vaccine distribution began within 24 hours of the FDA granting Emergency Use Authorization. More than 1,500 individual shipments were delivered in the first week. Pfizer will continue to ship its product weekly, fulfilling orders among 64 jurisdictions and five federal entities. The Operation Warp Speed feature page includes updated photos. 

KEY ENGAGEMENTS/OUTREACH:

HHS Secretary Azar joined the National Ceremonial COVID-19 Vaccination Kick Off Event with Surgeon General Jerome Adams on Monday, December 14, and visited another hospital to see more frontline healthcare workers receive vaccinations on Wednesday, December 16. 

Operation Warp Speed Deputy Director of Supply, Production and Distribution Maj. Gen. Chris Sharpsten and Deputy Secretary of the Department of Health and Human Services Eric Hargan visited the Washington, D.C. Veterans Affairs Medical Center as the first doses of the Pfizer COVID-19 vaccine were administered to healthcare workers.   

Operation Warp Speed’s Supply, Production and Distribution Deputy Chief Marion Whicker and Manufacturing lead Col. Mike Post conducted quality checks at Pfizer’s plant in Kalamazoo, Michigan, observing the pick-and-pack process, and following a vaccine shipment from the plant to an administration site.
 
Operation Warp Speed will hold a press conference following any announcements granting EUA for the Moderna vaccine. Sign up for email updates.  

SENIOR LEADER QUOTES:

“It is nothing short of a medical miracle to have FDA authorization of a vaccine for COVID-19 just over 11 months since the virus was made known to the world. This vaccine, like any vaccine FDA potentially authorizes, has been through multiple stages of safety review, and it has shown extraordinary effectiveness in protecting people from the virus. Vaccines will help bring this pandemic to an end, which is all the more reason to double down on the public health measures we need to stay safe in the coming months.” ~ U.S. Secretary of Health and Human Services Alex Azar

“Fortunately for the nation, some of the greatest logistical minds in the country are working daily at Operation Warp Speed with one goal – delivering safe and effective vaccines to the American people,” ~ Operation Warp Speed Deputy Chief Supply, Production and Distribution Marion Whicker. 

“This is a monumental week for us all as we distribute the first millions of doses of vaccines to the American people.  But each week that follows, we will have more doses ready for allocation and distribution.  We are also posturing to phase in the Moderna vaccine, if they receive an EUA.  This is about a steady cadence of delivery to bring the American people to a place of confidence that vaccine is coming.  We want to ensure the vaccine arrives safely and that it can be effectively administered once arrival occurs.” ~Operation Warp Speed Chief Operating Officer GEN Gus Perna

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.