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.
