This Week in Operation Warp Speed - Nov. 27, 2020

 Nov. 27, 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: 

AstraZeneca announced early results of its vaccine candidate based on interim analysis of trials in the U.K. and Brazil. AstraZeneca is the third major drug company to report late-stage data for potential COVID-19 vaccines. 

While authorized COVID-19 vaccines are likely forthcoming, research continues and clinical trials are still enrolling volunteer participants. Clinical trials need people from all age groups, races, ethnicities, and backgrounds. Large studies especially need volunteers over age 65, people with underlying medical conditions and members of minority populations. 

THERAPEUTICS DEVELOPMENT:

Regeneron announced its monoclonal antibody cocktail - casirivimab and imdevimab administered together – received Emergency Use Authorization by the FDA. Operation Warp Speed began distribution of the new drug cocktail this week where it is needed most around the country. The treatment is authorized for mild to moderate COVID-19 in adults and pediatric patients at least 12 years old who weigh at least 40 kg or 88 pounds and are at high risk for progressing to severe COVID-19 or hospitalization.

Operation Warp Speed’s Deputy Lead for Therapeutics Col. Deydre Teyhen discusses the types of treatments, ongoing research and the continued importance of ongoing research to treat COVID-19 in a video interview. 

As COVID-19 infections spike nationwide, the demand for convalescent plasma is outpacing donations. Americans who have recovered from COVID-19 in the last three months can donate now. Go to your local blood collection center, American Red Cross or America’s Blood Centers or visit www.TheFightIsInUs.org to become a donor.

MANUFACTURING, DISTRIBUTION AND ADMINISTRATION:

Operation Warp Speed partnered with Pfizer and McKesson for a series of trial shipments to delivery locations to test processes and systems. While shipments did not include actual vaccines or ancillary kitting, they provided recipients a first look at the shipping processes and containers, as well as temperature monitors that will be used for distributing the Pfizer vaccine. The shipments will continue to go to state-identified locations, which include both public health departments and administration sites, such as hospitals. Additional rehearsals are scheduled in the coming weeks, which will expand shipments across nearly all jurisdictions. 
  
KEY ENGAGEMENTS/OUTREACH:

In a continued effort to synchronize efforts with states, HHS Secretary Alex Azar, and OWS leaders including Chief Operating Officer Gen. Gus Perna and Vaccine Development Lead Dr. Matt Hepburn, held a call with governors this week to discuss the distribution strategy with a highlight on data use agreements and provider enrollment. Perna emphasized that jurisdictions are empowered to decide how their vaccine allocations are distributed. Read more.

HHS held multiple calls with stakeholders and the media as HHS began the allocation and distribution of the Regeneron antibody cocktail therapeutic following the FDA granting an emergency use authorization.

Operation Warp Speed held its second weekly news briefing Tuesday. HHS Secretary Alex Azar, and OWS co-leaders, Dr. Moncef Slaoui and Gen. Gus Perna will continue to provide weekly updates. Credentialed media may call in to ask questions and the briefing is broadcast on HHS and DOD sites. Next week’s briefing is tentatively set for Wednesday. 

SENIOR LEADER QUOTES:

"It is a remarkable tribute to the Operation Warp Speed approach that we now have significant supplies of two FDA-authorized antibody products, designed to treat a novel virus, just 11 months after the virus was identified... We are going to defeat this virus. Thanks to Operation Warp Speed and the hard work for so many dedicated public servants and innovators, there is light at the end of the tunnel." ~U.S. Department of Health and Human Services Secretary Alex Azar

"I really hope and look forward to seeing that the level of negative perception of the vaccine decreases and peoples' acceptance increases. That is going to be critical to help us. Most people need to be immunized before we can go back to a normal life." ~Operation Warp Speed Chief Science Advisor Dr. Moncef Slaoui

"We are working on our distribution plans constantly. We work rehearsals of different scenarios to make sure we are capturing all the nuances of the delivery. Each and every week we get stronger. Each week we are one week closer to distributing the vaccine. We are one week closer to refining to the exactness that we need to have to do this - and I'm very confident in that process." ~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.